Shut Up and Sell - the Corporate Physician's New Motto?

Evidence has been seeping into public view about the extent physicians who sign up to <a href="http://hcrenewal.blogspot.com/search/label/corporate%20physician">take care of patients as corporate employees</a> give up their professionalism.<br /><br /><b>Shut Up...</b><br /><br />In April, 2013, Medscape published an <a href="http://www.medscape.com/viewarticle/781964">article</a> whose striking title was "<i>Can You Speak Out Without Getting Fired or Being Labeled a Troublemaker?</i>"  The answer was basically "no."<br /><br /><blockquote class="tr_bq">Physicians often see problems at their workplaces relating to patient quality of care, financial practices, mistreatment of staff, and other issues. But <i>as more doctors take jobs as employees of hospitals, medical groups, and other large organizations, they increasingly face the same dilemmas as millions of other working stiffs. When they come across actions or policies that they don't think are right, they have to decide whether it's worth it to speak out and get labeled as a troublemaker -- or perhaps even get fired.</i><br /><br /> Across the country, a growing number of physicians are indeed losing their jobs -- and often their hospital staff privileges -- after protesting employment conditions. Such complaints may involve patient quality-of-care problems, short staffing, misallocation of funds, improper financial incentives, fraud and abuse, discrimination, overuse or withholding of medical services, or other misconduct, say organized medical groups, employment attorneys, and physician recruiters.</blockquote><br />Of course, physicians swear oaths to put the needs of their individual patients first, and doing so within a large organization might well involve protesting conditions and practices that may affect the quality of care or even endanger patients.  But woe unto physicians who try to fulfill their professional responsibility when doing so goes up against the top executives to whom the physicians must now report.<br /><br /><blockquote class="tr_bq">'We were naive when we went into this,' says Maria Rivero, MD, who with her professional colleague and significant other Derek Kerr, MD, filed administrative complaints against their long-time hospital employer in 2010. 'We thought if we just brought it to people's attention, they would fix the problem and leave us alone. <i>But if you blow the whistle on high-level executives, you need to prepare to be harassed and lose your job</i>.'</blockquote><br />Even working within the system to fix problems can lead to big trouble,<br /><br /><br /><blockquote class="tr_bq">Still, the formal professional approach doesn't always work either. Cloyd Gatrell, MD, an emergency physician who was employed by EmCare, says that he and his wife Kathryn, a nurse, voiced concerns and presented data to executives at Carlisle Regional Medical Center in Pennsylvania in 2008 and 2009 on <i>what they saw as inadequate nurse staffing levels that endangered patients.</i><br /><br />After getting no results, Dr. Gatrell contacted the state health department, prompting a state inspection that found insufficient staffing. In 2010, he was <i>fired by EmCare at the request of the hospital,</i> according to his 2011 lawsuit against the hospital and EmCare claiming violation of whistleblower protection laws. <i>His wife was fired earlier, and she sued separately.</i> The hospital issued a statement declining comment on the litigation.<br /><br />'We're supposed to be advocates for patients, but <i>being employed puts us in a precarious position in taking a position on patient interests that's against what the hospital administration favors,</i>' says Dr. Gatrell, whose suit is in the discovery stage. 'I think a physician still has that responsibility.'</blockquote><br />Physicians who sign contracts with corporate employers, perhaps thinking that they will have less bureaucracy with which to contend and a more certain salary than they did in private practice, seem blissfully, or willfully unaware that those contracts may take away their ability to control their practices and stand up for their patients. <br /><br /><br /><blockquote class="tr_bq">Still, federal and state whistleblower laws only provide protection from retaliation for physicians in certain situations, such as those employed by public entities or those who complain about civil rights violations or Medicare and Medicaid fraud and abuse. Otherwise <i>doctors may have to rely on contract provisions or on state employment law, which may not offer much protection.</i><br /><br />[An anesthesiologist on the AMA Board of Trustees and his hospital system's board,] Dr. Annis says that the AMA's new statement of principles for physician employment -- which asserts that physicians should not be retaliated against by their employers for speaking out on patient care issues -- <i>provides support for doctors when they raise legitimate professional concerns with their employers.</i> He says it's best for physicians to work through their medical staff organization.<br /><br />But Dr. Gatrell points out that <i>the AMA statement explicitly accepts that physician employment contracts may allow hospitals to strip doctors of their medical staff membership and clinical privileges at the same time they are terminated,</i> known as a 'clean sweep' clause. 'If that's accepted by the AMA, the rest of the principles protecting physicians are meaningless," he argues. "<i>If physicians can be fired without cause and then automatically lose their medical staff membership and its due process protection, how many will dare be a patient advocate?</i>'<br /><br />Some experts <i>advise physicians not to sign employment agreements with such onerous provisions</i>. But others say that physicians often have little leverage to remove them. 'It's not an equal negotiating table,' says Dr. Gatrell, who's now working for a small urgent care practice.</blockquote><br />A May, 2013 <a href="http://www.medscape.com/viewarticle/782136">article</a> again in Medscape about the "4 Top Complaints of Employed Doctors," explained why physicians often see a lot they could or should protest to assure the quality of their patients' care,<br /><br /><blockquote class="tr_bq"> Some doctors report that hospital administrators treat them with a lack of respect. One female doctor said, also on condition of anonymity, that her biggest challenge on her job was '<i>how to handle nonphysician high school grads bossing you around when they function as your 'superiors' in your employer's organization. They manage their insecurities by bullying physicians and through passive aggressiveness, but always seem to gain the upper hand with those at the top</i>.'</blockquote><br />These are the sorts of brilliant administrators often hired by brilliant top executives, maybe at a cheap price to keep the bottom line and <a href="http://hcrenewal.blogspot.com/search/label/executive%20compensation">executive compensation</a> healthy..  Furthermore, given that as we have discussed, "<a href="http://hcrenewal.blogspot.com/search/label/financialization">financialization</a>" of hospital management often puts a bigger priority on short-term revenue than on quality care, as per one senior physician,<br /><br /><br /><blockquote class="tr_bq"> 'physicians are being increasingly targeted when they get in the way' of hospitals' agendas</blockquote><br />To make more money faster, many hospital systems now seem to want physicians to only make referrals for lucrative tests and treatments within the system, even if some patients might be better served elsewhere,<br /><br /><br /><blockquote class="tr_bq"><i>The AMA recently issued guidelines for physician employment stating that 'a physician's paramount responsibility is to his or her patients.'</i> Employers should not retaliate against physicians for asserting their patients' interests, according to these guidelines. <i>'In any situation where the economic or other interests of the employer are in conflict with patient welfare, patient welfare must take priority,'</i> the AMA says.<br /><br />The guidelines also <i>call for employers and employed physicians to disclose to patients any agreements or understandings they have that restrict, discourage, or encourage particular treatment or referral options.</i><br /><br />Nevertheless, <i>employed physicians are often expected to refer patients within their own groups and send tests to a hospital laboratory or imaging center</i>. Hospitals may tell employed surgeons which kinds of joint implants to use, and according to a New York Times article even whether to implant defibrillators in Medicaid patients. It's unclear how often any of this is disclosed to patients.<br /><br />'What we doctors say is that we're ethically bound to our patients because we took an oath, and that's what our license is based on,' says Linda Brodsky. 'But many hospitals say, '<i>No, you're employed here, and what we say goes.</i>'</blockquote><br />Note that so far there seems to be little evidence that the AMA guidelines about physician employment are being honored other than in the breach.  It is also disappointing that the leadership of the medical society that represents internists seems so unworried,<br /><br /><blockquote class="tr_bq"> <i>David L. Bronson, MD, President of the American College of Physicians, disputes Brodsky's assertion that hospitals tend to squelch doctors who criticize leadership for policies that they believe harm patient care. In fact, he says, healthcare organizations may identify outspoken physicians as potential leaders,</i> 'as long as they're collaborative and trying to solve problems, and not just be a thorn in the side of everyone they know. Organizations are looking for physician leaders, and physicians who can collaborate and not just be adversarial can go far inside organizations.'</blockquote><br />I would guess, having seen so many examples of <a href="http://hcrenewal.blogspot.com/search/label/generic%20management">generic management</a>, <a href="http://hcrenewal.blogspot.com/search/label/mission-hostile%20management">mission-hostile management</a>, management that seems more <a href="http://hcrenewal.blogspot.com/search/label/financialization">focused on the money than patient care,</a> and management that seems to be able to <a href="http://hcrenewal.blogspot.com/search/label/executive%20compensation">make itself rich</a> without evidence that it has done anything noteworthy to uphold hospitals' clinical missions, that hospital systems that promote physicians who are willing to speak out against hired executives are vanishingly rare.<br /><br /><b>And Sell</b><br /><br />In June, 2013, Beckers Hospital Review published an <a href="http://beckershospitalreview.com/hospital-physician-relationships/teaching-doctors-how-to-sell.html">article</a> suggesting that now hospitals are going beyond just pressuring employed physicians to refer potentially profitable patients within the system, and now are pressuring physicians to act as salespeople to their colleagues,<br /><br /><blockquote class="tr_bq"> A few hospitals are beginning to train their employed physicians to "sell" the hospital, which involves asking referring doctors in the community to send patients their way....  <i>the pressure to bring doctors into sales is mounting.</i></blockquote><br />The author, the former publisher of Modern Healthcare, made a remarkable argument based on a definition that seems wildly optimistic,<br /><br /><blockquote class="tr_bq"> Customer service lies at the core of salesmanship. The Business Dictionary defines salesmanship as satisfying customer needs through a sincere and mutually beneficial process aimed at a long-term relationship.</blockquote><br />Of course, skeptical physicians used to exposure to the sales tactics pharmaceutical and device companies use (look <a href="http://hcrenewal.blogspot.com/2007/05/fool-me-once-shame-on-you-fool-me-twice.html">here</a>, <a href="http://hcrenewal.blogspot.com/2008/03/what-drug-reps-really-care-about.html">here</a>, and <a href="http://hcrenewal.blogspot.com/2008/04/more-about-cynical-world-of-drug-reps.html">here</a>,  for example) might wonder why the author did not discuss such marketing tactics as the employment of half-truths and biased information, and the use of emotional appeals to trump reason and logic. <br /><br />That the author was serious was shown by his list of seven pointers for hospitals seeking to transform its employed physicians into marketers.<br /><br />Of course, physicians who are already "key opinion leaders" employed by drug and device companies, whose marketing executives may think. that "key opinion leaders were sales people for us," (see <a href="http://hcrenewal.blogspot.com/2008/06/key-opinion-leaders-were-sales-people.html">this post</a>), might not be fazed by now being asked to market their own hospital.  Never mind about Principle II of the <a href="http://www.ama-assn.org/ama/pub/physician-resources/medical-ethics/code-medical-ethics/principles-medical-ethics.page?">AMA Code of Ethics</a><br /><br /><blockquote class="tr_bq">II. A physician shall uphold the standards of professionalism, be honest in all professional interactions, and strive to report physicians deficient in character or competence, or engaging in fraud or deception, to appropriate entities.</blockquote><br /><br /><b>The Moral of the Story</b><br /><br />We have previously discussed various aspects of the travails of the brave new world of the <a href="http://hcrenewal.blogspot.com/search/label/corporate%20physician">corporate physician</a>.  Physicians and other health professionals who sign on as full-time employees of large corporate entities have to realize that they are now beholden to managers and executives who may be <a href="http://hcrenewal.blogspot.com/search/label/mission-hostile%20management">hostile to their professional values</a>, and who are subject to <a href="http://hcrenewal.blogspot.com/search/label/perverse%20incentives">perverse incentives</a> that support such hostility, including the potential for huge <a href="http://hcrenewal.blogspot.com/search/label/executive%20compensation">executive compensation</a>.  Physicians seem to be willing to sign <a href="http://hcrenewal.blogspot.com/search/label/contracts">contracts </a>that underline their new subservience to their corporate overlords, and likely trap them within <a href="http://hcrenewal.blogspot.com/search/label/confidentiality%20clause">confidentiality clauses</a> that make blowing the whistle likely to lead to extreme unpleasantness. <br /><br />It is disappointing that even medical societies that ostensibly support physicians' professional values have been afraid to warn against such employment, or do much to help physicians trapped within it.<br /><br />Physicians who go to work for big corporations have to realize that they may be forced to put corporate executives' vested interests ahead of their patients.  Patients whose physicians work for big corporations must realize that their health care will now be corporate, with all that entails. <br /><br />  As I have said before, we need to challenge the notion that direct health care should ever be provided, or that medicine ought to be practiced by for-profit corporations. I submit that we will not be able to have good quality, accessible health care at an affordable price until we restore physicians as independent, ethical health care professionals, and until we restore small, independent, community responsible, non-profit hospitals as the locus for inpatient care. <br /><br /><br />

Shut Up and Sell - the Corporate Physician's New Motto?

Evidence has been seeping into public view about the extent physicians who sign up to take care of patients as corporate employees give up their professionalism.Shut Up...In April, 2013, Medscape publ…

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Health Care Academics' Unrest and Bad Health Care Leadership?

Last month we <a href="http://hcrenewal.blogspot.com/2012/08/will-another-study-on-physician-burnout.html">discussed</a> a recent, large scale study of physician burnout, and wondered whether it would finally inspire some discourse about why physicians are really so upset.  In particular, we hypothesized,  based on some real, if limited data, that physician angst, dissatisfaction, burnout, etc may mainly be a response to the problems with leadership and governance of health care organization we post about on <a href="http://hcrenewal.blogspot.com/">Health Care Renewal.</a><br /><br />After that post, one of our scouts found a very interesting and relevant article from earlier this year which got little attention at the time, but deserves more.  [Pololi LH, Krupat E, Civian JT, Ash AS, Brennan RT. Why are a quarter of faculty considering leaving academic medicine? A study of their perceptions of institutional culture and intentions to leave at 26 representative U.S. medical schools. Acad Med. 2012; 87: 859-69. Link <a href="http://www.ncbi.nlm.nih.gov/pubmed/22622213">here</a>.]<br /><br /><b>Study Design</b><br /><br />This was a cross-sectional survey of faculty at 26 medical schools in the US, selected to be similar to the general population of medical schools in the country.  At each school, 150 faculty were randomly chosen stratified by sex and age, and then the sample was enriched to include additional minority faculty and women surgeons, for a total of 4578.<br /><br />The faculty were sent a multi item survey to assess their perception of the organizational culture of their institutions, and asked about their intentions to continue in or leave their current positions and academic medicine.  Responses to each survey item were allowed to be from 1 = strongly disagree, to 5 = strongly agree.  The items on the survey were combined into various scales.  A number of items on the survey seemed to be related to issues we frequently discuss on Health Care Renewal.  These items ended up in three different scales, entitled Relatedness/Inclusion, Values Alignment, and Ethical/Moral Distress.  The survey items are listed below, grouped by issue, with the scales into which they were combined noted.<br /><br />Issue: <a href="http://hcrenewal.blogspot.com/search/label/mission-hostile%20management">Mission-Hostile Leadership</a><br /><br />Administration only interested in me for revenue   (Reverse coded) (Values Alignment)<br />Institution committed to serving the public (VA)<br />Institution's actions well-aligned with stated values and mission (VA)<br />Institution puts own needs ahead of educational/clinical missions (RC) (VA)<br />My values well-aligned with school's (VA)<br />Institution awards excellence in clinical care (VA)<br />Institution does not value teaching (RC) (VA)<br />Have to compromise values to work here (Ethical/Moral Distress)<br /><br />Issue: <a href="http://hcrenewal.blogspot.com/search/label/deception">Deceptive</a>, Unethical Leadership<br /><br />Felt pressure to behave unethically (Ethical/Moral Distress)<br />Need to be deceitful in order to succeed (EMD)<br />Others have taken credit for my work (EMD)<br /><br />Issue: Generation of the <a href="http://hcrenewal.blogspot.com/search/label/anechoic%20effect">Anechoic Effect</a> by  Suppression of <a href="http://hcrenewal.blogspot.com/search/label/free%20speech">Free Speech</a>, <a href="http://hcrenewal.blogspot.com/search/label/academic%20freedom">Academic Freedom</a>, Dissent, <a href="http://hcrenewal.blogspot.com/search/label/whistle-blowers">Whistle-Blowing,</a><br /><br />Feel ignored/ invisible (RC) (Relatedness/Inclusion)<br />Hide what I think and feel (RC) (R/I)<br />Reluctant to express opinion/ fear negative consequences (RC) (R/I)<br /><br />So in summary, the survey contained quite a few questions about mission-hostile management, comprising nearly all of the Values Alignment scale, some questions about deceptive or unethical leadership, all in the Ethical/Moral Distress scale, and some about generation of the anechoic effect by suppression of free speech, academic freedom, dissent, and whistle-blowing, all in the Relatedness/Inclusion scale.<br /><br /><b>Results</b><br /><br />The response rate was 52% (N=2381.)<br /><br />Unfortunately, the article did not include the distributions of the responses to individual survey items, and only included the mean and standard error of the scale scores.  The values for the scales of most interest were:<br />Relatedness/Inclusion  3.56 SE= 0.022<br />Values Alignment  3.25 SE=0.028<br />Ethical/Moral Distress 2.36 SE=0.022<br /><br />Note that the article did not address the degree individual items, especially those listed above, contributed to variation in the scale scores. <br /><br /><br />A small majority of faculty indicated their intentions to stay at their institutions (57%).  Of the remainder, 14% were considering leaving their school due to dissatisfaction, and another 21% were considering leaving academic medicine due to dissatisfaction.  The remainder were considering leaving due to personal/ family reasons or to retire.<br /><br />The authors did complex multinomial logit modeling to assess the relationships among the various scales, demographic factors, and intention to leave.  Most relevant to us, Relatedness/Inclusion was significantly related to intention to leave the institution due to dissatisfaction (Coefficient -0.69, p lt 0.001, OR =0.50), as was Values Alignment (-0.39, p=0.04, OR=0.68), but not Ethical/ Moral Distress.  Furthermore, Relatedness/Inclusion was related to intention to leave academic medicine due to dissatisfaction (-0.48, p lt 0.001, 0.62), as was Ethical/Moral Distress (0.60, p lt 0.001, OR =1.82). The article did not address whether individual survey items, including those of most interest listed above, were related to intention to leave.  The article also did not address whether responses to the survey or intention to leave varied across faculty characteristics, medical school characteristics, or individual medical schools.  <br /><br /><b>Summary and Comments</b><br /><br />This very large survey of faculty from multiple US medical schools showed that more than one-third were considering leaving their institutions or academic medicine due to dissatisfaction, indicating a striking prevalence of faculty distress.  Their responses to questions about perceived organizational cultural and leadership problems, including those possibly related to leadership's perceived hostility to the mission, leadership's perceived dishonesty or unethical behavior, and leadership's suppression of dissent, free speech, academic freedom, and whistle-blowing were related to their intentions to leave due to dissatisfaction.<br /><br />These results suggest the hypothesis that much of faculty angst may be due to the sorts of problems with leadership and hence organizational culture that we discuss on Health Care Renewal.  Since this was a cross-sectional survey, it certainly does not offer scientific proof of this hypothesis.  Note that there is other evidence from numerous cases discussed in Health Care Renewal, qualitative studies and our much smaller study published only in abstract form that also supports this hypothesis (look <a href="http://hcrenewal.blogspot.com/2012/08/will-another-study-on-physician-burnout.html">here</a>).  <br /><br />One part of the author's discussion of their findings was particularly relevant:<br /><br /><br /><blockquote class="tr_bq">Our findings are congruent with metaanalyses of 25 years of organizational justice research outside medicine. These studies suggest that employee perceptions of organizational justice and an ethical climate are related to increased job satisfaction, trust in leadership, enhanced performance, commitment to one’s employer, and reduced turnover.<br /><br /> The scale of ethical/moral distress (see Table 1) reflects<i> reactions to the prevailing norms and possible erosion of professionalism and increased organizational self-interest</i>. There is a growing belief that organizations influence and are responsible for the ethical or unethical behaviors of their employees.To our knowledge, faculty perceptions of 'moral atmosphere' and 'just community' embedded in our survey have not been previously investigated in academic medicine, even though the ethical concepts of professionalism and justice can be used to guide the pursuit of excellence in the missions of medical schools. Several scholars have called for academic medicine to attend to its social justice and moral mission. Faculty perceptions<br />of organizational justice are pivotal to the critical issue of professionalism in medicine. The ethical/moral distress scale in the survey reported here included items such as 'the culture of my institution discourages altruism' and 'I find working here to be dehumanizing.' (See Table 1 for other items in this scale.) In that ethical/moral distress was more strongly related to intent to leave academic medicine entirely than intent to leave one’s own institution, these negative feelings among faculty must be particularly disheartening to them and may color major career decisions.</blockquote>I believe that the study by Pololi et al adds to the evidence that physician distress is a symptom of a dysfunctional system in which major health care organizations have been taken over by leaders more devoted to self-interest and short-term revenue than the values prized by health care professionals and academics.  This applies obviously to academic medical institutions, but also to other organizations that might have been expected to defend such professional and academic values, such as professional associations, accrediting organizations, and health care foundations.  As we <a href="http://hcrenewal.blogspot.com/2012/08/will-another-study-on-physician-burnout.html">said before</a>, 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.   <br /><br /><!--0-->

Health Care Academics' Unrest and Bad Health Care Leadership?

Last month we discussed a recent, large scale study of physician burnout, and wondered whether it would finally inspire some discourse about why physicians are really so upset.  In particular, we hypo…

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BLOGSCAN: Key Opinion Leader Admits to being a Marketer

<span style="color: #38761d;">Without any notable shame, and </span><a href="http://www.kevinmd.com/blog/2012/08/doctors-key-opinion-leader-social-media.html"><span style="color: #38761d;">as a guest blogger</span></a><span style="color: #38761d;"> on KevinMd.  The post was about other physicians can become big-time KOLs by using social media, and refers to </span><a href="http://www.medcrunch.net/pharma-marketing-101-two-things-pharma-needs-from-you/"><span style="color: #38761d;">another post</span></a><span style="color: #38761d;"> 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.</span><br /><br /><span style="color: #38761d;">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. </span> 

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 media, and refers to another post which indicates that pharm…

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Cart Before the Horse, Part 3: AHRQ's "Health IT Hazard Manager"

<div style="text-align: center;"><span style="font-size: x-small;">(Addendum: the AHRQ hazards manager taxonomy report can see seen at <a href="http://healthit.ahrq.gov/sites/default/files/docs/citation/HealthITHazardManagerFinalReport.pdf.">http://healthit.ahrq.gov/sites/default/files/docs/citation/HealthITHazardManagerFinalReport.pdf.</a>)</span></div><br />In a July 2010 post "<a href="http://hcrenewal.blogspot.com/2010/07/meaningful-use-final-rule-have.html" target="_blank">Meaningful Use Final Rule: Have the Administration and ONC Put the Cart Before the Horse on Health IT?</a>" and an Oct . 2010 post "<a href="http://hcrenewal.blogspot.com/2010/10/cart-before-horse-again-institute-of.html" target="_blank">Cart before the horse, again: IOM to study HIT patient safety for ONC; should HITECH be repealed?</a>" I wrote about the postmodern "ready, fire, aim" approach to health IT:<br /><br />In the first post, I wrote:<br /><br /><blockquote class="tr_bq">... These "usability" problems require long term solutions. There are no quick fix, plug and play solutions. Years of research are needed, and years of system migrations as well for existing installations.<br /><br /><span style="color: red; font-style: italic; font-weight: bold;">Yet we now have an HHS Final Rule on "meaningful use" regarding experimental, unregulated medical devices the industry itself admits have major usability problems, along with a growing body of literature on the </span><span style="font-weight: bold;"><span style="font-style: italic;"><a href="http://www.ischool.drexel.edu/faculty/ssilverstein/cases/?loc=cases&sloc=2009">risks entailed</a>.</span></span><br /><div dir="ltr"></div><div dir="ltr"><span style="font-size: 0pt;"><span style="font-size: 0pt;"><span style="font-size: 100%;">For crying out loud, talk about putting the cart before the horse</span><span style="font-style: italic;"><span style="font-weight: bold;"><span style="font-size: 100%;">...</span> </span></span></span></span></div><br /><div dir="ltr" style="text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEhbxjl-AlGATfarPayjaUYkCOG4sUrulp4D88Nk7_z-eEbaWRl-xi1g0neGKWDhEL1w6-_-FCu4iBoJx9AUlU-bccaAmEcMfmGI1uoa4gTohjch5gzcx5tA9Ru-uMB0Mip6NE0PuUsfDXJ5/s1600/horse-cart.jpg"><img alt="" border="0" id="BLOGGER_PHOTO_ID_5493460657310735298" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEhbxjl-AlGATfarPayjaUYkCOG4sUrulp4D88Nk7_z-eEbaWRl-xi1g0neGKWDhEL1w6-_-FCu4iBoJx9AUlU-bccaAmEcMfmGI1uoa4gTohjch5gzcx5tA9Ru-uMB0Mip6NE0PuUsfDXJ5/s320/horse-cart.jpg" style="cursor: pointer; display: block; height: 168px; margin: 0px auto 10px; text-align: center; width: 253px;" /></a><span style="font-family: arial; font-size: 85%; font-style: italic;">Something's very wrong here...</span></div><span style="font-weight: bold;"><span style="font-style: italic;"></span></span><br /><span style="font-weight: bold;"><span style="font-style: italic;"></span></span>However, this situation is anything but humorous. <span style="font-weight: bold;"><span style="font-style: italic;"><span style="font-weight: bold;"><span style="font-style: italic;"></span></span></span></span><br /><span style="font-weight: bold;"><span style="font-style: italic;"><span style="font-weight: bold;"><span style="font-style: italic;"></span></span></span></span><br /><span style="font-weight: bold;"><span style="font-style: italic;"><span style="font-weight: bold;"><span style="font-style: italic;">How more "cart before the horse" can government get?</span></span></span></span></blockquote><br />In the second post, I wrote:<br /><br /><blockquote class="tr_bq">... So, in the midst of a National Program for Health IT in the United States (NPfIT in the U.S.), <span style="font-weight: bold;">with tens of billions of dollars earmarked for health IT already</span> (money we don't really have, but it can be printed quickly, or borrowed from China) the IOM is going to study health IT safety, prevention of health IT-related errors, etc. ... only <span style="font-weight: bold;">now?</span></blockquote><br /><b><i>Here we go yet again.</i></b><br /><br />The problem with the AHRQ (<a href="http://www.ahrq.gov/" target="_blank">Agency for Healthcare Research and Quality</a>, a division of HHS) announcement below of a webinar about a new tool for identifying, categorizing, and resolving health IT hazards, as I have written before, is putting the "cart before the horse" and throwing medical ethics to the wind.<br /><br />If we've just developed a tool "for identifying, categorizing, and resolving health IT hazards", the magnitude of which others such as IOM admit are unknown to our detriment (<span style="font-style: italic;">e.g., <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/Patient%20Safety%20and%20Health%20IT%20prepub.pdf">Health IT and Patient Safety: Building Safer Systems for Better Care</a>, pg. S-2)</span>, then health IT is, it follows, an experimental technology.<br /><br />If it is an experimental technology, AHRQ and others in HHS should probably be<b> raising the issue of a slow down or moratorium on widespread rollout under HITECH</b> until risk management and remediation is better understood.  At the very least they should be calling for patient informed consent that a device that will largely regulate their care is experimental, that a competency "gap" exists among healthcare practitioners within the "health IT environment" (meaning patients are at risk), and that patients should be offered the opportunity for informed consent with opt-out provisions.  The principals should not just be announcing a webinar:<br /><br /><blockquote class="tr_bq">Sent: Tuesday, June 05, 2012 12:23 PM<br />To: OHITQUSERS@LIST.NIH.GOV<br />Subject: Register Now! AHRQ Health IT Webinar "Purpose and Demonstration of the Health IT Hazard Manager and Next Steps" June 11, 2:30 PM ET<br /><br />Agency for Healthcare Research and Quality<br /><br />Purpose and Demonstration of the Health IT Hazard Manager and Next Steps<br /><br />June 11, 2012 — 2:30-4 p.m., EST<br /><br />The Agency for Healthcare Research and Quality (AHRQ) has <b>identified a gap in a health care/public health practitioner’s competency within the health IT environment</b>. This webinar is designed to increase practitioners’ competencies in several areas: improving health care decision making; supporting patient-centered care; and <b>enhancing the quality and safety of medication management by improving the ability to identify, categorize, and resolve health IT hazards. </b><br /><br />The Webinar will explore the <b>Health IT Hazard Manager—a tool for identifying, categorizing, and resolving health IT hazards</b>. When implemented, the tool allows health care organizations and software vendors alike to learn about potential hazards and work to resolve them, including the use of data <b>to communicate potential and actual adverse effects. </b>The session will discuss how the Health IT Hazard Manager was tested and refined as well as strategies and implications for deploying it. The target audience includes AHRQ grantees/researchers; health care providers, including physicians and nurses; consumers/patients; and health care policymakers.<br /><br />... Webinar learning objectives include:<br /><br />1. Describe the rationale for developing the Health IT Hazard Manager and how it evolved through alpha and beta testing.<br />2. Explain the process for identifying and categorizing health IT-related hazards. <br />3. Demonstrate how the Health IT Hazard Manager <b>would be used</b> <i style="color: red;"><b>[i.e., it's not yet in use, despite mandates for HIT rollout with penalties for non-adopters - ed.]</b></i> within and across care delivery organizations and health IT software vendors.<br />4. Discuss policy and process implications for deploying the Health IT Hazard Manager via different organizations (i.e., AHRQ; Office of the National Coordinator for Health IT; Patient Safety Organization(s); Accrediting bodies; IT entities). </blockquote><br />In effect, HHS seems to be saying "we're working on the HIT risk problem, but roll it out anyway; if you get harmed or killed, tough luck."  This seems a form of negligence.<br /><br />Have we thrown out all we know about <a href="http://grants.nih.gov/grants/policy/hs/ethical_guidelines.htm" target="_blank">medical research and human subjects protections</a> in face of the magical powers and profits of computers in medicine?<br /><br />-- SS

Cart Before the Horse, Part 3: AHRQ's "Health IT Hazard Manager"

(Addendum: the AHRQ hazards manager taxonomy report can see seen at http://healthit.ahrq.gov/sites/default/files/docs/citation/HealthITHazardManagerFinalReport.pdf.)In a July 2010 post "Meaningful Use…

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Courses and Conferences on Health Care Ethics, Corruption, Marketing

Two courses and two conferences of interest to Health Care Renewal readers are coming soon.<br /><br /><strong>Short Course: Why Do Physicians Not Make Rational, Evidence Based Decisions?</strong><br /><br /><br />A full-day course at the <a href="http://smdm2012.com/">14th Biennial European Meeting of the Society for Medical Decision Making</a> on Sunday, 10 June, 2012 in Oslo, Norway. Taught by bloggers Dr Roy Poses and Dr Wally Smith, the course will address both the effects of cognitive psychological limitations and of external influences by vested interests leading to less than optimal decisions.<br /><br />A full description of the course is <a href="http://smdm2012.com/course_proposals">here</a>. <br />  <br /><strong>Online Course: Corruption in the Health Sector</strong><br /><br />A 30 hour online course given by the <a href="http://www.u4.no/">U4 Anti-Corruption Resource Center</a>, offered in collaboration with the Boston University School of Public Health.  The course is "on causes and consequences of corruption in the health sector; vulnerabilities in drug supply systems, informal payments, and strategies to minimise the problems."  <br /><br />A full description is <a href="http://www.u4.no/training/online-training/corruption-in-the-health-sector">here</a>.  <br /><br /><strong>Conference: Deception, Incentives and Behavior</strong><br /><br />A two-day conference given by the Rady School of Management, University of California - San Diego, on 20-21 April, 2012 in San Diego, California, USA.  This will be a multidisciplinary meeting to facilitate "research of deception and related unethical behavior in the fields of economics and psychology/judgment and decision making (JDM)."<br /><br />The conference web-site is <a href="http://rady.ucsd.edu/dib-symposium">here</a>.  <br /><br /><strong>Conference: Third Annual PharmedOut Conference on How Patient Harms May Result from Industry Promotion</strong><br /><br />A two-day conference given by <a href="http://www.pharmedout.org/">PharmedOut</a> at Georgetown University in Washington, DC on <br />14-15 June, 2012.  The conference will focus on the how industry promotion may lead to under-use, over-use, or mis-use of drugs and devices.<br /><br />The conference web-site is <a href="http://pharmedout.org/2012Conference.htm">here</a>.

Courses and Conferences on Health Care Ethics, Corruption, Marketing

Two courses and two conferences of interest to Health Care Renewal readers are coming soon.Short Course: Why Do Physicians Not Make Rational, Evidence Based Decisions?A full-day course at the 14th Bie…

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The First State's Deadest (Deadliest?) Duck - Is This ED EHR Harming or Killing Anyone in NSW?

Nobody seems to be asking this simple question:<br /><br style="color: rgb(255, 0, 0);"><span style="font-weight: bold; color: rgb(255, 0, 0);">Is This ED EHR harming or killing anyone in NSW?</span><br /><br />It cannot be "<a href="http://hcrenewal.blogspot.com/2012/01/another-our-crappy-computers-screwed-up.html">not compromising patient care</a>" <span style="font-style: italic;">on first principles.</span><br /><br />This type of practical and ethical question seems to never get asked, while what appears to be a tit-for-tat political kerfuffle goes on.<br /><br />This is due in part to the baffling special accommodations afforded worldwide towards an extremely profitable but potentially extremely dangerous medical device, as well as due to the issues I described in my post about <span style="font-weight: bold;">reckless technophilia</span> and the accompanying <span>disregard for rights of others</span> <a href="http://hcrenewal.blogspot.com/2012/02/health-it-ddulites-and-disregard-for.html">here</a>.<br /><br /><h2 style="font-weight: normal;"></h2><blockquote><h2 style="font-weight: bold;"><span style="font-size:100%;">The Register</span></h2><h2 style="font-weight: bold;"><span style="font-size:100%;"><a href="http://www.theregister.co.uk/2012/02/12/firstnet_flops_again/">NSW government accused of dodgy software cover-up</a></span></h2> <p style="font-weight: bold;" class="standfirst">FirstNet: the First State's deadest duck <span style="font-weight: bold; font-style: italic; color: rgb(255, 0, 0);"> [or "deadliest duck?" - ed.]</span><br /></p> <p class="byline">By <a title="Send email to the author" href="http://forms.theregister.co.uk/mail_author/?story_url=/2012/02/12/firstnet_flops_again/">Richard Chirgwin</a></p> <p class="dateline">Posted in <a href="http://www.blogger.com/business/">Business</a>, <a title="More stories published on this date" href="http://www.blogger.com/2012/02/12/">12th February 2012 22:00 GMT</a></p> <div id="body"> <p>The buggy FirstNet emergency department software has become the subject of a <span style="font-weight: bold;">political argument</span> in NSW. <span style="font-weight: bold; font-style: italic; color: rgb(255, 0, 0);"> [What about a clinical and ethical argument? - ed.]</span><br /></p> <p>In one of those paradoxes of democracy, an opposition which, in government, was responsible for a now-despised implementation is now using the IT project as a stick to beat a government which was in opposition when the system was chosen.</p> <p>Last week, the <i>Sydney Morning Herald</i> obtained a report into the system by Deloitte, under a freedom of information request. It <a href="http://www.smh.com.au/it-pro/government-it/hospital-computer-system-found-lacking-20120210-1so7j.html">says</a> [1] the Deloitte report criticises FirstNet because it is:</p> <p>- Is chronically under-funded;</p> <p>- Produces inadequate records;</p> <p>- Was unreliable in delivering messages, and did not provide alerts when messages failed to reach their destination; and</p> <p>- Demanded excessive amounts of screen time from clinicians.</p> <p style="font-weight: bold; font-style: italic; color: rgb(255, 0, 0);">[But is it harming or killing anyone? Are those statistics being collected robustly and scientifically, or are self-serving statements by hospital executives that "care was never compromised, and nobody was injured" simply being taken at face value?<br /></p><p style="font-weight: bold; font-style: italic; color: rgb(255, 0, 0);">Further, the obvious increased risk of harm due to deficient IT currently in operation is being cavalierly ignored. This is alien to medicine, and could cause career termination or land people in jail in fields such as aviation if planes with known potentially-dangerous avionics software or other defects are kept flying - ed.]</p><p>In spite of its inadequacies, the Deloitte report seen by the <i>SMH</i> said the $AU100-plus million Cerner FirstNet system is <span style="font-weight: bold;">too entrenched to abandon.</span></p> <p><span style="font-weight: bold; font-style: italic; color: rgb(255, 0, 0);">[I'm quite sure dead or injured patents would not appreciate that explanation - ed.]</span><br /></p><p>Over the weekend, opposition health spokesperson Dr Andrew McDonald issued a statement accusing NSW health minister Jillian Skinner of covering up the report since August 2011.</p> <p>However, other published studies into FirstNet, such as a detailed investigation by Sydney University e-health expert Professor Jon Patrick <a href="http://sydney.edu.au/engineering/it/%7Ehitru/index.php?option=com_content&task=view&id=91&Itemid=146">here</a> [2], identify problems similar to those apparently cited by Deloitte. This study was undertaken to investigate issues with FirstNet outlined in November 2008 in a special commission of review, conducted by Peter Garling,</p> <p>While noting that FirstNet represented an improvement on some aspects of its predecessor, Garling said<span style="font-weight: bold;"> the system attracted complaints that it was unfriendly to users, that the vendor and Health Department did not respond to complaints about the software, and that emergency department patients were being held in triage for excessive times, while clinical staff fought with the software</span>.</p> <p><span style="font-weight: bold; font-style: italic; color: rgb(255, 0, 0);">[What sane patient would want such a system used in their care? - ed.]</span><br /></p><p>Deloitte, on the other hand, was far less critical of FirstNet in 2008, when in a <a href="http://www.health.nsw.gov.au/resources/news/pdf/triage-bench-rev.pdf">review</a> [3] of triage benchmarks it managed to turn up a downtime issue, difficulty in uploading triage data to the Health Department, and the identification of the wrong doctor or nurse with a patient’s records.<br /></p></div> <div id="pf-links"> <h3>Links</h3> <ol><li><a href="http://www.smh.com.au/it-pro/government-it/hospital-computer-system-found-lacking-20120210-1so7j.html">http://www.smh.com.au/it-pro/government-it/hospital-computer-system-found-lacking-20120210-1so7j.html</a></li><li><a href="http://sydney.edu.au/engineering/it/%7Ehitru/index.php?option=com_content&task=view&id=91&Itemid=146">http://sydney.edu.au/engineering/it/~hitru/index.php?option=com_content&task=view&id=91&Itemid=146</a></li><li><a href="http://www.health.nsw.gov.au/resources/news/pdf/triage-bench-rev.pdf">http://www.health.nsw.gov.au/resources/news/pdf/triage-bench-rev.pdf</a></li></ol></div></blockquote><br />Stunning.<br /><br />On the argument that "the older system was worse", or the corollary argument that "paper harms and kills too", I suggest anyone who proffers that argument should realize <a href="http://en.wikipedia.org/wiki/Rofecoxib">VIOXX (refoxicib)</a> <span class="st"><em></em></span>helped far more people than it harmed in reducing pain while sparing them from GI side effects compared to "older" drugs.<br /><br /><a href="http://www.npr.org/templates/story/story.php?storyId=4054991">Over 84 million people</a> were prescribed rofecoxib at some time and only mere thousands, or tens of thousands, are presumed to have been injured or died.<br /><br />Therefore, following their own illogic and ethical (dis)orientation, they should put all their family members on the drug - especially the elderly with cardiovascular disease - to benefit from pain relief and VIOXX's other miraculous effect, <a href="http://www.sciencedaily.com/releases/2006/08/060830215121.htm">suppression of colonic polyps</a>.<br /><br />Surely those benefits outweigh the risks, and therefore it is ethical to do so, no?<br /><br />Of course not.<br /><br />Health IT, as I've written in many posts on this blog, has a magnitude of harms that is admittedly unknown. Health IT needs significant further study and improvement, certainly before national rollouts, and before decisions are made that particular systems are "<span>too entrenched to abandon."</span><br /><br />-- SS

The First State's Deadest (Deadliest?) Duck - Is This ED EHR Harming or Killing Anyone in NSW?

Nobody seems to be asking this simple question:Is This ED EHR harming or killing anyone in NSW?It cannot be "not compromising patient care" on first principles.This type of practical and ethical quest…

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A Critical Review of a Critical Review of e-Prescribing ... Or Is It CPOE?

In PLoS medicine, the following article was recently published by researchers at the University of New South Wales in Australia:<br /><span style="font-weight: bold;"><br /></span><blockquote>Westbrook JI, Reckmann M, Li L, Runciman WB, Burke R, et al. (2012) Effects of Two <a href="http://www.plosmedicine.org/article/info%3Adoi%2F10.1371%2Fjournal.pmed.1001164"><span style="font-weight: bold;">Commercial Electronic Prescribing Systems on Prescribing Error Rates in Hospital In-Patients: A Before and After Study</span></a>. PLoS Med 9(1): e1001164. doi:10.1371/journal.pmed.1001164</blockquote><br /><br />The section I find most interesting is this:<br /><br /><blockquote>We conducted a before and after study involving medication chart audit of 3,291 admissions (1,923 at baseline and 1,368 post e-prescribing system) <span style="font-weight: bold;">at two Australian teaching hospitals. </span>In Hospital A, the Cerner Millennium e-prescribing system was implemented on one ward, and three wards, which did not receive the e-prescribing system, acted as controls. In Hospital B, the iSoft MedChart system was implemented on two wards and <span style="font-weight: bold;">we compared before and after error rates.</span> Procedural (e.g., unclear and incomplete prescribing orders) and clinical (e.g., wrong dose, wrong drug) errors were identified. <span style="font-weight: bold;">Prescribing error rates per admission and per 100 patient days; rates of serious errors (5-point severity scale, those ≥3 were categorised as serious) by hospital and study period; and rates and categories of postintervention “system-related” errors </span>(where system functionality or design contributed to the error) were calculated.</blockquote><br />Here is my major issue:<br /><br />Unless I am misreading, this research took place <span style="font-weight: bold;">in hospitals</span> (i.e., "wards" in hospitals) and does not seem to focus (if even refer to) <span style="font-style: italic;">discharge prescriptions</span>.<br /><br />I think it would be reasonable to say that what are referred to as "e-Prescribing" systems are systems used at <span style="font-style: italic;">discharge</span>, or in outpatient clinic/offices to <span style="font-weight: bold;">communicate with a pharmacy selling commercially and not involved in inpatient care.</span><br /><br />From the U.S. Centers for Medicare and Medicaid Services (CMS), for example:<br /><br /><b></b><blockquote><a href="https://www.cms.gov/EPrescribing/"><b>E-Prescribing</b></a> - a prescriber's ability to electronically send an accurate, error-free and understandable prescription <span style="font-weight: bold; font-style: italic; color: rgb(255, 0, 0);">[theoretically, that is - ed.]</span> directly to a pharmacy from the point-of-care<br /></blockquote><br />I therefore think the terminology used in the article as to the type of system studied is not well chosen. I believe it could mislead readers not experienced with the various 'species' of health IT.<br /><br />This study appears to be of an inpatient <a href="http://en.wikipedia.org/wiki/Computerized_physician_order_entry">Computerized Practitioner Order Entry</a> (CPOE) system, not e-Prescribing.<br /><br />Terminology matters. For example, in the U.S. the HHS term "certification" is misleading purchasers about the quality, safety and efficacy of health IT. HIT certification as it exists today (granted via <a href="http://healthit.hhs.gov/portal/server.pt?open=512&mode=2&objID=3120">ONC-Authorized Testing and Certification Bodies</a>) is merely a features-and-functionality "certification of presence." It is not like an Underwriter Labs (UL) safety certification of an electrical appliance that the appliance will not electrocute you.<br /><br />(This is not to mention the irony that one major aspect of Medical Informatics research is to <span style="font-weight: bold;">remove ambiguity from medical terminology</span>, e.g., via the decades-old <a href="http://www.nlm.nih.gov/research/umls/">Unified Medical Language System</a> project or UMLS. However, as I've often written, the HIT domain lacks the rigor of medical science itself.)<br /><br />I note that if this were a grant proposal for studying e-Prescribing, I would return it with a low ranking and a reviewer comment that the study proposed is actually of CPOE.<br /><br />That said, looking at the nature of this study:<br /><br />The conclusion of this paper was as follows. I am omitting some of the actual numbers such as confidence intervals for clarity; see the full article available freely at above link for that data:<br /><br /><blockquote>Use of an e-prescribing system was associated with a statistically significant reduction in error rates in all three intervention wards. The use of the system resulted in a decline in errors at Hospital A from 6.25 per admission to 2.12 and at Hospital B from 3.62 to 1.46. This decrease was driven by a large reduction in unclear, illegal, and incomplete orders. The Hospital A control wards experienced no significant change. There was limited change in clinical error rates, but serious errors decreased by 44% across the intervention wards compared to the control wards. <span style="font-weight: bold;"><br /><br />Both hospitals experienced system-related errors (0.73 and 0.51 per admission), which accounted for 35% of postsystem errors in the intervention wards; each system was associated with different types of system-related errors.</span></blockquote><br />I note that "system related errors" were defined as errors "where system functionality or design contributed to the error." In other words,<span style="font-style: italic;"> these were unintended adverse events as a result of the technology itself.</span><br /><br />The authors conclude:<br /><br /><blockquote>Implementation of these commercial e-prescribing systems resulted in statistically significant reductions in prescribing error rates. Reductions in clinical errors were limited in the absence of substantial decision support, but a statistically significant decline in serious errors was observed. </blockquote><br />The authors do acknowledge some limitations of their (CPOE) study:<br /><br /><blockquote>Limitations included a <span style="font-weight: bold;">lack of control wards at Hospital B</span> and an <span style="font-weight: bold;">inability to randomize wards </span>to the intervention.</blockquote><br />Thus, this was mainly a pre-post observational study, certainly not a randomized controlled clinical trial.<br /><br />Not apparently accounted for, either, were potential confounding variables related to the CPOE implementation process (as in <a href="http://www.blogger.com/comment.g?blogID=9551150&postID=5650114337316261515&isPopup=true">this comment thread</a>).<br /><br />In that thread I wrote to a commenter<span style="font-weight: bold; font-style: italic;"> </span><span style="font-style: italic;"><span style="color: rgb(255, 0, 0);">[</span></span><a style="font-style: italic;" href="http://hcrenewal.blogspot.com/2010/01/more-on-perversity-in-hit-world.html">a heckler, actually</a><span style="font-style: italic;">, <span style="color: rgb(51, 0, 51);">apparently an employee of HIT company</span> </span><a style="font-style: italic;" href="http://www.meditech.com/">Meditech</a><span style="font-style: italic;"><span style="color: rgb(255, 0, 0);">]</span></span> <span style="color: rgb(51, 0, 51);">with a stated absolute faith in pre-post studies that:</span><br /><br /><blockquote>... A common scenario in HIT implementation is to first do a process improvement analysis to improve processes prior to IT implementation, on the simple calculus that "bad processes will only run faster under automation." There are many other changes that occur pre- and during implementation, such as training, raising the awareness of medical errors, hiring of new support staff, etc.<br /><br />There can easily be scenarios (I've seen them) where poorly done HIT's distracting effects on clinicians is moderated to some extent by process and other improvements. Such factors need to be analyzed quite carefully, datasets and endpoints developed, and data carefully collected; the study design and preparation needs to occur before the study even begins. Larger sample sizes will not eliminate the possible confounding effects of these factors and many more not listed here.<br /><br />The belief that simple A/B pre-post test that look at error rate comparisons are adequate is seductive, but it is wrong. </blockquote><br />Stated simply, in pre-post trials the results may be affected by changes that occur <span style="font-style: italic;">other than the intervention</span>. HIT implementation does not involve just putting computers on desks, as I point out above.<br /><br />In other words, the study was essentially <a href="http://hcrenewal.blogspot.com/2011/08/from-senior-clinician-down-under.html">anecdotal</a>.<br /><br />The lack of RCT's in health IT are, in general, one violation of traditional medical research methodologies for studying medical devices. That issue is not limited to this article, of course.<br /><br />Next, on ethics:<br /><br />CPOE has already been demonstrated <span style="font-style: italic;">in situ</span> to create all sorts of new potential complications, such in at Koppel et al.'s "<a href="http://jama.ama-assn.org/content/293/10/1197.abstract">Role of Computerized Physician Order Entry Systems in Facilitating Medication Errors</a>", <cite><abbr title="JAMA: The Journal of the American Medical Association" class="slug-jnl-abbrev">JAMA.</abbr> <span class="slug-date-vip"> <span class="slug-pub-date"> </span></span></cite>2005;293(10):1197-1203. doi: 10.1001/jama.293.10.1197 that concluded:<br /><blockquote><br /><strong></strong> In this study, we found that a leading CPOE system <span style="font-weight: bold;">often facilitated medication error risks</span>, with many reported to occur frequently. As CPOE systems are implemented, clinicians and hospitals must attend to errors that these systems cause in addition to errors that they prevent. </blockquote><br />CPOE technology, at best, should be considered <span style="font-style: italic;">experimental</span> in 2012.<br /><br />In regards to e-Prescribing proper, there's this: <a href="http://hcrenewal.blogspot.com/2011/06/electronic-medication-prescribing-magic.html">Errors Occur in 12% of Electronic Drug Prescriptions, Matching Handwritten</a> and this: <a href="http://hcrenewal.blogspot.com/2011/07/eprescribing-assuming-issues-like-this.html"><span style="font-size:100%;"></span></a><a href="http://hcrenewal.blogspot.com/2011/07/eprescribing-assuming-issues-like-this.html"><span>Upgrading e-prescribing system can bump up error risk</span></a> to consider; in other words, the literature is conflicting, confirming the technology remains <span style="font-style: italic;">experimental.</span><br /><br />This current study confirmed some (CPOE) errors that would not have occurred with paper did occur with cybernetics, amounting to "35% of postsystem errors in the intervention wards."<br /><br />In other words, patient Jones was now subjected to a cybernetic error that would not have occurred with paper, in the hopes that patients Smith and Silverstein would be spared errors that might have occurred without cybernetic aid.<br /><br />Even though the authors observe that "human research ethics approval was received from both hospitals and the University of Sydney", since patient Jones <span style="font-weight: bold;">did not provide informed consent to the experimentation</span> with what really are experimental medical devices as I've written often on this blog [see note 1], I'm not certain the full set of ethical issues have been well-addressed. It's not limited to this occasion, however. <span style="font-weight: bold;">This phenomenon represents a pervasive, continual world-wide oversight with regard to clinical IT. </span><br /><br />Furthermore, and finally: of considerable concern is another common limitation of all health IT studies, which I believe is often willful.<br /><br />What really should be studied before justifications are given to spend tens of millions of dollars/Euros/whatever on CPOE or other clinical IT is this:<br /><br /><span style="font-weight: bold;">The impact of possible</span> <strong style="font-style: italic;">non</strong><span style="font-style: italic; font-weight: bold;">-cybernetic interventions</span> (e.g., additional humans and processes) to improve "medication ordering" (either CPOE, or ePrescribing) that might be FAR LESS EXPENSIVE, and that might have far less IT-caused unintended adverse consequences, than cybernetic "solutions."<br /><br />Instead, pre-post studies are used to justify expenditures of millions (locally) and tens or hundreds of billions (nationally), with results sometimes like <a href="http://hcrenewal.blogspot.com/2011/09/npfit-programme-going-pffft.html">this</a> affecting an entire country.<br /><br />There is something very wrong with this, both scientifically and ethically.<br /><br />-- SS<br /><br /><span style="font-size:85%;">Note:</span><br /><span style="font-size:85%;"><br />[1] If these devices are not experimental, why are so many studying them to see if they actually work, to see if they pose unknown dangers, and to try to understand the conflicting results in the literature? More at this query link: <a href="http://hcrenewal.blogspot.com/search/label/Healthcare%20IT%20experiment">http://hcrenewal.blogspot.com/search/label/Healthcare%20IT%20experiment</a></span><br /><br /><span style="font-weight: bold;">Addendum Feb. 10, 2012:</span><br /><br />An anonymous commenter points out an interesting issue. They wrote:<br /><br /><blockquote>The study was flawed due to its failure to consider delays in care and medication administration as an error caused by these experimental devices.<br /><br />Delays are widespread with CPOE devices. One emergency room resorted to paper file cards and vacuum tubes to communicate urgency with the pharmacy. Delays were for hours.</blockquote><br />I agree that lack of consideration of a temporal component, i.e., delays due to technology issues, is potentially significant.<br /><br />I, for example, remember a more than five-minute delay in getting sublingual nitroglycerin to a relative with apparent chest pain due to IT-related causes. The problem turned out to be gastrointestinal, not cardiac; however, in another patient, the hospital might not be so lucky.<br /><br /><span style="font-weight: bold;">Addendum Feb. 12, 2012:</span><br /><br />A key issue in technology evaluation studies is to <span style="font-weight: bold;">separate the effects of the technology intervention from other, potentially confounding variables</span> which always exist in a complex <a href="http://en.wikipedia.org/wiki/Sociotechnical_systems">sociotechnical system</a>, especially in a domain such as medicine. This seems uncommonly done in HIT evaluation studies. Not doing so will likely inflate the apparent contribution of the technology.<br /><br />A "control ward" where the same education and training, process re-engineering, procedural improvements, etc. were performed as compared to the "intervention ward" (but without actual IT use) would probably be better suited to pre-post studies such as this.<br /><br />A "comparison ward" where human interventions were implemented, as opposed to cybernetic, would be a mechanism to determine how efficacious and cost-effective the IT was compared to less expensive non-cybernetic alternatives.<br /><br />-- SS

A Critical Review of a Critical Review of e-Prescribing ... Or Is It CPOE?

In PLoS medicine, the following article was recently published by researchers at the University of New South Wales in Australia:Westbrook JI, Reckmann M, Li L, Runciman WB, Burke R, et al. (2012) Ef…

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Cybernetik Über Alles: Computers Have More Rights Than Patients?

<div style="text-align: center;"><span style="font-size: 85%;">[Note: this essay contains many hyperlinks. They can be right-clicked and opened in a separate tab or window.]</span></div><br />What medical devices are shielded from liability?<br /><br />Are there other examples of legislation seeking legal protections for wide-scale use of medical devices that even the device's trade group leadership admits are <a href="http://hcrenewal.blogspot.com/2010/07/barry-chaiken-md-mph-lets-be-patient.html">not ready, and are experimental</a>?<br /><br />Here we have a proposal from a member of the U.S. Congress to shield <span style="font-weight: bold;">health IT software</span>, a medical device (per <a href="http://hcrenewal.blogspot.com/2011/04/fda-decides-regulating-implantable.html">FDA's Director of CDRH - the Center for Device and Radiological Health</a> and <a href="http://hcrenewal.blogspot.com/2009/06/improving-patient-safety-in-eu-hit.html">others</a>), and its users from liability through an apparently unique special accommodation.<br /><br />This from iHealthBeat.org:<br /><div class="date"></div><blockquote><div class="date">Thursday, October 27, 2011<span style="font-weight: bold;"><br /></span></div><div class="date"><a href="http://www.ihealthbeat.org/articles/2011/10/27/bill-would-establish-new-legal-protections-for-ehr-adopters.aspx">Bill Would Establish New Legal Protections for EHR Adopter</a><a href="http://www.ihealthbeat.org/articles/2011/10/27/bill-would-establish-new-legal-protections-for-ehr-adopters.aspx">s</a></div>On Wednesday, Rep. Tom Marino (R-Penn.) introduced legislation (<a href="http://thomas.loc.gov/cgi-bin/bdquery/z?d112:h.r.3239:" target="_blank">HR 3239</a>) that would create certain legal protections for Medicare and Medicaid providers who have implemented electronic health record systems, the <a href="http://www.timesleader.com/news/Marino__Bill_offers_safeguards_for_electronic_records_10-26-2011.html" target="_blank"><i>Wilkes-Barre Times Leader</i></a><i> </i>reports.<br />The bill -- called the Safeguarding Access for Every Medicare Patient Act -- would <span style="font-weight: bold;">create a system for reporting potential medical errors that occur when using EHRs, but it would not allow such information to be used as legal admission of wrongdoing.</span><br />The bill would cover certain physicians and hospitals that serve Medicare and Medicaid beneficiaries. It also would cover participants and users of health information exchanges.<br />Marino, who is a member of the House Judiciary Committee, said that offering the new legal protections to health care providers would <span style="font-weight: bold;">p</span><span style="font-weight: bold;">romote greater use of EHRs and encourage Medicare and Medicaid providers to continue serving beneficiaries. <span style="color: red; font-style: italic;">[As if they could not do so without EHR's? - ed.]</span></span><br />He said, "Many providers are reluctant to use [EHRs] because they believe the practice will make them more vulnerable to unnecessary legal action," <span style="color: red; font-style: italic; font-weight: bold;">[unnecessary? How about real and necessary</span>, <span style="color: red; font-style: italic; font-weight: bold;">as per the White Paper</span> <a href="http://www.acgroup.org/images/2011_White_Paper_-_Do_EHRs_Increase_Liability.pdf"><span style="font-style: italic; font-weight: bold;">Do EHR's Increase Liability</span></a><span style="color: red; font-style: italic; font-weight: bold;"><a href="http://www.acgroup.org/images/2011_White_Paper_-_Do_EHRs_Increase_Liability.pdf">?</a> - ed]</span> adding, "This [bill] protects access for seniors in the Medicare and Medicaid programs" (Riskind, <i>Wilkes-Barre Times Leader</i>, 10/27).<br /><div id="articlebody"></div></blockquote><div id="articlebody"></div><br />From Rep. Marino's <a href="http://marino.house.gov/press-release/bill-would-protect-access-medicare">website</a> (my comments are in <span style="color: red; font-style: italic; font-weight: bold;">[bracketed red italics]</span>):<br /><br /><b></b><br /><blockquote><div align="center"><b>Marino Introduces Safeguarding Access For Every Medicare Patient Act</b></div><div align="center"><b>FOR IMMEDIATE RELEASE</b><br /><b>Oct. 26, 2011</b><b><br /></b></div>WASHINGTON -- U.S. Rep. Tom Marino, PA-10, has introduced legislation that offers limited legal protection<span style="color: red; font-style: italic; font-weight: bold;"></span> to Medicare and Medicaid providers who use electronic records. <span style="color: red; font-style: italic; font-weight: bold;">[Which, I fear, could effectively act as, or mutate into, absolute protection in the environs of the legal system - ed.]</span><br />HR3239, the Safeguarding Access For Every Medicare Patient Act, would<span style="font-weight: bold;"> ensure patient access to Medicare and Medicaid providers</span>; <span style="font-weight: bold;">reduce health care costs<span style="font-style: italic;"> <span style="color: red;">[really? That's not what</span> <a href="http://hcrenewal.blogspot.com/2009/06/wharton-on-healthcare-it-can-i-go-home.html">Wharton</a> <span style="color: red;">and <a href="http://hcrenewal.blogspot.com/2010/03/hospitals-under-knife-sacrificing.html">others</a> write - ed.]</span></span></span>; guarantee incentives to providers to remain in the Medicare and Medicaid programs; and promote participation in health information technology.<br />Providers will eventually be required to participate in electronic recordkeeping or face a reduction in payments.<br />Marino said the bill offers incentive in the form of legal protection to providers who may be reluctant to remain in the Medicare and Medicaid programs <span style="font-weight: bold;">due to low reimbursement rates which are constantly being targeted for further reductions</span>.<br /><span style="color: red; font-style: italic; font-weight: bold;">[I imagine the known risks of health IT such as these</span><span style="color: red;"> <span style="font-style: italic;"><span style="font-weight: bold;">at</span></span></span><span style="font-style: italic; font-weight: bold;"><span style="color: red;"></span> "<a href="http://hcrenewal.blogspot.com/2011/01/maude-and-hit-risk-mother-mary-what-in.html">MAUDE and HIT Risks: What in God's Name is Going on Here?</a>" </span><span style="color: red; font-style: italic; font-weight: bold;">are a minor consideration if you receive legal immunity - ed.]</span><br />HR3239 would create a system for reporting potential errors that occur when using electronic records without the threat of that information being used as an admission of guilt.<span style="color: red; font-style: italic; font-weight: bold;"> [Even if the physician or nurse is guilty of EHR-caused or aggravated, i.e., "<a href="http://hcrenewal.blogspot.com/2011/10/nist-on-ehr-mission-hostile-user.html">use error</a>" per NIST, malpractice - ed.]</span><br />It also prevents electronic records from being used as an easy source for “<span style="font-weight: bold;">fishing expeditions</span>,’’<span style="font-weight: bold;"> <span style="font-style: italic;"><span style="color: red;">[like</span> <a href="http://hcrenewal.blogspot.com/2011/09/sweet-death-that-wasnt-very-sweet-how_24.html">this case</a><span style="color: red;">, <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/cases/?loc=cases&sloc=diary">this case</a>, <a href="http://hcrenewal.blogspot.com/2010/07/maude-database-patient-outcome-death.html">this case</a> and <a href="http://hcrenewal.blogspot.com/2011/03/thanks-to-wonders-of-ehr-this-premature.html">this case</a> where patients died? - ed.]</span> </span></span> while making sure that parties responsible for errors are held accountable <span style="color: red; font-style: italic; font-weight: bold;">[how? -ed]</span>.<br />The proposal allows for providers who use electronic records to take remedial measures without having those actions be used to establish guilt <span style="color: red; font-style: italic; font-weight: bold;">[even though remediation may be very relevant to malpractice, patient injury and death prior to the remediation, and the remediation is informed by the error - ed.]</span>; places time limits on the filing of lawsuits; and offers protection against libel and slander lawsuits.<br /><span style="font-style: italic; font-weight: bold;"><span style="color: red;">[If this provision were to allow clinicians to speak publicly about HIT flaws without legal retaliation or </span><a href="http://www.aapsonline.org/peerreview/epidemic.php">sham peer review</a><span style="color: red;">, I'd be all for it - ed.]</span></span><br />“Many providers are reluctant to use electronic records because they believe the practice will make them more vulnerable to unnecessary legal action,” Marino said. <span style="font-style: italic; font-weight: bold;"><span style="color: red;">[I think it's much more likely they are reluctant to use them due to the aforementioned hair-raising MAUDE reports and literature such as</span> <a href="http://hcrenewal.blogspot.com/2011/02/updated-reading-list-on-health-it.html">here</a>, <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/cases/?loc=cases&sloc=2009">here</a> <span style="color: red;">and</span> <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/cases/?loc=other">here</a> - <span style="color: red;">ed.]</span></span><span style="color: red;"> </span>and “Every time a doctor or hospital chooses not to participate because of these fears, our seniors lose another provider. This protects access for seniors in the Medicare and Medicaid programs.”<br />Marino said HR3239 is a two-pronged attack against rising health care costs: It provides legal protection to providers while encouraging the use of health information technology which has been shown to reduce costs. <span style="color: red; font-style: italic; font-weight: bold;">[See above links on that issue - ed.]</span><br />“Best of all, passage of this bill would require no new spending,” Marino said.<span style="color: red; font-style: italic; font-weight: bold;"> [Besides the hundreds of billions to be spent on the IT itself - ed.]</span></blockquote><br />This sounds like a healthcare IT vendor marketing piece, with claims refuted repeatedly here at HC Renewal, usually via the biomedical literature. It's slick, purporting to "protect Medicare access" while actually promoting health IT sales.<br /><br />Did Rep. Marino get snowed by the health IT lobby? (See "<a href="http://www.washingtonpost.com/wp-dyn/content/article/2009/05/15/AR2009051503667.html?hpid=topnews">The Machinery Behind Healthcare Reform</a>" in the Washington Post.)<br /><br />A major question is:<br /><br />What are the patients and their rights to redress for injuries that occur due to EHR's? Chopped liver?<br /><br />Isn't this bill really saying that patients are experimental subjects with limited rights? In other words, that improving EHR's should be at the expense of the unfortunate patients treated under its auspices? That the computers have more rights than the patients?<br /><br />That line of thinking about what in reality is unconsented medical experimentation (i.e., "First, let's experiment" as opposed to "First, do no harm") <span style="font-weight: bold;">has led to some very dark places in medicine</span>, and not just in ancient history (e.g., see "<a href="http://hcrenewal.blogspot.com/2011/09/bioethics-panel-blasts-late-u.html">Bioethics panel blasts late U. Pittsburgh professor</a>").<br /><br />See <a href="http://hcrenewal.blogspot.com/2011/02/updated-reading-list-on-health-it.html">this reading list</a> for more on these issues. <span style="font-weight: bold;"> Also see the many other posts on this blog</span> about health IT quality, usability, efficacy, risk (and that the levels of that risk are admittedly unknown), lack of informed consent, and other issues <span style="font-weight: bold;">via query links such as</span> <a href="http://hcrenewal.blogspot.com/search/label/healthcare%20IT%20dangers" style="font-weight: bold;">here</a><span style="font-weight: bold;">, </span><a href="http://hcrenewal.blogspot.com/search/label/Healthcare%20IT%20experiment" style="font-weight: bold;">here</a><span style="font-weight: bold;">, </span><a href="http://hcrenewal.blogspot.com/search/label/Healthcare%20IT%20failure" style="font-weight: bold;">here</a> and <a href="http://hcrenewal.blogspot.com/search/label/healthcare%20IT%20defects" style="font-weight: bold;">here</a> - and the hyperlinks within those lists of posts - to more fully understand this perspective.<br /><br />The text of the proposed legislation is <a href="http://thomas.loc.gov/cgi-bin/query/z?c112:H.R.3239:">here</a>. While not all bad, it raises a number of concerns.<br /><br />Excerpts are as follows:<br /><br /><h3></h3><blockquote><h3 style="font-weight: normal;"><span style="font-size: 100%;"><span style="font-weight: bold;">H. R. 3239</span></span></h3><h3 style="font-weight: normal;"><span style="font-size: 100%;">To provide certain legal safe harbors to Medicare and Medicaid providers who participate in the EHR meaningful use program or otherwise demonstrate use of certified health information technology.</span></h3><h3><span style="font-size: 100%;">... SEC. 4. RULES RELATING TO E-DISCOVERY.</span></h3><ul><span style="font-size: 100%;"> In any health care lawsuit against a covered entity that is related to an EHR-related adverse event, with respect to <span style="font-weight: bold;">certified</span> EHR technology used or provided by the covered entity, electronic discovery shall be limited to--</span></ul><span style="font-size: 100%;"><span style="color: red; font-style: italic; font-weight: bold;"></span></span><br /><ul><ul><span style="font-size: 100%;"><span style="color: red; font-style: italic; font-weight: bold;">[I'm not sure what "certification" has to do with litigation, since "certification" of health IT has nothing to do with safety or usability; see note below - ed.]</span><br /><br />(1) information that is <span style="font-weight: bold;">related to</span> <span style="color: red; font-style: italic; font-weight: bold;">[what does that mean? - ed.]</span> such EHR-related adverse event; and</span></ul></ul><ul><ul><span style="font-size: 100%;"> (2) information from the <span style="font-weight: bold;">period in which</span> such EHR-related adverse event occurred.<br /><br /><span style="color: red; font-style: italic; font-weight: bold;">[eDiscovery related to EHR-related adverse events is already difficult, e.g., obtaining complete metadata. What these provisions would do is likely to increase the complications through legal maneuvers on terms such as"related to", "period" etc. - ed.]</span></span></ul></ul><h3><span style="font-size: 100%;">SEC. 5. LEGAL PROTECTIONS FOR COVERED ENTITIES.</span></h3><ul><span style="font-size: 100%;"> (a) General- For a covered entity described in section 2, the following protections apply:</span></ul><ul><ul><span style="font-size: 100%;"> (1) ENCOURAGING SPEEDY RESOLUTION OF CLAIMS-</span></ul></ul><ul><ul><ul><span style="font-size: 100%;"> (A) GENERAL- A claimant may not commence a health care lawsuit against a covered entity on any date that is 3 years after the date of manifestation of injury or 1 year after the claimant discovers, or through the use of reasonable diligence should have discovered, the injury, whichever occurs first. This limitation shall be tolled to the extent that the claimant is able to prove--</span></ul></ul></ul><ul><ul><ul><ul><span style="font-size: 100%;"> (i) fraud;</span></ul></ul></ul></ul><ul><ul><ul><ul><span style="font-size: 100%;"> (ii) intentional concealment; or</span></ul></ul></ul></ul><ul><ul><ul><ul><span style="font-size: 100%;"> (iii) the presence of a foreign body, which has no therapeutic or diagnostic purpose or effect, in the person of the injured person.</span></ul></ul></ul></ul><ul><ul><span style="font-size: 100%;"> ... (2) EQUITABLE ASSIGNMENT OF RESPONSIBILITY- In any health care lawsuit against a covered entity--</span></ul></ul><ul><ul><ul><span style="font-size: 100%;"> (A) each party to the lawsuit other than the claimant that is such a covered entity shall be liable for that party's several share of any damages only and not for the share of any other person and such several share shall be in direct proportion to that party's proportion of responsibility for the injury, as determined under clause (iii);</span></ul></ul></ul><ul><ul><ul><span style="font-size: 100%;"> (B) whenever a judgment of liability is rendered as to any such party, a separate judgment shall be rendered against each such party for the amount allocated to such party <span style="color: red; font-style: italic; font-weight: bold;">[does that include the IT vendor? - ed.]</span> ; and</span></ul></ul></ul><ul><ul><ul><span style="font-size: 100%;"> (C) for purposes of this paragraph, the trier of fact shall determine the proportion of responsibility of each such party for the claimant's harm.</span></ul></ul></ul><ul><ul><span style="font-size: 100%;"> (3) <span style="font-weight: bold;">SUBSEQUENT REMEDIAL MEASURES</span>- Evidence of subsequent remedial measures to an EHR-related adverse event with respect to certified EHR technology used or provided by the covered entity (including changes to the certified EHR system, additional training requirements, or changes to standard operating procedures) by a covered entity<span style="font-weight: bold;"> shall not be admissible in health care lawsuits. </span><span style="color: red; font-style: italic; font-weight: bold;"><br /><br />[This in and of itself seems to give special accommodation to health IT, since remediation helps make the case for the presence of problems to begin with - ed.]</span></span></ul></ul><ul><ul><span style="font-size: 100%;"> (4) INCREASED BURDEN OF PROOF PROTECTION FOR COVERED ENTITIES- Punitive damages may, if otherwise permitted by applicable State or Federal law, be awarded against any covered entity in a health care lawsuit only if it is <span style="font-weight: bold;">proven by clear and convincing evidence that such entity acted with reckless disregard for the health or safety of the claimant. </span>In any such health care lawsuit where no judgment for compensatory damages is rendered against such entity, no punitive damages may be awarded with respect to the claim in such lawsuit.<br /><br /><span style="font-style: italic; font-weight: bold;"><span style="color: red;">[Would that apply to a case such as</span> <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/cases/?loc=cases&sloc=clinical%20computing%20problems%20in%20ICU">this?</a> <span style="color: red;">Does it apply to the health IT vendors and their often cavalier software development and quality practices</span></span></span><span style="font-size: 100%;"><span style="font-style: italic; font-weight: bold;"><span style="color: red;">, if patients become injured, such as <a href="http://sydney.edu.au/engineering/it/%7Ehitru/index.php?option=com_content&task=view&id=91&Itemid=146">here</a>, "A Study of an Enterprise Health Information System?" How about to <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/cases/?loc=cases&sloc=lawsuit">this case</a>, "A Lawsuit Over Healthcare IT Whistleblowing?" - ed.]</span></span></span></ul></ul><span style="font-size: 100%;"></span> <br /><ul><ul><span style="font-size: 100%;"> (5) PROTECTION FROM LIBEL OR SLANDER- Covered entities and employees, agents and representatives of covered entities are immune from civil action for libel or slander arising from information or entries made in certified EHR technology and for the transfer of such information to another eligible provider, hospital or health information exchange, if the information, transfer of information, or entries were made in good faith and without malice. <span style="color: red; font-style: italic; font-weight: bold;"><br /><br />[Does that include defects reports? - ed.]</span></span></ul></ul></blockquote><ul><ul></ul></ul><br /><br />From an ethical perspective, when you know a technology can be unsafe, but you don't know the levels of risk it creates, and the literature is conflicting on the benefits (prima facie evidence the technology is still <span style="font-style: italic;">experimental</span>), you <span style="font-weight: bold;">do not</span> promote its wide-scale use in medicine and offer special accommodations to the technology's producers and users. Period. This is especially true without explicit patient informed consent and opportunity for opt-out. To promote such technology is not ethical.<br /><br />Note: I believe the misunderstanding of "certification" of health IT contributes to the problems with such proposals. "Certification" of HIT has <span style="font-weight: bold;">little if anything to do with safety, reliability, usability</span>, etc. (e.g,, see <a href="http://hcrenewal.blogspot.com/2010/03/on-oncs-proposed-establishment-of.html" rel="nofollow">http://hcrenewal.blogspot.com/2010/03/on-oncs-proposed-establishment-of.html</a>).<br /><br />"Certification" of health IT is <span style="font-weight: bold;">not</span> validation of safety, usability, efficacy, etc., but a pre-flight checklist of features, interoperability, security and the like. The certifiers admit this explicitly. See the <a href="http://www.cchit.org/about">CCHIT web pages</a> for example. ("CCHIT Certified®, an independently developed certification that includes a rigorous inspection of an EHR’s integrated <span style="font-weight: bold;">functionality, interoperability and security</span>.")<br /><br />Health IT "certification" is <span style="font-style: italic;">not</span> like <a href="http://www.ul.com/global/eng/pages/">Underwriters Laboratories (UL) certification of appliances</a>. ("<span class="st">Independent, not-for-profit <span style="font-weight: bold;">product safety testing and certification</span> organization ... </span>With more than a 116-year proven track record, UL has been <span style="font-weight: bold;">defining safety from the public adoption of electricity to new breakthroughs that help protect our future</span>. UL employees are committed to <span style="font-weight: bold;">safeguarding people, places and products </span>in new and innovative ways for today’s borderless world.")<br /><br />-- SS<br /><br /><span style="font-weight: bold;">10/28/11 Addendum:</span><br /><br />This Representative seems to represent <a href="http://marino.house.gov/our-district">districts in Pennsylvania served by the Geisinger </a>healthcare system, including <a href="http://maps.google.com/maps?client=firefox-a&rls=org.mozilla:en-US:official&channel=s&hl=en&biw=1920&bih=887&q=danville+pa&um=1&ie=UTF-8&hq=&hnear=0x89cf6538e03a582d:0xceea3df3d7837f38,Danville,+PA&gl=us&ei=TiarToSNGMrs0gG29oWCDw&sa=X&oi=geocode_result&ct=image&resnum=2&ved=0CD0Q8gEwAQ">Danville, PA</a> where their <a href="http://www.geisinger.org/locations/index.html">main campus</a> is located. His legislative assistant on healthcare represented Geisinger to me in a conversation today in glowing terms. However, I suggest that Geisinger does not have a perfect track record, e.g., see the post "<a href="http://hcrenewal.blogspot.com/2011/08/safe-technology-factors-contributing-to.html">A 'safe' technology? Factors contributing to an increase in duplicate medication order errors after CPOE implementation</a>" and its reader comments and links.<br /><br /><span style="font-weight: bold;">10/30/11 Addendum:</span><br /><br />It occurred to me that in the post "<a href="http://hcrenewal.blogspot.com/2010/12/is-healthcare-it-solution-to-wrong.html">Is Healthcare IT a Solution to the Wrong Problem?</a>" referencing a study published in the Nov. 25, 2010 New England Journal of Medicine entitled "<a href="http://www.nejm.org/doi/full/10.1056/NEJMsa1004404">Temporal Trends in Rates of Patient Harm Resulting from Medical Care</a>" [Landrigan N Engl J Med 363;22] I pointed out that the abilities of health IT to "reduce medical error" may be significantly less than imagined.<br /><br />This is because most medical errors <span style="font-weight: bold;">have little to do with record keeping, but instead with human factors. </span>See the post at <a href="http://hcrenewal.blogspot.com/2010/12/is-healthcare-it-solution-to-wrong.html">http://hcrenewal.blogspot.com/2010/12/is-healthcare-it-solution-to-wrong.html</a>.<span style="font-weight: bold;"><br /></span>-- SS<span style="font-weight: bold;"><br /></span>

Cybernetik Über Alles: Computers Have More Rights Than Patients?

[Note: this essay contains many hyperlinks. They can be right-clicked and opened in a separate tab or window.]What medical devices are shielded from liability?Are there other examples of legislation…

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Why 99 Percent of the Irrationally Exuberant About Health IT Need To Be Removed From Healthcare

At Roy Poses' cross post "<a href="http://www.kevinmd.com/blog/2011/10/99-percent-health-care-angry.html">Why 99 percent of health care should be angry</a>" over at the KevinMD blog, I introduced a comment into the "eruption of controversy" (his term <a href="http://hcrenewal.blogspot.com/2011/10/peer-benchmarking-lake-wobegone-effect.html">here</a>) caused by his post.<br /><br />My comment was on the topic of government and health IT:<br /><br /><div class="dsq-comment-header-meta-wrapper"> <cite id="dsq-cite-339026207" class="dsq-comment-cite"> <a id="dsq-author-user-339026207" href="http://twitter.com/scotsilv" target="_blank" rel="nofollow"></a></cite></div><blockquote><div class="dsq-comment-header-meta-wrapper"><cite id="dsq-cite-339026207" class="dsq-comment-cite"><a id="dsq-author-user-339026207" href="http://twitter.com/scotsilv" target="_blank" rel="nofollow">scotsilv</a> </cite><span class="dsq-comment-header-time"><a href="http://www.kevinmd.com/blog/2011/10/99-percent-health-care-angry.html#comment-339026207" title="Link to comment by scotsilv">3 days ago</a><br /><br /></span> </div> <div class="dsq-comment-text" id="dsq-comment-text-339026207"> As one of Roy Poses' co-bloggers and a Medical Informaticist, I can say with certainty that government involvement in healthcare has been disastrous. Specifically, via ONC, ARRA and the HITECH Act, prematurely pushing still-experimental healthcare information technology on an unsuspecting medical profession (for the most part) and public. See "An updated reading list on health IT" at <a href="http://tinyurl.com/emrreadinglist" rel="nofollow">http://tinyurl.com/emrreadingl...</a>, .</div></blockquote><div class="dsq-comment-text" id="dsq-comment-text-339026207"> </div><br />A reply typical of the irrationally exuberant was added to the thread (emphases mine):<br /><br /><div class="dsq-comment-header-meta-wrapper"> <cite id="dsq-cite-340176765" class="dsq-comment-cite"> <span id="dsq-author-user-340176765"></span></cite></div><blockquote><div class="dsq-comment-header-meta-wrapper"><cite id="dsq-cite-340176765" class="dsq-comment-cite"><span id="dsq-author-user-340176765">Brett Mello</span> </cite><span class="dsq-comment-header-time"> <a href="http://www.kevinmd.com/blog/2011/10/99-percent-health-care-angry.html#comment-340176765" title="Link to comment by Brett Mello">1 day ago</a> </span><a href="http://www.kevinmd.com/blog/2011/10/99-percent-health-care-angry.html#comment-339026207" title="Jump to comment" class="dsq-reply-link">in reply to scotsilv</a><br /><br /></div> <div class="dsq-comment-text" id="dsq-comment-text-340176765">What are you basing your "certainty" on? <span style="font-weight: bold;">The examples discussed in the links sound like a case of bad configuration of an EMR. </span> It could also be a just a poor solution from a vendor. <span style="font-weight: bold;">Do you know if these were even a certified applications? </span>I would like to suggest not painting all EMR implementations and the overall value of EMR’s <span style="font-weight: bold;">from a single, albeit tragic, example. </span> <span style="font-weight: bold; font-style: italic; color: rgb(255, 0, 0);">[I.e., an "anecdote" - ed.] </span> A well implemented EMR, configured in collaboration with an organization’s physicians, <span style="font-weight: bold;">has been repeatedly proven to reduce medical and medication errors.</span> <span style="font-weight: bold;">Why would any educated person, including legislators and executives, support the use of a tool that would increase harm, not safety.</span><br /><br />Education aside, we will all be patients at some point <span style="font-weight: bold;">so our innate need for self preservation would seem contrarian to arbitrary investments in useless technology to manage our care</span>. Our current health delivery method <span style="font-weight: bold;">produces far more harm than the new technology </span>being implemented to address it. <span style="font-weight: bold;">We need to embrace technology and make it work for us rather than putting our heads in the sand. </span>Take the following quote as an example:<br /><br />"That it will ever come into general use, notwithstanding its value, is extremely doubtful because its beneficial application requires much time and gives a good bit of trouble, both to the patient and to the practitioner because its hue and character are foreign and opposed to all our habits and associations." - <span style="font-weight: bold;">The London Times, 1834 commenting on the "stethoscope"</span></div><br /></blockquote>Note that this reply came after I presented a link to a <a href="http://tinyurl.com/emrreadinglist">long list of articles</a>, more than 50, with links to each article or its abstract for ease of reference, and a personal account of healthcare IT failure.<br /><br />The articles challenge the beliefs in technological determinism common about health IT, i.e., that computers + medicine 'automagically' lead to better medicine, because, well, of the addition of computers, which must improve medicine, just - because.<br /><br />The reason I write that the reply was typical of the irrationally exuberant is due to the interrelationship between irrationality, logical fallacy, and absence of evidence. These characteristics are usually present in the writings proffered by those so afflicted - and, to those with vested interests in health IT, a.k.a. conflicts of interest, I should add.<br /><br />I replied:<br /><br /><div class="dsq-comment-header-meta-wrapper"> <cite id="dsq-cite-340927212" class="dsq-comment-cite"> <a id="dsq-author-user-340927212" href="http://pulse.yahoo.com/_TKZLL7R5AHU4BRHMNQSSX4TFPU" target="_blank" rel="nofollow"></a></cite></div><blockquote><div class="dsq-comment-header-meta-wrapper"><cite id="dsq-cite-340927212" class="dsq-comment-cite"><a id="dsq-author-user-340927212" href="http://pulse.yahoo.com/_TKZLL7R5AHU4BRHMNQSSX4TFPU" target="_blank" rel="nofollow">medinf</a> </cite><span class="dsq-comment-header-time"><a href="http://www.kevinmd.com/blog/2011/10/99-percent-health-care-angry.html#comment-340927212" title="Link to comment by medinf">16 hours ago</a> </span><a href="http://www.kevinmd.com/blog/2011/10/99-percent-health-care-angry.html#comment-340176765" title="Jump to comment" class="dsq-reply-link">in reply to Brett Mello</a> </div> <div class="dsq-comment-text" id="dsq-comment-text-340927212"><br />You are lacking references supporting your arguments, which in themselves display logical fallacy.<br /><br />I urge all readers to see my linked references list at the top of this thread, examine some of them (such as Jon Patrick's work on gross EHR defects, the ECRI Institute's Top Ten List of Healthcare Hazards, Romano et al.'s "Electronic Health Records and Clinical Decision Support Systems: Impact on National Ambulatory Care Quality" and others).<br /><br />There are articles from reputable sources indicating today's health IT, lacking cognitive support and other necessities for clinicians (such as per the National Research Council itself in an investigation led by health IT pioneers Octo Barnett and William Stead, see <a href="http://www8.nationalacademies.org/onpinews/newsitem.aspx?RecordID=12572" rel="nofollow">http://www8.nationalacademies....</a> ) does not improve quality of care, and can cause harm.<br /><br />These articles should raise caution in any physician, nurse or hospital contemplating use of this technology. These reports should not be cavalierly ignored, but should be a flag for great caution. The point is, with the literature conflicting, the technology should be considered experimental and caution used when deployed on human subjects. That includes both patients and clinicians, the former who can be injured or killed, the latter whose careers can be ruined through computer-caused or computer-aggravated errors. <span style="font-weight: bold; font-style: italic; color: rgb(255, 0, 0);">[Note: in health IT experiments, clinicians are, in fact, also experimental subjects - ed.]</span><br /><br />Re: "The examples discussed in the links sound like a case of bad configuration of an EMR" - you omit the existence of clinical IT defects and problems such as poor software engineering causing unreliability, mission hostile human-computer interfaces (e.g., see <a href="http://www.tinyurl.com/hostileuserexper" rel="nofollow">http://www.tinyurl.com/hostile...</a> ), incorrect or incomplete decision support algorithms, terminological problems, and other issues. You seem to indicate the findings in the reading list may be "anecdotal." A crushing reply to that line of thought, from an expert in Australia, is here: <a href="http://hcrenewal.blogspot.com/2011/08/from-senior-clinician-down-under.html" rel="nofollow">http://hcrenewal.blogspot.com/...</a> .<br /><br />As far as "certification" of HIT, this has little if anything to do with safety, reliability, usability, etc. ( e.g,, see <a href="http://hcrenewal.blogspot.com/2010/03/on-oncs-proposed-establishment-of.html" rel="nofollow">http://hcrenewal.blogspot.com/...</a> ). "Certification" of health IT is not validation of safety, usability, efficacy, etc., but a pre-flight checklist of features, interoperability, security and the like. The certifiers admit this explicitly. See the CCHIT web pages for example.<br /><br />You use the logical fallacy of "appeal to authority" - or show severe naivete - in asking "why would any educated person, including legislators and executives, support the use of a tool that would increase harm, not safety."<br /><br />"We need to embrace technology and make it work for us rather than putting our heads in the sand" - I ask - why now, if the technology is not ready? This seems like an appeal to novelty and perhaps the bandwagon fallacy (see <a href="http://www.nizkor.org/features/fallacies/" rel="nofollow">http://www.nizkor.org/features...</a> ).<br /><br />Regarding your 1834 London Times quote, that was in a time before the human subjects experimentation guidelines such as the Belmont Report, World Medical Association Declaration of Helsinki, Guidelines for Conduct of Research Involving Human Subjects at NIH, the Nuremberg Code, and others came into being.<br /><br />That said, the use of the 1834 stethoscope analogy is a type of red herring fallacy (<a href="http://www.nizkor.org/features/fallacies/red-herring.html" rel="nofollow">http://www.nizkor.org/features...</a> ). A stethoscope and enterprise clinical IT have little in common, the latter being potentially harmful to the point of causing patient death through interference in clinical care. (I note that if the 1834 story was brought up as an allusion to doctors and nurses who dislike today's IT being "Luddites" or the like, then that's an ad hominem fallacy.)<br /><br />We as a society have supposedly learned something since 1834 regarding experimental medical devices. Or have we? FDA's Jeffrey Shuren MD, JD, Director of CDRH has admitted explicitly that health IT are medical devices with definite, but unknown, levels of risk - FDA stats "may represent only the tip of the iceberg in terms of the HIT-related problems that exist" were the exact words. That is prima facie evidence the devices are experimental.<br /><br />However FDA refrains from regulating them under the FD&C Act, as they do pharma IT, other medical devices, drugs, etc. because they are a political "hot potato" - as at <a href="http://hcrenewal.blogspot.com/2011/04/fda-decides-regulating-implantable.html" rel="nofollow">http://hcrenewal.blogspot.com/...</a> , <a href="http://hcrenewal.blogspot.com/2010/02/fda-on-health-it-adverse-consequences.html" rel="nofollow">http://hcrenewal.blogspot.com/...</a>, and <a href="http://hcrenewal.blogspot.com/2010/08/smoking-gun-internal-fda-memorandum-of.html" rel="nofollow">http://hcrenewal.blogspot.com/...</a> ).<br /><br />As is customary at Healthcare Renewal, at those three posts are links to source, quoted in full context.</div></blockquote><br />I've replied to so many irrationally exuberant commenters on this very blog, that I could have authored the reply above in my sleep.<br /><br />Two points:<br /><br />1. My reply and its links (and the source those links lead to) can and should be used as a "template" by clinicians to educate themselves, to reply to the health IT irrationally exuberant in their organizations, and to those in government prematurely pushing this technology onto clinicians;<br /><br />2. The health IT irrationally exuberant, being irrational, ill-informed, and often markedly resistant to education, need to be removed from healthcare entirely. Their cavalier attitudes about cybernetic medical experiments are dangerous, and <span style="font-weight: bold;">have no place in medical affairs.</span> Such people impede, rather then help remediate the quality, safety, usability, and efficacy of health IT. In doing so, <span style="font-weight: bold;">they contribute to increased risk and to actual patient harm.</span> The irrationally exuberant are part of the problem, not part of the solution.<br /><br />-- SS

Why 99 Percent of the Irrationally Exuberant About Health IT Need To Be Removed From Healthcare

At Roy Poses' cross post "Why 99 percent of health care should be angry" over at the KevinMD blog, I introduced a comment into the "eruption of controversy" (his term here) caused by his post.My comme…

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