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UK: ISO draft standards for the development, manufacture and deployment of healthcare IT focus on SAFETY

The UK's NHS has not had the best of success to date implementing national health IT, as indicated by reports <a href="http://www.publications.parliament.uk/pa/cm200809/cmselect/cmpubacc/153/15304.htm">here</a> and <a href="http://www.connectingforhealth.nhs.uk/about/foi">here</a>, for example. However, they have appeared to have learned from their mistakes and in fact are on the way to being far ahead of the U.S. in terms of understanding what it truly takes for HIT to be efficacious - and perhaps even more importantly, as safe as possible. From an informatics colleague who informed me of these developments: <blockquote>The UK has recently adopted the ISO draft standards for the development and deployment of HIT. They don't go as far as premarket approval, but do require vendors to develop and deliver to healthcare organizations a formal hazard assessment for their products, require both to continually update their risk assessments, and require care delivery organizations to have an explicit process for identifying & mitigating risks, and formally accepting (or not) the residual risks that remain. The thinking is these standards will be adopted across the EU once the ISO approval process is completed.</blockquote> These two remarkable documents are available from the UK's NHS: <div class="PlainText"><blockquote><a href="http://www.isb.nhs.uk/documents/isb-0160/dscn-18-2009">http://www.isb.nhs.uk/documents/isb-0160/dscn-18-2009</a> "Health informatics — Guidance on the management of clinical risk relating to the deployment and use of health software" Formerly ISO/TR 29322:2008(E) DSCN18/2009 and <a href="http://www.isb.nhs.uk/documents/isb-0129/dscn-14-2009">http://www.isb.nhs.uk/documents/isb-0129/dscn-14-2009</a> "Health Informatics — Application of clinical risk management to the manufacture of health software" Formerly ISO/TS 29321:2008(E) DSCN14/2009 </blockquote> From the first of these, the overall intro: <blockquote>ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The work of preparing International Standards is normally carried out through ISO technical committees. Each member body interested in a subject for which a technical committee has been established has the right to be represented on that committee. International organizations, governmental and non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization.</blockquote> Then on to matters at hand: <blockquote>Introduction The threat to patient safety There is mounting concern around the world about the substantial number of avoidable clinical incidents which have an adverse effect on patients, of which a significant proportion result in avoidable death or serious disability, see references [1], [2], [3], [4], [5] and [6]. A number of such avoidable incidents involved poor or "wrong" diagnoses or other decisions. A contributing factor is often missing or incomplete information, or simply ignorance, e.g. of clinical options in difficult circumstances or of the cross-reaction of treatments (a substantial percentage of clinical incidents are related to missing or incomplete information). It is increasingly claimed that information systems such as decision support, protocols, guidelines and pathways could markedly reduce such adverse effects. [As I have written in many places such as <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/cases/?loc=cases&sloc=2009">here</a> and <a href="http://hcrenewal.blogspot.com/2010/07/new-england-journal-on-meaningful-use.html">here</a>, this may or may not be true regarding today's commercial healthcare IT as it is currently designed and deployed. Evidence supporting the assertion, especially robust studies such as randomized controlled clinical trials, is scarce, and evidence contradicting it is growing. The technology remains experimental - ed.] If for no other reason – and there are others – this is leading to increasing deployment and use of increasingly complex health software systems, such as for decision support and disease management. It can also be anticipated that, due to pressures on time and to medico-legal aspects, clinicians will increasingly rely on such systems, with less questioning of their "output", as a "foreground" part of care delivery rather than as a "background" adjunct to it. Indeed, as such systems become integrated with medical care, any failure by clinicians to use standard support facilities may be criticised on legal grounds. Increased use of such systems is not only in clinical treatment but also in areas just as important to patient safety, such as referral decision-making. Failure to make a "correct" referral, or to make one "in time", can have serious consequences. Economic pressures are also leading to more decision support systems. The area of generic and/or economic prescribing is the most obvious, but achieving economy in the number and costs of clinical investigative tests is another. Thus the use of health software and medical devices in increasingly integrated systems, e.g. networks, can bring substantial benefit to patients. However unless they are proven to be safe and fit for purpose they may also present potential for harm or at least deter clinical and other health delivery staff from making use of them, to the ultimate detriment of patients. Annex A provides some examples of the potential for harm. Harm can of course result from unquestioning and/or non-professional use, although the manufacturers of health software products, and those in health organizations deploying and using such products within systems, can mitigate such circumstances through, for example, instructions for use, training and on-screen presentation techniques, guidance, warnings or instructions. Some of these system deficiencies are insidious, may be invisible to the end user [an obviously perilous situation - ed.] and are typically out of the sole control of either the manufacturer or the deploying health organization.</blockquote> The reports note the obvious, something that the health IT vendors' <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/cases/?loc=cases&sloc=koppel_kreda">contractual gag clauses</a> and secrecy in the health IT industry make difficult to rigorously evaluate: <blockquote>A necessary pre-cursor for determining and implementing controls to minimize risks to patients, from a health software systems that is manufactured and then deployed and used within a health organization, is a clear understanding of the risks which the deployed system might present to patients if malfunction or an unintended event were to occur, and the likelihood of such a malfunction or event causing harm to the patient.</blockquote> These risks cannot be properly evaluated in an industry where the flows of information are dominated by the vendors. Some examples of potential for harm, from annex (appendix) A, will likely sound quite familiar to readers of Healthcare Renewal: <ul><li>Patient (mis)identification</li><li>Inadvertent accidental prescribing of dangerous drugs (such as methotrexate)</li><li>Incorrect patient details retrieved from radiology information system</li><li>CT and MRI images could not be seen after being moved to PACS</li><li>Drug mapping error</li><li>Pre-natal screening risk computation errors</li><li>Radiotherapy errors</li><li>Slack security</li></ul> I especially note the following in the first document (on deployment): <blockquote>5.3 Competencies of personnel Persons performing risk management tasks will need to have the knowledge, experience and competencies appropriate to the tasks assigned to them. This will need to include, where appropriate, knowledge and experience of the particular health software systems (or similar health software products) and applications, the technologies involved and risk management techniques. This should include appropriate registered clinical input throughout the process. Appropriate competency and experience records will need to be maintained. Clinical risk management tasks can, and should, be performed by a project team that contains representatives of each of the functions that are involved in deploying and subsequently using the health software systems or system, with each contributing their specialist knowledge to build both awareness and consensus. Of particular importance will be clinical input from clinicians who are familiar with the practical realities of the environments within which the software system will be used and the clinical processes to which the software system is directed. </blockquote> Emphasis on the last sentence is mine. At a time when U.S. CIOs and health IT "talking heads" still find the need to write touchy-feely "Master of the Obvious" articles extolling the virtues of permitting clinicians 'input' into health IT projects, usually under the aegis of unempowered "Directors of Informatics" or "Chief Medical Information Officers" (a.k.a. Directors of Nothing and Chiefs of Nothing, with no true executive presence or authority), the latter direct, definitive sentence is refreshing. Miracle of miracles, even postmarketing surveillance is covered (the pharma and medical device industries have been mandated by regulators to conduct such studies on their products for decades): <blockquote>11 Post-deployment monitoring Both manufacturers and organizations deploying and using health software and other products within systems, have a business need to establish, document and maintain a process to collect and review information about the clinical safety performance of the products and system in the post-deployment phase, at least to help manage their liabilities but also to enable them to optimize their products and systems.</blockquote> There is much more in these documents. Download and read the PDF's. I will have more to say in future posts, but thank god someone is considering the risks to patients of this technology, touted as universally beneficent by health IT exceptionalists, in a serious manner. Now if only we can import this thinking into the United States. -- SS </div>

UK: ISO draft standards for the development, manufacture and deployment of healthcare IT focus on SAFETY

The UK's NHS has not had the best of success to date implementing national health IT, as indicated by reports here and here , for examp...

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2 Legal Settlements + 1 Corporate Integrity Agreement = $130 Million Retirement Package?

Omnicare's Trail of Legal Settlements Last year, we <a href="http://hcrenewal.blogspot.com/2009/11/omnicare-ivax-settle.html">discussed</a> a $98 million settlement made by Omnicare, US based corporation that manages pharmacy-benefits, of allegations that it received kickbacks from generic drug manufacturers for buying and recommending their drugs.  Omnicare had previously submitted to a corporate integrity agreement in 2006, and paid $102 million to settle allegations it defrauded Medicaid.  At the time, we noted that this was yet another of the many cases in which the organization alleged to be involved in wrong-doing paid a fine, but no one who authorized, directed, or implemented the bad behavior was subject to any negative consequences. So last week, Cincinnati.com ran a <a href="http://news.cincinnati.com/article/20100806/BIZ01/8070349/-130M-payout-for-ex-Omnicare-CEO">story</a> on the retirement of the CEO who presided over Omnicare during the time of the alleged misconduct.  Before reading further, would anyone care to guess whether the company's previous bad behavior would negatively impact his fortunes? Contrasted with the Size of the CEO's Retirement Package No exactamente: <blockquote>As Omnicare Inc.'s new leadership begins to reshape its corporate culture - one that had included generous pay for senior executives - the Fortune 500 firm's exiting CEO stands to collect one of the largest payouts landed by a U.S. corporate executive in recent history. Former president and CEO Joel Gemunder, who surprised analysts and investors when he retired on July 31, is in line to receive more than $130 million in severance, pension and departing payouts. At 71, Gemunder had led Omnicare Inc., the nation's largest provider of pharmaceuticals for the elderly, for nearly 30 years. On his retirement, Gemunder was up for a lump sum pension payment of more than $91 million. That's in addition to a monthly pension payment of $1,719 and roughly $5.38 million from a deferred compensation plan. Gemunder also will receive $16.2 million in cash severance payable through next July. His 2.7 million in stock options and more than 705,100 shares of restricted common stock also became fully vested on his retirement. Collectively, the shares were worth more than $21.7 million, according to the company's most recent proxy.</blockquote> To recapitulate so far: the company had to make two settlements of charges of kickbacks and fraud, totalling about $200 million, and accept a corporate integrity agreement. The CEO on whose watch this occurred left the company with a $130 million retirement package. Can we spell "impunity?" Protest from the Main-Stream Media But this case was different from many of the legal settlements that we have <a href="http://hcrenewal.blogspot.com/search/label/legal%20settlements">chronicled</a> in the past. In those previous cases, we noted how corporate bad behavior cost the organization as a whole, and hence collectively cost the stock-owners, the employees, and the customers/ clients/ patients involved, but not the leaders who authorized and directed the bad behavior, nor the particular people who implemented it. Hardly anyone else, however, took notice. However, after Mr Gemunder's obese retirement package was made public, there was actually outrage <a href="http://online.wsj.com/article/SB10001424052748704182304575415813408838600.html">in the opinion section </a>of the Wall Street Journal: <blockquote>Health-care costs, the national debt and taxes are all going up, and Joel Gemunder is one reason why. Until Mr. Gemunder's abrupt retirement was announced on Monday, he was CEO of Covington, Ky.-based Omnicare, the nation's largest dispenser of pharmaceuticals to nursing homes. Omnicare gets most of its revenue from Medicare, Medicaid and other companies sucking on these same government feeding tubes. Omnicare also lives up to its name, serving 1.4 million beds in 47 states. Mr. Gemunder, 71, had been in charge since 1981, but now he's split with one of the largest lump-sum pension payouts in history, The Wall Street Journal reported. He's getting a $91 million pension payout, plus severance, vesting of restricted stock and other goodies that bring his final payday to at least $130 million. And that's on top of the $14 million he bagged last year. As CEO, Mr. Gemunder touted 'cost reduction initiatives,' including salary cuts for employees, but these initiatives didn't apply to himself. And what did the shareholders get for their money? Omnicare shares took a tumble last week after the company reported a shocking drop in the number of prescriptions it fills. Omnicare stock peaked in March 2006 at more than $61, but now trades under $23. That's a drop of more than 60% -- versus a roughly 11% decline in the S&P 500 during the same period. And what did the taxpayers and customers get? Omnicare has long been plagued by huge litigation costs amid allegations of kickback and billing schemes.</blockquote> It's nice to have company. And it's very nice that the issue of the impunity enjoyed by leaders of top health care organizations has made it into the main-stream media. Now it is time to do something about it. Summary Let me say it again:  The Omnicare settlement coupled with its CEO's outlandish retirement package fit right into the <a href="http://hcrenewal.blogspot.com/search/label/legal%20settlements">parade of legal settlements</a> we have discussed. As we have said again and again, the usual sorts of legal settlements we have described do not seem to be an effective way to deter future unethical behavior by health care organizations. Even large fines can be regarded just as a cost of doing business. Furthermore, the fine's impact may be diffused over the whole company, and ultimately comes out of the pockets of stockholders, employees, and customers alike. It provides no negative incentives for those who authorized, directed, or implemented the behavior in question. My refrain has been: we will not deter unethical behavior by health care organizations until the people who authorize, direct or implement bad behavior fear some meaningfully negative consequences. Real health care reform needs to make health care leaders accountable, and especially accountable for the bad behavior that helped make them rich. Postscript: A Conflicted Board Member? The Cincinati.com story described the bizarre process used to set the size of the Omnicare CEO's retirement package. <blockquote>Just ahead of Gemunder on the big pension list is Thomas M. Ryan, president and CEO of CVS Caremark Corp. with $94.4 million at the end of 2009. CVS posts annual sales in excess of $98 billion compared to Omnicare's $6.17 billion. Annual profit at CVS is $3.6 billion compared to $ 211 million at Omnicare. Despite the sizable differences, CVS is among 40 companies whose CEOs pay is considered when Omnicare's executive compensation committee determines pay for its top executives, according to the firm's April proxy. The company's compensation committee, which declined comment for this story, is made up of three long-time directors Andrea R. Lindell, board chair John T. Crotty and Steven J. Heyer. Other companies considered include New York-based Bristol-Myers Squibb Co. with $17.8 billion in sales; Dublin, Ohio-based Cardinal Health, Inc. with $99 billion in sales and New Jersey-based Medco Health Solutions, Inc. with $72 billion in sales. 'These companies are enormously bigger than you would expect for a comparative group' for Omnicare, Crystal said. 'It's the equivalent of the local ball team that's not in the major leagues using their comparative group as the New York Yankees.'</blockquote> Note that one member of the compensation committee that used this absurd standard to set the CEO's compensation was one Andrea R Lindell. The above story did not identify her further, but as we <a href="http://hcrenewal.blogspot.com/2009/11/omnicare-ivax-settle.html">noted</a> last year, she "is also <a href="http://webcentral.uc.edu/eProf/viewoutput.cfm?Action=PublicDoc&code=WebPage&shci=0&epid=OTAwNA%3D%3D">Dean of the College of Nursing</a> at the University of Cincinnati. One would think that someone who thus boasts 'the success of our students, faculty, staff and alumni who work together to promote excellence in education, research, service and practice' needs to keep a closer eye on the ethical aspects of her company's management. But as the New York Times just <a href="http://www.nytimes.com/2010/08/01/business/01prez.html">noted</a> on the front-page of last Sunday's business section, as another blow to the <a href="http://hcrenewal.blogspot.com/search/label/anechoic%20effect">anechoic effect</a>, "Academics may be trained to ask tough questions in their own fields, but when confronted with tricky business issues far above their level of expertise they 'often become as meek as church mice'...." and hence are just the sort of directors that self-interested CEOs intent on lining their own pockets love.  So this case becomes another reason to take seriously the increasingly frequent <a href="http://hcrenewal.blogspot.com/search/label/conflicts%20of%20interest">conflicts of interest</a> generated <a href="http://hcrenewal.blogspot.com/2006/03/new-species-of-conflict-of-interest-in.html">when top leaders of non-profit health care organizations sit on boards of for-profit health care corporations</a>.  These conflicts may not only distract the leaders from the mission of the non-profit organizations, but also distract them from their fiduciary duties to the stock-holders of the for-profit corporations.

2 Legal Settlements + 1 Corporate Integrity Agreement = $130 Million Retirement Package?

Omnicare's Trail of Legal Settlements Last year, we discussed a $98 million settlement made by Omnicare, US based corporation that mana...

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Despite Scandal, Former UnitedHealth CEO was Ninth Best Paid CEO of the Decade

A little while ago, the Wall Street Journal <a href="http://online.wsj.com/article/SB10001424052748703724104575379680484726298.html">reported</a> on the highest paid US corporate CEOs of the past decade.  One name stood out for those interested in  health care: Dr William W McGuire, the former CEO of giant health care insurance company/ managed care organization UnitedHealth Group.  Dr McGuire was number 9 on the <a href="http://online.wsj.com/public/resources/documents/st_execpay1007_20100725.html">list</a>, with a total realized compensation of $469,300,000.  We started <a href="http://hcrenewal.blogspot.com/2005/05/how-can-1248-million-year-ceo-make.html">discussing</a> the disconnect between Dr McGuire's corpulent pay and his company's failure to uphold its stated ideals back in 2005, when he was reported to have received more than $124 million to lead a company which championed "affordable" health care.  Later, it turned out that much of Dr McGuire's compensation came in the form of back-dated stock-options, and the resulting <a href="http://hcrenewal.blogspot.com/2006/08/more-entangled-web-unitedhealth-case.html">scandal</a> was followed by his <a href="http://hcrenewal.blogspot.com/2006/10/another-really-big-one-bites-dust-ceo.html">resignation</a>.  Later, Dr McGuire was forced to <a href="http://hcrenewal.blogspot.com/2007/12/some-payback-by-former-managed-care-ceo.html">give back</a> some the options.  The <a href="http://hcrenewal.blogspot.com/2009/08/final-settlement-of-unitedhealth.html">final settlement</a> of the fiasco cost UnitedHealth $895 million, and Dr McGuire $30 million and the cancellation of 3.6 million stock options. Meanwhile, UnitedHealth was compiling an unenviable record of ethical lapses: <ul><li>as <a href="http://www.courant.com/business/hc-natbizdigbrf0530.art2may30,0,109447.story">reported</a> by the Hartford Courant, "UnitedHealth Group Inc., the largest U.S. health insurer, will refund $50 million to small businesses that New York state officials said were overcharged in 2006."</li><li>UnitedHalth promised its investors it would continue to raise premiums, even if that priced increasing numbers of people out of its policies (see post <a href="http://hcrenewal.blogspot.com/2008/05/commercial-managed-care-organizations.html">here</a>);</li><li>UnitedHealth's acquisition of Pacificare in California allegedly lead to a "meltdown" of its claims paying mechanisms (see post <a href="http://hcrenewal.blogspot.com/2008/01/bungled-not-brilliant-results-of.html">here</a>);</li><li>UnitedHealth's acquisition of Sierra Health Services allegedly gave it a monopoly in Utah, while the company allegedly was transferring much of its revenue out of the state of Rhode Island, rather than using it to pay claims (see post <a href="http://hcrenewal.blogspot.com/2007/03/unitedhealth-declares-health-care.html">here</a>)</li><li>UnitedHealth frequently violated Nebraska insurance laws (see post <a href="http://hcrenewal.blogspot.com/2007/01/on-performance-on-one-supposedly.html">here</a>);</li><li>UnitedHealth settled charges that its Ingenix subsidiaries manipulation of data lead to underpaying patients who received out-of-network care (see post <a href="http://hcrenewal.blogspot.com/2009/01/unitedhealth-and-ingenix-settles.html">here</a>).</li></ul>At the same time, UnitedHealth continues to <a href="http://www.unitedhealthgroup.com/AboutUs/MissionAndValues.aspx">boast</a> that: <blockquote>Our mission is to help people live healthier lives. * We seek to enhance the performance of the health system and improve the overall health and well-being of the people we serve and their communities. * We work with health care professionals and other key partners to expand access to quality health care so people get the care they need at an affordable price. * We support the physician/patient relationship and empower people with the information, guidance and tools they need to make personal health choices and decisions.</blockquote> Dr McGuire certainly expanded his access to money, which doubtless empowered him.    And as we noted <a href="http://hcrenewal.blogspot.com/2010/04/what-me-worry-redux-another-leader.html">here</a>, his successor, Mr Stephen J Helmsley, seems to be going down the same path.  In 2009 his total compensation was $8.9 million, and he sold stock options obtained from previous compensation packages for $98.6 million.  Mr Helmsley was a top leader (President and Chief Operating Officer [COO]) of UnitedHealth during Dr McGuire's reign as CEO, so should be viewed as having some responsibility for the excesses of the McGuire years. Despite recent attempts to reform health care, or at least health insurance, it seems that the health insurance industry still leads the way in providing its leaders perverse incentives while failing to hold them accountable for their organizations' unethical behavior and subversion of their stated missions.  Is it any wonder that these organizations continue to act unethically, and that the costs of the goods and services they provide rise continuously? If we truly want health care that is accessible, of high quality, at a fair price, and more importantly, if we want health care that is honest and focused on patients, we need to provide health care leaders with clear, rational incentives in these directions, and make them fully accountable for their actions, and the courses of their organizations under their leadership.

Despite Scandal, Former UnitedHealth CEO was Ninth Best Paid CEO of the Decade

A little while ago, the Wall Street Journal reported on the highest paid US corporate CEOs of the past decade. One name stood out for thos...

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Internal FDA memorandum of Feb. 23, 2010 to Jeffrey Shuren on HIT risks. Smoking gun? I report, you decide.

From the <a href="http://hcrenewal.blogspot.com/2010/08/more-on-huffington-post-investigative.html">aforementioned</a> Huffington Post Investigative Fund article <a href="http://huffpostfund.org/stories/2010/08/fda-obama-digital-medical-records-team-odds-over-safety-oversight">"</a><a href="http://www.huffingtonpost.com/2010/08/04/fda-obama-digital-medical_n_670036.html" style="font-weight: bold;" target="_blank">FDA, Obama Digital Medical Records Team at Odds over Safety Oversight</a><a href="http://huffpostfund.org/stories/2010/08/fda-obama-digital-medical-records-team-odds-over-safety-oversight">"</a> and timeline of industry resistance to government oversight of health IT (<a href="http://web.archive.org/web/20101109120130/http://huffpostfund.org/stories/2010/08/safety-overshadowed" target="_blank">link</a>), one document stands out in my mind. <div dir="ltr">The internal FDA memorandum of Feb. 23, 2010 ("not intended for public use") to Jeffrey Shuren on HIT risks. which I have now re-hosted <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/Internal-FDA-Report-on-Adverse-Events-Involving-Health-Information-IT.pdf">at this link</a> (PDF) is quite fascinating. <div style="text-align: center;"><a href="http://www.ischool.drexel.edu/faculty/ssilverstein/Internal-FDA-Report-on-Adverse-Events-Involving-Health-Information-IT.pdf"><img alt="" border="0" id="BLOGGER_PHOTO_ID_5501940929848764066" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEj2Ha1OH1pZDWOm42XIES7MCCW2pPGLoTGP1Kyj3wqt7HzQ32wRDvdjJi6OwnSjeWp6JyH0EAC7dE9GaRHTphliQHSjkWK7H4MPBwmQ6GgZYIHhLvdy-gmm7Z0B58mtbX18b-_nAFQgUqN0/s320/fda_memo.jpg" style="cursor: pointer; display: block; height: 472px; margin: 0px auto 10px; text-align: center; width: 364px;" /></a>Internal FDA Memo ("not intended for public use") on potential dangers of health IT.  Download the full PDF by clicking <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/Internal-FDA-Report-on-Adverse-Events-Involving-Health-Information-IT.pdf">here</a>.</div> The memo begins:</div><blockquote style="margin-bottom: 0px; margin-top: 0px;"><div dir="ltr"> This report serves to characterize medical device reports (MDRs) in the Manufacturer and User Facility Experience (MAUDE) database, inclusive of MedSun reports, pertaining to Health Information Technology (H-IT) safety issues as requested by the Office of the Center Director, Center for Devices and Radiological Health (CDRH), in contrast to the previously submitted MedSun and Office of Compliance information. </div></blockquote><div dir="ltr"></div><div dir="ltr">   (I've mentioned MAUDE <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/cases/?loc=cases&sloc=MAUDE">here</a> and <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/cases/?loc=cases&sloc=maude_death">here</a>, including a report of an HIT-related patient death at the latter link.) To those "anecdotalists" in the healthcare information technology community who believe reports of HIT-related harm are "anecdotal, and anecdotes don't make data" (as opposed to the "<a href="http://online.wsj.com/article/SB122910977401502369.html?mod=loomia&loomia_si=t0:a16:g2:r3:c0.0175368:b0" target="_blank">Markopolists</a>"): When an internal FDA review of their own data concludes the following, I invite you to think about the point of view that maintains that reports of HIT-related patient injury and death are so 'fragmentary' as to not merit (actually, demand) significant resources be diverted to rigorously addressing the issue of HIT risk:</div><div dir="ltr"></div><blockquote style="margin-bottom: 0px; margin-top: 0px;"><div dir="ltr"> In summary, the results of this data review suggest significant clinical implications and public safety issues surrounding Health Information Technology. The most commonly reported H-IT safety issues included wrong patient/wrong data, medication administration issues, clinical data loss/miscalculation, and unforeseen software design issues; all of which have varying impact on the patient’s clinical care and outcome, which included 6 death and 43 injuries. The absence of mandatory reporting enforcement of H-IT safety issues limits the number of relevant MDRs and impedes a more comprehensive understanding of the actual problems and implications. </div></blockquote><div dir="ltr"></div><div dir="ltr">   This is especially true considering the FDA's own noted limitations of their information sources:</div><div dir="ltr"></div> <blockquote style="margin-bottom: 0px; margin-top: 0px;"><div dir="ltr">Limitations of the MAUDE search and final subset of MDRs include the following:</div><div dir="ltr"> 1. Not all H-IT safety issue MDRs can be captured due to limitations of reporting practices including</div><div dir="ltr">... (a) Vast number of H-IT systems that interface with multiple medical devices currently assigned to multiple procodes making it difficult to identify specific procodes for H-IT safety issues; ... (b) Procode assignments are also affected by the ability of the reporter/contractor to correctly identify the event as a H-IT safety issue; ... (c) Correct identification by the reporter of the suspect device brand name is challenged by difficulties discerning the actual H-IT system versus the device it supports. 2. Due to incomplete information in the MDRs, it is difficult to unduplicate similar reports, potentially resulting in a higher number of reports than actual events. 3. Reported death and injury events may only be associated with the reported device but not necessarily attributed to the device. Memo: H-IT Safety Issues 4 Correct identification by the reporter of the manufacturer name is convoluted by the inability to discern the manufacturer of the actual H-IT system versus the device it supports. 5 The volume of MDR reporting to MAUDE may be impacted by a lack of understanding the reportability of H-IT safety issues and enforcement of such reporting.</div></blockquote><div dir="ltr">   If HIT were VIOXX or Phen-Fen, the class action lawsuits would likely be starting already. (Note: for more on why there is a scarcity of data on HIT related adverse events, see my paper "Remediating an Unintended Consequence of Healthcare IT: A Dearth of Data on Unintended Consequences of Healthcare IT" at <a href="http://www.scribd.com/doc/28747771/Remediating-an-Unintended-Consequence-of-Healthcare-IT-A-Dearth-of-Data-on-Unintended-Consequences-of-Healthcare-IT">this Scribd link</a>. This paper was not accepted on first draft by the medical informatics peer review process. I received anonymous review comments such as one that paradoxically stated that the paper "did not contain anything that could not be read in any big city newspaper", an odd comment indeed considering the topic. On that basis I decided not to attempt a revision but to post the paper publicly. -- SS) One has to ask why this internal FDA report has not been made public until the Huffington Post article, nor been acted upon vigorously. The term of art is "double standard" compared to pharmaceuticals and other medical devices. When the NEJM starts publishing unreferenced statements of absolute certainty like this from ONC Chair Blumenthal: </div><blockquote style="margin-bottom: 0px; margin-top: 0px;"><div dir="ltr">The widespread use of electronic health records (EHRs) in the United States is inevitable. EHRs will improve caregivers’ decisions and patients’ outcomes. Once patients experience the benefits of this technology, they will demand nothing less from their providers. Hundreds of thousands of physicians have already seen these benefits in their clinical practice. </div></blockquote> <div dir="ltr"> and the HuffPo Investigative Fund quotes him as follows: </div><div dir="ltr"></div><blockquote style="margin-bottom: 0px; margin-top: 0px;"><div dir="ltr">“We know that every study and every professional consensus process has concluded that electronic health systems strongly and materially improve patient safety. And we believe that in spreading electronic health records we are going to avoid many types of errors that currently plague the healthcare system,” Blumenthal said when unveiling new regulations in Washington on July 13.</div></blockquote><div dir="ltr"></div><div dir="ltr">   ... a statement easily demonstrable to be without merit, in fact, then one has to wonder <a href="http://hcrenewal.blogspot.com/2010/07/new-england-journal-on-meaningful-use.html" style="font-weight: bold;" target="_blank">where science has gone</a>. One also has to wonder if someone is short-circuiting the FDA's role in regulating this technology.Could Blumenthal (in essence a family doctor), Sibelius (a trial lawyer), DeParle, or others, or the White House itself be telling FDA how to conduct its business? Are they impeding FDA's regulatory role in the irrationally exuberant multi-billion $$$ race to HIT utopia? Finally, it is my belief that numerous health IT/medical informatics academics and talking heads who've steadfastly avoided the issue of health IT-related patient harm, or scoffed at it in legally-discoverable forums, might find themselves as defendants in upcoming plaintiff lawsuits. "Knew, or should have known" is the phrase that might apply. As I learned from my pre-informatics Transit Authority medical management experience, juries will likely not take kindly to academic and marketing arguments akin to Scott Adam's sarcastic example of the logical fallacy of "ignoring all anecdotal evidence":</div><div dir="ltr"> <blockquote>"I always get hives immediately after eating strawberries. But without a scientifically controlled experiment, it's not reliable data. So I continue to eat strawberries every day, since I can't tell if they cause hives." </blockquote></div><div dir="ltr"></div><div dir="ltr">-- SS</div>

Internal FDA memorandum of Feb. 23, 2010 to Jeffrey Shuren on HIT risks. Smoking gun? I report, you decide.

From the aforementioned Huffington Post Investigative Fund article " FDA, Obama Digital Medical Records Team at Odds over Safety Overs...

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More on Huffington Post Investigative Fund: "FDA, Obama Digital Medical Records Team at Odds over Safety Oversight"

Re: today's Huffington Post Investigative Fund article "<a href="http://huffpostfund.org/stories/2010/08/fda-obama-digital-medical-records-team-odds-over-safety-oversight">FDA, Obama Digital Medical Records Team at Odds over Safety Oversight</a>." (I'd written some preliminary comments at an earlier post entitled "<a style="font-style: italic;" href="http://hcrenewal.blogspot.com/2010/08/huffington-post-investigative-fund-fda.html">Huffington Post Investigative Fund: FDA, Obama Digital Medical Records Team at Odds over Safety Oversight</a>.") First, some relatively obvious questions about the Cerner health IT crashes at the <a href="http://www.trinity-health.org/index.htm">Trinity Health System</a> chain of hospitals featured in the story: <ul><li>How many patients were affected? Is the number actually known?</li><li>Were affected patient charts corrected? </li><li>What restrictions, if any, have been placed on physicians, other clinicians, employees, contractors, staff, etc. about speaking to the press on the Trinity Health HIT malfunctions?</li><li>If any restrictions were placed, are they in violation of Joint Commission Safety Standards as in my July 22, 2009 JAMA letter to the editor "Health Care Information Technology, Hospital Responsibilities, and Joint Commission Standards" <a href="http://jama.ama-assn.org/cgi/content/extract/302/4/382">at this link</a>?</li><li>Did this healthcare system sign "hold harmless" clauses with Cerner, as per Koppel and Kreda's 2009 JAMA article "Health Care Information Technology Vendors' Hold Harmless Clause - Implications for Patients and Clinicians, JAMA 2009;301(12):1276-1278, at <a href="http://jama.ama-assn.org/cgi/content/extract/301/12/1276">this link</a>? </li><li>Did this healthcare system sign a gag clause with Cerner, the vendor of their affected systems according to the Huffington Post article?</li><li>Medical adverse events from medical record errors can occur quickly, or be more delayed. If patient harm comes of the IT errors that occurred, will the healthcare system file a public report?</li></ul> Now, on to some specific comments and observations on the Huffington Post Investigative Fund article. The Huffington Post article begins: <blockquote>Computers at a major Midwest hospital chain went awry on June 29, posting some doctors’ orders to the wrong medical charts in a few cases and possibly putting patients in harm’s way. The digital records system “would switch to another patient record without the user directing it to do so,” said Stephen Shivinsky, vice-president for corporate communications at Trinity Health System. Trinity operates 46 hospitals, most in Michigan, Iowa and Ohio.</blockquote> The bolded passage sounds like obfuscatory PR language, as if the EMR system changed the window focus to another patient's window (people do this all the time when they have multiple windows open in a GUI). If so, that would not be a major problem - the user would just switch back via clicking on the desired window. Let's state what it sounds like the problem really was with crystal clarity: Data a clinician entered into the window of primary focus (say, on Mary Jones) would end up in the electronic record of a window that was not the window of primary focus and in the background (say, that of Tom Smith). The clinician would be unaware this had occurred, and two errors would then occur. The first error was that appropriate data would be missing for Mary. The second is that inappropriate data would be present for Tom. These events put both patients at risk of medical error. <blockquote>Less than two weeks later, an unrelated glitch caused Trinity to shut down its $400 million system for four hours at 10 hospitals in the network because electronic pharmacy orders weren’t being delivered to nurses for dispensing to patients, he said.</blockquote> Was this 'glitch' [a code word for "we are not in control of our system, it is in control of us" - ed.] related to the problem above? If so, that would suggest major system problems deep within its code. If not, it suggests lax overall quality control of this IT. <blockquote> “As soon as it was brought to our attention, we moved to fix the problem,” Shivinsky said of Trinity’s system </blockquote> This statement says nothing. One would not expect them to wait to fix a potentially dangerous problem. <blockquote>He said nobody was injured in either event, ...</blockquote> As in my prior post, the correct statement would be: <blockquote>Nobody was injured, yet, due to the errors. </blockquote> ... the Cerner Corp. system now works properly, Does that mean all the problems are fixed? The article implies not via its ending where Shivinsky is quoted that: <blockquote>... Meanwhile technicians are still trying to figure out the root cause. “We’ll get to the bottom of it and fix it,” he said. </blockquote>By the way, I note the following employee reporting site on Cerner's environment: <a href="http://www.jobvent.com/cerner-corp--job-reviews-C1174">link</a>. Could this be a factor in Richard Granger, the former head of the UK's NHS national IT programme <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/cases/?loc=cases&sloc=granger_speaks_out">saying that</a>: <blockquote> "Sometimes we put in stuff that I'm just ashamed of ... Some of the stuff that Cerner has put in recently is appalling ... Cerner and prime contractor Fujitsu had not listened to end users ... Failed marriages and co-dependency with subcontractors ... A string of problems ranging from missing appointment records, to inability to report on wait times ... Almost a dozen cancelled go-live dates ... Stupid or evil people ... Stockholm syndrome -identifying with suppliers' interests rather than your own ... A little coterie of people out there who are "alleged experts" who were dismissed for reasons of non-performance."</blockquote> I can only wonder. <blockquote>... and the hospital chain determined that “technician error” led to the system shutdown and that the mixing up of patients was the result of a “Cerner coding issue” involving software that occurred after an upgrade.</blockquote> What was the "technician" doing that led to the shutdown, what was the technician's background and qualifications to be doing it to a mission critical medical device? Further, what, exactly, was the "Cerner coding issue?" Was it Cerner's fault? Trinity's? Both? Were other organizations using the same software similarly affected? How will other healthcare organizations learn if the cause of the problems is not revealed? <blockquote>Even absent any harm to patients, such incidents underscore possible risks faced by even large health organizations that have eagerly embraced new medical software to track patient records and treatment. As the Obama administration ramps up plans to create a digital medical file for every American by 2014 – at an anticipated tab to taxpayers of up to $27 billion – technology’s boosters tend to tout its potential benefits to patients and ability to slow runaway medical costs.</blockquote> That's not been my observation. Look at the UK for instance: <blockquote>The <st1:place st="on"><st1:country-region st="on">UK</st1:country-region></st1:place> Public Accounts Committee report on disastrous problems in their £12.7 billion national EMR program is <a href="http://www.publications.parliament.uk/pa/cm200809/cmselect/cmpubacc/153/15304.htm">here</a>. <o:p></o:p> Gateway reviews of the UK National Programme for IT from the Office of Government Commerce (OGC) are <a href="http://www.connectingforhealth.nhs.uk/about/foi">here</a> (released under the UK’s Freedom of Information Act), and a summary of 16 key points is <a href="http://www.computerweekly.com/blogs/tony_collins/2009/06/16-key-points-in-gateway-revie.html">here</a>.</blockquote> I wish there were strong documentary evidence on the latter point about major savings, and that there wasn't evidence to the contrary. The healthcare system doesn't have enough spare capital to throw away on the hopes some touted technology (from which an industry stands to make billions) is a panacea. <blockquote> Yet despite the high political and financial stakes, the administration has established no national mandatory monitoring procedure for the new devices and software. That no process exists to report and track errors, pinpoint their causes and prevent them from recurring is largely the result of two decades of resistance by the technology industry, a review of government records and interviews by the Huffington Post Investigative Fund shows. The industry argues that even with flaws, digital systems are an improvement over current paper records.</blockquote> That is no excuse for decades of toleration of the flaws. It is an amoral position. As at my July 28 post <a href="http://hcrenewal.blogspot.com/2010/07/open-question-on-moral-authority-and.html">"An Open Question on Moral Authority and Healthcare IT"</a>, it is playing God. The HuffPo article continues: <blockquote> “There’s an assumption that just because you have an electronic system, it’s going to be safer, so people let down their guards,” said Vimla Patel, who directs research on the topic at the University of Texas Health Science Center in Houston.</blockquote> It's not an "assumption." This meme has been pushed so long by the HIT industry and its irrationally exuberant, uncritical supporters, it's become an accepted statement of fact - as per my July 14 post <a href="http://hcrenewal.blogspot.com/2010/07/new-england-journal-on-meaningful-use.html">"Science or Politics? The New England Journal and "The 'Meaningful Use' Regulation for Electronic Health Records"</a> where the Chairman of ONC states it as fact in the New England Journal of Medicine, with nary a footnote to back it up: <blockquote>Blumenthal - The widespread use of electronic health records (EHRs) in the United States is inevitable. EHRs will improve caregivers’ decisions and patients’ outcomes. Once patients experience the benefits of this technology, they will demand nothing less from their providers. Hundreds of thousands of physicians have already seen these benefits in their clinical practice.</blockquote> That's pretty definitive. If there's a trace of doubt, I don't see it. <blockquote>Monitoring could help others learn from problems faced by early users of the technology, which is being sold nationally, or how they were remedied. Shivinsky said he wasn’t sure if federal officials had been notified of the difficulties at Trinity — or would be. No rule requires it.</blockquote> Why is there no rule? What if this were a medical device such as a CT scanner, or heart defibrillator? Why does health IT get special accommodation when it is now a regulator and governor of clinician communications and actions, placed in between clinician and patient? <blockquote>Almost a month after the first event at Trinity, David Blumenthal, the government’s top medical health information technology official, didn’t know about it. “First I’ve heard about it,” Blumenthal said when told by a reporter July 20, as he left a Capitol Hill hearing. Since then, Blumenthal has declined to discuss the incident or its implications. </blockquote> That's perhaps because it conflicts with his other assertions on health IT technological determinism, noted above. How many other "events" is he aware of? <blockquote>Kelli Christman, a spokesman for Cerner, the manufacturer of the software used at Trinity, did not respond to repeated emails and phone calls over the past week seeking comment.</blockquote> What are they hiding? Perhaps other affected healthcare systems? <blockquote>... Many industry groups contend that FDA regulation would “stifle innovation” and stall the national drive to wire up American medicine. That view resonates among the dozens of health information technology experts serving as consultants to Blumenthal’s office and on advisory groups. Blumenthal also has been skeptical of the need for regulation and argued that even if some miscues occur, digital systems are far less prone to error than paper ones.</blockquote> In an industry with contractual gag clauses and clinician fear of speaking about HIT problems (e.g., of retaliation by hospital officials), how can anyone be sure of this? Is this a scientific statement, or a marketing position? See may paper <a href="http://www.scribd.com/doc/28747771/Remediating-an-Unintended-Consequence-of-Healthcare-IT-A-Dearth-of-Data-on-Unintended-Consequences-of-Healthcare-IT" class="title">"Remediating an Unintended Consequence of Healthcare IT: A Dearth of Data on Unintended Consequences of Healthcare IT</a>" for more on this issue. <blockquote> “We know that every study and every professional consensus process has concluded that electronic health systems strongly and materially improve patient safety. And we believe that in spreading electronic health records we are going to avoid many types of errors that currently plague the healthcare system,” Blumenthal said when unveiling new regulations in Washington on July 13.</blockquote> This statement is without merit, as per my prior post "<a href="http://hcrenewal.blogspot.com/2010/08/huffington-post-investigative-fund-fda.html">Huffington Post Investigative Fund: FDA, Obama Digital Medical Records Team at Odds over Safety Oversight</a>." Further: note to Dr. Blumenthal: <a href="http://www.s8int.com/crichton.html">Consensus is not science</a>: <blockquote> [Chrichton, Caltech Michelin Lecture, 2003] ... I want to pause here and talk about this notion of consensus, and the rise of what has been called consensus science. I regard consensus science as an extremely pernicious development that ought to be stopped cold in its tracks. Historically, the claim of consensus has been the first refuge of scoundrels; it is a way to avoid debate by claiming that the matter is already settled. Whenever you hear the consensus of scientists agrees on something or other, reach for your wallet, because you're being had. Let's be clear: the work of science has nothing whatever to do with consensus. Consensus is the business of politics. Science, on the contrary, requires only one investigator who happens to be right, which means that he or she has results that are verifiable by reference to the real world. In science consensus is irrelevant. What is relevant is reproducible results. The greatest scientists in history are great precisely because they broke with the consensus. There is no such thing as consensus science. If it's consensus, it isn't science. If it's science, it isn't consensus. Period</blockquote> Blumenthal goes on: <blockquote>In public remarks that day, Blumenthal said he “expects” an eventual certification process for the digital systems to “collect information about the problems that occur with the implementation of electronic health records, if any.” He did not say when that would happen. </blockquote> Eventual? Why not NOW, considering that the HIT industry has been in business for decades? The infrastructure for such reporting already exists, such as the <a href="http://www.fda.gov/Safety/MedWatch/default.htm">FDA MedWatch</a> system and <a href="http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/search.cfm">Manufacturer and User Facility Device Experience</a> (MAUDE) database - where, by the way, an HIT-related death was reported (<a href="http://www.ischool.drexel.edu/faculty/ssilverstein/cases/?loc=cases&sloc=maude_death">link</a>). Imagine the aviation, nuclear energy industry or pharma making such outrageous statements about getting around to collecting information on potentially hazardous flaws "eventually." <blockquote>In a later interview, Blumenthal said “safety concerns are not being ignored,” but wouldn’t comment further.</blockquote> Yes, they are being ignored. Worse, they're being suppressed as in this case example, <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/cases/?loc=cases&sloc=lawsuit">"A Lawsuit Over Healthcare IT Whistleblowing and Wrongful Discharge: Malin v. Siemens Healthcare</a>." <blockquote> ... Dozens of other health information technology insiders, from academics to front-line users who believe digital medical records can promote better and cheaper health care, told the Investigative Fund in interviews that they nonetheless fear safety issues will mount as doctors and hospitals move quickly to install the systems and collect stimulus checks.</blockquote> Just anecdotal, according to ONC and others. <blockquote>“People just assume that computers will make things safer,” said Nancy Leveson, a safety engineering expert at Massachusetts Institute of Technology. “While they can be designed to eliminate certain kinds of hazards, they increase others and sometimes they introduce new types of hazards.”</blockquote> This is a principle direct from the discipline of <a href="http://rkcsi.indiana.edu/archive/SI/Arts/SI_report_Aug_14.doc">Social Informatics</a>. Social Informatics (SI) refers to the body of research and study (e.g,, as collected <a href="http://rkcsi.indiana.edu/">here</a>) that examines social aspects of computerization, including the roles of information technology in social and organizational change, the uses of information technologies in social contexts, and the ways that the social organization of information technologies is influenced by social forces and social practices. <blockquote>Some experts are calling for closer government monitoring of the systems to protect the public. “We need to have some scrutiny at the front end and have an approval process to make sure they are safe before they’re deployed,” said Sharona Hoffman, a law professor at Case Western Reserve University, who has written about the issue in academic journals.</blockquote> I am one of those experts, and I agree. <blockquote>... In 2004, digital record keeping got a boost when President George Bush signed an executive order to create a digital medical file for every American within a decade, a goal officials said at the time they could reach “without substantial regulation.” “The time wasn’t right at that time to move forward or the support wasn’t there (for safety regulations),” said Robert Kolodner, who ran the national coordinator’s office during some of the Bush years.</blockquote> Again, I ask - why the hell not? When is a good time to discuss healthcare and HIT safety? Would such attitudes be tolerated in other industries? I dare say, hell no. <blockquote>Edward H. Shortliffe, president of the American Medical Informatics Association and a longtime industry figure, agreed that safety issues weren’t a “primary concern” as tech companies began to expand their offerings.</blockquote> That is a startling revelation - it could be the basis for medical malpractice plaintiff lawsuits on the basis of negligence, all the way to <a href="http://www.answers.com/topic/criminal-negligence">criminally negligent homicide</a> if a patient dies of an HIT-related event. <blockquote><a style="font-weight: bold;" href="http://www.answers.com/topic/criminal-negligence">Criminal negligence</a>: The failure to use reasonable care to avoid consequences that threaten or harm the safety of the public and that are the foreseeable outcome of acting in a particular manner.</blockquote> The HuffPo article further observes: <blockquote> Earlier this year, the [health IT] trade group convened an expert panel to study the issues for the first time, but its findings have yet to be made public. Shortliffe said he didn’t think the organization would take a stand on government regulation of the industry, but said: “We recognize that there are significant challenges that the field as a whole is facing.”</blockquote> The "first time" in an industry messing with people's medical care for decades? How is this possible? <blockquote>... ONC director Blumenthal, the point man for the administration, has called the FDA’s injury findings “anecdotal and fragmentary.” </blockquote> Just how many "anecdotes" do we need in an industry that places gag clauses on health IT users? [March 2011 addendum - see thoughts on health IT "anecdotes" at this posting: <a href="http://hcrenewal.blogspot.com/2011/03/those-who-dismiss-heathcare-and-healht.html">Those Who Dismiss Healthcare (and Healthcare IT) Adverse Events Reports as Mere "Anecdotes" Have Lost, Supreme Court-Style</a> - ed.] <blockquote> He told the Investigative Fund that he believed nothing in the report indicated a need for regulation [i.e., absence of evidence in a tight-lipped industry as evidence of absence - ed.] Yet others see anecdotes as a starting point for a more methodical look at problems that arise.</blockquote> Who is more attuned to risk mitigation when they see red flags? Who are the clinician scientists, and who are the "see no evil, hear no evil, speak no evil" politicians? <blockquote>The same day that Blumenthal, Sebelius and other federal health officials unveiled their digital records plan in Washington, an obscure government agency held a conference less than 20 miles away in suburban Maryland to discuss the state of quality controls. Ben-Tzion Karsh, an engineering professor at the University of Wisconsin in Madison who attended the National Institute of Standards and Technology conference said he heard a “broad consensus” among experts that electronic medical records need to function better and safer. “The truth is that we do not at this time know what would make an EHR (electronic health record) safe,” he said. Others said that despite the rosy view taken by many political figures in Washington, many systems on the market today aren’t designed in ways that prevent and limit new errors—and that nobody is holding the industry accountable.</blockquote><div style="overflow: hidden; color: rgb(0, 0, 0); background-color: transparent; text-align: left; text-decoration: none; border: medium none;"> </div>Again I ask: how is this possible after decades of this industry's selling of products to hospitals for use on actual patients? Also, the simple question arises: is this technology truly ready for the ambitious national roll out plans of the past two administrations? I've touched on many of these issues in past years on this blog and at my <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/cases">academic website on HIT problems</a>. I see a clear runaway train and train wreck headed down the tracks. The next few years in health IT should prove interesting indeed. -- SS

More on Huffington Post Investigative Fund: "FDA, Obama Digital Medical Records Team at Odds over Safety Oversight"

Re: today's Huffington Post Investigative Fund article " FDA, Obama Digital Medical Records Team at Odds over Safety Oversight ....

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A Few Additional Comments on the GE Radiation Debacle

Roy Poses beat me to posting about the General Electric CT over-irradiation debacle (<a href="http://hcrenewal.blogspot.com/2010/08/ge-dont-know-much-about-radiation.html">GE: Don't Know Much About Radiation Safety, Don't Know Much About Physics</a>). I am going to add two points: Point 1: The National Research Council in its <a href="http://www8.nationalacademies.org/onpinews/newsitem.aspx?RecordID=12572">2009 report on health IT</a> warned that "current approaches to healthcare IT are insufficient", and one of the major caveats was that: <blockquote> ... greater emphasis should be placed on information technology that provides health care workers and patients with cognitive support, such as assistance in decision-making and problem-solving.</blockquote> In fact the lack of cognitive support for clinicians was one of the report's major themes. "Cognitive support" by definition means producing devices (whether physical or virtual) that are intended for busy clinical settings where situations often resemble a madhouse - not calm, solitary office environments (borrowing from Joan Ash's <a href="http://www.eurekalert.org/pub_releases/2003-11/ohs-mhd112403.php">findings on CPOE flaws</a>): <blockquote>"Many information systems simply don't reflect the health care professional's hectic work environment with its all too frequent interruptions from phone calls, pages, colleagues and patients. Instead these are designed for people who work in calm and solitary environments. This design disconnect is the source of both types of silent errors …Some patient care information systems require data entry that is so elaborate that time spent recording patient data is significantly greater than it was with its paper predecessors," the authors wrote. "What is worse, on several occasions during our studies, overly structured data entry led to a loss of cognitive focus by the clinician." </blockquote> It does not mean, as reported on July 31, 2010 in the <a href="http://www.nytimes.com/2010/08/01/health/01radiation.html?pagewanted=3&_r=1">New York Times</a>, that designers and vendors of these medical devices should take the stance of blaming the user: <blockquote>A GE spokesman, Arvind Gopalratnam, said the way scanners were programmed was “determined by the user and not the manufacturer.” GE, he added, has no record of Glendale seeking its help setting up the new procedure in 2009. ... GE says the hospitals should have known how to safely use the automatic feature. Besides, GE said, the feature had “limited utility” for a perfusion scan because the test targets one specific area of the brain, rather than body parts of varying thickness. In addition, experts say high-clarity images are not needed to track blood flow in the brain. GE further faulted hospital technologists for failing to notice dosing levels on their treatment screens. But representatives of both hospitals said GE trainers never fully explained the automatic feature. </blockquote> Imagine the reaction if Boeing blamed pilots for collisions if those pilots, busy with other matters, were only alerted to an impending collision via a range reading on their cluttered instrument panel - rather than a LOUD AUDIBLE ALARM - such as WARNING, WARNING, COLLISION IMMINENT. Point 2: What's really missing here was attention to cognitive support for busy clinicians. This, of course, requires proper senior management - senior management with the appropriate expertise. Proper senior management then controls talent management down the chain of an organization. If the leaders "don't know nothing 'bout trigonometry", they will be less likely to put mathematicians in appropriate leadership roles. If management doesn't understand Medical Informatics, they will be less likely to put informaticists into leadership roles as well. One major focus of Medical Informatics is cognitive support of busy clinicians in their all too real-world environments. Why might the latter point be relevant at GE? In 1999 after working for a competitor of GE, Comdisco Healthcare Group, who among other business aspects reconditioned and resold capital equipment such as CT scanners, I wrote this in an essay on "<a href="http://www.ischool.drexel.edu/faculty/ssilverstein/informaticsmd/infordef1.htm#isnot">what medical informatics is not</a>": <blockquote>... I've noted a number of large vendors and even national medical organizations whose so-called "Medical Informatics Directors" had neither clinical backgrounds nor training in medical informatics (nor in information science of any kind). MIS managers, social workers, and clinicians with no more experience than some tinkering with a home Macintosh can be found as "Directors of Medical Informatics" in the (unfortunately) unregulated healthcare IT industry. Sometimes the term is used as a sales slogan. General Electric displayed a huge banner over their booth proclaiming themselves "the world leader in Radiology Informatics" at the 1999 <a href="http://www.rsna.org/">Radiological Society of North America</a> (RSNA) conference in Chicago. Unfortunately, nobody present, including sales, management, and engineering representatives, could explain to me what that term meant. They actually said they did not know. I had only identified myself as a physician at that point, not as a medical informatics professional, and expressed incredulity on nobody being able to explain the banner to me. Under pressure, one GE engineer offered the statement "I think it has something to do with computers attached to our x-ray machines." </blockquote> It's now 2010. It seems GE still may not know what Medical Informatics is. Handing busy clinical end users a revolver with a single bullet in the chamber, and asking them to play Russian Roulette under busy circumstances with a warning to "check the chamber carefully each time before you pull the trigger", is simply unacceptable for computerized medical device design. -- SS

A Few Additional Comments on the GE Radiation Debacle

Roy Poses beat me to posting about the General Electric CT over-irradiation debacle ( GE: Don't Know Much About Radiation Safety, Don...

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GE: Don't Know Much About Radiation Safety, Don't Know Much About Physics

Don't know much about history Don't know much biology Don't know much about a science book Don't know much about the french I took. (<a href="http://artists.letssingit.com/sam-cooke-lyrics-wonderful-world-wzxlmlw">Wonderful World</a>, sung by Sam Cook) This is becoming the theme song for executives of health care corporations.  We have posted about a series of cases in which major health care corporations suddenly seemed unable to carry out their core business functions, a phenomenon I am going to start calling "core business incompetence."  Some recent examples: -  Baxter International apparently failed to check the purity of heparin it bought from a foreign supplier; the contaminated heparin resulted in approximately 81 deaths. (See post <a href="http://hcrenewal.blogspot.com/2010/07/more-about-what-we-dont-know-about.html">here</a>.) -  A major Genzyme manufacturing facility had multiple quality problems, resulting in the production of a very expensive, but contaminated biologic medication. (See post <a href="http://hcrenewal.blogspot.com/2010/05/genzyme-settles.html">here</a>.) -  Three Johnson and Johnson manufacturing facilities had multiple quality problems, resulting in the production of contaminated batches of over-the-counter medications for children. (See post <a href="http://hcrenewal.blogspot.com/2010/07/are-ill-informed-leaders-cause-of-drug.html">here</a>.) -  Aetna made mathematical errors in computing the rates it proposed charging; WellPoint made computer errors that exposed sensitive policy-holder information.  (See blog post <a href="http://hcrenewal.blogspot.com/2010/06/wellpoint-dont-know-much-about-computer.html">here</a>.) Manufacturing pure, unadulterated medicines is a core function of a drug company.  Correctly calculating policy-costs and correctly handling patient data are core functions of health insurance companies.  But in the above cases, three large pharmaceutical companies and two large insurance companies could not perform these core functions competently. Radiation Sickness from CT Scans In the last few days, more details of what appears to be another example of core incompetency afflicting a major health care organization has surfaced.  The details were <a href="http://www.nytimes.com/2010/08/01/health/01radiation.html">reported</a> by Walt Bogdanich in the New York Times. Here is the summary: <blockquote>When Alain Reyes’s hair suddenly fell out in a freakish band circling his head, he was not the only one worried about his health. His co-workers at a shipping company avoided him, and his boss sent him home, fearing he had a contagious disease. Only later would Mr. Reyes learn what had caused him so much physical and emotional grief: he had received a radiation overdose during a test for a stroke at a hospital in Glendale, Calif. Other patients getting the procedure, called a CT brain perfusion scan, were being overdosed, too — 37 of them just up the freeway at Providence Saint Joseph Medical Center in Burbank, 269 more at the renowned Cedars-Sinai Medical Center in Los Angeles and dozens more at a hospital in Huntsville, Ala. The overdoses, which began to emerge late last summer, set off an investigation by the Food and Drug Administration into why patients tested with this complex yet lightly regulated technology were bombarded with excessive radiation. After 10 months, the agency has yet to provide a final report on what it found. But an examination by The New York Times has found that radiation overdoses were larger and more widespread than previously known, that patients have reported symptoms considerably more serious than losing their hair, and that experts say they may face long-term risks of cancer and brain damage. </blockquote> So not to mince words, in this sad case, many patients seem to have been subject to radiation poisoning from a diagnostic x-ray procedure (not from radiation therapy for cancer.)  Most people (and physicians) may have not previously thought that radiation poisoning was a possible harm from a single diagnostic CT scan. A Design Failure? Moreover, it appears that the radiation poisoning did not result from some freak accidents or malfunction: <blockquote>The review also offers insight into the way many of the overdoses occurred. While in some cases technicians did not know how to properly administer the test, interviews with hospital officials and a review of public records raise new questions about the role of manufacturers, including how well they design their software and equipment and train those who use them. </blockquote> Also, <blockquote>None of the overdoses can be attributed to malfunctions of the CT scanners, government officials say. At Glendale Adventist Medical Center, where Mr. Reyes and nine others were overdosed, employees told state investigators that they consulted with GE last year when instituting a new procedure to get quicker images of blood flow, state records show. But employees still made mistakes. As a result, hospital officials said, a feature that technicians thought would lower radiation levels actually raised them. Cedars-Sinai gave a similar explanation. 'There was a lot of trust in the manufacturers and trust in the technology that this type of equipment in this day and age would not allow you to get more radiation than was absolutely necessary,' said Robert Marchuck, the Glendale hospital’s vice president of ancillary services. A GE spokesman, Arvind Gopalratnam, said the way scanners were programmed was 'determined by the user and not the manufacturer.' GE, he added, has no record of Glendale seeking its help setting up the new procedure in 2009. Most of the known overdoses, including the biggest, occurred on scanners made by GE Healthcare. At two hospitals that use Toshiba scanners — Los Angeles County-U.S.C. and South Lake in Florida — officials said the manufacturer suggested machine settings that ultimately produced too much radiation. Representatives of Toshiba agreed to be interviewed in their California office but abruptly canceled. </blockquote> In particular, <blockquote>To this day, no one at Cedars-Sinai knows who programmed the scanners that delivered the overdoses, officials there say. But in written statements to The Times, hospital officials said they had figured out how they might have occurred. Normally, the more radiation a CT scan uses, the better the image. But amid concerns that patients are getting more radiation than necessary, the medical community has embraced the idea of using only enough to obtain an image sufficient for diagnosis. To do that, GE offers a feature on its CT scanner that can automatically adjust the dose according to a patient’s size and body part. It is, a GE manual says, 'a technical innovation that significantly reduces radiation dose.' At Cedars-Sinai and Glendale Adventist, technicians used the automatic feature — rather than a fixed, predetermined radiation level — for their brain perfusion scans. But a surprise awaited them: when used with certain machine settings that govern image clarity, the automatic feature did not reduce the dose — it raised it. As a result, patients at Cedars-Sinai received up to eight times as much radiation as necessary, while the 10 overradiated at Glendale received four times as much, state records show. GE says the hospitals should have known how to safely use the automatic feature. Besides, GE said, the feature had 'limited utility' for a perfusion scan because the test targets one specific area of the brain, rather than body parts of varying thickness. In addition, experts say high-clarity images are not needed to track blood flow in the brain. GE further faulted hospital technologists for failing to notice dosing levels on their treatment screens. But representatives of both hospitals said GE trainers never fully explained the automatic feature. In a statement, Cedars-Sinai said that during multiple training visits, GE never mentioned the 'counterintuitive' nature of a feature that promises to lower radiation but ends up raising it. The hospital also said user manuals never pointed out that the automatic feature was of limited value for perfusion scans. A better-designed CT scanner, safety experts say, might have prevented the overdoses by alerting operators, or simply shutting down, when doses reached dangerous levels. </blockquote> Summary: Core Incompetence To summarize, GE diagnostic CT scan machines apparently were designed so that they could deliver so much radiation that their use could cause radiation sickness. The machines had no built in safeguards to limit the dose of radiation. Users, that is, X-ray technicians, could program the machine so as to deliver dangerous radiation doses, but GE did not warn them that this was the case, nor provide a machine feature that would give a real-time warning of incipient overdose. Thus it appears that GE, which has been <a href="http://www.boston.com/business/technology/articles/2010/08/03/ge_intel_form_chronic_care_venture/">described</a> as "the world’s biggest maker of health care imaging and information technology systems," failed in its core function of designing and manufacturing safe diagnostic x-ray machines. (Presumably the same might be said of Toshiba, but the NY Times report does not include so much detail about problems with its machines.) A straightforward explanation of the magnitude of the core incompetence was provided by one of the patients who got radiation sickness: <blockquote>To Mr. Heuser, it is unconscionable that equipment able to deliver such high radiation doses lacks stronger safety features. 'When you are in a car and it backs up, it goes beep, beep, beep,' he said. 'If you fill the washing machine up too much, it won’t work. There is no red light that says you are overradiating.' </blockquote> It really seems like we are seeing an epidemic of core incompetence by major US health care corporations. I can only speculate about why this occurring. One explanation is that the organizations may be lead by people who do not understand the health care context, and do not understand the scientific, engineering, and technical issues involved with core competence. Many health care corporations have come to be lead by people with no experience or background in relevant areas. For example, the current, and often acclaimed CEO of GE is <a href="http://www.ge.com/company/leadership/ceo.html">Jeffrey Immelt</a>, who "earned a B.A. degree in applied mathematics from Dartmouth College in 1978 and an M.B.A. from Harvard University in 1982." The leader of GE Healthcare is <a href="http://www.ge.com/company/leadership/bios_exec/john_dineen.html">John Dineen</a>, who "is a graduate of the University of Vermont where he earned Bachelor's degrees in biology/genetics and computer science," and "joined GE in 1986 as a telecommunications engineer." Another, even more speculative explanation is that many major US and global health care organizations seem to have been infected with the virus of putting short-term financial results ahead of everything else, leading to cutting of costs and particularly human expertise in the areas most core to the organizations' functions, and pushing for hurried results even at the expense of clear thinking, carefully engineering, and consideration of the effects on patients and other humans of the resulting mistakes. Hopefully, further investigation will reveal more about what went wrong in this case. Meanwhile, I say again, again, again,... As long as "imperial CEOs" can continue to get extremely rich while presiding over incompetence and stupidity, if not worse), we can expect the foolishness to continue. Meanwhile, the foolishness drives up costs and drives down quality of health care for the poor suffering patients, let alone the physicians and other health care professionals who must deal with it. To really reform health care, we need to provide incentives for competent, honest leadership, and make that leadership accountable for its shortcomings. Postscript - Why the Rush to Aggressive Treatment? The NY Times article described the rush to get one of the afflicted patients to the CT scan: <blockquote>on the morning of July 4, when a 52-year-old executive producer of films, H. Michael Heuser, arrived in the emergency department with stroke symptoms. A 'code brain' was immediately called, signaling a life-or-death situation. A blood clot in the brain can be dissolved with medicine, but doctors must do it within several hours, before brain cells die from a lack of oxygen. So Mr. Heuser was rushed into a room with several CT scanners, where he underwent one brain perfusion study and at least one more later. A CT perfusion scan, which lasts about 45 seconds, can identify a stroke through a series of blood flow images. Mr. Heuser did have a stroke, from which he would recover. But other parts of his body inexplicably began to break down. </blockquote> However, there is no clear evidence that such a rapid and drastic approach is really that good for patients. A recently updated <a href="http://www.ncbi.nlm.nih.gov/pubmed/18843603">Cochrane review </a>concluded: "In patients with acute ischaemic stroke, immediate anticoagulant therapy is not associated with net short or long-term benefit. Treatment with anticoagulants reduced recurrent stroke, deep vein thrombosis and pulmonary embolism, but increased bleeding risk. The data do not support the routine use of any the currently available anticoagulants in acute ischaemic stroke." However, many physicians seem to advocate the drastic approach based on some controlled trials that showed at best small improvements in average neurological function for patients receiving rapid anti-coagulation (and which were done before anyone thought about radiation sickness as a possible harm of the approach.) Once again, an aggressive, technological, expensive approach, possibly advocated by people who stood to gain financially from it, may not be as advantageous as it appears.

GE: Don't Know Much About Radiation Safety, Don't Know Much About Physics

Don't know much about history Don't know much biology Don't know much about a science book Don't know much about the french ...

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