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News Flash: 1945 Law Allows Concentration of Power in US Health Insurance

Last week, some media reports noted that US Congressional Democrats countered an insurance industry study suggesting health care reform would cost much more than estimated by threatening a repeal of the McCarran-Ferguson Act's anti-trust exemption for health insurance. For example, <a href="http://prescriptions.blogs.nytimes.com/2009/10/14/for-insurers-a-question-of-trust-and-antitrust/">in the New York Times Prescriptions Blog</a>: <blockquote>In a rare appearance as a witness at a Senate hearing, the majority leader, Harry Reid of Nevada, told the Judiciary Committee on Wednesday that it should repeal a 1945 law that granted the insurance industry limited exemption to national antitrust laws by allowing states to regulate insurers. The law, the McCarran-Ferguson Act, is often cited by Mr. Reid and other critics of the health insurance industry as a reason why coverage can be so expensive for many people. They say the law allows insurers to monopolize markets and fix prices in ways that are usually illegal. 'Since 1945, the insurance industry has enjoyed exemption from federal antitrust laws because of the McCarran-Ferguson Act,' Mr. Reid said. 'Providing an exemption for insurance companies to antitrust laws has been anticompetitive and damaging to the American economy,' Mr. Reid continued. 'Health insurance premiums have continued to rise at a rapid rate, forcing businesses to cut back on health insurance coverage and forcing many families to choose between health insurance and basic necessities.' He added: 'Insurance companies have become so large they dominate entire regions of the country. They have become so powerful they block start-up businesses from entering the market, and they put smaller companies out of business. They have become so dominant that they dictate business practices. They are so influential that they exert tremendous influence over public policy.' </blockquote>Also, the chief anti-trust enforcement officer in Obama administration weighed in with similar sentiments, as reported by Bloomberg News <a href="http://www.philly.com/inquirer/world_us/20091015_Insurers__exemption_is_said_to_boost_costs.html">via the Philadelphia Inquirer</a>: <blockquote> Christine Varney, the Obama administration's chief antitrust enforcer, told lawmakers yesterday that repealing the insurance industry's antitrust exemption would spur competition and further the drive to control the cost of health insurance. Varney, head of the Justice Department's antitrust division, told the Senate Judiciary Committee that ending the exemption would 'allow competition to have a greater role in reforming health and medical malpractice insurance markets.' </blockquote> So why would this discussion be relevant to Health Care Renewal? First of all, the exemption of insurance companies from anti-trust laws (US laws designed to prevent monopolies and other anti-competitive business practices) may have allowed these companies to grow into business behemoths, and for individual companies to dominate local insurance markets. In some locales, businesses and individuals have very few health insurance policies available because only a few companies dominate the market. In fact, every recent year, the US American Medical Association (AMA) has put out a report on insurance market consolidation decrying concentration among power in local markets among few companies. For example, the <a href="http://www.ama-assn.org/ama/pub/news/news/health-insurers-consolidate.shtml">AMA news release </a>for the 2009 report said: <blockquote> The vast majority of health insurance markets in the U.S. are dominated by one or two health insurers, according to a new study by the American Medical Association (AMA) that examined insurer competition in markets across the country. Most alarmingly, in nearly all 314 metropolitan areas studied, there is evidence that patients and physicians have fewer options and are left vulnerable to the demands of the health insurer. </blockquote> So this does seem to be a case of concentration, if not necessarily abuse of power in health care. Why this is real news however, is that the 1945 McCarran-Ferguson Act, its baleful influence, and calls for its repeal are not old news. In fact, up to now, they have not been news, or part of health care policy discussions at all. My first response to the news articles above was "the McCarran what act?" I had never heard of this 64 year old law, and never heard it cited as an enabler of concentration of power in health insurance, and never heard a call for its repeal. Maybe that means I am no expert in this field. But, the first 10 pages of a Google Scholar search for the terms "McCarran Ferguson health insurance exemption" revealed precisely one article in the health care / services/ policy research literature that discussed this act (from 1998, in Health Affairs,(1) and without clearly relating the act to concentration of power in health insurance.) Similarly, a PubMed search, using the term "McCarran-Ferguson Act" produced nine articles, none in mainstream health care/ services/ policy research journals, much less general medical journals (three were in the Am J Law Med, 2 in AIDS Policy Law, one in Benefits Q, one in J Am Osteopath Assoc, one in J Pediatr Health Care, one in Am J Hosp Pharm, the most recent published in 2004, all the others in 1999 or earlier. There was nothing except the article above in Health Affars, nothing in Medical Care, nothing in Health Services Research, and nothing in any of the big general medical journals.) Therefore, maybe the 1945 McCarran-Ferguson Act was a major cause of consolidation in the health insurance market, and this consolidation may be an important contributor to high health care costs and poor health care access. But this notion apparently has not appeared in any major medical or health care/ services/ policy research journal in the last 20 years. If the McCarran-Ferguson Act has been around for 64 years, and is a major cause of rising health care costs and declining health care access, why has no one bothered to discuss it where any physician or health care/ policy researcher might see it? It seems that the failure to bring the McCarran-Ferguson Act into polite conversation is another example of the <a href="http://hcrenewal.blogspot.com/2007/08/bling-bling-poltical-correctness-and.html">anechoic effect</a>. We have noted again and again that for physicians or health care professionals to discuss certain aspects of our dysfunctional health care system, often aspects that relate high costs, declining access, and poor costs to concentration and abuse of power, is "just not done." So it seems like discussing how a federal law from another era barred government action to prevent concentration of power in the health care industry, concentration of power that made some people very rich, was "just not done." Of course, if there was any discussion of this law and its effects, maybe someone would have called for its repeal before 2009. Dr Aubrey Blumsohn provided <a href="http://scientific-misconduct.blogspot.com/2007/05/on-decorum-in-medicine.html">a reminder </a>from the UK to us in the US: ""the desire to maintain decorum and status in medicine seems also to overwhelm all standards of decency. Our profession is inclined to fixate on the irrelevant while ignoring some very bad things." If we really want to improve health care here in the US, and around the world, a modest beginning would be to begin open discussion of the various skeletons rattling around in the health care closet. Reference 1. Nichols LM, Blumberg LJ. A different kind of ‘New Federalism’? the Health Insurance Portability And Accountability Act of 1996. Health Aff 1998; 17 (3): 25. [Link <a href="http://healthaff.highwire.org/cgi/reprint/17/3/25">here</a>.]

News Flash: 1945 Law Allows Concentration of Power in US Health Insurance

Last week, some media reports noted that US Congressional Democrats countered an insurance industry study suggesting health care reform woul...

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Manage your tasks with Google

People use all kinds of tools to help them get stuff done — paper to-do lists, messages with a certain label or stars in Gmail, notes in Google Calendar, a couple different iGoogle gadgets and so on. Late last year, we added a lightweight way to help you keep track of what you need to do in Gmail Labs — <a href="http://gmailblog.blogspot.com/2008/12/new-in-labs-tasks.html">tasks</a>. Since then, it's <a href="http://gmailblog.blogspot.com/2009/07/tasks-graduates-from-gmail-labs.html">graduated from Labs</a>, and you can <a href="http://mail.google.com/mail/help/tasks/">manage your tasks</a> not only in Gmail, but also in Google Calendar, iGoogle and from your mobile phone (by going to gmail.com/tasks from your phone's browser). Your task list stays up to date no matter how you access it — so for example, if you create a task with a due date on your mobile device, the next time you consult your Google Calendar you'll see that task on your calendar for that day. <object height="295" width="480"><param name="movie" value="http://www.youtube.com/v/qrka_3jui8M&hl=en&fs=1&rel=0"><param name="allowFullScreen" value="true"><param name="allowscriptaccess" value="always"><embed src="http://www.youtube.com/v/qrka_3jui8M&hl=en&fs=1&rel=0" type="application/x-shockwave-flash" allowscriptaccess="always" allowfullscreen="true" width="480" height="295"></embed></object> Starting today, there's a full-screen version of the <a href="http://www.google.com/ig/directory?type=gadgets&url=www.google.com/ig/modules/tasks.xml">Tasks gadget</a> for iGoogle. Click on the <a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEh3VtliMk8N-h9qFDXeDGTX43KbnrhFHygh72UqYGBup_q4guqKV3-b2b03mjTfGg7dYeLpSQTL2GmIg4LC-71ci_vPRLZYYhHROFsYri7x_CxI8kxq_9l0acInI7Sb8dosvSXPrBF33w_o/s1600-h/t1.png" onblur="try {parent.deselectBloggerImageGracefully();} catch(e) {}"><img alt="" border="0" id="BLOGGER_PHOTO_ID_5394752558479521266" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEh3VtliMk8N-h9qFDXeDGTX43KbnrhFHygh72UqYGBup_q4guqKV3-b2b03mjTfGg7dYeLpSQTL2GmIg4LC-71ci_vPRLZYYhHROFsYri7x_CxI8kxq_9l0acInI7Sb8dosvSXPrBF33w_o/s400/t1.png" style="cursor: pointer; width: 16px; height: 18px;" /></a> icon in the top-right corner and you'll be able to see and organize all your tasks at once. For those of you who are already familiar with tasks, here are some power tips to help make you more productive: <ul><li>When you have completed a task and no longer want it to appear on your list, click "Clear completed" in the actions menu. You can review your completed tasks later by clicking "View completed tasks." Clearing completed tasks is different from deleting them — if you delete a task, it's gone for good and you'll no longer see it anywhere in tasks.</li><li>In the default "My order" view, press tab to indent a task you're editing, making it a sub-task of the one above. Press shift + tab to reverse this operation.</li><li>Try ctrl + up/down (⌘ + up/down on a Mac) to move the task you're editing up and down the list. Move a task that has sub-tasks, and they'll come along with it.</li><li>Ctrl + up/down also works in sort by date view, where it will alter the task's due date by one day. You can use this to quickly plan out your week's activities or postpone a task for another day.</li><li>Press shift + enter to edit the details of a task, including its notes and due date. You can also use this view to move your task to another list. </li></ul>We have more features in the pipeline, so if you're interested in hearing the latest on tasks, <a href="http://twitter.com/googletasks">follow us on Twitter</a>. Posted by David Barrett-Kahn, Software Engineer, Tasks team

Manage your tasks with Google

People use all kinds of tools to help them get stuff done — paper to-do lists, messages with a certain label or stars in Gmail, notes in Goo...

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Self-improving results now in the Google Search Appliance

The <a href="http://google.com/gsa">Google Search Appliance</a> (GSA) is getting an <a href="http://googleenterprise.blogspot.com/2009/10/singing-new-tune-google-search.html">update</a> today, with a bunch of <a href="http://www.youtube.com/watch?v=sDFDE4LHblY">new features </a>aimed at making enterprise search easier for everyone inside a company. One of our favorites, the <a href="http://www.youtube.com/watch?v=jmtpJGpqAXs">Self-learning Scorer</a>, learns from employees' searches to tune itself and improve over time. If employees repeatedly choose, say, the fourth result for a given query the GSA will learn that's probably the most relevant one and bring it up to the top the next time the query is searched for. Over time, the GSA auto-tunes, serving up better and better internal search results without any extra administrative work. You can read more about the Self-learning Scorer and check out the GSA's other new features in <a href="http://googleenterprise.blogspot.com/2009/10/singing-new-tune-google-search.html">our post</a> on the Google Enterprise Blog. Posted by Sibabrata Ray and Liviu Panait, Engineers, Google Enterprise Search team

Self-improving results now in the Google Search Appliance

The Google Search Appliance (GSA) is getting an update today, with a bunch of new features aimed at making enterprise search easier for ev...

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HHS to promote low-cost electronic health record software packages including the VA's VistA

If I were a proprietary health IT vendor, the following bolded passage in the new Healthcare Bill (PDF <a href="http://finance.senate.gov/press/Bpress/2009press/prb101909.pdf">here</a>) would make me a bit nervous: SEC. 1102. ENCOURAGING MEANINGFUL USE OF ELECTRONIC HEALTH RECORDS. (a) STUDY.—The Secretary of Health and Human Services shall conduct a study of methods that can be employed by qualified health benefits plans offered through an exchange to encourage increased meaningful use of electronic health records by health care providers, including— <blockquote>(1) payment systems established by qualified health benefit plans that provide higher rates of reimbursement for health care providers that engage in meaningful use of electronic health records; and (2) promotion of low-cost electronic health record software packages that are available for use by health care providers, including software packages that are available to health care providers through the Veterans Administration.</blockquote> The VA system, VistA/CPRS ("computerized patient record system"), was developed with taxpayer money and is freely available. A free working demo is downloadable <a href="http://www1.va.gov/cprsdemo/">here</a> (Windows only). This represents a needed "public option" for healthcare IT, the estimates of cost of adoption of proprietary systems now at somewhere between $20 and $50 billion dollars, give or take. (I believe the actual figure to be far higher due to IT sector dyscompetence in HIT as I wrote at my post "<a href="http://hcrenewal.blogspot.com/2009/10/fuzzy-math-rising-costs-in-governments.html">Fuzzy Math Indeed</a>.") To put that figure in context, $50 billion is enough to build approximately five hundred shiny new 100-bed hospitals, or one hundred 500-bed hospitals, at ~$1 million per bed. Entrepreneurial companies have sprung up to adopt it for the private healthcare sector such as <a href="http://worldvista.sourceforge.net/About/indexworldvista.html">WorldVista</a>. They probably won't be charging the multimillion dollar rates that the private HIT sector does, and the quality will likely be higher. -- SS

HHS to promote low-cost electronic health record software packages including the VA's VistA

If I were a proprietary health IT vendor, the following bolded passage in the new Healthcare Bill (PDF here ) would make me a bit nervous: S...

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Flying in a WiFi wonderland: Free Internet from Google on Virgin America flights

We know the holiday season seems to come earlier every year (sorry, Halloween), but before you make your final travel plans, we're excited to let you know that we're partnering with <a href="http://www.virginamerica.com/va/home.do">Virgin America</a> to <a href="http://www.freeholidaywifi.com/">provide free WiFi</a> on every Virgin America flight between November 10, 2009 and January 15, 2010. The holidays can be full of dates and details to remember, and it's easy to get stressed out somewhere between planning a long distance, multi-generational family gathering and combing the Internet for the latest impossible-to-find furry contraption for your toddler. And when you have to do all that while coordinating air travel at the same time as several million of your closest friends, things can get <a href="http://images.google.com/images?hl=en&um=1&sa=1&q=home+alone&aq=f&oq=&aqi=g10&start=0">downright dramatic</a>. Whether it's using Gmail to confirm an airport pick up time with your brother, doing some last minute gift shopping for your niece on Google Product Search or searching Google.com for a good sweet potato pie recipe before touchdown — we hope this makes it a bit easier to stay connected with family and friends while you're up in the air. You can find out more about our partnership, where Virgin America flies and how the in-flight WiFi service works at <a href="http://www.freeholidaywifi.com/">www.freeholidaywifi.com</a>. Posted by Jeff Aguero, Product Marketing Manager

Flying in a WiFi wonderland: Free Internet from Google on Virgin America flights

We know the holiday season seems to come earlier every year (sorry, Halloween), but before you make your final travel plans, we're excit...

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"Going Google" with millions of businesses around the world

Each day, thousands of companies choose to "<a href="http://www.google.com/apps/intl/en/business/gogoogle-ent.html#utm_campaign=gogoogle&utm_source=en-na-us-ogblog-gogoogle_101909&utm_medium=blog">go Google</a>" — that is, switch to Google Apps. Over two million business and 20 million users in over 100 countries and more than 40 languages have adopted <a href="http://www.google.com/apps/intl/en/business/gogoogle.html#utm_campaign=gogoogle&utm_source=en-na-us-ogblog-gogoogle_101909&utm_medium=blog">Apps for their workplace</a>, and we're happy to welcome companies around the world such as Konica Minolta, Rentokil Initial and TOTO that have just decided to go Google. These companies no longer have to deal with the hassles of managing email servers or rolling out software updates, and their employees now enjoy the convenience of shared documents and calendars, Gmail and more. Since we <a href="http://googleblog.blogspot.com/2009/08/going-google-with-google-apps.html">first asked</a> for your "gone Google" stories in August, we've seen thousands of <a href="http://twitter.com/GoogleAtWork/favorites">tweets</a> and hundreds of comments explaining how and why your company decided to go Google with Apps, as well as with other Google enterprise products such as <a href="http://www.google.com/postini/gogoogle.html#utm_campaign=gogoogle_pos&utm_source=en-na-us-ogblog-gogoogle_101909&utm_medium=blog">Google Postini Services</a> and the <a href="http://www.google.com/enterprise/search/gsa.html#utm_campaign=gogoogle&utm_source=en-na-us-ogblog-gogoogle_101909&utm_medium=blog">Google Search Appliance</a>. Jeffrey D. from Ottawa, Canada told us that with Apps, he "was able to set up a new business in minutes with email, calendar, docs, and sync with [his] BlackBerry." <a href="http://twitter.com/happymacs/status/3111574146">@happymacs</a> from San Diego, CA tweeted how they liked the ability to "search every single email received in the past 2.5 years in under 2 seconds"; while <a href="http://twitter.com/appfrica/status/3102474107">@Appfrica</a> highlighted the sobering fact that the cost of an alternative software solution would employ a person in Uganda for a month. Today, we're excited to support this global momentum with the expansion of the "Gone Google" initiative to additional countries including the U.K., France, Canada, Japan, Australia and Singapore. We hope our messages — in train stations such as Paddington, La Défense and Shinagawa, and at airports in Singapore, Toronto, Dallas and beyond — help companies, schools and organizations learn all about the benefits of going Google with our enterprise products. Here's a sneak peek at what you can expect to see both here in the U.S. and abroad: <object height="340" width="560"><param name="movie" value="http://www.youtube.com/v/iP2oWfDMvqc&hl=en&fs=1&rel=0&hd=1"><param name="allowFullScreen" value="true"><param name="allowscriptaccess" value="always"><embed src="http://www.youtube.com/v/iP2oWfDMvqc&hl=en&fs=1&rel=0&hd=1" type="application/x-shockwave-flash" allowscriptaccess="always" allowfullscreen="true" width="560" height="340"></embed></object> If you've already gone Google, you can <a href="http://www.youtube.com/watch?v=MdAMLEujm5M">share your company's Gone Google story</a> with us, or use some of our tools to help <a href="http://www.google.com/apps/intl/en/business/spreadtheword.html#utm_campaign=gogoogle&utm_source=en-na-us-ogblog-gogoogle_101909&utm_medium=blog">spread the word</a> about switching to Google Apps. We hope you'll be part of the story. Posted by Tom Oliveri and Vivian Leung, Google Enterprise Team

"Going Google" with millions of businesses around the world

Each day, thousands of companies choose to " go Google " — that is, switch to Google Apps. Over two million business and 20 millio...

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Our Policy Is To Always Have Unabashed Faith In The Computer ... Except When It Screws Up, And Then It's The Doctor's Fault

Healthcare IT such as electronic medical records (EMR/EHR) and computerized physician order entry (CPOE) systems are a perfected, safe technology, one might think, from the almost hagiographic and entirely uncritical P.R. about HIT, all the way up to the President of the United States. (Not bad for an entirely unregulated industry. Pharma IT should only have it so well.) Paraphrasing Capt. Chesley Sullenberger in a <a href="http://online.wsj.com/article/SB10001424052748703790404574469160016077646.html">recent WSJ article</a>, however, I'm a long term optimist about HIT, but a short term realist. Healthcare cannot be 'transformed' by a technology that itself has major problems and needs transformation. These issues should have been substantially remediated before forced national rollouts, I feel. That's especially true given the inherent dangers in medicine. You can't be a wishful thinker. You have to know what you know, and perhaps more importantly in medicine, what you don't know (this is especially true both for those in IT who lack formal clinical or biomedical backgrounds, and for those in medicine who lack formal biomedical informatics or computer science backgrounds). You also need to know what your tools can and can't do. Sticking one's head in the sand is no way to approach HIT. <a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEgIqCS12K1usmZMlxOoFAud0IU-EE_YeYoCGMIjhSRmlO2uIdWpffcisgn5KDlF1pN8ND6cslVzDqpu-OFmMANL6O2NEY5haMuuDLuSR6vpQ9rQ_3qxYv-Fps4KU43lqGEwVflq89aB4abY/s1600-h/headinsand.jpg" onblur="try {parent.deselectBloggerImageGracefully();} catch(e) {}"><img alt="" border="0" id="BLOGGER_PHOTO_ID_5394097962244199106" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEgIqCS12K1usmZMlxOoFAud0IU-EE_YeYoCGMIjhSRmlO2uIdWpffcisgn5KDlF1pN8ND6cslVzDqpu-OFmMANL6O2NEY5haMuuDLuSR6vpQ9rQ_3qxYv-Fps4KU43lqGEwVflq89aB4abY/s320/headinsand.jpg" style="margin: 0px auto 10px; display: block; text-align: center; cursor: pointer; width: 171px; height: 150px;" /></a> That said, here are some sample voluntary reports on HIT malfunctions from just one vendor, taken from the FDA Medical Devices database, the <a href="http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/search.CFM">Manufacturer and User Facility Device Experience (MAUDE) database</a>, links included. These are production systems used on real, live patients, not prototypes: <blockquote> MAUDE data represents reports of adverse events involving medical devices. The data consists of voluntary reports since June 1993, user facility reports since 1991, distributor reports since 1993, and manufacturer reports since August 1996. MAUDE may not include reports made according to exemptions, variances, or alternative reporting requirements granted under 21 CFR 803.19.</blockquote> Emphases below are mine. My comments are in [red italic]. Case 1: (note - added to this post 7/2010) <a href="http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1656460">http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1656460</a> CERNER MILLENIUM POWERCHART CPOE Event Date 11/19/2006 Event Type: Death Patient Outcome: Death The medication review screen of the subject device does not specify the exact dose in milligrams of combination medications. For example, narcotics are combined with tylenol in at least two strengths. Liquid narcotic tylenol-oxycodone combination is reported in ml, not mg. The exact dose of tylenol is not specified and requires knowledge of the combination medication dose in the volume specified. Certain fields of the grid do not specify the volume, but rather state "date/time" requiring another click or pop up screen. The immediate knowledge of tylenol dosage in mg is directly related to understanding and preventing excessive doses. In the subject, 10 ml of acetaminophen-oxycodone is indicated as having been given 3 times over 4 hours. That means that 1950 mg of tylenol was administered in 4 hours while the patient was in a state of starvation and receiving other medication that increase the effects of tylenol. This dose would equate to 11,700 mg of tylenol over 24 hours, nearly 3 times the maximum daily dose in otherwise health people. In the ensuing days, the patient developed acute renal failure, presumably acute tubular necrosis, and died. In the absence of other etiology, the excess tylenol was the culprit. This was not considered as etiology ante-mortem. The counterintuitive screen impaired the professionals. The pharmacist did not recognize and stop the medication, the nurses administered it, and the excessive dose, clinically meaninglessly listed as a volume of 10 ml -given 3 times in 4 hours- of acetaminophen-oxycodone, was missed by the physicians. Adverse events have been ascribed to "user error" by vendors. The device offers a potent propensity to life endangering oversights. There are other screens on this device which present information that interfere with clinically useful visualization of data. [Who designed these screens, I ask? Clinicians, or business IT personnel used to designing inventory systems for widget control? - ed.] The data does not flow to the professionals. It is not represented in a meaningfully useful manner. The professionals need to hunt for it. As such, the user unfriendly screens [see <a href="http://www.tinyurl.com/hostileuserexper">this link</a> on mission hostile HIT - ed.] impair safe medical care consistent with the impediment to expedient professional understanding of what, exactly, is the dose of medication and how much was administered to the patient. This sentinel case of death is directly attributed to user unfriendly screens on this device. Case 2: <a href="http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=64345">http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=64345</a> Cerner Millennium RadNet Auto Launch Study and Auto Launch Report software functionalities. Defects in the Auto Launch functionality make it possible for a mismatch of patient data. [That is, in radiology reports. The dangers of transpositions is obvious.] Case 3: <a href="http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=722614">http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=722614</a> The issue involves powerchart local access medication administration task, used when certain cerner millennium solutions are not available. At powerchart local access sites that utilize coordinated universal time (utc) functionality, medication administration tasks might be displayed with incorrect times. When a pt download occurs from cerner millennium servers to powerchart local access, and there is no cerner millennium application session active, powerchart local access adds or subtracts the number of hours equal to the time zone difference from greenwich mean time. Scheduled medication administration tasks may show an incorrect administration time and the possibility exists for a pt to receive medications earlier or later than intended. [As just one example of the dangers with this type of defect, an elderly patient with sepsis might get an early dose of <a href="http://www.uptodate.com/patients/content/topic.do?topicKey=%7E33VV7w5pdwZSOF" style="font-weight: bold; font-style: italic;">aminoglycoside</a>, causing peak levels to rise to nephrotoxic and ototoxic levels - ed.] Case 4: <a href="http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=946706">http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=946706</a> Patient care delay. The issue involves functionality in cerner millennium powerchart office and powerchart core and affects users that utilize the powerchart inbox and message center inbox. In results to endorse or sign and review, if the user clicks ok and next multiple times in quick succession [e.g., a busy clinician with sick patients, waiting for the computer to respond - ed.] while attempting to sign a result or a document, the display could lag behind the system's processing of the action [that is to say, the human-programmed and supposedly tested and validated computer "system" -ed.], and multiple results or documents could be signed without the user's review. In message center, when clicking ok and next or accept and next, or when deleting or completing messages and moving to the next task, a document could be signed or a message could be deleted without the user's review. Results could be endorsed or documents could be signed without physician review, which could impact patient care. Cerner received communication that a patient's follow-up care was delayed as a result of this issue. [Luck prevailed that no injury occurred - in this reported case. One wonders if that is true of all the users who experienced this problem. Also, I do not recall such errors happening on paper order forms due to, say, a busy clinician tapping his pen on the paper - ed.] Case 5: <a href="http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=888215">http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=888215</a> The issue involves the pharmacy medmanager functionality. If the user performs a modify action on an order with an existing duration and duration unit, the order's stop date might not be recalculated. Specifically, this occurs when only the duration value is changed prior to entering the original duration unit. Pt care could be adversely affected, as medication therapy could be concluded prematurely or could last longer than intended based on the order details prior to the modification. This issue can be avoided if the user performs a renew action instead of a modify action to change an order's duration. If performing a modify action is required, users can manually set the stop date and time during the modify action. Cerner received communication that a pt's surgery required rescheduling as a result of this issue. [Again, was the lack of patient harm due to careful clinicians who at that moment just happened to not be distracted or cognitively overloaded or overworked or exhausted from on-call, or an act of Providence? Were other non-reported users at other organizations less lucky? - ed.] Case 6: <a href="http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=920819">http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=920819</a> The issue involves the results to endorse (rte) inbox functionality in powerchart, powerchart office and firstnet and affects users that use the rte inbox to view radiology reports that have been created in radnet. Radiology results might fail to be displayed in the ordering provider's results to endorse folder in the inbox. Treatment or diagnosis decisions could be delayed if the clinician is relying on the display of a result in the inbox results to endorse folder to initiate patient follow-up. Note: the final results are posted to the flowsheet and are available on the patient's chart. Cerner received communication that a patient's follow-up care was delayed as a result of this issue. [Were any diagnoses of, say, cancer missed by other organizations affected? -ed.] Case 7: <a href="http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=700117">http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=700117</a> The issue involves the direct charting flowsheet and icu flowsheet, used within the powerchart system. When the result details box is accessed for a negative result value in either the icu flowsheet or the direct charting flowsheet in powerchart, either by right-clicking a negative, unsigned result value and selecting chart details from the context menu, or by right-clicking a negative signed result value and selecting modify, the dialog box displays a blank result value. When the user clicks ok in the result details dialog box, the value is changed to zero in the result cell in the flowsheet. [Of all places, health IT in ICU's should be extensively validated before going into production - ed.] Case 8: <a href="http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=715963">http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=715963</a> The issue involves the careadmin medication administration wizard used within the carenet system. When scanning a medication in careadmin, the system fails to recognize mckesson identifiers or other miscelaneous identifiers and properly identify the scanned product, which could result in the documentation of an incorrect dose in the careadmini window. In such situations, the system does not display overdose or underdose or route/form compatibility warnings as it should. Patients could receive an inappropriate dose of medication. Cerner has not been made aware of any adverse patient care events that resulted from this issue. [Thank god for that - but were any unreported by other organizations? - ed.] Case 9: <a href="http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=753029">http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=753029</a> Microbiology set up a program within the cerner computer system to automate the reporting system for hsv (herpes simplex virus)testing. The system was tested with the assistance of cerner and found to be working appropriately. The new system was operational for approximately 3 weeks when it was determined that the first word of the sentence, "no" was inappropriately dropping off of the following sentence: "no herpes simplex virus type 1 or herpes simplex virus type 2 detected by dna amplification. " as such, two of five patients were incorrectly informed that they had hsv before the error was detected. One had started an antiviral creme treatment. The other three did not have follow-up visits until after the correct results were determined. Cerner has looked at the program and has not provided an answer for the system issue. In the interim, the previous manual review and entry process is being used. [How does the word "no", an essential descriptor in a medical test, simply get "dropped?" Does <a href="http://www.norad.mil/" style="font-style: italic; font-weight: bold;">NORAD's</a> ballistic missile warning system ever do that, i.e., "no ICBM's incoming" reported as "ICBM's incoming"?- ed.] --------------------------------- Additional reported errors can be seen in a file downloadable by clicking <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/maude/Adverse_Event_CPOE__MAUDE.pdf" style="font-weight: bold;">on this link</a> (PDF). Some of these are a bit startling. --------------------------------- Still others can be seen at: <a href="http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=695436"> </a><a href="http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=695436" target="_blank">http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=695436</a> <a href="http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=688925" target="_blank">http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=688925</a> <a href="http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=996685"> </a><a href="http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=996685" target="_blank">http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=996685</a> <a href="http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1075747" target="_blank">http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1075747</a> <a href="http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=574578" target="_blank">http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=574578</a> <a href="http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1288623"> </a><a href="http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1288623" target="_blank">http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1288623</a> <a href="http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1370640" target="_blank">http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1370640</a> <a href="http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=834678" target="_blank">http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=834678</a> Again, these are reports about just one HIT vendor but this piece is not just about them. Other HIT vendor products have similar issues. Health IT remains an experimental technology. The MAUDE reports are voluntary, however, so the absence of a report does not mean an absence of a problem. (I note MAUDE queries on a number of major HIT vendors produce no results, or results limited to HIT that is closely associated with physical "medical devices" -- as opposed to virtual ones -- such as radiology systems.) For example, while a query on mfg. "Cerner" brings up hits, a query on another vendor shows this result: <blockquote>No records were found with Manufacturer: Allscripts Report Date From: 10/01/1998 Report Date To: 09/30/2009 </blockquote> ... and this: <blockquote>No records were found with Manufacturer: Nextgen Report Date From: 10/01/1997 Report Date To: 09/30/2009 </blockquote> ... while a <a href="http://google2.fda.gov/search?q=nextgen&x=0&y=0&client=FDAgov&site=FDAgov&lr=&proxystylesheet=FDAgov&output=xml_no_dtd&getfields=*">broader FDA search on "Nextgen"</a> brings up exactly <a href="http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1055515">one relevant hit</a> on "Nextgen EMR - Medical Device" -- without specifics as to the "malfunction" noted under product code "<a href="http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPCD/classification.cfm?ID=3355">HGM</a>" - which on lookup is a perinatal monitoring system. A <a href="http://google2.fda.gov/search?q=allscripts&x=0&y=0&client=FDAgov&site=FDAgov&lr=&proxystylesheet=FDAgov&output=xml_no_dtd&getfields=*">broader search on Allscripts</a> only brings up drug related issues such as this curious 2002 <a href="http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2002/ucm145211.htm">warning letter</a> about the marketing of guaifenesin, a cough medicine, from FDA's Center for Drug Evaluation and Research. Either these vendors are not reporting HIT problems, or are listed under another name. Rather unlikely is that they have <a href="http://www.healthcareitnews.com/news/allscripts-shareholders-file-class-action-suit">no problems</a> to <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/DUCOM_EMR_Complaint.pdf">report</a> (latter hyperlink is PDF). As another example, a search on brand name "Centricity" brings up "hits" mostly on specialized GE products such as PACS. So, is HIT safe, or can "glitches" affect patient care? Should this industry be entirely unregulated, or its products "certified" by groups with conflicts of interest such as those affiliated with industry trade groups? Should vendors be <a href="http://jama.ama-assn.org/cgi/content/extract/301/12/1276">held harmless</a> for HIT defects that harm patients? I report, you decide. -- SS

Our Policy Is To Always Have Unabashed Faith In The Computer ... Except When It Screws Up, And Then It's The Doctor's Fault

Healthcare IT such as electronic medical records (EMR/EHR) and computerized physician order entry (CPOE) systems are a perfected, safe techn...

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