Medical Informatics, Pharma, Health IT, and Golden Advice That Sits Sadly Unused

In recent correspondences with colleagues I was reminded of a letter I wrote seven years ago that was published in Bio-IT World, a journal about biomedicine focusing mainly on pharma, bioinformatics and related fields.

As the sole formally-trained Medical Informatics specialist at Merck, I wrote:

Medical Informatics MIA [Missing in Action - ed.]
Bio-IT World
August 13, 2002

Dear Bio-IT World:

I enjoyed reading the article "Informatics Moves to the Head of the Class" (June Bio·IT World). Thank you for spotlighting the National Library of Medicine (NLM) training programs in medical informatics and bioinformatics, of which I am a graduate (Yale, 1994).

Bioinformatics appears to receive more media attention and offer more status, career opportunities, and compensation than the less-prestigious medical informatics.

This disparity, however, may impede the development of next-generation medicines. Bioinformatics discoveries may be more likely to result in new medicines, for example via pharmacogenomics, when they are coupled with large-scale, concurrent, ongoing clinical data collection. At the same time, applied medical informatics, as a distinct specialty, is essential to the success of extensive clinical data collection efforts, especially at the point of care.

Hospital and provider MIS personnel are best equipped for implementing business-oriented IT, not clinical IT. Implementing clinical IT in patient-care settings constitutes one of the core competencies of applied medical informaticists.

Informatics specialists with a bioinformatics focus — even those coming from the new joint programs — usually are not proficient in hospital business and management issues that impede adoption of clinical IT in patient care settings. Such organizational and territorial issues are in no small way responsible for the low utilization of clinical IT in patient care settings.

It will be important for medical informaticists focused in the clinical domain and bioinformaticists specializing in the molecular domain to collaborate with other specialists in order to best integrate clinical and genomic data.

Further information on these issues can be found in the book Organizational Aspects of Health Informatics: Managing Technological Change, by Nancy M. Lorenzi and Robert T. Riley (Springer-Verlag, 1995). Various publications from the medical informatics community, such as the American Medical Informatics Association (www.amia.org) and the International Medical Informatics Association (www.imia.org), are also useful.

Scot Silverstein, MD
Director, Published Information Resources & The Merck Index
Merck Research Laboratories

I was also responsible for the entry of the term "Medical Informatics" into the controlled vocabulary pool used for various purposes at Merck.

As far as I can tell, the Medical Informatics talent gap still exists in all major pharmas despite writings on the topic from colleagues as well as myself. With the present turmoil including declining pipelines, mergers and mass layoffs pending in many large pharmas, and even despite Medical Informatics on a fast path to being declared a full medical subspecialty, it is likely this gap will persist for years longer. This is a shame. The field offers insights that can help R&D substantially, and I speak from direct experience from my time in that domain.

I am reminded via all this of another industry that seems to hurt itself via ignoring the advice of Medical Informatics professionals, the health IT industry. Healthcare IT is actually the core competence of Medical Informatics professionals, but those people are under-represented in the higher ranks of the health IT industry as well. Many job postings seek such people, but for lower level roles (as I've posted here in the past), and/or conflate formal training with informal experience and with those who qualify for the title of Medical Informaticist like I qualify (being an amateur radio licensee, extra class) as a professional RF engineer.

The irony is this: the wisdom of the Medical Informatics field on health IT goes back not years, but decades. It is advice that could have made the vendors much higher margins, allowed them to produce better products, avoid the government regulation that is now nearly inevitable (in some EU countries, clinical IT has already been determined to be a medical device requiring regulation), and in many cases, enabled corporate longevity.

Yet the teachings and accumulated wisdom of the field were, and largely still are, ignored, making books such as the new "H.I.T. or Miss: Lessons Learned from Health Information Technology Implementations" necessary even in 2009.

Here is just a small sampling of that wisdom:

Dr. Donald A. B. Lindberg (now Director of the U.S. National Library of Medicine at NIH), 1969:
"Computer engineering experts per se have virtually no idea of the real problems of medical or even hospital practice, and furthermore have consistently underestimated the complexity of the problems…in no cases can [building appropriate clinical information systems] be done, simply because they have not been defined with the physician as the continuing major contributor and user of the information."


Dr. Octo Barnett's [Harvard] health IT Ten Commandments, 1970:
1. Thou shall know what you want to do
2. Thou shall construct modular systems - given chaotic nature of hospitals
3. Thou shall build a computer system that can evolve in a graceful fashion
4. Thou shall build a system that allows easy and rapid programming development and modification
5. Thou shall build a system that has consistently rapid response time and is easy for the non-computernik to use
6. Thou shall have duplicate hardware systems
7. Thou shall build and implement your system in a joint effort with real users in a real situation with real problems
8. Thou shall be concerned with realities of the cost and projected benefit of the computer system
9. Innovation in computer technology is not enough; there must be a commitment to the potentials of radical change in other aspects of healthcare delivery, particularly those having to do with organization and manpower utilization
10. Be optimistic about the future, supportive of good work that is being done, passionate in your commitment, but always guided by a fundamental skepticism.

[Dr. Barnett played a key role in the 2009 National Research Council report about current approaches to health IT being inadequate, Press Release at http://www8.nationalacademies.org/onpinews/newsitem.aspx?RecordID=12572, and full report "COMPUTATIONAL TECHNOLOGY FOR EFFECTIVE HEALTH CARE: IMMEDIATE STEPS AND STRATEGIC DIRECTIONS. - ed.]


Dr. Morris Collen's Five Rules, 1972
Most common causes of health IT failure:

• Suboptimal mix of medical and computer specialists … resulting in communications difficulties and in the computer staff underestimating the vast medical needs
• Gross underestimation of the large amounts of money needed
• Suboptimal systems approach with serious incompatibilities between modules
• Unacceptable terminals
• Inadequate management organization and poor judgment
  

Dr. R. Friedman, Reasons for slow spread of EMR, 1977:

• Poor engineering and unreliability
• Physicians not provided with computer-based applications that exceeded their own capability!
• Inability to prove a positive effect on patient care
• Difficulty transferring one application from one institution to another
  

(All taken from Collen's "A history of Medical Informatics in the United States, 1950-1990".)

I might add that the PC did not even exist in 1977, unless you consider the Altair and Heathkit H8 "personal computers."

Four-decades-old wisdom like this, and much more, sits out there in the ether and in the Medical Informatics field's professionals like a pot of gold, but is apparently considered as valuable as lead by the HIT - and pharma - industries. I find this amazing - and a pity.

-- SS

NSW Nightmare and Overuse of Computers: Do We Really Need Full EHR's in ED's?

At "From Down Under: The Story of the Deployment of an ED Clinical Information System ‐ Systemic Failure or Bad Luck" I posted excerpts from a paper of the same name by an Australian medical informatics specialist, Professor Jon Patrick from the Health Information Technologies Research Laboratory (HITRL), University of Sydney, about what appears to be an Emergency Department (ED) nightmare. The paper is here. [10/24 note: not available at present at this link or from its author in Australia; I pulled it from the Drexel U. server in the U.S. at the author's request while his right to post it on his department's server in Australia is being discussed Down Under - ed.]

[2010 update: the paper is now at the following link (PDF): A Critical Essay on the Deployment of an ED Clinical Information System - Systemic Failure or Bad Luck, version 6. Prof. Jon Patrick, Health Information Technologies Research Laboratory, University of Sydney, Australia, Dec. 2009.]

Those excerpts should be frightening to anyone who ever gets ill and might need to visit an ED (meaning, all of us).

An ED electronic health record system (EHR) is being installed in an entire Australian state, New South Wales (NSW), with 200+ hospitals that apparently presents a mission hostile user experience and is causing great opposition by critical care physicians in a setting where death can occur - suddenly and irreversibly - in the flash of an eye.

His essay about the problems with complex EHR's (of American design and manufacture, no less) being installed in Australian ED's -- without doubt a highly expensive undertaking -- raises several questions about both the EHR industry and hospitals themselves.

When I was a CMIO at a 1400+ bed hospital system a decade ago, a regional center in a state with very few hospitals at all (Medical Center of Delaware, now Christiana Care Health System), I counseled that the best solution in my opinion for the very, very busy ED was document imaging of paper, supplemented by a nurse/intake triage system to rapidly record and/or confirm basics (e.g., meds/major problems/allergies/vitals) that was interfaced to the main EHR system.

I based this on the assessment that in the ED, a localized and "closed" environment, the incidence of charts getting lost or writing being illegible resulting in adverse outcomes was minimal. ED charts also did not get lost when patients moved to the floors and the information passed along on paper was adequate for quick transfer and acceptance. Therefore we felt images of past ED charts (of paper) would be satisfactory for assisting care in the ED, where time constraints and hectic pace made the type of EHR system and primary data entry described in the Australian paper disadvantageous (and for exactly the reasons described in the above linked essay from Down Under).

Document imaging is a proven technology that works well even in high volume settings. For example I managed a pharma departmental budget of $13 million, as did an entire pharma company, using an enterprise document imaging system.

I've also been startled by the ED EHR installed at the hospital where I take my mother, who unfortunately has needed far too many admissions in recent years than I care to see. Some of the ED staff were my former medical colleagues and even high school classmates. They've told me, in no uncertain terms, that they felt the system was terrible, again for many of the reasons cited in the Australian essay. My own views of it (albeit brief) showed what appeared to be a mission hostile user environment, including multiple very tiny pulldowns, cornucopia-like picklists, and screens.

Most recently that system did not prevent busy ED docs from almost giving my mother Levaquin after her telling the triage nurse it had caused tendon rupture in the past - and the data being entered. They actually brought in a bag of it to hang, and if I'd not been there as medical advocate for my mother they might have given it. Then when she got to the floor, the next day they almost gave it to her again, except by this time mom was her own medical advocate. I trained in that hospital, and as Admitting Officer for the ED held the record for the most number of admissions, ever, in one night (New Year's Eve 1986), when it was beyond crazy, starting out with one of our own physicians being brought in, shot in the chest, and dying after open heart massage just to set the mood.

The surgeons did the cutting. The heart massage was relegated to the physician present who didn't cut - the internal medicine representative - me.

We managed to treat hundreds and admit several dozens of sick patients using paper, and despite our gloomy emotional state not a single error occurred, to my knowledge.

With all this in mind, I raise these questions:

• Can the EHR industry actually produce a competent ED EHR that can be used by ED physicians to enter detailed data in real time?

• Do we really need full EHR's in the ED?

• A related question: is the extent of ED adverse events related to lost or illegible ED charts (that could not be remediated with non-technology-based solutions far less expensive and troublesome than EHR's) known to a significant degree of confidence?

• Is there trustworthy literature that shows that the time, expense, and resources for a full ED EHR are worth it in terms of clinical outcomes, ROI etc.? (By trustworthy, I mean scientific peer reviewed literature without author conflict of interest - common in biomedicine as readers of this and other healthcare blogs know, e.g., see this link - not glossy pseudo-P.R. health IT throwaway journals.)

• Considering that the literature on benefits of EHR's in general is equivocal, I should also ask, is there literature that refutes the value of full ED EHR's, or shows it as possibly having a negative return?
  

Or:

• Are we over-computerizing healthcare, even specialties and subspecialties where doing so might actually be deleterious due to the nature of their specific medical environments, just because "we can" (and because there is money to be made by some)?

• Are we doing so based on irrational exuberance, leap of faith, hope, and/or an uncritical belief that if health IT provides benefits to medical domain "A0", it therefore must benefit medical domains and subdomains B1 to B99 through Z1 to Z99 as well?
  

I am concerned about the probability that the latter is the case.

I think it not unreasonable to ask these questions before we in the United States spend billions of dollars on our own ED's.

-- SS

Private medical records offered for sale

Private medical records have been offered for sale in the U.K.

And quite cheaply, too...

e-Health Insider (Europe)
Private Medical Records Offered for Sale
Oct. 20, 2009

Medical records of patients treated at a private British hospital, The London Clinic, have been illegally sold to undercover investigators.

The revelations were made in ITV’s Tonight Programme report, Health Records For Sale, broadcast last night.

The programme reported that hundreds of files containing details of patients’ conditions, home addresses and dates of birth were offered to undercover reporters for just £4 each by sales executives from India, contacted online.

That's about $6.56 U.S. each. A genuine bargain for those intrepid medical identity thieves, and pesky government death panels ...

The records offered for sale appear to have been medical records that consultants working at the London Clinic, the hospital processes its own records internally, who contracted with a firm called DGL (DGL) Information Technologies UK to digitise their records.

DGL is then claimed to have sub-contracted to another firm, Scanning and Data Solutions (SDS), which scanned them into computers in the UK. SDS in turn is said to have sub-contracted further work on the files to a company in Pune, India, which had signed tight confidentiality agreements.

With all this contracting and subcontracting - four layers? - adding potential security breach possibilities, and if this is not an uncommon practice, perhaps paper is safer than electronic health records?

... The reporters bought more than 100 records belonging to UK patients but were told they could obtain up to 30,000 more on demand. Confidential records were offered by condition such as particular cancers.

Of 116 files bought by ITV, 100 of which were confirmed as genuine, were for patients who had been treated in private hospitals. Although not NHS records they did contain some NHS data, including referral letters from GPs.

The potential abuses resulting from such sales are of great concern. If it happened in the UK, it can happen in the U.S.

One patient whose record was affected by the security breach said in the documentary that the data breach was ‘one step up from grave-robbing’.

I agree with that assessment.

These practices call for the most severe penalties, and if the authorities lack the will, confidence in EMR privacy, confidentiality and security will suffer, along with the physician-patient relationship.

The old ST:TOS line "Sometimes a man will tell his bartender things he'll never tell his doctor" could become too applicable for comfort.

Sometimes a man will tell his bartender things he'll never tell his doctor ... especially if they suspect their data is for sale to the Talosians, Captain ...

-- SS

From Down Under: The Story of the Deployment of an ED Clinical Information System ‐ Systemic Failure or Bad Luck?

I'd opine that bad luck had little to do with it.

A paper by an Australian professor of informatics about travails with a new ED EHR, manufactured by a large American HIT vendor, appeared recently (it is currently unavailable.) I remind that the issues affect a most critical area, the ED's in over 200 hospitals in Australia's most populous state, New South Wales (NSW). The paper is here.

[10/24 note: not available at present at this link or from its author in Australia; I pulled it from the Drexel U. server in the U.S. at the author's request while his right to post it on his department's server in Australia is being discussed Down Under - ed.]

[Jan. 2010 followup: an attempted censorship situation was resolved. See this update. Current paper in ver. 6 is here - PDF.]

Highlights:

... One criticism of [new ED EHR] is that the clinical documentation is built on the American model which doesn't fit the Australian workflow. In the same vein another commentator said it was a "system designed by administrators for administrators with no understanding whatsoever of clinical workflow and need".

... At the operational level in EDs staff dislike the software for various reasons such as: too many keystrokes to load data, hence, too complicated search pathways to find data, plus they are unable to get extraction of reports.

Their dislike has reached very intense levels with many staff dismissive of its usefulness. In more than one hospital the system was credited with causing a 50% decrease in the number of patients seen by a doctor in the first 20 minutes of arrival at the ED. In at least one hospital the direct data entry of clinical notes as done with [old ED EHR] [an earlier system - ed.] has been abandoned and transferred to paper as the [new ED EHR] process was seen as too cumbersome and time costly.

... Other comments about [new ED EHR] were: "I prefer looking at a paper result than the counter-intuitive waste of my time trolling through the system.

... I keep forgetting how the damn thing is supposed to work and find it more a time waster than a help."

... Similarly, "every single user *hates* it with a passion ... ENTERING the data is a pure nightmare"

And another:

... "it is exclusively used by the nurses and entirely ignored by the doctors"

And another:

... "Clumsy, complicated (not complex), user hostile, and above all slow at any task I tried".

... “We stated the system was dangerous (multiple reasons) and that we would not use it in its current state. We also got agreement that the nurse practitioner not use it for clinical details."

... “We in X and Y had a major confrontation with the NSW ‘gurus’ and refused to use it in ED in its current state. A clinician produced a well researched document to support our claims of its cumbersome stupidity. “People present (at the meeting) were local vmos, nurse practitioner who works in ED and the local ceo etc, plus reps from [new ED EHR vendor] , NSW health etc. One clinician was present by videoconference. Nurses presented a long document detailing multiple concerns.

“The meeting was quite emotional and heated as they tried over and over again to pull the wool over our eyes. For example, they started out offering “more support”. One clinician replied that this was like giving us a defective car then sending out someone to show us how to drive it.

I asked was the support available at 3 A.M.? Blank faces.

They dissimulated info that “other doctors” in small country hospitals were trialing the system and had “no problems”. When asked which hospitals and which doctors again blank faces. They finally came up with a name who one of our partners rang that night and found him to be furious his name was used and that they were about to dump the system too...

The conclusion probably sounds familiar to HC Renewal readers:

... I wish to make a salient point about the nature of the delivered software with respect to the whole process of change management in the introduction of new IT infrastructure. In these situations there is always a great deal of noise and attention given to the processes of systems review, workflow redesign, and staff training.

In many ways this is paying attention to the smoke rather than the fire. The actual design and operation of the software is fundamental to the successful introduction of information technology. It is a necessary condition that the software works in a fashion that optimally fits the activities and workflow of the recipient organisation, and this fit is the single largest determinant of a successful system wide implementation. Like any foundation if it is not properly designed and constructed the edifice above it will collapse no matter what amount of attention and details you put into it. The delivered software is the foundation of any clinical information system. It would seem that in this case this understanding has not been grasped by authorities in NSW.

... Without optimal design and implementation there will be no cost efficiencies and productivity gains delivered by IT, but rather, it will contribute to the spiralling expense. We can only hope that Government will understand that a modest investment in R&D for clinical information systems is needed to create the desired improvements in productivity, cost reduction and patient safety.

I believe our own government here could learn from this.

Read the whole thing, including the series of ethical issues the author raises. I believe the lessons apply not just to the one vendor mentioned, but to most HIT vendors, especially the large ones.

Also note the observations from another Australian, Dr David G More MB, PhD, FACHI in an essay entitled "The Blight on the Landscape Health IT Awards" at this link.

-- SS

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, in the New York Times Prescriptions Blog:

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.'

Also, the chief anti-trust enforcement officer in Obama administration weighed in with similar sentiments, as reported by Bloomberg News via the Philadelphia Inquirer:

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.'

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 AMA news release for the 2009 report said:

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.

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 anechoic effect. 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 reminder 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 here.]

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:

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—

(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.

The VA system, VistA/CPRS ("computerized patient record system"), was developed with taxpayer money and is freely available. A free working demo is downloadable here (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 "Fuzzy Math Indeed.") 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 WorldVista. They probably won't be charging the multimillion dollar rates that the private HIT sector does, and the quality will likely be higher.

-- 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 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 recent WSJ article, 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.




That said, here are some sample voluntary reports on HIT malfunctions from just one vendor, taken from the FDA Medical Devices database, the Manufacturer and User Facility Device Experience (MAUDE) database, links included. These are production systems used on real, live patients, not prototypes:

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.

Emphases below are mine. My comments are in [red italic].

Case 1: (note - added to this post 7/2010)
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1656460
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 this link 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:
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=64345
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:
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=722614
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 aminoglycoside, causing peak levels to rise to nephrotoxic and ototoxic levels - ed.]

Case 4:
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=946706
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:
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=888215
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:
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=920819
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:
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=700117
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:
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=715963
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:
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=753029
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 NORAD's 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 on this link (PDF). Some of these are a bit startling.

---------------------------------

Still others can be seen at:

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=695436

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=688925

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=996685

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1075747

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=574578

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1288623

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1370640

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=834678

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:

No records were found with Manufacturer: Allscripts Report Date From: 10/01/1998 Report Date To: 09/30/2009

... and this:

No records were found with Manufacturer: Nextgen Report Date From: 10/01/1997 Report Date To: 09/30/2009

... while a broader FDA search on "Nextgen" brings up exactly one relevant hit on "Nextgen EMR - Medical Device" -- without specifics as to the "malfunction" noted under product code "HGM" - which on lookup is a perinatal monitoring system.

A broader search on Allscripts only brings up drug related issues such as this curious 2002 warning letter 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 no problems to report (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 held harmless for HIT defects that harm patients?

I report, you decide.

-- SS