FDA MAUDE Database: Patient Outcome - Death

I present another health IT problem case from the FDA's voluntary MAUDE (Manufacturer and User Facility Device Experience) database below.

From FDA's description of MAUDE:

• 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.
• The on-line search allows you to search CDRH database information on medical devices which may have malfunctioned or caused a death or serious injury. MAUDE is scheduled to be updated monthly and the search page reflects the date of the most recent update. FDA seeks to include all reports received prior to the update. However, the inclusion of some reports may be delayed by technical or clerical difficulties.
• MAUDE data is not intended to be used either to evaluate rates of adverse events or to compare adverse event occurrence rates across devices. Please be aware that reports regarding device trade names may have been submitted under different manufacturer names. Searches only retrieve records that contain the search term(s) provided by the requester.

I somehow missed the following case when I wrote the Oct. 2009 post 'Our Policy Is To Always Have Unabashed Faith In The Computer ... Except When It Screws Up, And Then It's The Doctor's Fault' but I have added it there as well:

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.

How many cases like this, as well as "near misses" related to health IT go unreported, nationwide and worldwide?

As in my paper "Remediating an Unintended Consequence of Healthcare IT: A Dearth of Data on Unintended Consequences of Healthcare IT", nobody really knows; these devices are unregulated with no requirements for reporting.

However, let's roll it out nationally anyway, because HIT will deterministically "revolutionize" medicine. Just ignore those spoil-the-party, man-behind-the-curtain prattle from writers like these.

We can safely ignore all contrarian research and literature, of course, as we all know HIT will revolutionize medicine from the definitive certainty of HHS in "The 'Meaningful Use' Regulation for Electronic Health Records", NEJM, Blumenthal and Tavenner (10.1056/NEJMp1006114, July 13, 2010):

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.

[Except for those who haven't - ed.]

And our government's called BP Energy Company cavalier?

I offer no additional comments.

-- SS

NORCAL Mutual Insurance Company: "Electronic Health Records: Recognizing and Managing the Risks"

The Insurance Industry is catching on that EMR's and other clinical IT are not exactly the cybernetic miracles they're sometimes held out to be, for example as implied in this statement from HHS in the July 13, 2010 NEJM that-

... EHRs will improve caregivers’ decisions and patients’ outcomes. Once patients experience the benefits of this technology, they will demand nothing less from their providers.

NORCAL Mutual Insurance Company, for example, produces a near-monthly publication entitled "Claims Rx." Its purpose:

The goal of Claims Rx is to help physicians better recognize their medical professional liability risks and implement strategies to minimize those risks. The topics addressed here are derived from numerous sources including closed malpractice claims analyses, emerging liability trends and current medical literature. Each issue is meticulously reviewed by an editorial board consisting of physicians, nurses, risk management specialists and attorneys with a mind toward optimal patient safety and proactive risk management.

The October 2009 issue, found at this link in PDF, is entitled "Electronic Health Records: Recognizing and Managing the Risks." It contains advice to physicians to limit their liability, reduce errors, and presents de-identified examples of HIT-related horror stories.

Some of the advice offered includes:

Electronic health records (EHRs) hold great promise of improving patient safety and decreasing medical liability exposure, but their use is creating a variety of new risk management and patient safety issues.

For some reason, the "great promises" made over the past fifty years still seem elusive...but we'll get it right some day...(perhaps when these issues among others are solved).

Some of these issues are directly associated with EHRs (e.g., providers disregard warnings generated by the EHR), but many of the risk concerns associated with EHRs are analogous to problems that currently exist in paper documentation systems.

The marketing puffery that today's EMR's are vastly superior to paper might be just that - marketing puffery.

In this month’s Claims Rx we present a number of shorter-than-usual case studies that exemplify various aspects of unsafe EHR documentation and communication practices. The scenarios are based on NORCAL closed claims, facts presented in appellate opinions, research findings and the observations of NORCAL Risk Management Specialists.

What many of the examples show is that EHRs do not eliminate many of the dangerous documentation and communication practices that have historically led to patient injury and malpractice lawsuits.

I would add "EHR's in their present form do not eliminate dangerous practices", designed as if they were clinical data inventory systems by business-IT eggheads rather than as clinical tools "of, by and for clinicians." (One might ask why we are about to spend 100+ billion dollars on them in national rollout the next few years.)

Consequently, while it is important to address new issues that arise with EHRs, many of the risk management recommendations that apply to a paper-based documentation system remain valid.

This Claims Rx will discuss the risks associated with various aspects of EHRs and will provide guidance for instituting policies and procedures designed to enhance the quality and safety of patient care, while diminishing professional liability risk.

A number of case examples then follow. I will reproduce two, but all can be read via downloading the PDF at the link above.

Saving Images in the Wrong Patient’s Chart

Just as an image can be misfiled or lost in a paper system, it can be misfiled in an electronic one. However, as the following case shows, it can be less obvious that an image has been misfiled in an electronic system.

Case Study

Patient #1 and patient #2 both presented to the Emergency Department (ED) complaining of abdominal pain. CT scans of the abdomen and pelvis were completed for both patients. A radiology tech mistakenly gave patient #2’s images the identification number assigned to patient #1 and uploaded the images into the Picture Archiving Computer System (PACS).

A short time later, the tech realized his mistake and called the on-duty teleradiologist to tell him about the mistake and request that the mislabeled images be deleted from the system. However, the on-duty teleradiologist did not have access to delete images from the PACS; this had to be done by the PACS administrator. The tech then corrected the labeling problem and sent the images out to the teleradiology service for a preliminary review and resent the correctly labeled images to the PACS.

Patient #1’s PACS file now contained both his own and patient #2’s images. A few days later the tech told his supervisor about the mislabeling, and assumed that the supervisor would remedy the problem. Pursuant to hospital policy, the tech should have immediately contacted the PACS administrator.

The teleradiology service reported that patient #1’s CT scan was normal. Patient #2’s CT scan, however, showed a large tumor (about the size of a grapefruit) on the patient’s kidney. The service faxed the reports to the radiology department at the hospital.

The next morning, the on-duty radiologist reviewed the PACS images from the night before. He disregarded the teleradiology service reports because they did not correspond to what he saw in the PACS. Because patient #2’s scan had been completed before patient #1’s, patient #2’s images were the first series in his file.

The on-duty radiologist noted the large tumor and dictated a note. Because patient #2’s images still carried patient #1’s identification number, the radiologist’s report was assigned to patient #1.

Patient #1 was subsequently seen by a number of specialists for the supposed tumor on his kidney. Seven days after the CT scan, he underwent a nephrectomy [lovely- ed.]. During the surgery, no mass could be positively identified on his kidney by his surgeons. Postoperatively, no tumor was identified in the removed kidney and pathology returned benign.

(Please note, once the filing mistake was recognized, patient #2 was notified and underwent a timely and successful nephrectomy.)

[In other words, through serendipity only one person was harmed, not two - ed.]

One wonders how many "cases" like this will arise out of the major-vendor EHR upgrade flaw that is claimed to have led patient data to go into wrong charts at not one, but several hospitals:

HIStalk Monday Morning Update 7/12/10

From Holy Smoke: “Re: Cerner. Misidentification incidents have been reported with Cerner PowerChart and Millenium in hospitals in Indiana, Michigan, and others after a Cerner upgrade. Entries are placed in the wrong electronic chart and reviewed data is for the wrong patient.” Unverified. I saw nothing in the FDA’s Maude database, so if it’s happening, customers should file an experience report.

(See my July 11, 2010 post 'Health IT and 'High Regulatory Standards': Criminal Negligence for Implementing Defective Systems That Put Data in the Wrong Charts?').

Next from NORCAL:

Checking the Wrong Box

In the following case, the appearance of the computer screen probably played a role in the medication error.

Case Study

A patient presented to his primary care physician (PCP) for the treatment of headaches and episodes of altered consciousness. The PCP prescribed amitripyline at 10 mg nightly. The PCP told the patient to escalate the dosage by 10 mg every three to four days until the pain was relieved, but not to exceed 50 mgs without consulting him.

When creating the prescription, the PCP intended to check off the 10-mg box in the computerized physician order entry (CPOE), but inadvertently checked the 100-mg box, which was right above it. In the medication instructions section, he indicated that five pills could be taken per night, so the patient would not have to return to the pharmacy and pay an additional co-pay if he ultimately needed the larger dose.

The pharmacist had noticed that the dose seemed high and requested that a call be made to the PCP prior to it being dispensed. A nurse at the PCP’s office picked up the call, and because she was very busy that day, told the pharmacy to dispense the medication as it had been ordered — she did not check the dose. Three days later, the patient took five of the 100-mg pills together. Early the next morning, the PCP was contacted by an emergency department (ED) physician who reported that the patient was in the ED reporting dizziness, an altered state of consciousness, an inability to coordinate his movements and a rapid heartbeat.

He was further informed by the ED physician that the patient had taken five 100-mg amitripyline tablets. The PCP then checked the patient’s record and realized his mistake.

[It's serendipitous that the patient was not in the morgue when the mistake was realized - ed.]

Read the rest of the cases and the explanations at the Electronic Health Records: Recognizing and Managing the Risks "Claims Rx" document from NORCAL here (PDF).

In these cases, both technological and "people" issues were responsible for the malpractice events.

However, healthcare is an extremely complex endeavor requiring exquisite attention to detail (or your patient's dead).

These IT systems could have been designed to provide cognitive, ease-of-use, and known-error revision (or at least known-error flagging) support to clinicians that could have helped prevent these errors.

HIT designers need to do their part if they want to be considered part of the clinical team.

If they don't do their part voluntarily and stop with the mission-hostile,1970's-paradigm "inventory system of widgets" health IT, as I've written before, they will increasingly find themselves part of that team in an involuntary manner - as defendants in litigation.

Finally, due to issues such as: an utter lack of governmental regulation of the HIT industry and a lack of defect and error reporting requirements; contractual gag and hold-harmless clauses (as raised by Penn researchers Koppel and Kreda in JAMA here); physician fear of hospital retaliation such as sham peer review for HIT whistleblowing especially now that more physicians are becoming hospital employees; and other causes, there is no reliable data on the incidence of EHR-related medical errors and malpractice.

As in my paper "Remediating an Unintended Consequence of Healthcare IT: A Dearth of Data on Unintended Consequences of Healthcare IT", there is also no reliable data on "near misses" or potential IT related mishaps that were averted by serendipity. These near misses expose patients to risk. With no reporting, there is no systematic data that can be used for remediation and prevention.

I thus present once again the following thoughts from my post Science or Politics? The New England Journal and "The 'Meaningful Use' Regulation for Electronic Health Records":

I believe we should hold off national Health IT roll outs until we:

• learn sufficiently from failures such as the UK CfH and our own military's AHLTA debacle on how to avoid same, which can injure and kill patients and wastes massive money and resources healthcare can ill afford, and more importantly that can be better used elsewhere - such as care of the poor;

• improve the technology's usability, safety and efficacy through the years of Medical Informatics and other disciplinary research needed, that was short circuited through the invention of the ONC office by Bush (although national HIT then remained a goal, not a mandate), and the 'militarization' of ONC under Obama whereby HIT was unilaterally declared a proven technology and mandated for national rollout;

• end the contractual and fear-based censorship of information on health IT problems, and patient injuries and deaths related to the devices; and

• meaningfully regulate these devices that have increasingly become governors of care delivery.

I have written extensively on these topics at this blog, at my academic website on health IT failure, and other sources (see list at end of my bio).

When there are significant doubts about a medication or medical device, we ought not push for national rollout.

Health IT devices have gotten special accommodation, and it's not on the basis of any rigorous science I am familiar with.

-- SS

Science or Politics? The New England Journal and "The 'Meaningful Use' Regulation for Electronic Health Records"

In the NEJM article "The 'Meaningful Use' Regulation for Electronic Health Records", David Blumenthal, M.D., M.P.P. (ONC Chair) and Marilyn Tavenner, R.N., M.H.A. (10.1056/NEJMp1006114, July 13, 2010) available at this link, the opening statement is (emphases mine):

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.

I think it fair to say those are grandiose statements and predictions presented with a tone of utmost certainty.

(My 84 year old mother must be the sole exception to those "patient demands" for electronic health record-mediated cybernetic miracles).

My mother, in ICU on ventilator after iatrogenic cerebral hemorrhage, May 2010,
after receiving the rewards of electronic medical record beneficence.
Still in hospital as of this writing in mid July.

Even though it is a "perspectives" article, I once long ago learned that in writing in esteemed scientific journals of worldwide impact, statements of certainty were at best avoided, or if made should be well documented.

I note the lack of footnotes showing the source(s) of these statements.

I also note the lack of mention of literature refuting or potentially refuting these statements of certainty. I can think of a few examples of the latter [ref. 1-13 below, certainly not a comprehensive list].

In politics, however, no such sourcing is necessary. It's easy for a politician to say "Free markets will not give us the healthcare system we want" or, conversely, "I never heard about the DOJ's selective dismissal of charges against people intimidating voters at a voting site in Philadelphia."

So, did the NEJM publish fact, or political platitude?

Can someone provide a list of peer reviewed, rigorous studies that back the assertions of certainty in 10.1056/NEJMp1006114, and override the body of literature that could cast doubt on these assertions of certainty?

Since it's people's lives at stake, not an inventory of widgets, I've promoted the idea of holding off on national roll outs until we:

• learn sufficiently from failures such as the UK's NPfIT (National Programme for IT) in the NHS and our own military's AHLTA debacle on how to avoid same, which can injure and kill patients and wastes massive money and resources healthcare can ill afford, and more importantly that can be better used elsewhere - such as care of the poor;

• improve the technology's usability, safety and efficacy through the years of Medical Informatics and other disciplinary research needed, that was short circuited through the invention of the ONC office by Bush (although national HIT then remained a goal, not a mandate), and the 'militarization' of ONC under Obama whereby HIT was unilaterally declared a proven technology and mandated for national rollout;

• end the contractual and fear-based censorship of information on health IT problems, and patient injuries and deaths related to the devices; and

• meaningfully regulate these devices that have increasingly become governors of care delivery.
  

I have written extensively on these topics at this blog, at my academic website on health IT failure, and other sources (see list at end of my bio).

When there are significant doubts about a medication or medical device, we ought not push for national rollout.

Health IT devices have gotten special accommodation, and it's not on the basis of any rigorous science I am familiar with.

-- SS

References: (hyperlinks to these and others can be found at my medical informatics teaching sites here and here):

1. Health IT Project Success and Failure: Recommendations from Literature and an AMIA Workshop by Bonnie Kaplan and Kimberly D. Harris-Salamone. From the May/June 2009 issue of JAMIA.

2. "E-Health Hazards: Provider Liability and Electronic Health Record Systems.” Hoffman and Podgurski’s followup paper on EHR medical and legal risks

3. Role of Computerized Physician Order Entry Systems in Facilitating Medication Errors. Ross Koppel, PhD, et al, Journal of the American Medical Association, 2005;293:1197-1203

4. Electronic Health Record Use and the Quality of Ambulatory Care in the United States. Arch Intern Med. 2007;167:1400-1405. The authors examined electronic health records (EHR) use throughout the U.S. and the association of EHR use with 17 basic quality indicators. They concluded that “as implemented, EHRs were not associated with better quality ambulatory care.”

5. Pessimism, Computer Failure, and Information Systems Development in the Public Sector. (Public Administration Review 67;5:917-929, Sept/Oct. 2007, Shaun Goldfinch, University of Otago, New Zealand)

6. Bad Health Informatics Can Kill. his site contains summaries of a number of reported incidents in healthcare where IT was the cause or a significant factor. It comes from the Working Group for Assessment of Health Information Systems of the European Federation for Medical Informatics (EFMI).

7. The U.S. National Research Council’s "Current Approaches to U.S. Health Care Information Technology are Insufficient."

8. The UK Public Accounts Committee report on disastrous problems in their £12.7 billion national EMR program.

9. Gateway reviews of the UK National Programme for IT from the Office of Government Commerce (OGC) (released under the UK’s Freedom of Information Act).

10. A report on the serious problems with the Department of Defense’s AHLTA system, Electronic Records System Unreliable, Difficult to Use, Service Officials Tell Congress. (This system, as I wrote here, is slated for abandonment. I cannot imagine it was greatly improving outcomes).

11. A New York Times report “Little Benefit Seen, So Far, in Electronic Patient Records” on Jha’s research at the Harvard School of Public Health, that compared 3,000 hospitals at various stages in the adoption of computerized health records and found little difference in the cost and quality of care.

12. An American Journal of Medicine paper “Hospital Computing and the Costs and Quality of Care: A National Study” by Himmelstein and Woolhandler at Harvard Medical School, that also concluded “as currently implemented, hospital computing might [very] modestly improve process measures of quality but not administrative or overall costs."

13. A Milbank Quarterly article “Tensions and Paradoxes in Electronic Patient Record Research: A Systematic Literature Review Using the Meta-narrative Method" by Greenhalgh, Potts, Wong, Bark and Swinglehurst at University College London.

Addendum 7/14:

I think this statement at "The Road to Hellth" blog in a post entitled "Meaningful Ruse" that cites my posts is apropos:

... Meaningful use entered our vocabulary in early 2009 as part of a $20+ billion gift from doctors, hospitals and the taxpayers to the needy folks at Cerner, GE, Siemens, Allscripts, Epic and other purveyors of complex, expensive and difficult-to-use and potentially even dangerous medical software products.

-- SS

Meaningful Use Final Rule: Have the Administration and ONC Gone Insane on Health IT?

Meaningful use before meaningful usability?

The Dept. of HHS today has released the final version of "Meaningful Use" rules on HIT, which can be seen here: Meaningful Use – Final Version Full Text.

By what category of diligence were the rules for "meaningful use" finalized on the same date that a NIST conference is being held on health IT "usability" ("Usability in Health IT: Technical Strategy, Research, and Implementation", http://www.nist.gov/itl/usability_hit.cfm), implying there's a problem with usability of these experimental devices physicians are supposed to "meaningfully use?"

Don't take my word on the issue of usability problems...

The National Research Council of the National Academies (considered the highest scientific authority in the U.S.) issued a 2009 report on HIT. In that report, presided over by noted HIT pioneers G. Octo Barnett (Harvard/MGH) and William Stead (Vanderbilt), were findings that current HIT does not support clinicians' cognitive needs as here:

CURRENT APPROACHES TO U.S. HEALTH CARE INFORMATION TECHNOLOGY ARE INSUFFICIENT

WASHINGTON -- Current efforts aimed at the nationwide deployment of health care information technology (IT) will not be sufficient to achieve medical leaders' vision of health care in the 21st century and may even set back the cause, says a new report from the National Research Council. The report, based partially on site visits to eight U.S. medical centers considered leaders in the field of health care IT, concludes that 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.

How about HIT industry trade/"educational" group HIMSS itself? I think reasonable people might conclude the technology is not ready for "meaningful use" on a national scale from their mid 2009 report:

Defining and Testing EMR Usability: Principles and Proposed Methods of EMR Usability Evaluation and Rating (PDF)
HIMSS EHR Usability Task Force
June 2009

EXECUTIVE SUMMARY
Electronic medical record (EMR) adoption rates have been slower than expected in the United States, especially in comparison to other industry sectors and other developed countries. A key reason, aside from initial costs and lost productivity during EMR implementation, is lack of efficiency and usability of EMRs currently available. Achieving the healthcare reform goals of broad EMR adoption and “meaningful use” will require that efficiency and usability be effectively addressed at a fundamental level.

These "usability" problems require long term solutions. There are no quick fix, plug and play solutions. Years of research are needed, and years of system migrations as well for existing installations.

Yet we now have an HHS Final Rule on "meaningful use" regarding experimental, unregulated medical devices the industry itself admits have major usability problems, along with a growing body of literature on the risks entailed.

For crying out loud, talk about putting the cart before the horse...

Something's very wrong here...

However, this situation is anything but humorous.

How more insane can government get?

Poor usability promotes medical error. Medical error puts patients at risk of iatrogenic injury and death - such as the one suffered in May 2010 by my own mother.

My mother, in ICU on ventilator after iatrogenic cerebral hemorrhage, May 2010, after receiving the 'rewards' of electronic medical record beneficence that caused a critical cardiac medication to 'disappear' from her current meds list. Still in hospital as of this writing in mid July.

Are we are entering an era of cybernetic medical assault on our patients (and perhaps criminal negligence and manslaughter, a term I do not use lightly) through irrational exuberance in computing -- and through exuberance about the profits to be made by the HIT industry?

Unless we slow down in our exuberance and recklessness on HIT diffusion, my fear is that we very well might be.

-- SS

Addendum:

Also see my followup July 14, 2010 post "Science or Politics? The New England Journal and "The 'Meaningful Use' Regulation for Electronic Health Records."

-- SS

Health IT and 'High Regulatory Standards': Criminal Negligence for Implementing Defective Systems That Put Data in the Wrong Charts?

Over at the HIStalk blog (a blog whose owner remains anonymous, and who uses an ISP that does not reveal information that could be used to identify him, apparently out of fear of retaliation for controversial stories he posts), the following appeared:

Monday Morning Update 7/12/10

From Holy Smoke: “Re: Cerner. Misidentification incidents have been reported with Cerner PowerChart and Millenium in hospitals in Indiana, Michigan, and others after a Cerner upgrade. Entries are placed in the wrong electronic chart and reviewed data is for the wrong patient.” Unverified. I saw nothing in the FDA’s Maude database, so if it’s happening, customers should file an experience report.

While the reports are "unverified", I can add that the FDA MAUDE database would not show any data if this problem were recent, as I believe MAUDE contributions are reviewed by FDA before posting.

(7/21/10 addendum: various sources confirm this occurred at a religious-denomination hospital chain headquartered in the Great Lakes region of the U.S.)

However, as I wrote in Oct. 2009 at "Our Policy Is To Always Have Unabashed Faith In The Computer ... Except When It Screws Up, And Then It's The Doctor's Fault", the MAUDE database does contain some error reports from this vendor (one of the very few HIT vendors who actually file such reports) such as:

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.

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 while attempting to sign a result or a document, the display could lag behind the system's processing of the action, 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.

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.

Assuming the current reports from anonymous whistleblower "Holy Smoke" are true, I note the following.

My observations apply to any vendor and/or healthcare organization that puts defective HIT into use in patient care--

At my April 2010 post "Healthcare IT Corporate Ethics 101: 'A Strategy for Cerner Corporation to Address the HIT Stimulus Plan'", I'd written:

A profoundly disappointing lesson in the ethics of the healthcare IT sector (and the B-schools as well) can be gleaned from the following, a paper written by a Cerner employee and two health industry colleagues for a Duke Fuqua School of Business course.

The course is "Health Economics & Strategy (HLTHMGMT 326), Distance Executive MBA" (syllabus here in PDF) ... The paper is entitled "A STRATEGY FOR CERNER CORPORATION TO ADDRESS THE HIT STIMULUS PLAN."

The paper was scrubbed from the Duke Fuqua School of Business Site on or around April 16, 2010 but a cached copy is available here. In that paper what I believe is a combination in restraint of trade was suggested:

This paper seeks to clarify these implications [of the the economic 'stimulus' package - ed.], understand the strengths and weaknesses of various players in the industry and recommend a strategy for Cerner Corporation to maximize its profit from the stimulus package and thereby secure a dominant position in the HIT industry.

... We recommend that Cerner collaborate with other incumbent vendors to establish high regulatory standards, effectively creating a barrier to new firm entry.

High standards? I have some suggestions regarding "high regulatory standards."

I agree that high, in fact, the highest regulatory standards should be upheld.

I think I can safely state that a common regulatory standard in healthcare is that those involved in patient care, even peripherally, act with sound judgment and with patient well being as a foremost concern. Those acting recklessly and dangerously might be found negligent in a civil sense, or if acting recklessly in a willful and knowing manner, might be found criminally negligent.

Two descriptions of criminal negligence:

Criminal negligence - (law) recklessly acting without reasonable caution and putting another person at risk of injury or death (or failing to do something with the same consequences).

Criminal negligence is conduct which is such a departure from what would be that of an ordinary prudent or careful person in the same circumstance as to be incompatible with a proper regard for human life or an indifference to consequences. Criminal negligence is negligence that is aggravated, culpable or gross.(PDF).

It is damn well clear that electronic medical records systems must function without unpredictable data errors that put data into the wrong persons' charts, thus producing two errors and two possibilities for patient harm: an erroneous absence of appropriate data in one patient's chart, and an erroneous presence of inappropriate data in another's.

This is not a theoretical argument open to debate, and this is not a drill.

As in the bottom half of my May 2010 post "Did EPIC CEO Judy Faulkner of Epic declare that ‘healthcare IT usability would be part of certification over her dead body?'", I report that a recent data error involving one single medication nearly killed my mother, caused great pain and suffering that continue almost two months later, and has resulted in her being an invalid with continuing, ongoing complications she may not survive.

In addition, the "learned intermediary" excuse used to punt liability onto physicians and other clinicians for patient harm due to IT errors does not apply here, and this is also not open to debate. Physicians, even the most learned, are not clairvoyant; they should not be expected to know which chambers are empty and which chambers are loaded in a game of cybernetic Russian Roulette with the data on their patients.

Having an EMR maintain fundamental relational integrity, i.e., not place clinical data entered in good faith by trusting clinicians in another patients' chart, is not rocket science.

Those who design, those who implement, and those who put into production (i.e., for use by physicians, nurses and other clinicians in the care of patients) any health IT "upgrade" without the extensive testing, testing and more testing necessary to prove proper operation on such a fundamental point as maintenance of relational integrity (i.e., correct patient identity in data storage and retrieval) knew, should have known, or should have made it their business to know that doing so puts patients at risk of injury or death.

Putting an "upgraded" software application with such fundamental defects into actual use in real, live patients care environments - for whatever reason, e.g., finances, vendor marketing pressures, meeting planned objectives and numbers, obtaining a bonus, etc. - reflects in my view:

"... a departure from what would be that of an ordinary prudent or careful person in the same circumstance as to be incompatible with a proper regard for human life or an indifference to consequences."

Thus:

In upholding the highest regulatory standards, if patients are harmed or die as a result of this type of HIT snafu, criminal charges against the responsible IT, clinical and administrative personnel would be an appropriate remedy to this type of negligence.

It should be noted that, as a result of my mother's injury, I am now on a path to become a provider of litigation support to plaintiffs injured by EMR-related medical errors and malpractice.

This is not a career path I intended for myself when I entered the academic field of Medical Informatics two decades ago (although it will leverage my background in interacting with lawyers and giving depositions as a former occupational medicine physician in the public transit industry).

However, and regrettably, as I wrote at "$4 Billion Military EMR "AHLTA" to be Put Out of Its Misery?", in my view as of 2010 legal actions are the only way that the domain of healthcare IT can be returned to a field "of, by and for" clinicians, instead of "of, by and for" those who live off the lifeblood of clinicians and their patients.

-- SS

Jurassic Attitudes about Medical Informatics: in the U.S. Navy?

The message below to a listserv for Chief Medical Informatics Officers and related positions was recently forwarded to me by a colleague. I cannot believe what I am reading, as it reflects attitudes I'd thought were extinct by the late 1990's ("I don't see the value of clinical informatics").

The last time I'd heard such nakedly Jurassic views, and other anti-physician informatics attitudes as in this 1999 essay I penned, was from the C-level officers of the hospital where I was CMIO in that time frame, Christiana Care Health System in Delaware.

From: (Withheld)
Date: Sun, Jul 4, 2010 at 9:24 AM

Hi All,

I was recently told by one of our senior leaders that he saw no value to Clinical Informatics and followed that up by disbanding the Clinical Informatics Directorate at the BUMED (Headquarters of Navy Medicine) level.

I successfully countered that argument with a more senior leader, but I tried to find objective evidence of the value of Clinical Informatics without success. As an academic family physician who lives, eats and breathes evidence-based medicine, I try to make all my decisions and arguments for and against positions/programs based on the best available evidence. In this case, all I could use was potential value and logic.

My question is this: Does anyone out there (and I have already discussed this with [name redacted - ed.]) have any objective evidence that shows the value of clinical informatics to the Enterprise (which has multiple definitions, but suffice it to mean across an entire health care system.however large)? I have already talked with [name redacted - ed.] about including a survey of CEO's/COO's/CMO's/CIO's as to the value they see in clinical informatics, but that is some time in the future. I really need some data now. Anyone have anything? Any and all assistance is greatly appreciated.

In the face of the apparent spectacular failure of AHLTA ($4 Billion Military EMR "AHLTA" to be Put Out of Its Misery? Also, Does the VA Have $150 Million to Burn on IT That Was Never Used?), I certainly view such statements as extraordinary, and in a very negative sense.

While I could help with cases showing the "value of clinical informatics" right up to the Office of the National Coordinator, my mother was recently severely injured by an HIT mishap in the public hospital sector. This came after my written warnings to the CEO of that hospital a month prior that I was noticing major EHR problems impairing clinician-clinician communications, and that in my professional view patients would likely be injured. I did not realize one of those patients would be my own 84-y.o. mother (see http://hcrenewal.blogspot.com/2010/05/did-epic-ceo-judy-faulkner-of-epic.html , bottom section). The letter went unanswered except for a response from an underling, in essence denigrating medical informatics.

It has become my opinion that Jurassic attitudes about medical informatics are virtually unremediable; they suggest an underlying technical and mental deficit in those who proffer such opinions that is not correctible by evidence and logic. (I can predict with a good degree of certainty that this "senior leader" had a role in AHLTA's demise.)

I suggest a different approach: surely patients received suboptimal care (and perhaps suffered injury) under AHLTA. The freebie newspapers serving the soldiers such as I have seen in my visits to Fort Dix, where my mother has commissary/PX privileges as a result of my father's service-connected injuries and disability, might find such a story "interesting."

In the meantime, I am doing a John Galt regarding persons espousing the "I don't see the value of informatics" view. I'm frankly tired that such people remain in the healthcare workforce. While I could provide a lot of material supporting the value of informatics (actually, its essential nature) that I and others have written over the years, I choose to no longer do so.

The military person proffering this view is apparently a "senior leader"; it's their responsibility and indeed obligation to make the Navy better. Let them lead.

And let the pieces fall where they may.

-- SS

$4 Billion Military EMR "AHLTA" to be Put Out of Its Misery? Also, Does the VA Have $150 Million to Burn on IT That Was Never Used?

I have heard from numerous reliable sources that the military's $4 billion+ EMR known as "Armed Forces Health Longitudinal Technology Application" (AHLTA) is to be declared a failure, and replaced.

I'd written about AHLTA's considerable problems at the post "If The Military Can't Get Electronic Health Records Right, Why Would We Think Conflicted EHR Companies And IT-Backwater Hospitals Can?" at http://hcrenewal.blogspot.com/2009/06/if-military-cant-get-electronic-health.html .

From that post:

[AHLTA has been described as] difficult for physicians to use. Intolerable. Slow. Unreliable. Frequently crashes. Near mutiny. Morale. Affecting patient care, decreasing patient load. Can it get worse?

Yes ... When the Army's Surgeon General observes that clinicians "spend as much or more time working around the system as they do with the system", and that the superusers are not enthusiastic about the system, and a Congressional hearing is held entitled "where do we go from here?" (it's clear to this author that they have no clue), one should start to very critically question basic assumptions about health IT.

One wonders if anyone responsible for AHLTA ever read my now decade-old site on health IT dysfunction, now at this link at Drexel University, or its many hyperlinks to additional resources.

Meanwhile, the VA is having its own problems as noted on the HISTalk blog:

[HISTalk News 6/30/10] Back in March, I dug out a juicy nugget from an internal VA report: it was scrapping a $150 million patient scheduling system without ever bringing it live. The GAO weighs in with its official report (warning: PDF), pegging the cost at $127 million and saying “VA has not implemented any of the planned system’s capabilities and is essentially starting over.” The contractor that developed the system with “a large number of defects” walks away with $65 million. GAO finds much to criticize about the VA’s involvement: lack of competitive bidding, sloppy specs, unreliable status reports, and lack of action by project oversight groups when the project started tanking.

The linked PDF report from the U.S. Government Accountability Office (GAO), entitled "INFORMATION TECHNOLOGY - Management Improvements Are Essential to VA’s Second Effort to Replace Its Outpatient Scheduling System", reveals errors that cause me to question whether the project leadership ever passed their introductory undergraduate IT courses (assuming they had any).

From that report:

VA’s efforts to successfully complete the Scheduling Replacement Project were hindered by weaknesses in several key project management disciplines and a lack of effective oversight that, if not addressed, could undermine the department’s second effort to replace its scheduling system:

• VA did not adequately plan its acquisition of the scheduling application and did not obtain the benefits of competition.
• VA did not ensure requirements were complete and sufficiently detailed to guide development of the scheduling system.
• VA performed system tests concurrently, increasing the risk that the system would not perform as intended, and did not always follow its own guidance, leading to software passing through the testing process with unaddressed critical defects.
• VA’s project progress and status reports were not reliable, and included data that provided inconsistent views of project performance.
• VA did not effectively identify, mitigate, and communicate project risks due to, among other things, staff members’ reluctance to raise issues to the department’s leadership.
• VA’s various oversight boards had responsibility for overseeing the Scheduling Replacement Project; however, they did not take corrective actions despite the department becoming aware of significant issues.
  

The impact of the scheduling project on the HealtheVet initiative cannot yet be determined because VA has not developed a comprehensive plan for HealtheVet that, among other things, documents the dependencies among the projects that comprise the initiative.

My question is:

By what miracle of God will the military's AHLTA's and the VA's scheduling system "replacements" be any better than what now exists? Through reliance on commercial EMR vendors and management consultant "experts", perhaps?

If so, I wish the military and VA the best of luck. They will need it.

The problems with computing in complex settings such as medicine are pervasive, far beyond the military. It is increasingly clear that the leadership of the healthcare IT ecosystem (and probably even the broader IT ecosystem) consists of recycled incompetents, never held accountable for project failures, even massive ones, instead moving on to wreak mayhem elsewhere. This has certainly been my own experience in both the hospital and pharma sectors.

Competent experts who actually try to do meaningful work (a.k.a. "rock the boat" or "non-team players" in the parlance of the incompetent and/or the power seekers) have become hopelessly marginalized - or unemployed. See the post "Edwin Lee on the Tiger We Are Now Riding" by Roy Poses. Our economy and even society is falling apart as a result of these leadership problems; Lee's post "Lightweight oil executives produce worthless disaster plans" as linked above is pathognomonic of these failures. Writes Lee:

... This week the executives of the other major oil companies (besides BP) presented their oil spill contingency plans to Congress. Several things were immediately evident: the plans were all grossly inadequate and carelessly done, they were all developed by the same outside consulting firm and they were essentially carbon copies of BP’s nearly useless plans. In other words, they were empty “cover your ass” documents rather than serious contingency plans. Some people may find this surprising. From my experience, it’s what we can and should expect from the vast majority of large, public institutions because of a universal and deeply flawed process for selecting their leaders.

... Those who are chosen to lead fit a mold: mediocre, short term thinkers with similar work experiences, outlooks, temperaments and personal incentives. Disaster response, creative thinking and fundamental changes are outside their limited range of interests or competencies.

Here is the major problem in a nutshell: no real accountability where it matters.

What follows from this is a first principle:

Recycled incompetents will never produce good information systems.

I am now speaking from personal experience, not just academic. My own mother has been seriously injured in part as a result of problematic health IT, and may remain crippled as a result, while major health IT commercial vendor CEO's have been reported as making statements that health IT usability -- one of AHLTA's major deficiencies - "will be part of certification over her dead body" (as described in my post at http://hcrenewal.blogspot.com/2010/05/did-epic-ceo-judy-faulkner-of-epic.html).

Why don't we recycle physicians with track records of killing patients? Better yet, make them Chairs of clinical departments?

The answer is obvious, but the IT culture seems immune to such considerations.

The UK's National Programme for IT in the NHS (NPfIT) is AHLTA on a national scale:

The UK Public Accounts Committee report on disastrous problems in their £12.7 billion national EMR program is here.

Gateway reviews of the UK National Programme for IT from the Office of Government Commerce (OGC) are here (released under the UK’s Freedom of Information Act), and a summary of 16 key points is here.

My prediction is this:

I do not believe health IT has advanced enough beyond the experimental stage for clinically efficacious, safe, cost effective mass dissemination.

Further, I do not believe that the human capital necessary to make such dissemination happen in a clinically efficacious, safe, cost effective manner exists in the IT industry.

Talent management in that industry -- based on cheap, just-in-time, "programming language/platform du jour", "smart people cannot or should not learn but should be declared obsolete", and Bart Simpson-style attitudes about ability and expertise -- does not allow the needed human capital to exist. A remarkable and revealing example comes from an article about health IT leadership a number of years ago in the journal “Healthcare Informatics”:

I don't think a degree gets you anything," says healthcare recruiter Lion Goodman, president of the Goodman Group in San Rafael, California about CIO's and other healthcare MIS staffers. Healthcare MIS recruiter Betsy Hersher of Hersher Associates, Northbrook, Illinois, agreed, stating "There's nothing like the school of hard knocks." In seeking out CIO talent, recruiter Lion Goodman "doesn't think clinical experience yields [hospital] IT people who have broad enough perspective. Physicians in particular make poor choices for CIOs. They don't think of the business issues at hand because they're consumed with patient care issues," according to Goodman.

The "management improvements" sought by the VA may simply not be possible, until the IT field undergoes something comparable to the "Flexner report" that the medical professions and their educational programs underwent a century ago.

And perhaps until health IT leadership personnel begin to lose their homes and fortunes in court to harmed patient plaintiffs, to the point where the leadership start begging competent, marginalized professionals who actually know what they're doing to save their sorry asses.

-- SS

7/6 addendum:

For more on the topic of dinosaur-era attitudes about Medical Informatics that lead to such debacles, see my July 5, 2010 post "Jurassic Attitudes about Medical Informatics: in the U.S. Navy?"

Did EPIC CEO Judy Faulkner of Epic declare that ‘healthcare IT usability would be part of certification over her dead body?'

At the HisTALK blog 5/31/10 update, a site with thousands of readers involved in all aspects of health IT, the following anonymous (at this point) report appeared:

From Tabula Rosa: “Re: EMR usability. At one of the ONC Policy Committee meetings, [founder and CEO] Judy Faulkner of Epic supposedly declared that ‘usability would be part of certification over her dead body.’ I wonder if she has similar sentiments about making software accessible to people with disabilities?” Unverified. This inspired my new poll question – keep reading below.

Epic Systems Corporation is one of the largest health IT vendors in the U.S.

If this report is true, it would have very, very serious implications towards the healthcare IT industry's attitudes about the usability - and ultimately the safety - of its products.

The essential nature of usability and the relationship to safety is not an issue for debate - period. It was settled long ago in relation not only to IT, but also to devices and machinery that use IT. For instance, see the mid 1980's wisdom written for the U.S. Air Force on user interfaces at my eight part series on mission hostile health IT user experiences at http://tinyurl.com/hostileuserexper. Microsoft and other responsible IT vendors spend billions on usability research.

I think it incumbent of the U.S. Office of the National Coordinator for Health IT, and its leader Dr. David Blumenthal, to confirm or deny that such a statement was made, on or off-record, at an ONC policy committee meeting, and if it was made, its exact context.

If it was made, it would raise the following questions:

• Would its utterer be saying this out of concern that their products have usability deficiencies that competitors do not, and that are not correctable in a short time frame?
• How much concern would such a statement indicate for the complex jobs of physicians, nurses and other clinicians whose safe conduct of their medical obligations depends on health IT?
• How much concern would such a statement imply towards the injured and dead bodies of patients affected by health IT of deficient usability?
• Since the CEO sets the tone for their company and has the ultimate responsibility for its conduct (and its Board of Directors as well), would such a statement reflect willful negligence and perhaps criminal conduct?

The last question is pertinent, for if, say, the CEO of Boeing were to relate that "usability of the control systems of its aircraft would be an FAA certification requirement over his or her dead body", or the CEO of oil drilling companies said same about their instrumentation that helps avoid underwater blowouts, I believe it would rise to the level of criminally negligent conduct.

This is all the more pertinent to me, as my mother was just seriously injured by a medication error that resulted from an apparent inability to move a few kilobytes of correct medication data (about which she was asked to confirm in the ED at presentation) from ED to floor. End result - a cascade of resultant complex medical problems resulting in a life-threatening 4.5 cm intracerebellar hemorrhage and emergency craniotomy. I do not know if she will survive.

I had warned this hospital's CEO and Chief of the Medical Staff - in writing - of deficiencies in its EHR systems regarding physician-physician communications a little more than one month ago, in fact, explaining that in my expert opinion, patients might get harmed.

Little did I know my own mother would be that patient a few weeks later.

I am seriously wondering, in fact, if the average hospital has the gravitas and political and technologic maturity to truly implement health IT so that the technology is uniformly beneficial, instead of spontaneously harmful, to meet the needs of the grandiose plans for national health IT.

The lack of seriousness, petty political fights, and technological dyscompetence and incompetence I have noted in my 20 years in this field do not seem surmountable in any time frame I consider "soon."

Here seems to be the health IT industry and hospital MIS department view of healthcare IT, as some sort of game to be played for profit, power and political advantage:




Here is the reality of health IT dysfunction, as my mother is now cruelly experiencing:





-- SS

Addendum May 31, 2010:

The comment thread at the bottom of HISTalk's Monday Morning Update 5/31/10 (from where the above EPIC CEO quote came) demonstrates numerous attitudes that give life to my concern that many uni-disciplinary, technology-focused HIT industry personnel may in fact be culturally and educationally unprepared, unwilling and/or unable to be collaborative, humane, safety-conscious members of the medical teams they are ostensibly hired to facilitate.

-- SS

Cerner - Fuqua School of Business 'Corporate Ethics 101' Paper and Website Disappear

On April 16 at "Healthcare IT Corporate Ethics 101: A Strategy for Cerner Corporation to Address the HIT Stimulus Plan" I wrote about a Duke Fuqua School of Business paper (apparently authored by a Cerner official) promoting a business strategy of regulatory manipulation to restrain the free market for HIT products.

The paper, and the Fuqua School of Business web page "Past Papers" on which the paper was promoted, have both disappeared as of this April 18 writing.

I have posted an image of the "Past Papers" page and updated my link to an archived copy of the paper, but the scrubbing of the Fuqua site and removal of the paper is interesting.

-- SS

Addendum Apr. 19 -

A former HIMSS staffer related to me that I am likely blacklisted from the HIT vendor industry as a result of my writings on health IT on this site and at my academic site dating to 1999, via verbal exchanges and even in writing among HIT organizations. It could explain why my CV's been uniformly ignored by that industry since the early 2000's.

If so, so be it. Who else might be on that blacklist, I wonder?

Also, didn't Richard Nixon get into a bit of trouble for maintaining such a list after it was discovered?

Healthcare IT Corporate Ethics 101: 'A Strategy for Cerner Corporation to Address the HIT Stimulus Plan'

Combination in restraint of trade: An illegal compact between two or more persons to unjustly restrict competition and monopolize commerce in goods or services by controlling their production, distribution, and price or through other unlawful means. Such combinations are prohibited by the provisions of the Sherman Anti-Trust Act and other antitrust acts.

I have written on these blog pages that the IT industry has staged an invasion of the healthcare professions.

One of these invasions has to do with the ethics of the IT industry, ethics at odds with medical ethics and the Hippocratic oath. The HIT industry is characterized by an overarching interest in profits and cavalier attitudes towards HIT-related adverse clinical events through sales of inferior products (domestically as well as abroad) based on archaic technologies, exaggerated claims of benefits, ultra-aggressive marketing, and legalized suppression of adverse events information about unproven, non-secure, largely experimental health IT medical devices.

I find it truly remarkable, more than 20 years into consumer availability of the GUI, that in the 2009 publication "Principles and Proposed Methods of EMR Usability Evaluation and Rating" (PDF) the major HIT trade group HIMSS admits that:

Electronic medical record (EMR) adoption rates have been slower than expected in the United States, especially in comparison to other industry sectors and other developed countries. A key reason, aside from initial costs and lost productivity during EMR implementation, is lack of efficiency and usability of EMRs currently available.

Unbelievable. What has this industry been doing for the past few decades?

Worse, the health IT industry is entirely unregulated and has pushed to maintain that status quo. Now the HIT industry may be clamoring for industry regulation as a means of restraint of trade as described below.

The public is beginning to wake up to the vendor and HIT trade group puffery, at least with regard to security hazards and exaggeration of the benefits:

Electronic health records prompt security, costs concerns
Richmond Times-Dispatch
By Tammie Smith
Published: April 5, 2010

The thought of one's personal medical information being just a computer click away does not sit well with many consumers. In a March 2009 survey of 1,238 randomly selected adults by the Kaiser Family Foundation, the Harvard School of Public Health and National Public Radio, 59 percent of respondents didn't think confidentiality of electronic medical records could be assured ... 76 percent thought it was likely that an unauthorized person would get access to medical records online.

... While there are anecdotal stories of electronic health records improving outcomes, the data are mixed on whether they save money. A Harvard Medical School study published in the American Journal of Medicine last year linked 2003-2007 cost and quality data for 4,000 hospitals, including the 100 "most wired" hospitals. The researchers concluded that the electronic health records systems in place so far "might modestly improve" quality quality but produced no savings on administrative or overall costs.

'Anecdotal'? 'might'? 'modestly'? Is that worth spending hundreds of billions of dollars on, at a time when the healthcare system is struggling to make ends meet, I ask?

Unfortunately, the public and healthcare regulators need a further awakening about the Healthare IT industry's ethics.

A profoundly disappointing lesson in the ethics of the healthcare IT sector (and the B-schools as well) can be gleaned from the following, a paper written by a Cerner employee and two health industry colleagues for a Duke Fuqua School of Business course.

The course is "Health Economics & Strategy (HLTHMGMT 326), Distance Executive MBA" (syllabus here in PDF). The course's stated purpose:

We will apply the tools of economics and strategy to address the challenges and opportunities of today's health care managers and policy makers. We will begin most classes with analysis of recent news, then discuss a case, and conclude with additional insight on the application of economics and strategy.

The paper is entitled -

"A STRATEGY FOR CERNER CORPORATION TO ADDRESS THE HIT STIMULUS PLAN" (PDF).

*** April 18 NOTE: the paper apparently has been scrubbed and is no longer available from the above link as it was on April 16. A copy is here (PDF).

It is actually highlighted at Duke professor David Ridley's page "Duke University Fuqua School of Business: Past Papers."

*** April 18 NOTE: the "Past Papers" page has also seemingly been scrubbed. This is how it looked two days ago:

(click to enlarge)

This appears to be a Final Paper for an online MBA program course for executives. These are therefore not just students in the academic sense; as in my own healthcare informatics courses, I've had 'students' who concurrently were executives and managers in healthcare companies and organizations.

All three authors are listed at business networking site LinkedIn.com:

• Dan Aycock - appears as Business Strategist at Cerner
• Aparna Prasad - MBA Candidate at The Fuqua School of Business, Duke University
• Barri Stiber - Administrative Fellow at Legacy Health - formerly Senior Analyst at The Advisory Board Company

The paper is emblazoned with the Cerner corporate logo on its cover page and could be mistaken for an official document:

Paper's cover page. Click to enlarge

From the paper, an example of HIT corporate ethics (and business school ethics as well):

Electronic health records (EHRs) have the potential to improve the healthcare system through several means including reduced medical errors, better coordination of care, and reduced costs. However, adoption of EHR systems in the U.S. has been slow; only 1.5% of acute care hospitals have comprehensive EHR systems.

While the Bush administration made efforts to spur adoption of these systems, the Obama administration’s American Recovery and Reinvestment Act of 2009 (ARRA) has pushed EHR adoption to the fore with over $20 billion dollars in incentives. With such a large infusion into a relatively small market the effects of the stimulus package have enormous strategic implications for EHR vendors.

This paper seeks to clarify these implications, understand the strengths and weaknesses of various players in the industry and recommend a strategy for Cerner Corporation to maximize its profit from the stimulus package and thereby secure a dominant position in the HIT industry.

... We recommend that Cerner collaborate with other incumbent vendors to establish high regulatory standards, effectively creating a barrier to new firm entry. Other strategic recommendations to capture market share, facilitate EHR adoption, and improve Cerner’s operational readiness are detailed and framed within an implementation plan.

I am going to highlight one key sentence for emphasis:

We - recommend - Cerner - collaborate - with - other - incumbent - vendors - to - establish - high - regulatory - standards, effectively - creating - a - barrier - to - new - firm - entry.

Did I read that correctly?

The paper goes on to explain:

... With the introduction of stimulus funding, this industry is ripe for disruptive innovation, which could significantly change the competitive landscape. Examining Christensen’s work on disruptive innovation outlined in Figure 6, the primary factor that will influence the entry of new HIT vendors is regulation.

Therefore, the technology standards and definitions of “meaningful use” which are under development have the potential to raise or reduce barriers to entry, limiting or enhancing the ability for disruptive innovations to enter at a lower performance point. When asked about which competitors the organization is most concerned about, a Siemens Executive indicated “it is these new guys who could come in and undercut prices with substandard products.”

["New guys" ="substandard"? This from a company that apparently fired an informatics physician for raising concerns that a substandard ICU system was going to kill patients - ed.]

Therefore, incumbent firms, like Cerner, have strong incentives to influence regulation in their favor, keeping barriers to entry high.

[Influence in their favor, not in the favor of patients, to maintain the industry oligarchy? - ed]

In other words, to stifle disruptive innovation and prevent newcomers from entry into the HIT business, large HIT vendors should influence regulation towards high standards impossible for newcomers to meet.

NOT that they should influence regulation for the sake of patient safety!

This student is apparently a Cerner strategist seeking an MBA. His colleague Barri Stiber was a Senior Analyst at The Advisory Board Company, a company that serves "nearly 3,000 progressive organizations worldwide—health care, health benefits, and educational organizations alike—providing innovative solutions to their most pressing challenges such that they can “hardwire” best-practice performance."

This paper raises a number of questions:

• Does this paper reflect a strategy that would amount to illegal restraint of trade and/or fall under the federal RICO act, through knowingly and willfully advancing a lobbying strategy to strangle fair competition?

• Were any of these authors on Cerner's payroll when this was written?

• Are Mr. Aycock or other authors giving such advice to Cerner management presently?

• Did or does Cerner use this paper or derivatives thereof internally?

• Does this paper reflect on the business ethics of Cerner or other large HIT vendors? Will they openly condemn its ideas as both wrong minded and monopolistic, using their influence to create a market adverse to smaller competitors - not to mention the paper's seeming lack of concern for what really matters - the "customer" (patients)?

• Did or does this paper reflect a more widespread healthcare IT large player collusion on restraint of trade?
  

• Is this how the Advisory Board company conducts its business in advising healthcare organizations?

• What type of professor would exalt a paper via posting it as an example for other students to emulate, a paper whose basic premise is unethical, or at the very least on the precipice of unethicality?

• Does this professor teach such ethics?

• Why was this paper not returned to its authors with a big, red "F" on it? That's what I would have done.

• What other papers are accepted by this professor that demonstrate similar business "strategies" in other sectors?

Finally, and perhaps most importantly:

• Does this paper reflect, or did it influence, current Cerner or other large HIT vendor business strategy?
  

Recent developments are consistent with that, i.e., Cerner starting to acknowledge need for regulation, per the Feb. 2010 story "FDA Considers Regulating Safety of Electronic Health Systems" by the Huffington Post Investigate Fund, http://huffpostfund.org/stories/2010/02/fda-considers-regulating-safety-electronic-health-systems).

From that article:

.... Yet some inside the industry favor stepped-up scrutiny. One major vendor, Cerner Corporation, which has voluntarily reported safety incidents to the FDA in recent years, signaled its support for a rule that would make those reports mandatory. Cerner has reported potential safety concerns because it is the “right thing to do,” a company official said.

I was puzzled by that turnaround.

Perhaps now I know from where it arose.

It certainly is the "right thing to do." It's the right thing to do to enhance profits and enforce restriction of market entry by "disruptively innovative" newcomers.

Those newcomers might actually hold the answers to improving healthcare IT and reducing costs through fair, free market competition, saving lives and money the healthcare system dearly needs. (For example, see my post "Hospitals Under the Knife: Sacrificing Hospital Jobs for the Extravagance of Healthcare IT".)

-- SS

Addendum Apr. 16 -

A commenter speculates that:

... When I did my MBA, back in the day, we were one of the first programs to have a working business background as a requirement for admission. From that base I would make the following guesses:

• The people were not only on the company payroll, but also were having their tuition paid for by the company.
• This document was widely circulated within the company,
• The document was highlighted as a means for the university to curry favor with the company thus increasing recruits or for financial gain.

... The modern remote MBA program is in many instances simply a way to check a box for employees on the fast track to senior management. Often papers are written with the support of the company and access to department heads who contribute to material turned in.

From my experience this is not some theoretical exercise, but a document that, even retiled, will be used internally to drive policy.

While that is speculation, it is certainly plausible; nothing would surprise me in the health IT industry.

Addendum Apr. 19 -

A former HIMSS staffer related to me that I am likely blacklisted from the HIT vendor industry as a result of my writings on health IT on this site and at my academic site dating to 1999, via verbal exchanges and even in writing among HIT organizations. It could explain why my CV's been uniformly ignored by that industry since the early 2000's.

If so, so be it. Who else might be on that blacklist, I wonder?

Also, didn't Richard Nixon get into a bit of trouble for maintaining such a list after it was discovered?

-- SS