VA / DoD EHR Interface Debacle: Will It Take the Luminosity Of A Dozen Supernovas To Shed Light On The Obvious About Healthcare IT?

(12/2010 note: I have observed a large number of "hits" on this post from multiple offices of the Mitre Corporation in the past several weeks. Dear Mitre, I ask that if you use my materials in your proposals or writings, that you please let me know. Thank you. My email address is in my profile under "Contributors." -- SS)

The VA and DoD have been working for a number of years on interfacing the VistA EHR system and the military's EHR, AHLTA (why anyone would want to interface to AHLTA in its present state is of concern to me, but...)

[Note: this is not to denigrate the military, and I am very thankful to all who serve and defend our country and freedoms. HIT problems seem unfortunately universal - ed.]

The interface attempt, likely done by the usual actors in the traditional "business IT" manner has resulted in the predictable:

Glitch prompts VA to shut e-health data exchange with Defense
NextGov.com
By Bob Brewin 03/04/2010

The Veterans Affairs Department closed off access to the Defense Department's huge electronic health record system on Monday because it found errors in some patients' medical data clinicians downloaded from the Defense network, according to a departmental patient safety alert, which Nextgov obtained.

Although no patient was injured, the errors shed light on how software glitches could affect the accuracy of electronic medical records and a planned national system that has been backed by the Bush and Obama administrations.

"Shed light on how software glitches could affect the accuracy of electronic medical records?"

As my early medical mentor, Hahnemann cardiothoracic surgery pioneer Victor P. Satinsky would have said about purveyors of such wisdom: they are Masters of the Obvious.

I ask:

Why do we keep needing to "shed light" on the blatantly obvious, in your face, computer science 101 reality about electronic information systems? The light was shed when the first stored-program computers were developed in the late 1940's.

Exactly how much light do we need to shed before IT personnel "get it" about the need for the most extreme diligence in IT-based medical records?

Perhaps the light of a dozen supernovas?

Is this the amount of light it will take before the IT world "gets it" about the need for the utmost engineering rigor in healthcare IT? (click image to play video).

It's fortunate the error was found in a somewhat less than life-threatening manner:

VA first discovered the problem in late February, when one of its doctors accessed the Defense health records system, called AHLTA, to review the prescription information of a female patient. The data showed a Defense physician had prescribed her an erectile dysfunction drug. The VA doctor suspected the system displayed erroneous information [although females have been known to use these drugs- ed.] and a check with the Defense medical facility that supposedly prescribed the drug informed VA that the data was wrong and the VA query had returned information for another patient.

... When doctors queried the Defense system for patient information, they received no data, a portion of the data, incorrect information, or the complete, correct data for the patient, according to the alert.

[Where have I seen these types of patient data errors mentioned recently? Perhaps at my recent post "FDA on Health IT Adverse Consequences: 44 Reported Injuries And 6 Deaths In Two Years, Probably Just Tip of Iceberg" ? - ed.]

The glitch did not cause harm to any patient, but "the potential exists for decisions regarding patient care to be made using incorrect or incomplete data," said Jean Scott, director of the Veterans Health Administration's Information Technology Patient Safety Office, in the alert issued on Wednesday.

Indeed.

"The VA clinician may see the patient's data during one session, but another session may not display the data previously seen," the alert noted. "This problem occurs intermittently and has been reported when querying DoD laboratory, pharmacy and radiology reports."

I would add that "intermittent errors" are by definition unpredictable. This is the most dangerous type of IT malfunction of all.

Until those systems are reactivated, VA doctors will have to obtain a patients' health information from their paper medical files, faxes or PDF attachments that are e-mailed to the physicians, Scott said.

What? That old-fashioned, unreliable 5,000 year old artifact upon which the foundations of modern medicine were built, and favored by Luddites?

The errors occurred in the Bidirectional Health Information Exchange, a project started in 2004 that allows clinicians in VA and Defense to view health information in patient files. Older code in the system became stressed at peak periods when clinicians were making the most number of queries, said Roger Baker, chief information officer at VA. At these times, the system did not clear out a memory cache, resulting in memory leaks "so that information from one patient is presented as it is from another," he explained.

Good software and information architecture engineering practices call exactly for testing under stress. Failure to clear caches, memory leaks, etc. are fundamental flaws that should never be permitted to see the light of day in clinical settings. That is what acceptance testing is designed to do. That's what mission critical software undergoes in other sectors. That is what drug and device clinical trials are designed to do.

At this link, for example, is NASA's Certification Processes for Safety-Critical and Mission- Critical Aerospace Software from 2003 (PDF). From that document:

... Since safety-critical aerospace software is prevalent and important to human life, what is the rationale behind certification of such software? In other words, how do engineers know when a new software product works properly and is safe to fly? In the United States, software must undergo a certification process described in various standards by various regulatory bodies including NASA and the Requirements and Technical Concepts for Aviation (RTCA) which is enforced by the Federal Aviation Administration (FAA).

There are no analogous requirements or enforcement in the healthcare IT sector. None.

In fact, the VA, of all places, should have been exceptionally wary of these types of malfunctions and exercised the highest levels of engineering rigor.

Why?

See "IT Vulnerabilities Highlighted by Errors, Malfunctions at Veterans Medical Centers" at this link. From that posting, reflecting a March 4, 2009 JAMA article by the same title by Bridget M. Kuehn (JAMA 2009;301(9):919-920):

... After a software update of the electronic medical records system at VA hospitals in August [2008], health care workers at these facilities began to report that as they moved from the records of one patient to those of a second patient, they would sometimes see the first patient's information displayed under the second patient's name. [If not for the diligence of the users then, that type of error could have led to dead patients -ed.]

This records-scrambling problem was reported at 41 of the 153 VA medical centers, said Gail Graham, deputy chief officer of Health Information Management at Veterans Health Administration Headquarters in Washington, DC. Graham explained that the jumbling of records was an uncommon occurrence that only occurred after a particular sequence of events.

... Health care workers at the VA medical centers were notified about this potential problem in October, and on December 20, the centers received a software "patch" to fix the problem.

Nine VA medical centers reported another type of problem related to their electronic records system: physician orders to stop medication were missed, causing some patients to receive intravenous medications longer than necessary. The problem occurred because after the software upgrade, physician orders to discontinue such medications, which had previously appeared at the top of the screen, were not displayed.

In 3 cases, patients received infusions of drugs such as heparin for up to 11 hours after their physician had ordered the drug to be discontinued. Graham said the affected patients were not notified because they had not been harmed by the oversights. This software problem was corrected on December 8.

As I noted in that post: "... if this type of error occurs once too often, your patient's dead."

Back to the current VA / DoD interface "glitch":

... The VA has fixed the [current] bug and plans to bring the BHIE back online on March 9. Baker emphasized the bug's effect on the medical records of patients that VA and Defense clinicians share was sporadic and occurred in one out of 100 queries. The glitch caused errors only in the records that VA clinicians accessed. Defense doctors still have access to records Veterans Affairs stores.

"Only" 1 out of 100? ... that's only 10,000 errors per million EHR queries. Not too bad at all ... how many soldiers are in a military division?

Baker said the department's response to the glitch showed VA's overall health system worked "because there is always a doctor in the loop" who checks the accuracy of a patient's health data in combination with a well established patient safety organization that quickly alerts clinicians to any errors.

The "system worked" because luck prevailed that fallible, busy human clinicians were not deceived by erroneous information provided by a computer? I fall back on first principles of IT:

A computer can free professionals from tedious, repetitive work which does not require judgment. It can provide facts and figures with lightning speed, giving domain experts more time to exercise their judgment thoughtfully

The system is not working when computers add to the tedium, and having to expend precious cognitive capacity in ferreting out computer errors is certainly in that category. This excuse reminds me of a recent quote from our Homeland Security secretary about how the "system worked" when an airplane nearly was blown out of the sky.

These failure excuses, possibly written by a public relations 'spin doctor' in an effort at damage control, remind me of a humorous sign I bought in a novelty store once, for placing on the wall: "Our policy is to always blame the computer."

Perhaps clinicians need to stand up for this motto: No more alpha and beta software rollouts in healthcare.

Robert Charette, a risk management consultant and president of the ITABHI Corp. in Fredericksburg, Va., which consults with Defense, said VA was lucky it discovered an error as obvious as prescribing an erectile dysfunction drug for a female patient. He wondered if VA would have detected the error if it were for drugs with similar names, adding that despite the low error rate, "it's the one out of 100 that can bite you."

It's also the one out of fifty thousand that can bite you, for instance as Merck recently discovered.

Baker said the complexity of medical records systems like BHIE would make regulating such networks [by agencies such as FDA - ed.] a daunting task.

I thought we were just at the point of transforming health with one thunderous click of a mouse after another per our prior HHS secretary at the 2005 HIMSS summit. Perhaps not...

Dave deBronkart, a patient advocate in Nashua, N.H., who spoke at last week's Health IT Policy Committee meeting, said in an interview with Nextgov that the glitch paralleled the problems he encountered last year when he tried to transfer information from his hospital medical record to Google Health, an online electronic health record database the search giant launched in 2008.

I wrote about that at "Should Google Seek the Resignations of Those Responsible for This Healthcare IT Debacle?" here.

If the United States wants to develop a national health electronic record system, it needs to make sure heath information exchanges work correctly, said deBronkart, who added VA should be commended for reacting quickly to the software problem and issuing the patient safety alert.

I believe this is not possible under the current leadership, organizational and regulatory structures found in the healthcare IT sector. As I've written before, healthcare cannot be 'reformed' or even improved by IT, until IT and its culture are themselves reformed.

For more on these issues, see my site below.

-- SS

For more on HIT challenges see "Contemporary Issues in Medical Informatics: Common Examples of Healthcare Information Technology Difficulties" - http://www.ischool.drexel.edu/faculty/ssilverstein/cases/

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

I Ask Again: Should The U.S. Call A Moratorium On Ambitious National Electronic Health Records Plans?

In Nov. 2008 I wrote a post "Should The U.S. Call A Moratorium On Ambitious National Electronic Health Records Plans?"

The question was raised based on reports of serious difficulty experienced by the UK in their national program for electronic health records, Connecting for Health.

I commented on how the world financial crisis of 2008-09, combined with chronic project difficulties and mismanagement and profound clinician resistance was creating such high levels of doubt about the UK's Connecting for Health (CfH) national program for electronic health records (EHR's), that the program was under consideration for actual cancellation.

From the British press:

Bank bailout puts £12.7bn NHS computer project in jeopardy

Christine Connelly, the Department of Health's recently appointed head of informatics, is understood to be reviewing whether the programme is a cost-effective way of improving the quality and safety of patient care.

She will have to find compelling arguments to stop the Treasury earmarking health service IT as a candidate for cuts to compensate for the billions spent on the bailout of the banks. However, the high cost of cancelling contracts with IT suppliers may be a factor saving the programme from cancellation.

It is simply stunning that the UK might be "locked in" to a potential disaster by IT vendors. (How is this allowed to happen?)

I'd also commented on how the lack of true Medical Informatics education and expertise in the new UK CfH "head of informatics" (and predecessors, for that matter) was a symptom of a much larger disease in healthcare IT.

The disease is a paradoxical (especially for medicine) and turned-on-its-head leadership structure where "amateurs" reign. Amateurs, in the sense that my significant telecommunications experience and even licensure as a radio amateur (ham) extra class, a hobby, would not qualify me to, say, lead a national telecommunications projects for the British Armed Forces due to lack of professional telecommunications training and credentials.

Read my Nov. 2008 "Moratorium" post for details on the UK problems.

Since that time, there have been two remarkable events in the United States (when I wrote the above posting, I had no idea whatsoever that the following would occur):

In Dec. 2008, the Joint Commission (the organization that accredits healthcare organizations here) issued a Sentinel Event Alert on HIT recommending that significantly more caution be taken in its design and implementation due to risks posed by the technology. In "Joint Commission Sentinel Event Alert On Healthcare IT" I commended the JC for taking such a step, likely to be viewed with disdain by the business sector and those infatuated with HIT as a "magic bullet" panacea for healthcare.

Then, in Jan. 2009, the highest scientific authority in the U.S., the National Research Council (NRC) of the National Academies issued their report after a several-year study of HIT entitled "Computational Technology for Effective Health Care: Immediate Steps and Strategic Directions," a rather innocuous sounding title for a potentially explosive report.

The National Academies perform an unparalleled public service by bringing together committees of experts in all areas of scientific and technological endeavor. These experts serve pro bono to address critical national issues and give advice to the federal government and the public.

Four organizations comprise the Academies: the National Academy of Sciences, the National Academy of Engineering, the Institute of Medicine and the National Research Council.

I believe the title of the Press Release about the NRC report summarizes the report more accurately than its native title. The Press Release title is: "National Research Council: Current Approaches to Health IT Insufficient."

I presented the release at the post "Current Approaches to Health IT Insufficient ... and Other Master of the Obvious News."

While I do not know if my work had any influence on this report, its conclusions parallel those of myself and a relatively small number of colleagues who've stuck to unpopular (with the industry, that is) contrarian views on the unquestioned goodness of HIT. It is likely a number of the authors of this report were aware of my work over the years, as a frequent poster in the American Medical Informatics Association listservs and frequent writer and speaker on these issues, including some outspoken comments made at AMIA when some of the authors were in attendance. I believe the report can be better summarized by the following quote:

"Healthcare IT, dominated by non-medical IT personnel who views these tools as IT systems that happen to involve clinicians, rather than clinical tools that happen to involve computers, have mismanaged HIT through their false assumptions, lack of knowledge and lack of insight for at least several decades." - Silverstein

The NRC report found that current efforts aimed at the nationwide deployment of health care IT are not sufficient to achieve medical leaders' vision of health care in the 21st century and may even set back the cause. This conclusion was reached based partially upon site visits to eight U.S. medical centers considered leaders in the field of health care IT.

It concluded 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 , as opposed to its current "medicine as a business" paradigm providing clinicians with, essentially, an inventory system based on 19th century accounting theorem (the major critique of IT, in fact, by Peter Drucker in his latter years). As I observed in 1999:

Management expert Peter F. Drucker, one of the most respected names in modern management thinking, offers some highly relevant insights about information issues in his book "Management Challenges for the 21st Century" (HarperBusiness, 1999). These insights amplify the importance of medical information specialists (medical informaticists) taking leadership roles in healthcare organizations, and the problems with allowing MIS to predominate on medical information issues and clinical information tool development and evaluation.

Drucker writes that "the information revolution...is not happening in IT or MIS, and is not led by CIO's...what has triggered the [real] information revolutions and is driving them is the failure of the 'information industry' - the IT people, the MIS people, the CIO's - to provide information. For 50 years, information technology has centered on data...and technology [not useful information]."

He continues, "The data available in business enterprises are still largely based on early 19th century accounting theorem. MIS has taken the data based on this theorem and computerized it. They are the data of the traditional accounting system. IT...collected the [accounting system's] data, manipulated them, analyzed them and presented them. On this rested, in large measure, the tremendous impact the new technology had on what cost accounting data were designed for: operations. But it also explains IT's near-zero impact on the management of business itself."

I'd also observed at that time that Medical Informatics and its teachings can thus be seen as a means to an end: the creation and dissemination of useful information that advances the practice, science and management of healthcare, not just facets of its operations.

In 2008 I wrote that:

... I believe the unimaginative, process over results, tightfisted control, bureacratic "data-processing" culture of the business IT (management information systems) world to be the lineal descendant of IBM's patchcord plug-panel programmed, card tabulating machines from which IBM made a large portion of their profit in the days before the electronic computer. You perhaps required such a culture when you were running huge businesses from stacks of tens of thousands of punched cards. However, such a model does not work well in meeting the information needs of clinical medicine.

... Medical informatics, a pioneering field, in many ways saw the electronic computer not as a card-based data processing machine but as a canvas for development of creative works to serve the needs of clinical medicine and its practitioners.

The National Research Council report in fact incarnates my contention that HIT is not a subspecies of MIS or management information system (i.e., business IT). I maintain that only the assumption that it is, combined with leadership by non clinicians, could result in outcomes such as this:

The report describes difficulties with data sharing and integration, deployment of new IT capabilities, and large-scale data management. Most importantly, current health care IT systems offer little cognitive support; clinicians spend a great deal of time sifting through large amounts of raw data (such as lab and other test results) and integrating it with their medical knowledge to form a whole picture of the patient. Many care providers told the committee that data entered into their IT systems was used mainly to comply with regulations or to defend against lawsuits, rather than to improve care. As a result, valuable time and energy is spent managing data as opposed to understanding the patient.

Provision of cognitive support for clinicians is perhaps an alien concept to those mired in data processing paradigms.

It seems critical that the National Research Council's recommendations for

"interdisciplinary research in biomedical informatics, computer science, social science, and health care engineering"

occur, in order to change current thinking and practices in HIT design, implementation and lifecycle. Further, this research must occur, and in a manner unbiased by industry interests, before more tens or hundreds of billions of dollars are sunk into yet more HIT systems that miss the mark.

Even the vaunted VistA system of the Veterans Administration has some problems:

Software hiccups cause drug, treatment errors at VA
Associated Press
Posted: January 14, 2009 - 5:59 am EDT

Patients at Veterans Affairs health centers around the country were given incorrect doses of drugs, had needed treatments delayed and may have been exposed to other medical errors because of software glitches that showed faulty displays of their electronic health records.

The glitches, which began in August 2008 and lingered until last month, were not disclosed by the Veterans Affairs Department to patients even though they sometimes involved prolonged infusions of drugs such as heparin, which in excessive doses can be life-threatening, according to internal documents obtained by the Associated Press under the Freedom of Information Act.

There is no evidence that any patients were harmed, even as the VA says it continues to review the situation. But the issue is more pressing as the federal government begins promoting universal use of EHRs. President-elect Barack Obama has made it a part of an additional $50 billion a year in spending for health IT programs that he has proposed.

The VA's recent glitches involved medical data—vital signs, laboratory results and active medications—that sometimes popped up under another patient's name on the computer screen. Records also failed to clearly display a doctor's stop order for a treatment, leading to reported cases of unnecessary doses of intravenous drugs such as blood-thinning heparin.

In a statement, the VA said there were nine reported cases where patients at the VA medical centers in Milwaukee, Durham, N.C., and Marion, Ind., were given incorrect doses—six of them involving heparin drips that were given for up to 11 hours longer than necessary. The other cases involved infusions of either sodium chloride or dextrose mixtures that were prolonged for up to 15 hours past the doctor's prescribed deadline.

This is a rather major "glitch", even more unnerving in that it was sporadic and geographically dispersed.

With these issues in mind, I again ask the question, backed up not just by my own relatively unknown and trivial work but by the national accrediting agency for healthcare in the U.S., and the highest scientific body here as well:

Should The U.S. Call A Moratorium On Ambitious National Electronic Health Records Plans?

$50 billion a year is big money that might be better spent elsewhere - such as providing care for the poor and for disadvantaged children - until we know how to get HIT right.

I suggest it may be best not to go all-out for HIT under the current paradigm. It is my belief, in fact, based on the above issues plus a chronic influx of HIT difficulty and mismanagement stories I hear from colleagues, ex-colleagues, recruiters, etc., that healthcare organizations not contractually obligated should consider a postponement of plans to purchase clinical IT (i.e., systems for direct use by clinicians such as EHR's).

This postponement should last at least until the issues that lead to ineffective and counterproductive HIT can be better understood and corrections initiated in the industry.

-- SS