Medical center has more than 6000 "issues" with Cerner CPOE system in four months - has patient harm resulted?

As I have written at Healthcare Renewal before, computerized physician order entry systems (CPOE's) are known to present risks to patients through induction of medical errors.

This technology is held out to be ready for national diffusion, right up to the POTUS. Per ONC director Blumenthal in the July 13, 2010 NEJM:

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.

Vendors deny major problems with their CPOE and other health IT products.

The true story is a bit more complex.

Fortunately, there are some medical centers who are open and honest about HIT problems. These medical centers seem a rarity. However, those that do share are actually conducting themselves in an honorable and mission-true manner, per Joint Commission Safety Standards, the ethics of the medical profession, and the expectations of the public. They should be commended.

One such example is Munson Medical Center in Michigan.

From the October 2010 "News for Physicians affiliated with Munson Medical Center" newsletter, a large medical center in Northern Michigan, about more than six thousand "issues" with their Cerner CPOE:

POE Program Continues to be Improved, Enhanced

The Provider Order Entry (POE) program continues to be improved. Since implementation in June [four months ago - ed.], more than 6,000 issues have been reported. Issues are defined as an aspect of the program not working as intended [does that include medication and treatment errors and 'near-misses'? - ed.], process issues [can these 'issues' kill? - ed.], education needs, or PowerPlan [Cerner - ed.] change requests.

About 600 of these remain open. Issues are prioritized by the POE Team and addressed according to existing standards.

One wonders how many of those 6,000, and how many of the 600 remaining "issues" fall into categories of "likely to cause patient harm in short term if uncorrected" or "may cause in patient harm in medium or long term."

I note that Cerner CPOE is not a new product, nor are similar products from other vendors also afflicted with long lists of "issues." That there could be more than 6,000 "issues" at a new site suggests deep rooted, severe problems with CPOE specifically and health IT design and implementation processes in general.

Did patient harm result here or at other CPOE sites (using products of any vendor, not just this one) that had hundreds or thousands of "issues"? We may never know.

That national rollout is mandated as if this technology were proven, safe, and plug and play is a scandal of UK NPfIT-like proportions.

-- SS

Health IT: On Anecdotalism and Totalitarianism

At the article Blumenthal on EMRs: Debate "raging" over competition vs. standards (http://www.massdevice.com/news/blumenthal-emrs-debate-raging-over-competition-vs-standards), ONC czar David Blumenthal is cited as saying several interesting things:

... EMRs make him a better physician, he said, recounting personal anecdotes of discovering patients' allergies through automated EMR alerts and using stored image date to more quickly get a diagnosis for a patient without subjecting them to more radiation and toxic radiation agents ...

It's the EMR "anecdotalists" (as opposed to the "Markopolists") who say that "anecdotes" of HIT-related injury are meaningless. They deem reports of safety issues and HIT-related misadventures and risk as simply "anecdotal", and that "anecdotes don't make evidence" (or "anecdotes don't make data").

Yet anecdotal reports of EMR "saves" are used by a czar to justify tens of billions of dollars of expenditures?

To the anecdotalists, I say: you can't have it both ways.

That same article concludes with this concerning statement:

... Blumenthal, adamantly pro-EMR, said there is a move afoot to add technical fluency into certification for healthcare providers. "Boards of certification, all the primary care boards of medicine have adopted principles that will lead them to create requirements for the use of electronic health systems as a research requirement, and even the medical licensing boards are beginning to think about whether the maintenance of licensure should be dependent, to some degree, on using electronic health systems," he said. "Information is the lifeblood of medicine, and unless physicians and other healthcare professionals are capable of using the most modern technology available for managing information, I think they will have trouble claiming, in the 21st century, the unique competence that entitles them to being licensed and board certified. I think they'll have trouble holding up their heads as professionals and claiming that they are at the top of their game and capable of providing the best care that technology allows."

It appears that my observation ten years ago of a cross-occupational invasion on Medicine by the IT domain (and its purveyors) was prescient. They've continued the march, and now they're now literally at the castle gates.

I commented on this issue in more detail a few weeks ago at my post "American Board of Medical Specialties to "incorporate tools to promote meaningful use of health IT into its maintenance-of-certification program".

I have two questions:

1) Was it the intention of the Medical Informatics pioneers to prohibit physicians from being licensed and/or board certified on the basis of using health IT? If such a seemingly totalitarian intention existed, that's fine, I just want to hear it debated.

2) Is the mere consideration (let alone enactment) of such a restriction, for all specialties, truly evidence based?

(Note some merely skimming-the-surface "evidence" at my post "Science or Politics? The New England Journal and "The 'Meaningful Use' Regulation for Electronic Health Records".)

-- SS

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

From the aforementioned Huffington Post Investigative Fund article "FDA, Obama Digital Medical Records Team at Odds over Safety Oversight" and timeline of industry resistance to government oversight of health IT (link), one document stands out in my mind.

The internal FDA memorandum of Feb. 23, 2010 ("not intended for public use") to Jeffrey Shuren on HIT risks. which I have now re-hosted at this link (PDF) is quite fascinating.

Internal FDA Memo ("not intended for public use") on potential dangers of health IT. Download the PDF here.

The memo begins:

This report serves to characterize medical device reports (MDRs) in the Manufacturer and User Facility Experience (MAUDE) database, inclusive of MedSun reports, pertaining to Health Information Technology (H-IT) safety issues as requested by the Office of the Center Director, Center for Devices and Radiological Health (CDRH), in contrast to the previously submitted MedSun and Office of Compliance information.

(I've mentioned MAUDE here and here, including a report of an HIT-related patient death at the latter link.)

To those "anecdotalists" in the healthcare information technology community who believe reports of HIT-related harm are "anecdotal, and anecdotes don't make data" (as opposed to the "Markopolists"):

When an internal FDA review of their own data concludes the following, I invite you to think about the point of view that maintains that reports of HIT-related patient injury and death are so 'fragmentary' as to not merit (actually, demand) significant resources be diverted to rigorously addressing the issue of HIT risk:

In summary, the results of this data review suggest significant clinical implications and public safety issues surrounding Health Information Technology. The most commonly reported H-IT safety issues included wrong patient/wrong data, medication administration issues, clinical data loss/miscalculation, and unforeseen software design issues; all of which have varying impact on the patient’s clinical care and outcome, which included 6 death and 43 injuries. The absence of mandatory reporting enforcement of H-IT safety issues limits the number of relevant MDRs and impedes a more comprehensive understanding of the actual problems and implications.

This is especially true considering the FDA's own noted limitations of their information sources:

Limitations of the MAUDE search and final subset of MDRs include the following:

1. Not all H-IT safety issue MDRs can be captured due to limitations of reporting practices including

... (a) Vast number of H-IT systems that interface with multiple medical devices currently assigned to multiple procodes making it difficult to identify specific procodes for H-IT safety issues;
... (b) Procode assignments are also affected by the ability of the reporter/contractor to correctly identify the event as a H-IT safety issue;
... (c) Correct identification by the reporter of the suspect device brand name is challenged by difficulties discerning the actual H-IT system versus the device it supports.
2. Due to incomplete information in the MDRs, it is difficult to unduplicate similar reports, potentially resulting in a higher number of reports than actual events.
3. Reported death and injury events may only be associated with the reported device but not necessarily attributed to the device.
Memo: H-IT Safety Issues
4 Correct identification by the reporter of the manufacturer name is convoluted by the inability to discern the manufacturer of the actual H-IT system versus the device it supports.
5 The volume of MDR reporting to MAUDE may be impacted by a lack of understanding the reportability of H-IT safety issues and enforcement of such reporting.

If HIT were VIOXX or Phen-Fen, the class action lawsuits would likely be starting already.

(Note: for more on why there is a scarcity of data on HIT related adverse events, see my paper "Remediating an Unintended Consequence of Healthcare IT: A Dearth of Data on Unintended Consequences of Healthcare IT" at this Scribd link. This paper was not accepted on first draft by the medical informatics peer review process. I received anonymous review comments such as one that paradoxically stated that the paper "did not contain anything that could not be read in any big city newspaper", an odd comment indeed considering the topic. On that basis I decided not to attempt a revision but to post the paper publicly. -- SS)

One has to ask why this internal FDA report has not been made public until the Huffington Post article, nor been acted upon vigorously. The term of art is "double standard" compared to pharmaceuticals and other medical devices.

When the NEJM starts publishing unreferenced statements of absolute certainty like this from ONC Chair Blumenthal:

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.

and the HuffPo Investigative Fund quotes him as follows:

“We know that every study and every professional consensus process has concluded that electronic health systems strongly and materially improve patient safety. And we believe that in spreading electronic health records we are going to avoid many types of errors that currently plague the healthcare system,” Blumenthal said when unveiling new regulations in Washington on July 13.

... a statement easily demonstrable to be without merit, in fact, then one has to wonder where science has gone.

One also has to wonder if someone is short-circuiting the FDA's role in regulating this technology.

Could Blumenthal (in essence a family doctor), Sibelius (a trial lawyer), DeParle, or others, or the White House itself be telling FDA how to conduct its business? Are they impeding FDA's regulatory role in the irrationally exuberant multi-billion $$$ race to HIT utopia?

Finally, it is my belief that numerous health IT/medical informatics academics and talking heads who've steadfastly avoided the issue of health IT-related patient harm, or scoffed at it in legally-discoverable forums, might find themselves as defendants in upcoming plaintiff lawsuits. "Knew, or should have known" is the phrase that might apply.

As I learned from my pre-informatics Transit Authority medical management experience, juries will likely not take kindly to academic and marketing arguments akin to Scott Adam's sarcastic example of the logical fallacy of "ignoring all anecdotal evidence":

"I always get hives immediately after eating strawberries. But without a scientifically controlled experiment, it's not reliable data. So I continue to eat strawberries every day, since I can't tell if they cause hives."

-- SS

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

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

(I'd written some preliminary comments at an earlier post entitled "Huffington Post Investigative Fund: FDA, Obama Digital Medical Records Team at Odds over Safety Oversight.")

First, some relatively obvious questions about the Cerner health IT crashes at the Trinity Health System chain of hospitals featured in the story:

• How many patients were affected? Is the number actually known?
• Were affected patient charts corrected?
  
• What restrictions, if any, have been placed on physicians, other clinicians, employees, contractors, staff, etc. about speaking to the press on the Trinity Health HIT malfunctions?
• If any restrictions were placed, are they in violation of Joint Commission Safety Standards as in my July 22, 2009 JAMA letter to the editor "Health Care Information Technology, Hospital Responsibilities, and Joint Commission Standards" at this link?
• Did this healthcare system sign "hold harmless" clauses with Cerner, as per Koppel and Kreda's 2009 JAMA article "Health Care Information Technology Vendors' Hold Harmless Clause - Implications for Patients and Clinicians, JAMA 2009;301(12):1276-1278, at this link?
  
• Did this healthcare system sign a gag clause with Cerner, the vendor of their affected systems according to the Huffington Post article?
• Medical adverse events from medical record errors can occur quickly, or be more delayed. If patient harm comes of the IT errors that occurred, will the healthcare system file a public report?

Now, on to some specific comments and observations on the Huffington Post Investigative Fund article.

The Huffington Post article begins:

Computers at a major Midwest hospital chain went awry on June 29, posting some doctors’ orders to the wrong medical charts in a few cases and possibly putting patients in harm’s way.

The digital records system “would switch to another patient record without the user directing it to do so,” said Stephen Shivinsky, vice-president for corporate communications at Trinity Health System. Trinity operates 46 hospitals, most in Michigan, Iowa and Ohio.

The bolded passage sounds like obfuscatory PR language, as if the EMR system changed the window focus to another patient's window (people do this all the time when they have multiple windows open in a GUI). If so, that would not be a major problem - the user would just switch back via clicking on the desired window.

Let's state what it sounds like the problem really was with crystal clarity:

Data a clinician entered into the window of primary focus (say, on Mary Jones) would end up in the electronic record of a window that was not the window of primary focus and in the background (say, that of Tom Smith).

The clinician would be unaware this had occurred, and two errors would then occur. The first error was that appropriate data would be missing for Mary. The second is that inappropriate data would be present for Tom. These events put both patients at risk of medical error.

Less than two weeks later, an unrelated glitch caused Trinity to shut down its $400 million system for four hours at 10 hospitals in the network because electronic pharmacy orders weren’t being delivered to nurses for dispensing to patients, he said.

Was this 'glitch' [a code word for "we are not in control of our system, it is in control of us" - ed.] related to the problem above? If so, that would suggest major system problems deep within its code. If not, it suggests lax overall quality control of this IT.

“As soon as it was brought to our attention, we moved to fix the problem,” Shivinsky said of Trinity’s system

This statement says nothing. One would not expect them to wait to fix a potentially dangerous problem.

He said nobody was injured in either event, ...

As in my prior post, the correct statement would be:

Nobody was injured, yet, due to the errors.

... the Cerner Corp. system now works properly,

Does that mean all the problems are fixed? The article implies not via its ending where Shivinsky is quoted that:

... Meanwhile technicians are still trying to figure out the root cause. “We’ll get to the bottom of it and fix it,” he said.

By the way, I note the following employee reporting site on Cerner's environment: link. Could this be a factor in Richard Granger, the former head of the UK's NHS national IT programme saying that:

"Sometimes we put in stuff that I'm just ashamed of ... Some of the stuff that Cerner has put in recently is appalling ... Cerner and prime contractor Fujitsu had not listened to end users ... Failed marriages and co-dependency with subcontractors ... A string of problems ranging from missing appointment records, to inability to report on wait times ... Almost a dozen cancelled go-live dates ... Stupid or evil people ... Stockholm syndrome -identifying with suppliers' interests rather than your own ... A little coterie of people out there who are "alleged experts" who were dismissed for reasons of non-performance."

I can only wonder.

... and the hospital chain determined that “technician error” led to the system shutdown and that the mixing up of patients was the result of a “Cerner coding issue” involving software that occurred after an upgrade.

What was the "technician" doing that led to the shutdown, what was the technician's background and qualifications to be doing it to a mission critical medical device?

Further, what, exactly, was the "Cerner coding issue?" Was it Cerner's fault? Trinity's? Both?

Were other organizations using the same software similarly affected?

How will other healthcare organizations learn if the cause of the problems is not revealed?

Even absent any harm to patients, such incidents underscore possible risks faced by even large health organizations that have eagerly embraced new medical software to track patient records and treatment. As the Obama administration ramps up plans to create a digital medical file for every American by 2014 – at an anticipated tab to taxpayers of up to $27 billion – technology’s boosters tend to tout its potential benefits to patients and ability to slow runaway medical costs.

That's not been my observation. Look at the UK for instance:

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.

I wish there were strong documentary evidence on the latter point about major savings, and that there wasn't evidence to the contrary. The healthcare system doesn't have enough spare capital to throw away on the hopes some touted technology (from which an industry stands to make billions) is a panacea.

Yet despite the high political and financial stakes, the administration has established no national mandatory monitoring procedure for the new devices and software. That no process exists to report and track errors, pinpoint their causes and prevent them from recurring is largely the result of two decades of resistance by the technology industry, a review of government records and interviews by the Huffington Post Investigative Fund shows. The industry argues that even with flaws, digital systems are an improvement over current paper records.

That is no excuse for decades of toleration of the flaws. It is an amoral position. As at my July 28 post "An Open Question on Moral Authority and Healthcare IT", it is playing God.

The HuffPo article continues:

“There’s an assumption that just because you have an electronic system, it’s going to be safer, so people let down their guards,” said Vimla Patel, who directs research on the topic at the University of Texas Health Science Center in Houston.

It's not an "assumption." This meme has been pushed so long by the HIT industry and its irrationally exuberant, uncritical supporters, it's become an accepted statement of fact - as per my July 14 post "Science or Politics? The New England Journal and "The 'Meaningful Use' Regulation for Electronic Health Records" where the Chairman of ONC states it as fact in the New England Journal of Medicine, with nary a footnote to back it up:

Blumenthal - The widespread use of electronic health records (EHRs) in the United States is inevitable. EHRs will improve caregivers’ decisions and patients’ outcomes. Once patients experience the benefits of this technology, they will demand nothing less from their providers. Hundreds of thousands of physicians have already seen these benefits in their clinical practice.

That's pretty definitive. If there's a trace of doubt, I don't see it.

Monitoring could help others learn from problems faced by early users of the technology, which is being sold nationally, or how they were remedied. Shivinsky said he wasn’t sure if federal officials had been notified of the difficulties at Trinity — or would be. No rule requires it.

Why is there no rule? What if this were a medical device such as a CT scanner, or heart defibrillator? Why does health IT get special accommodation when it is now a regulator and governor of clinician communications and actions, placed in between clinician and patient?

Almost a month after the first event at Trinity, David Blumenthal, the government’s top medical health information technology official, didn’t know about it. “First I’ve heard about it,” Blumenthal said when told by a reporter July 20, as he left a Capitol Hill hearing. Since then, Blumenthal has declined to discuss the incident or its implications.

That's perhaps because it conflicts with his other assertions on health IT technological determinism, noted above. How many other "events" is he aware of?

Kelli Christman, a spokesman for Cerner, the manufacturer of the software used at Trinity, did not respond to repeated emails and phone calls over the past week seeking comment.

What are they hiding? Perhaps other affected healthcare systems?

... Many industry groups contend that FDA regulation would “stifle innovation” and stall the national drive to wire up American medicine. That view resonates among the dozens of health information technology experts serving as consultants to Blumenthal’s office and on advisory groups. Blumenthal also has been skeptical of the need for regulation and argued that even if some miscues occur, digital systems are far less prone to error than paper ones.

In an industry with contractual gag clauses and clinician fear of speaking about HIT problems (e.g., of retaliation by hospital officials), how can anyone be sure of this? Is this a scientific statement, or a marketing position?

See may paper "Remediating an Unintended Consequence of Healthcare IT: A Dearth of Data on Unintended Consequences of Healthcare IT" for more on this issue.

“We know that every study and every professional consensus process has concluded that electronic health systems strongly and materially improve patient safety. And we believe that in spreading electronic health records we are going to avoid many types of errors that currently plague the healthcare system,” Blumenthal said when unveiling new regulations in Washington on July 13.

This statement is without merit, as per my prior post "Huffington Post Investigative Fund: FDA, Obama Digital Medical Records Team at Odds over Safety Oversight."


Further: note to Dr. Blumenthal: Consensus is not science:

[Chrichton, Caltech Michelin Lecture, 2003] ... I want to pause here and talk about this notion of consensus, and the rise of what has been called consensus science. I regard consensus science as an extremely pernicious development that ought to be stopped cold in its tracks. Historically, the claim of consensus has been the first refuge of scoundrels; it is a way to avoid debate by claiming that the matter is already settled. Whenever you hear the consensus of scientists agrees on something or other, reach for your wallet, because you're being had.

Let's be clear: the work of science has nothing whatever to do with consensus. Consensus is the business of politics. Science, on the contrary, requires only one investigator who happens to be right, which means that he or she has results that are verifiable by reference to the real world.

In science consensus is irrelevant. What is relevant is reproducible results. The greatest scientists in history are great precisely because they broke with the consensus. There is no such thing as consensus science. If it's consensus, it isn't science. If it's science, it isn't consensus. Period

Blumenthal goes on:

In public remarks that day, Blumenthal said he “expects” an eventual certification process for the digital systems to “collect information about the problems that occur with the implementation of electronic health records, if any.” He did not say when that would happen.

Eventual? Why not NOW, considering that the HIT industry has been in business for decades? The infrastructure for such reporting already exists, such as the FDA MedWatch system and Manufacturer and User Facility Device Experience (MAUDE) database - where, by the way, an HIT-related death was reported (link).

Imagine the aviation, nuclear energy industry or pharma making such outrageous statements about getting around to collecting information on potentially hazardous flaws "eventually."

In a later interview, Blumenthal said “safety concerns are not being ignored,” but wouldn’t comment further.

Yes, they are being ignored. Worse, they're being suppressed as in this case example, "A Lawsuit Over Healthcare IT Whistleblowing and Wrongful Discharge: Malin v. Siemens Healthcare."

... Dozens of other health information technology insiders, from academics to front-line users who believe digital medical records can promote better and cheaper health care, told the Investigative Fund in interviews that they nonetheless fear safety issues will mount as doctors and hospitals move quickly to install the systems and collect stimulus checks.

Just anecdotal, according to ONC and others.

“People just assume that computers will make things safer,” said Nancy Leveson, a safety engineering expert at Massachusetts Institute of Technology. “While they can be designed to eliminate certain kinds of hazards, they increase others and sometimes they introduce new types of hazards.”

This is a principle direct from the discipline of Social Informatics. Social Informatics (SI) refers to the body of research and study (e.g,, as collected here) that examines social aspects of computerization, including the roles of information technology in social and organizational change, the uses of information technologies in social contexts, and the ways that the social organization of information technologies is influenced by social forces and social practices.

Some experts are calling for closer government monitoring of the systems to protect the public. “We need to have some scrutiny at the front end and have an approval process to make sure they are safe before they’re deployed,” said Sharona Hoffman, a law professor at Case Western Reserve University, who has written about the issue in academic journals.

I am one of those experts, and I agree.

... In 2004, digital record keeping got a boost when President George Bush signed an executive order to create a digital medical file for every American within a decade, a goal officials said at the time they could reach “without substantial regulation.”

“The time wasn’t right at that time to move forward or the support wasn’t there (for safety regulations),” said Robert Kolodner, who ran the national coordinator’s office during some of the Bush years.

Again, I ask - why the hell not? When is a good time to discuss healthcare and HIT safety? Would such attitudes be tolerated in other industries? I dare say, hell no.

Edward H. Shortliffe, president of the American Medical Informatics Association and a longtime industry figure, agreed that safety issues weren’t a “primary concern” as tech companies began to expand their offerings.

That is a startling revelation - it could be the basis for medical malpractice plaintiff lawsuits on the basis of negligence, all the way to criminally negligent homicide if a patient dies of an HIT-related event.

Criminal negligence: The failure to use reasonable care to avoid consequences that threaten or harm the safety of the public and that are the foreseeable outcome of acting in a particular manner.

The HuffPo article further observes:

Earlier this year, the [health IT] trade group convened an expert panel to study the issues for the first time, but its findings have yet to be made public. Shortliffe said he didn’t think the organization would take a stand on government regulation of the industry, but said: “We recognize that there are significant challenges that the field as a whole is facing.”

The "first time" in an industry messing with people's medical care for decades? How is this possible?

... ONC director Blumenthal, the point man for the administration, has called the FDA’s injury findings “anecdotal and fragmentary.”

Just how many "anecdotes" do we need in an industry that places gag clauses on health IT users?

He told the Investigative Fund that he believed nothing in the report indicated a need for regulation [i.e., absence of evidence in a tight-lipped industry as evidence of absence - ed.] Yet others see anecdotes as a starting point for a more methodical look at problems that arise.

Who is more attuned to risk mitigation when they see red flags? Who are the clinician scientists, and who are the "see no evil, hear no evil, speak no evil" politicians?

The same day that Blumenthal, Sebelius and other federal health officials unveiled their digital records plan in Washington, an obscure government agency held a conference less than 20 miles away in suburban Maryland to discuss the state of quality controls.

Ben-Tzion Karsh, an engineering professor at the University of Wisconsin in Madison who attended the National Institute of Standards and Technology conference said he heard a “broad consensus” among experts that electronic medical records need to function better and safer. “The truth is that we do not at this time know what would make an EHR (electronic health record) safe,” he said.

Others said that despite the rosy view taken by many political figures in Washington, many systems on the market today aren’t designed in ways that prevent and limit new errors—and that nobody is holding the industry accountable.

Again I ask: how is this possible after decades of this industry's selling of products to hospitals for use on actual patients?

Also, the simple question arises: is this technology truly ready for the ambitious national roll out plans of the past two administrations?

I've touched on many of these issues in past years on this blog and at my academic website on HIT problems.

I see a clear runaway train and train wreck headed down the tracks.

The next few years in health IT should prove interesting indeed.

-- SS

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

(Note: also see my followup post "More on Huffington Post Investigative Fund: "FDA, Obama Digital Medical Records Team at Odds over Safety Oversight")

The Huffington Post Investigative Fund has published a remarkable expose of health IT difficulties and the Big Politics that surround them regarding safety and efficacy:

FDA, Obama Digital Medical Records Team at Odds over Safety Oversight
Aug. 3, 2010
By Fred Schulte and Emma Schwartz

Computers at a major Midwest hospital chain went awry on June 29, posting some doctors’ orders to the wrong medical charts in a few cases and possibly putting patients in harm’s way.

The digital records system “would switch to another patient record without the user directing it to do so,” said Stephen Shivinsky, vice-president for corporate communications at Trinity Health System. Trinity operates 46 hospitals, most in Michigan, Iowa and Ohio.

[In other words, data entered by clinicians was going into the wrong charts. How many charts were involved? Does the hospital system even know, I wonder? - ed.]

Less than two weeks later, an unrelated glitch caused Trinity to shut down its $400 million system for four hours at 10 hospitals in the network because electronic pharmacy orders weren’t being delivered to nurses for dispensing to patients, he said.

... Even absent any harm to patients, such incidents underscore possible risks faced by even large health organizations that have eagerly embraced new medical software to track patient records and treatment. As the Obama administration ramps up plans to create a digital medical file for every American by 2014 – at an anticipated tab to taxpayers of up to $27 billion – technology’s boosters tend to tout its potential benefits to patients and ability to slow runaway medical costs.

Yet despite the high [actually, potentially catastrophic - ed.] political and financial [and clinical -ed.] stakes, the administration has established no national mandatory monitoring procedure for the new devices and software. That no process exists to report and track errors, pinpoint their causes and prevent them from recurring is largely the result of two decades of resistance by the technology industry, a review of government records and interviews by the Huffington Post Investigative Fund shows. The industry argues that even with flaws, digital systems are an improvement over current paper records.

I began to document some of the problems and the resistance of what Washington Post reporter Robert O'Harrow Jr. in May 2009 called the "Healthcare IT lobby" a decade ago in a website. That website, now hosted at Drexel University, is entitled "Contemporary Issues in Medical Informatics: Common Examples of Healthcare Information Technology Difficulties."

Few in government and industry were apparently listening, despite ongoing worldwide interest in the topic (PPT).

Read the Huffington Post report in its entirety. It includes a slide-show timeline of the health IT industry's sidestepping of government oversight and safety concerns.

As I am currently busy helping out my ill mother, I will offer more commentary later.

However, one quote really stuck out. Is the Chairman of the Office of the National Coordinator for Health IT (ONC) Dr. David Blumenthal lying, or simply misinformed?

Judging by the quality of academic discourse these days, I'd hope the latter (an alarming situation in and of itself), but the former is also possible.

He is quoted as stating:

“We know that every study and every professional consensus process has concluded that electronic health systems strongly and materially improve patient safety. And we believe that in spreading electronic health records we are going to avoid many types of errors that currently plague the healthcare system,” Blumenthal said when unveiling new regulations in Washington on July 13.

As at my July 14, 2010 post Science or Politics? The New England Journal and "The 'Meaningful Use' Regulation for Electronic Health Records" , however, I pointed out some examples that contradict this meme.

This list is just for starters:

(Hyperlinks to these and others can be found at my Medical Informatics teaching site 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.

14. Health Affairs, 29, no. 4 (2010): 639-646 Electronic Health Records’ Limited Successes Suggest More Targeted Uses, Catherine M. DesRoches et al.

15. NORCAL Mutual Insurance Company: "Electronic Health Records: Recognizing and Managing the Risks" (PDF here)

My healthcare informatics graduate students are well aware of studies such as these.

Why isn't ONC Chairman Dr. Blumenthal?

Perhaps equally as remarkable is this from Trinity Health, the healthcare system whose health IT crashed:

We are not aware of any patient safety or quality of care issues caused by this event,” he said.

Many of the "safety and quality" issues due to erroneous data in charts can come out weeks, months or even years later. The issue that the health IT cheerleaders seem to ignore is risk.

Has the erroneous data been identified and corrected, I wonder?

Probably not. According to the Huffington Post Investigative Fund article, they don't even know what caused the problem:

... While doctors were concerned about the problems, ...

[well, yes, I'd be quite frightened myself, especially considering who holds the liabilities for health IT defects - ed.]

... Shivinsky said that most are happy with the system and would “never go back to paper.”

[That sounds very nice. Is it true? - ed.]

Meanwhile technicians are still trying to figure out the root cause. “We’ll get to the bottom of it and fix it,” he said.

Eventually, I would hope, since the kludged "correction" I heard about is that clinicians can now only open one electronic patient chart at a time, potentially slowing and impairing their work.

I've emailed Mr. Shrivinsky asking if they'd truly identified and remediated the problem yet.

-- 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 in one of the world's most respected scientific medical journals.

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 exceptionally well referenced.

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 more than a few examples of the latter just off the top of my head [ref. 1-15 below, certainly not a comprehensive list but merely skimming the surface].

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 "hold vendor harmless clauses" (see Koppel and Kreda's 2009 JAMA article here), and fear-based censorship of information on health IT problems, 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.

14. Health Affairs, 29, no. 4 (2010): 639-646 Electronic Health Records’ Limited Successes Suggest More Targeted Uses, Catherine M. DesRoches et al.

15. NORCAL Mutual Insurance Company: "Electronic Health Records: Recognizing and Managing the Risks" (PDF here)

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

David Blumenthal on health IT safety: nothing to see here, move along

At "FDA on Health IT Adverse Consequences: 44 Reported Injuries And 6 Deaths In Two Years, Probably Just Tip of Iceberg" I wrote about a meeting of the HIT Policy Committee, Adoption/Certification Workgroup on February 25, 2010. The topic was "HIT safety." The agenda, presenters and presentations are available at this link.

At this meeting FDA testimony was given by Jeffrey Shuren, Director of FDA’s Center for Devices and Radiological Health. Dr. Shuren noted several categories of health IT-induced adverse consequences known by FDA. This information was striking.

He wrote:

... In the past two years, we have received 260 reports of HIT-related malfunctions with the potential for patient harm – including 44 reported injuries and 6 reported deaths. Because these reports are purely voluntary, they may represent only the tip of the iceberg in terms of the HIT-related problems that exist.

Well, there's absolutely nothing to worry about, according to the Office of the National Coordinator and Dr. David Blumenthal. Nothing to see here. Move on.

Blumenthal has just reportedly stated that:

http://www.massdevice.com/news/blumenthal-evidence-adverse-events-with-emrs-anecdotal-and-fragmented

... [Blumenthal's] department is confident that its mission remains unchanged in trying to push all healthcare establishments to adopt EMRs as a standard practice. "The [ONC] committee [investigating FDA reports of HIT endangement] said that nothing it had found would give them any pause that a policy of introducing EMR's could impede patient safety," he said.

I ask a simple question:

• Are these the words to be reasonably expected from an academic physician/scientist?

Perhaps I'm a bit behind these postmodern times, but I once believed the perhaps now old-fashioned and obsolete view that a scientist would not base a conclusion of medical safety in national dissemination of drug, device, or whatever on some analysis of anecdotal data, whether 'preliminary' or final.

Due to reasons such as the lack of knowledge of FDA as a place to report HIT problems, as well as fear by clinicians in reporting HIT problems at all, the cited FDA data (260 HIT-related adverse events over two years, including 44 reported injuries and six deaths) is most certainly anecdotal and incomplete, and potentially (per FDA's Jeff Shuren, MD, JD) the "tip of the iceberg."

I would not take the FDA data to be anything but a possible red flag, not a source of truth, one way or the other.

For example, the scant reports of health IT bugs and defects -- many of which admittedly could cause medical error -- in another database, MAUDE, voluntarily submitted by just a tiny fraction of the HIT vendors, should give a scientist pause. They are a sentinel. (See my 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" for several MAUDE database examples).

Obviously, the unreported, unrecognized (and therefore uncorrected) bugs and defects have the same potential. Those MAUDE reports alone should provide an impetus to call for full, rigorous, scientific, uncensored investigations on HIT safety, not make pronouncements on safety to a national audience.

Proof by lack of evidence is not what I was taught in medical school.

Blumenthal appears to be speaking not as a scientist, but as a marketer and (of course) politician.

This is quite disappointing.

However, as the man said, nothing to see here, move along.

By the way, I am assuming the "analysis" will be open to public scrutiny.

-- SS

Office of the National Coordinator for Health Information Technology (ONC): A One Man Show?

Generally, transparency in government means that the public it serves knows who that government is.

Yet the "Office of the National Coordinator: Key Personnel" page at HHS shows only this, the name of the Coordinator himself, Dr. David Blumenthal:

Only one person works at ONC? click to enlarge

What about the others as per the Org Chart?

ONC Org Chart (click to enlarge)

In the case of the Office of the National Coordinator for Healthcare IT, there are a number of possibilities for this apparent informational lapse:

• There is only one person working in this office;

• Only one person is considered "Key Personnel";

• This office, responsible for the national program for health IT and Electronic Medical Records in the U.S. that will "revolutionize" healthcare through better record keeping, has been careless in updating its Electronic Personnel Records;
  

• The names are buried somewhere not easy to find, or the identities of the personnel are being entirely withheld from the public to prevent the public from knowing who they are and what their past and present affiliations might be.

Why might that be an issue? Pro-IT industry conflicts of interest, qualifications, and anti-physician biases come to mind as just a few possibilities.

Where's the transparency?

Just asking.

-- SS

ONC Defines a Taxonomy of Robust Healthcare IT Leadership

As in my post "More On Healthcare Management By Domain Neutral Generalists", Roy Poses' post "Health Care Leaders: Don't Know Much About Health Care" and many others on the topic of ill informed healthcare management (query link) at Healthcare Renewal, a common theme is lack of appropriate education and background in many of today's healthcare leaders.

ONC, the Office of the National Coordinator of health IT at HHS, has apparently now defined a taxonomy of health IT leadership in their funding opportunity announcements (FOA's).

Note the formal educational recommendations I've highlighted. Seems they’ve heard the message about the importance of cross-disciplinary -- and formal -- education for health IT leaders and even lower level workers:

From the Founding Opportunity Announcement "Program of Assistance for University-Based Training" at http://healthit.hhs.gov/portal/server.pt?open=512&objID=1428&mode=2

... Targeted Information Technology Professionals in Healthcare Roles

The six types of roles targeted by this FOA are:

(i) Clinician/Public Health Leader: By combining formal clinical or public health training with training in health IT, individuals in this role will be able to lead the successful deployment and use of health IT to achieve transformational improvement in the quality, safety, outcomes, and thus in the value, of health services in the United States. In the health care provider settings, this role may be currently expressed through job titles such as Chief Medical Information Officer (CMIO), Chief Nursing Informatics Officer (CNIO). In public health agencies, this role may be currently expressed through job titles such as Chief Information or Chief Informatics Officer. Training appropriate to this role will require at least one year of study leading to a university-issued certificate or master’s degree in health informatics or health IT, as a complement to the individual’s prior clinical or public health academic training. For this role, the entering trainees may be physicians or other clinical professionals (e.g. advanced-practice nurses, physician assistants) or hold a master’s or doctoral degree(s) in public health or related health field. Individuals could also enter this training while enrolled in programs leading directly to degrees qualifying them to practice as physicians or other clinical professionals, or to master’s or doctoral degrees in public health or related fields (such as epidemiology). Thus, individuals could be supported for training if they already hold or if they are currently enrolled in courses of study leading to physician, other clinical professional, or public-health professional degrees.

(ii) Health Information Management and Exchange Specialist: Individuals in these roles support the collection, management, retrieval, exchange, and/or analysis of information in electronic form, in health care and public health organizations. We anticipate that graduates of this training would typically not enter directly into leadership or management roles. We would expect that training appropriate to this role would require specialization within baccalaureate-level studies or a certificate of advanced studies or post-baccalaureate-level training in Health Information Management, health informatics, or related fields, leading to a university-issued certificate or master’s degree.

(iii) Health Information Privacy and Security Specialist: Maintaining trust by ensuring the privacy and security of health information is an essential component of any successful health IT deployment. Individuals in this role would be qualified to serve as institutional/organizational information privacy or security officers. We anticipate that training appropriate to this role would require specialization within baccalaureate-level studies or a certificate of advanced studies or post-baccalaureate-level training in health information management, health informatics, or related fields, leading to a university-issued certificate or master’s degree.

(iv) Research and Development Scientist: These individuals will support efforts to create innovative models and solutions that advance the capabilities of health IT, and conduct studies on the effectiveness of health IT and its effect on health care quality. Individuals trained for these positions would also be expected to take positions as teachers in institutions of higher education including community colleges, building health IT training capacity across the nation. We anticipate that training appropriate to this role will require a doctoral degree in informatics or related fields for individuals not holding an advanced degree in one of the health professions, or a master’s degree for physicians or other individuals holding a doctoral degree in any health professions for which a doctoral degree is the minimum degree required to enter professional practice.

(v) Programmers and Software Engineer: We anticipate that these individuals will be the architects and developers of advanced health IT solutions. These individuals will be cross-trained in IT and health domains, thereby possessing a high level of familiarity with health domains to complement their technical skills in computer and information science. As such, the solutions they develop would be expected to reflect a sophisticated understanding of the problems being addressed and the special problems created by the culture, organizational context, and workflow of health care. We would expect that training appropriate to this role would generally require specialization within baccalaureate-level studies or a certificate of advanced studies or post-baccalaureate-level training in health informatics or related field, but a university-issued certificate of advanced training in a health-related topic area would as also seem appropriate for individuals with IT backgrounds.

(vi) Health IT Sub-specialist: The ultimate success of health IT will require, as part of the workforce, a relatively small number of individuals whose training combines health care or public health generalist knowledge, knowledge of IT, and deep knowledge drawn from disciplines that inform health IT policy or technology. Such disciplines include ethics, economics, business, policy and planning, cognitive psychology, and industrial/systems engineering. The deep understanding of an external discipline, as it applies to health IT, will enable these individuals to complement the work of the research and development scientists described above. These individuals would be expected to find employment in research and development settings, and could serve important roles as teachers. We would expect that training appropriate to this type of role would require successful completion of at least a master’s degree in an appropriate discipline other than health informatics, but with a course of study that closely aligns with health IT. We would further expect that such individuals’ original research (e.g. master’s thesis) work would be on a topic directly related to health IT.

They've also called on Community Colleges to take the lead in producing worker bees:

http://healthit.hhs.gov/portal/server.pt?open=512&objID=1414&mode=2

It is also recommended that the teachers of these worker bees have a formal cross disciplinary background.

These are encouraging signs, as they lend significant formalism to the current marketplace where, completely alien to the culture of medicine itself, anyone of any educational background (or no educational background) can be a healthcare IT / informatics "expert" and leader.

Even with these definitions, doing health IT "right" is still far, far harder than it looks, but at least the rigor of medicine is starting to be applied to the "anything goes" world of healthcare IT and IT workers in healthcare-related roles.

That domain has long suffered striking inattention to education and qualifications requirements, and a healthcare-dyscompetent leadership that I believe has significantly fueled healthcare IT difficulty and failure.

This is a helpful stance against devil-may-care attitudes such as those of major health IT leadership recruiters. From an article 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.

Now, if only ONC's thinking can percolate to the highest levels of healthcare and pharmaceutical leadership, including the "C" level and the boards of directors.

-- SS

On a Clinical IT Abomination and a Health IT Leadership Gap

... If there ever was a reason for physicians, other clinicians and patients to oppose the use of Electronic Medical Records forced upon them by third parties, here it is. Assuming this story is accurate, it reflects what I believe will be an increasing trend towards control of the medical profession via computer:

Association of American Physicians and Surgeons (AAPS)

August 2008 News

Innocent Caught in Dragnet

With a 19.7% increase in budget, and a 64-person increase in staff to a total of 1,495, the Office of Inspector General (OIG) is aggressively looking for fraud. The anti-fraud cash cow brings in $20 for $1 spent. To "find" fraud, the government gets creative, elevating ordinary billing disputes to fraud.

"The government overkills. It ruins their life. Doctors lose their career. They overbill Medicare, and it may have been sloppy," states attorney Patric Hooper. "But rather than pay back $100,000, they owe millions" (MCA 6/30/08).

One Pinellas County, Fla., physician was hauled off in handcuffs because of an ongoing dispute with UnitedHealth Care over E&M coding. What preceded the indictment was a refusal by the physician to use [healthcare IT] products sold by Ingenix, a United subsidiary. "It's clear from the documents that United filed the claim in retaliation," said the doctor's attorney. "I've never before encountered such a blatant attempt at coercion by a payer public or private" (ibid.).

Note that electronic medical record software, such as Amazing Charts, could make you liable for false claims, as through unintentional misuse of cut-and-paste functions or templates that automatically fill in blanks (ibid.).

Enforcement is being enhanced through use of anti-fraud "strike forces." The investigators are often retired policemen, and they do not treat physicians as "white collar" (MCA 6/30/08).

Some suggestions from Medicare Compliance Alert: Guard your NPI. Screen staff carefully, and watch out for "rogue employees" who might be identity thieves. Report business partners to the government; it can protect your own business. Have procedures in place to deal with search warrants. Be sure the information on your Medicare enrollment form is accurate; wrong information from a form filled in 20 years ago could result in a false claim (ibid.).

AAPS advice: consider opting out.

I believe a much more aggressive response is needed from the medical profession, including organized medicine, besides "opting out" of abusive third party payer arrangements.

In a former role of Manager of Medical Programs for a regional transit authority, I've seen labor unions that were representing bus drivers and janitors act far more aggressively and wisely in representing their members against management whims than organized medicine represents physicians against payer and government whims.

If organized medicine were performing its role in representing the profession aggressively, considering the evidence that paper charts can perform as well as electronic records in many circumstances and that most clinical IT benefits accrue to payers and other third parties, then major concessions would have been demanded of the primary beneficiaries for physicians to adopt electronic medical records.

"Musn't be too aggressive or appear disgruntled" is one of the reasons I've heard from academic colleagues that this does not occur. Physicians must be "gentlemen" and "team players." ("Team player" in today's context often means "co-conspirator to mediocrity" or to even worse).

I ask "why?" [should physicians avoid appearing angry]. The directness and actual aggressiveness of the labor union representatives I saw in action was quite effective in improving the conditions for their members. Interestingly, the union people were aggressive when "in role" yet polite when I encountered them in other settings, such as the daily commute to work. The public would likely respond to legions of angry doctors like few other means of communication could muster.

In a similar vein, I have heard from numerous circles that it's best to advocate for informatics leadership of Health IT (such as EMR, CPOE etc.) without demonstrating emotion or 'disgruntledness.' That raises several questions:

• Are physicians finding themselves marginalized and at the whim of IT managers, payers and other non clinical third parties because they have been just too angry and aggressive in demanding what was best for medicine and for themselves?

• Has there ever been any disagreement or conflict of such major proportions (and profitability) as healthcare that has been resolved purely through gentleman's dialog?

• Finally, are there lessons to be learned from these gentlemen who "petitioned for redress of grievances in the most humble of terms", only to be answered by even worse treatment?

On leadership of Health IT efforts: the sudden push by government towards universal HIT in recent years has often puzzled me. HIT rapidly moved from "experimental" status to godsend and panacea, although ample evidence was available that this was not the case. Enterprise EHR's seem to cost as much as entire new hospital wings. Yet ONC, AHRQ and other agencies seemed to start operating from the panacea assumption, largely since the internet hype that began at the end of the last decade.

The Office of the National Coordinator for Health IT (ONC) was established in 2004 to promote electronic health records in the United States. Regarding ONC, I've recently had some conversation with persons instrumental in the evolution of VistA, the Veteran Administration's EHR, and listened to presentations on VistA at a number of conferences.

It seems VistA is a very different universe from commercial HIT, one of strong collaboration and pride and creativity. This is likely due to its unique and relatively constrained purpose (care of veterans and family) and the non-profit nature of its history. You can get a good sense of this from the new book "Medical Informatics 20/20: Quality and Electronic Health Records through Collaboration, Open Solutions, and Innovation" (Amazon link here) written by key VistA personnel from that perspective. (Note: I use the book for teaching graduate students about the best ways to create and implement HIT and am cited in it for my views on social issues in HIT as at my website).

Commercial HIT is, on the other hand, highly corporatized, in the worst 2008 sense of the word. It is a highly competitive (need I say cutthroat) business, highly fragmented, proprietary, and anything but open. Commerical HIT is characterized by many stakeholders with widely varying agendas, forming an often dysfunctional "HIT ecosystem" (link) that largely excludes clinicians from meaningful decision making. The ecosystem is primarily centered on profit. It is an entirely different world than VistA.

In addition, hospital IS departments are usually woefully unprepared and incapable of meeting the challenges of clinical IT. IT is not a hospital core competence. Quite frankly, many of the IT leaders I've met in hospitals have been barely competent and in some cases downright abysmal where the needs and culture of practicing clinicians -- and sick patients -- are involved.

Physicians have been "resisting" health IT for 30+ years now. The diffusion of healthcare information technology after 30-plus years of effort and billions of dollars spent remains limited. As per the 2008 statistics in the NEJM article "Electronic Health Records in Ambulatory Care - A National Survey of Physicians", NEJM 359:50-60, just four percent of physicians in the U.S. reported having an extensive, fully functional electronic-records system, and just thirteen percent reported having a basic system. Most hospitals are also lacking the technology to any meaningful extent.

Yet those same physicians have to be restrained from using new therapeutic modalities and drugs where the benefit to patients is reasonably clear cut, even procedures and devices that are complex to perform or utilize.

Perhaps our society should take the 'resistance' to clinical IT as a phenomenon for serious consideration. One should perhaps ask themselves if they'd happily volunteer to receive a new therapy or drug that physicians have been 'resisting' for several decades.

Clinical IT is a world further characterized by issues such as these (thanks to Al Borges, MD and Health IT discussion site EMRUpdate.com for some of these links):

• "Oh no! Half of all current EMRs fail!", from 1/2007 Technology for Doctors (link to PDF)
  

• "Avoiding EMR meltdown: How to get your money's worth. About a third of practices that buy electronic medical records systems stop using them within a year. A little homework can help ensure you buy one that will work for you.", from 12/2006 AMNews (link)
  

• Quote: "The failure rates of EMR implementations are also consistently high at close to 50%", from Proceedings of the 11th International Symposium on Health Information Management Research – iSHIMR 2006 (link to PDF)
  

• Quote: "Industry experts estimate that failure rates of Electronic Medical Record (EMR) implementations range from 50–80%.", from 7/2006 A Commonsense Approach to EMRs (link to PDF)

• Kaiser Permanante HIT Meltdown (link)

• UK: Milton Keyne's Care Records System caused 'near meltdown' (link)
  

and many others of a similar nature.

This raises several questions:

• ONC was founded by our government. Where, exactly, was the government receiving its inputs on HIT pros and cons, drawbacks and challenges? The drawbacks have been known for a long time. Was the primary source of information from the pro-HIT optimists, opportunists and Pollyannas (per my HIT Ecosystem essay), lobbyists, and those whose experiences were largely positive in development of non commercial, large scale HIT (e.g., VA?) Could a term to describe what the administration has been told by the "HIT Ecosystem" members be this word?
  

• Was ONC founded on the premise that the commercial HIT 'ecosystem' operates like the VA, i.e., a world of collaboration and creativity? Could it be seeing commercial HIT through 'rose-colored glasses?'
  

• ONC seems to have focused on "technical" issues - standards, interoperability, etc. - at the expense of the social impediments and drawbacks to HIT. It seems the working assumption is that all that stands in the way of universal HIT, much like in the VA, is fine details of the technology and 'physician resistance.' Is ONC positioned to understand the commercial HIT sector and its issues, and in fact produce a candid and realistic "lessons learned" report as being called for in proposed House Energy and Commerce legislation?

These are very important questions. I do not know the answers. However, the decision makers in our government should ensure that they do.

-- SS