Senator Grassley asks hospitals about experiences with federal health information technology program

At a brief Oct. 24, 2009 posting "Washington Post: EMR's No Cure-All; Sen. Grassley Sends Letter of Inquiry to health IT vendors" (link) I mentioned an Oct. 16, 2009 letter to major healthcare IT vendors from Senator Charles E. Grassley (ranking member of the United States Senate Committee on Finance) initiating a Senate investigation of corporate practices. That letter is here (PDF).

A followup investigation has now begun by Sen. Grassley of hospitals themselves. Here is a link to his Senate website and a copy of the new letter dated Jan. 20, 2010.

This followup letter is being sent to:

Banner Health, Brigham & Women's Hospital Case Western Reserve University Hospital Health System, Catholic Healthcare West, Cedars Sinai Children’s National Medical Center, Geisinger Medical Center, Hackensack Hospital, HCA TriStar, Intermountain Healthcare, Indiana University Hospital, Jefferson Regional Medical Center, Kaiser Permanente System, Marshfield Clinic, Massachusetts General Hospital, Mayo Clinics, Memorial Hermann Healthcare System, Methodist Hospital of Indiana, North Shore-Long Island Jewish Health System, Palo Alto Medical Foundation, Rainbow Babies and Children’s Hospital, Saint Mary Mercy Hospital, Seattle Children’s Hospital, Stony Brook University Medical Center, Trinity Hospital System Tufts Medical Center, University of California San Francisco Medical Center, University of Pennsylvania Health System, University of Pittsburgh Medical Center, University of Virginia Medical Center, and Vanderbilt University Hospital.

According to Huffington Post Investigative Fund reporters Fred Schulte and Emma Schwartz in "Electronic Health Records Probe Expands to Hospitals", these organizations were chosen based on both "positive and negative" press reports, complaints, whistleblowers, and Grassley's own research. The Huffington Post quoted Sen. Grassley's spokesperson Jill Gerber in that regard.

The questions are probing:

1. Please describe in detail your facility’s process for identifying HIT products for purchase and choosing an HIT vendor(s).

a. What is the personnel structure of those involved in the purchase?
b. To what extent do physicians and other health care providers within your facility provide input regarding the specific HIT items to be implemented within your facility?
c. Who or what department within your facility is responsible for making HIT purchase decisions?

I have been writing for years on the strategically unsound practice of hospitals leaving these processes up to business IT (MIS) personnel and other non-clinical management, perhaps only then seeking a qualified physician information technology expert - or more typically, appointing a figurehead physician IT amateur - after the acquisition. That person is tasked with "making it all work" and convincing other doctors to use the technology.

(I use the term "figurehead" in that the incumbent Clinician Director of HIT or Chief Medical Information Officer/CMIO usually is an "internal consultant" with no direct control over resources or personnel, a Director of Nothing or Chief of Nothing if you will. I use the term "amateur" in the same sense that I am a telecommunications amateur, fine for an avocation but not for a lead role in a mission-critical setting.)

2. Three of the companies that I wrote to in October 2009 informed me that they do not manufacture HIT software or hardware, but instead assist their health care clients, such as hospitals, with the implementation and management of HIT systems. To what extent do you contract with such entities to assist with the purchase, implementation and/or management of HIT products in your facility?

I have also written on the huge amount of precious healthcare money wasted on management consulting companies for health IT, when a fraction of that money could pay for in-house, permanent expertise.

3. Please describe the training process implemented in your facility to familiarize employees with new technology systems.

a. How does your facility budget for HIT training?
b. What are the vendors’ roles in helping your facility train in the use of their products?

I sincerely hope these hospitals have not "shorted" training. On the other hand, that these systems require extensive training to use properly is part of the problem. Finally, no manner of training can compensate adequately for mission hostile health IT.

4. Does your facility have any policies or processes governing the reporting of problems or concerns by your health care employees related to the HIT products or systems implemented in your facility? If so, please provide a description of the policies or processes. If not, please explain why not.

I would have added "effective policies or procedures" to that question.

5. When patient care and/or safety problems related to HIT systems arise, how are these problems reported within the facility and what is the process or mechanism for addressing them?

a. Are these problems also reported to the HIT vendor, and if so, what is the process for reporting them?
b. If patient care and/or safety problems related to HIT systems are not routinely reported to the HIT vendors, please explain how your facility decides which problems or issues are reported to a vendor and/or addressed by a vendor and which problems are addressed internally by the facility.

These are questions about fundamental processes of quality control of the IT devices themselves. It would perhaps be a criminal affair if pharmaceutical companies and medical device companies did not have such processes in place regarding their products.

6. Please describe in detail any system your facility has in place to document, track, catalogue, and maintain complaints, concerns or issues related to HIT products that may directly or indirectly involve or impact the delivery of care or patient safety.

One would think there would be a robust database or library of such issues at every hospital deploying HIT. Not having such a resource would in my opinion reflect negligence in both the IT and clinical domains. It will be interesting to see the contents, or if they do not exist, the reasons why.

7. Please provide a list of HIT problems or complaints that have been identified by or reported to your facility since January 2008 that directly or indirectly impacted patient safety or the delivery of care, including any complications or adverse events that have occurred as a result of HIT product design and/or usability. Please describe whether and how each of those problems or complaints was resolved and whether these issues have resulted in a change in policy to prevent the problem in the future.

The answers should prove interesting. Hopefully, "near misses" are accounted for in prior questions.

8. Does your facility have policies regarding the discussion of problems in your HIT systems with other health care facilities or with government officials or any individuals or entities outside your facility? If so, please describe those policies. To what extent are these policies driven by contractual agreements with the HIT vendors, and to what extent do they stem from internal processes? Please provide examples of contracts with HIT vendors that include non-disclosure clauses.

Considering the widespread and uncomfortably similar stories people in my field have been hearing for quite awhile (in my case, for the past fifteen+ years), and as I have written before, there seems to be very little cross-institutional knowledge sharing on HIT pitfalls.

It was, in fact, not easy to get a book about HIT problems published for a wide audience - even in a de-identified form - in 2009. Most accounts of health IT consist of what Greenhalgh calls "sanitized accounts of project success."

These accounts are of little didactic value in helping other organizations avoid known deleterious practices (such as talent mismanagement, internal strife, failure to adapt IT to the environment, over-reliance on vendor promises, contract pitfalls, etc.) leading to HIT failure.

9. Some of the HIT vendors stated specifically in their responses to me that they do not include language that would hold them harmless for failures of their products or for the company’s own negligence or recklessness. However, they may include provisions that spell out the vendor’s and the health care client’s respective legal responsibilities and obligations in the use of the product. For example, one vendor stated that it is accountable for the performance of its product as long as the client uses the product appropriately. Another vendor stated that it is not liable when harm or loss results from the client’s use of the product in diagnosing and/or treating patients.

a. Do any of the HIT vendors include language in their contracts with your facility that could be considered “hold harmless” provisions, i.e., the transferring of liability associated with the services or products provided to your facility, or otherwise limit their liability? If so, please provide a copy of sample contracts containing such provisions.

Denial of inclusion of "hold harmless" provisions on the one hand, and statements about being "accountable for the performance of its product as long as the client uses the product appropriately" (whatever that means) and "not [being] liable when harm or loss results from the client’s use of the product in diagnosing and/or treating patients" (what are such systems for, playing Pong?) on the other hand, seem to be at odds.

10. What is the relationship between your facility and any HIT vendors?

a. HIT vendors that manufacture software, hardware and/or other products purchased by health care facilities have stated in their responses to me that they do not offer any financial incentives for purchasing their products, such as shares in the company or financial interests in a particular product. At least one vendor stated, however, that it does offer financial incentives in the form of discounts based on purchase size. Another vendor said that health care clients may receive royalty payments when the clients collaborate with the vendor to develop a product. What financial interest, if any, does your facility have in HIT vendors and/or their products?

b. Do the vendors offer your facility and/or any of your health care providers any financial incentives for purchasing the vendors’ products? If so, please describe the types and value of the incentives.

These are clearly questions about conflict of interest. My best advice to these organizations is "be honest."

11. Did your staff, health care providers and/or facility receive any payments, product discounts, or other items of value from any vendor for discussing and/or promoting that vendor’s HIT products? If so, please list the different types of payments and discounts and their value.

This is a question along the lines of the "Key Opinion Leaders" nurtured by pharmas with a green fertilizer that comes from trees, not cows. One vendor did seem to indicate that this occurs in the "10 secrets the EHR companies don't want you to know" essay here.

While that essay must be taken with a grain of salt, it would not surprise me to find out the HIT industry and the pharma industry share practices in common. Today's B-schools and our current dishonest culture produce the leaders and officers of both, after all.

-- SS

Washington Post Article: Electronic medical records not seen as a cure-all

Regarding the very well done Sunday Oct. 25, 2009 story in the Washington Post "Electronic medical records not seen as a cure-all" by staff writer Alexi Mostrous - signup may be required for access - I have several observations.

(Not including the observation that Mr. Mostrous probably deserves an award for being the first major newspaper reporter to broach this topic in a serious and balanced manner.)

First, I believe healthcare IT can live up to all the predictions made about its benefits - but only if done well. There is massive complexity behind those two words "done well", and that is HIT's key stumbling block in 2009. I believe we are only in the adolescent stage of knowing how to "do health IT well."

Second, I should point out that the intended consequences of health IT include, among many other things, the following "hiding in plain sight" (i.e., not often verbalized) intended consequences:

• The improvement of medicine ... in the context of protection of patient rights established over centuries of development of modern medicine.

• The improvement of IT itself through cross disciplinary collaboration between IT and medicine, of the science of IT (computer science), the social aspects of computerization ("sociotechnical issues"), and improvement of the our understanding of the intersection of medicine and computers.

Instead, we largely have the opposite. Patients' rights are trampled, and hostility and territoriality has arisen between clinicians (including medical informaticists) and IT, groups that rarely if ever interacted in hospitals ten or twenty years ago.

Of concern, when scientific study sections evaluate NIH grant proposals calling for testing of new IT that involves patients, patient protections and informed consent processes are a paramount concern since such activities are considered research. Yet, in implementing large clinical IT system in a hospital with new features, there are no formal regulations, and I'm not sure there's even IRB involvement in most cases. Patients do not get the chance to give informed consent to the use of these IT devices mediating their care. Why the difference?

The unintended results of computerization efforts have also included suppression of research on sociotechnical issues and on informatics, which must include study of the downsides of HIT, and of the failures in addition to the study of the successes. That is scientific fact - there is no room for debate, no room for spin on the need for careful study of the downsides of any mission critical domain. One would think there to be a vibrant literature on these issues, Yet searches on massive biomedical databases such as PubMed on, say, "cerner electronic health record" (or other vendors as well) are disappointing to say the least. Further, my own website on HIT difficulties remains nearly unique (PPT) after ten years online. That is not bragging; it is a disturbing finding to me - symptomatic of an industry that somehow has managed to avoid serious scrutiny.

In a field with downsides, there are:

1) those who know about the problems but fail to speak,
2) those who see the problems but fail to act, and
3) those who see, know and speak/write/research the problems.

That said, now on to the Washington Post article:

... bipartisan enthusiasm has obscured questions about the effectiveness of health information technology products, critics say. Interviews with more than two dozen doctors, academics, patients and computer programmers suggest that computer systems can increase errors, add hours to doctors' workloads and compromise patient care.

I would include the bipartisan enthusiasm under the subject header of "irrational exuberance", which itself falls under the header of "lack of domain knowledge." That itself is a consequence of both failure to study the issues, and suppression of those issues by those with an interest in doing so.

health IT's effectiveness is unclear.

The literature is indeed conflicting, and the need for rigorous scientific study has never been more essential considering the commitment of tens of billions of dollars towards health IT. The time for story telling, marketing based on opinion, name calling, leap-of-faith extrapolations of light year dimensions, and other forms of pseudoscience and non-science are over. The time for objective study is now.

The Senate Finance Committee has amassed a thick file of testimony alleging serious computer flaws from doctors, patients and engineers unhappy with current systems.

Being the ranking member of that committee, Sen. Grassley has a fiduciary responsibility to protect Medicare and Medicaid patients (and one might argue, to protect all patients since those programs often serve as models for private insurers). In that regard, the investigation he has initiated is part of his responsibility as a ranking member of Congress. Politics aside (and there are those who will resort to ad hominem "political witch hunt" arguments), he would have been negligent if he had not initiated an inquiry.

Sen. Grassley has taken on the pharma industry and the government's Food and Drug Administration itself, such as in this recent article "FDA fails to follow up on unproven drugs" where he concluded from a GAO study he ordered that "FDA has fallen far short of where it should be for patient safety." He seems quite serious about medical safety.

If only others in Congress had done their job similarly regarding national finance, we might now not be in the worst economic crisis since '29 with many major industries failing.

David Blumenthal, the head of health technology at the Department of Health and Human Services, acknowledged that the systems had flaws. "But the critical question is whether, on balance, care is better than before," he said. "I think the answer is yes."

This sounds uncomfortably like how a pharmaceutical company might respond to doubts about drug effectiveness and safety. In reality it's really irrelevant what he "thinks." Where's the data? Is this a political statement, a personal belief, or a statement backed up by scientific fact that is not cast into doubt by other research results? Our own National Research Council, Joint Commission, and other international organizations have written about their doubts and concerns about HIT [as that IT is designed and implemented in 2009]. If there is rigorous, systematic research weighing pro's and con's to back this assertion, I wish it would be published.

For his statement is really saying "we don't really know how many systems have flaws, we know some do, and we don't really know the full extent of the impact of those flaws, but because there can be some benefits, let's spend $50+ billion before we know the extent of the problems and fix them." I point out research from Harvard forty years ago, when Harvard informatics pioneer Dr. Octo Barnett published the "Ten Commandments of HIT." Two of those commandments were:

... 8. Thou shall be concerned with realities of the cost and projected benefit of the computer system [i.e., ROI - ed.]

10. Be optimistic about the future, supportive of good work that is being done, passionate in your commitment, but always guided by a fundamental skepticism.

The full set is in this post. Somewhere in the past 40 years, the rigorous ROI evaluations (which also must include systematic evaluations of risk, as any businessperson knows) and the fundamental skepticism seem to have gotten lost.

Over the next two months, Blumenthal will finalize the definition of "meaningful use," the standard that hospitals and physicians will have to reach before qualifying for health IT stimulus funds.

This is an example of putting the cart before the horse, and is a semantically-based, self contained logical fallacy of sorts. If a health IT system is harmful, the term "meaningful use" is itself Orwellian. If we don't know if HIT is beneficial, or have doubts, then such as term presupposes that health IT is inherently beneficial. A better term would have been "good faith use" - use based on the faith or hope that health IT will have an overall positive effect. The term "meaningful use" jumps the gun and is more a political slogan than a "meaningful term."

"If you look at other high-risk industries, like drug regulation or aviation, there's a requirement to report problems," said David C. Classen, an associate professor of medicine at the University of Utah who recently completed a study on health IT installations.

This is obvious, the reasons for it are obvious, and the reasons why health IT needs a requirement for problems reporting (one aspect of post-marketing surveillance, the "Phase IV" study as it is known in pharma) is obvious. Yet in 2009, no such requirement exists (see my post "Our Policy Is To Always Have Unabashed Faith In The Computer" for more on why we need reporting requirements.) Why do these requirements simply not exist in HIT?

"It's been a complete nightmare," said Steve Chabala, an emergency room physician at St. Mary Mercy Hospital in Livonia, Mich., which switched to electronic records three years ago. "I can't see my patients because I'm at a screen entering data." Last year, his department found that physicians spent nearly five of every 10 hours on a computer, he said. "I sit down and log on to a computer 60 times every shift. Physician productivity and satisfaction have fallen off a cliff."

The industry in the past has called such physicians "luddites", "resistant to change", "stubborn" etc. However, argumentum ad hominem is a fallacious mode of argument that has no place in a scientific field such as biomedicine. There also seems to be quite a lot of such concerns expressed by a large number of physicians, nurses, etc., and dismissing their concerns with a wave of the hand is cavalier in the extreme - again, these are first principles, without room for argument or debate. Let's study the issues rigorously and scientifically before resorting to ad hominem.

Other doctors spoke of cluttered screens, unresponsive vendors and illogical displays. "It's a huge safety issue," said Christine Sinsky, an internist in Dubuque, Iowa, whose practice implemented electronic records six years ago.

See my eight part series on mission hostile clinical IT here for examples of what Dr. Sinsky is referring to.

She emphasized that electronic records have improved her practice. "We wouldn't want to go back," she said. "But EHRs are still in need of significant improvement."

Yes, not cancellation, but improvement. And, quite importantly, before tens of billions of dollars are spent. Hospitals and physician offices are not an IT development laboratory, since the users of these facilities (patients) have very special rights and the clinicians, very special obligations and responsibilities.

Legal experts say it is impossible to know how often health IT mishaps occur. Electronic medical records are not classified as medical devices, so hospitals are not required to report problems.

That after decades of HIT development, sales and implementation we cannot know with certainty how often mishaps occur is, quite simply, a scandal of major proportions. Quoting an old House of God law, #10: "if you don't take a temperature, you can't find a fever." Another applicable aphorism seen on another discussion board: "you can only be so negligent or craven before the only remaining rationale is that you intended the result."

"Doctors who report problems can lose their jobs," Hoffman said.

I've taken risks with my own career in criticizing health IT, as have my colleagues. Hoffman is not exaggerating.

"Hospitals don't have any incentive to do so [speak out about problems with HIT] and may be in breach of contract if they do."

Imagine the outcry if the same prevailed regarding drugs or medical devices. The cemeteries would be lined with people whose epitaph could read "we bury our mistakes."

While orange-shirted vendor employees "ran around with no idea how to work their own equipment," the internist said, doctors struggled to keep chronically ill patients alive. "I didn't go through all my training to have my ability to take care of patients destroyed by devices that are an impediment to medical care."

This gets to issues I first raised in my website on HIT difficulties: who are these IT personnel, and what are their qualifications, exactly, to be working in mission critical medical environments? How is their competence evaluated?

I think these are questions that need to be answered.

-- SS

Washington Post: EMR's No Cure-All; Sen. Grassley Sends Letter of Inquiry to health IT vendors

Senator Grassley has sent a letter out to ten major health IT vendors seeking information on health IT problems and flaws. The letter can be retrieved from this link (PDF) at the Washington Post. Read the whole thing.

It is linked via a Washington Post story "Electronic medical records not a cure-all", Sunday Oct. 25, 2009, by staff writer Alexi Mostrous. The WaPo article itself seems to require registration. I will comment on the article in future posts.

Addendum 10/25: I have now commented on the article here.

-- SS