Wednesday, January 20, 2010

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


Anonymous said...

The stuff in its current form is not fit for purpose.

Congress was deceived by bloated claims from the vendors and their trade associations and the hospitals who are their "partners", whatever that means.

Follow the money from the beginning of this gig. Senator Grassley has the right idea.

"Guppy" Honaker said...

Ultimately, it will be money that speaks loudest in any health care issues (reform or otherwise) in the USA. Not surprising, it is big medical business (pharmaceuticals, health care conglomerates such as CIGNA, Banner Health, etc.)that are guiding and informing governmental regulators - not the other way around.

Keep up the good work on you blog. - David

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