EHRevent.org Leadership: "Heck, getting out of bed in the morning is dangerous- it just beats the alternative"

I have posted about the organization EHRevent.org on numerous occasions. I expressed concerns that this organization's representation as an alternative aggregator of health IT difficulty cases, compared to established organizations and resources such as FDA's Medwatch and MAUDE database, was probably not a good idea:

November 15, 2010: EHRevent.org: Web Site to Collect EHR Safety Reports

November 16, 2010: EHRevent: survey amateurism, bias, or something else?

November 17, 2010: Some answers about new site "EHRevent.org" for health IT and drug adverse event reporting

November 22, 2010: EHRevent.org CEO Edward Fotsch MD: The Real Challenge with EHRs is -- User Error?

July 24, 2011: EHRevent.org and "The National Database of EHR Errors Being Called For" - Where's the Beef?

The Nov. 22, 2010 post "EHRevent.org CEO Edward Fotsch MD: The Real Challenge with EHRs is -- User Error? " is particularly relevant to this one.

I saw the following remarkable comment by EHRevent.org CEO Edward Fotsch MD on the HISTalk blog. It was in a comment section regarding the new Institute of Medicine report "Health IT and Patient Safety: Building Safer Systems for Better Care" on health IT risks (my initial post on that topic is here):

ed fotsch Says:

Re: the IOM/ONC report it seems to me that the IOM started with the wrong question. Question #1 posed should have been- ‘Are Health IT/EHR systems, when implemented appropriately, safer and better than the current paper system in most hospitals and MD offices; as opposed to the question that apparently was posed: ‘are EHRs safe.’

Heck, getting out of bed in the morning is dangerous- it just beats the alternative. Once question #1 HAD been answered, question #2 could have been tee’d up- ‘How can we make EHRs better?” But that ship has sailed and now they and we in Tidy-Bowl mode. The wrong question was asked so we’re dealing with what may be the right answer to the wrong question. And it will be hard to get the toothpaste back in the tube, worms back in the can, etc. on this one from an ONC/IOM standpoint- and yes the press will have a field day, those running for office will have more fodder and Republicans (no issue per se with Republicans BTW) who are pushing for less (not more) government regulation will have a field day with this set of recommendations.

November 8th, 2011 at 10:53 pm

While I do not know Dr. Fotsch, my questions about this comment are as follows:

• Are its viewpoints entirely objective with regard to health IT?
  


• Is it consistent with a physician-executive who thinks critically about risk, and knows the literature (such as here), or with someone who leans toward technologically deterministic views about healthcare IT?


• Is it a reasonable view from the CEO of an organization seeking a position of enormous public responsibility as the "central place for reporting adverse EHR events or near misses or potential problems or issues with electronic health records", as described of EHRevent.org in the aforementioned Nov, 22, 2010 post?


• It is an appropriate comment for someone holding such a position?

These questions repeat some of the concerns as expressed in my previous posts.

I responded as follows at HIStalk in the same comment thread. Emphases in the original:

To Dr. Fotcsh:

My opinion differs. I believe the IOM asked the correct questions.

The answer to your proposed question “‘Are Health IT/EHR systems, when implemented appropriately, safer and better than the current paper system in most hospitals and MD offices” is – nobody really knows. The IOM explicitly acknowledges this:

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… “For example, the number of patients who receive the correct medication in hospitals increases when these hospitals implement well-planned, robust computerized prescribing mechanisms and use barcoding systems. But even in these instances, the ability to generalize the results across the health care system may be limited. For other products— including electronic health records, which are being employed with more and more frequency— some studies find improvements in patient safety, while other studies find no effect.

More worrisome, some case reports suggest that poorly designed health IT can create new hazards in the already complex delivery of care. Although the magnitude of the risk associated with health IT is not known, some examples illustrate the concerns. Dosing errors, failure to detect life-threatening illnesses, and delaying treatment due to poor human–computer interactions or loss of data have led to serious injury and death.”
----------------------------------

The technology is experimental.

In my opinion, that invokes the medical adage “First, do no harm.” There exist protocols for human subjects experimentation. The health IT industry has exempted itself from those protocols.

My overall thoughts on the IOM report are at http://hcrenewal.blogspot.com/2011/11/iom-report-on-health-it-safety-nix-fda.html

-- SS

EHRevent.org and "The National Database of EHR Errors Being Called For" - Where's the Beef?

At my Nov. 2011 posts on a new entity called "EHRevent.org" that is supposed to be a health IT industry watchdog, I expressed various forms of skepticism. See my Nov. 2010 posts at the following HC Renewal links:

November 15, 2010: EHRevent.org: Web Site to Collect EHR Safety Reports

November 16, 2010: EHRevent: survey amateurism, bias, or something else?

November 17, 2010: Some answers about new site "EHRevent.org" for health IT and drug adverse event reporting

November 22, 2010: EHRevent.org CEO Edward Fotsch MD: The Real Challenge with EHRs is -- User Error?

Now, approximately eight months later, I read this in the July 2011 EHREvent newsletter at this link, written by Michael Victoroff, MD, Editor in Chief:

... The media has drawn our attention to the case of Genesis Burkett, a newborn who recently died in a Chicago hospital when an order for intravenous fluids was incorrectly transcribed by a pharmacy technician. Some journalists have characterized this a “computer error” because the ordering physician entered the order (correctly) into an electronic system, and the pharmacy tech re-entered the order (incorrectly) into an automated compounding machine. [If so, perhaps one should wonder how mission hostile - see link - the user experience of that compounding machine might have been, which could have contributed to or caused the error - ed.]

Moreover, a decision support system that should have alerted at the mistake had been disabled. [Disabled by whom, exactly, and why? Perhaps because it, too, was ill conceived and user hostile? - ed.]

This case has been invoked as a warning about hazards of automation. Calls have been made for “mandatory reporting of adverse events related to HIT to a national database.”

Uh, hello? www.EHRevent.org is exactly the “national database” being called for. It is a fully accredited, federal Patient Safety Organization and part of an AHRQ network of error-reporting entities. Reports to EHRevent.org are fully confidential, and data that is collected is reportable only in de-identified or collective form.

("Uh, hello?" he writes?)

Uh, hello, Dr. Victoroff ... As in the old Wendy's commercial:

Where's the beef?

Where's the beef???

A search of the http://www.ehrevent.org/ website shows no accessible, searchable database that I can find.

If someone knows of such a publicly accessible database at least remotely similar to the FDA's MAUDE (Manufacturer and User Facility Device Experience) database at this link, please let me know.

The best I can find on a Google search on "EHRevent database" is a page of legalese containing these statements:

2.1 PDR Secure will develop a Patient Safety Evaluation System (“PSES”) for the collection, management, and analysis of information received from and/or reported to participating providers, to be accessed through a PDR Secure web portal [but, apparently, not public dissemination, and based on this language it seems dubious that even "participating providers" will get a complete, searchable corpus of reports - ed.]

... 2.4 PDR Secure will assemble a knowledgeable workforce, and in collaboration with its workforce (which may consist of employees, contractors, volunteers, representatives of participating providers and other Patient Safety Organizations, and other individuals as appropriate to the involved Patient Safety Activity), will develop and conduct Patient Safety Activities, including but not limited to data collection, appropriate studies, evaluative activities, reports, and recommendations, including, where feasible, “best practices” recommendations; and will offer the results to participating providers. [In other words, we disseminate what we think is relevant - ed.]

Examples of what the public can find - for free and at will - on the FDA MAUDE site are at the posts here:

January 21, 2011: HC Renewal - MAUDE and HIT Risks: What in God's Name is Going on Here?

Drexel Health IT website
Real-World, Though Limited, Examples of Healthcare IT Malfunction From the FDA MAUDE Database
http://www.ischool.drexel.edu/faculty/ssilverstein/cases/?loc=cases&sloc=MAUDE

Drexel Health IT website
FDA MAUDE DATABASE: Patient outcome = death
http://www.ischool.drexel.edu/faculty/ssilverstein/cases/?loc=cases&sloc=maude_death

Unless I am missing some MAUDE analog at EHRevent.org, a claim that "EHRevent.org is exactly the national database [on EHR medical device problems, dangers, harms etc. - ed.] being called for" raises some questions:

• Called for by whom: patients and their advocates, or, an industry interested in secrecy and turf protection?
• If the public does not have unfettered, searchable access to the set of de-identified case reports being submitted to EHRevent, as they do to FDA's MAUDE and other public databases, how can the public know their publications are complete, unbiased, and not selectively preferential towards certain HIT vendors and/or user organizations?
• Is EHRevent's model based on the watchdog's opinions of what's important for the public to know, or will it allow the public to make its own informed choices?
• Will EHRevent publicly demand the recall of EHR medical devices repeatedly reported to them to be harmful, as would the FDA or other governmental regulators regarding dangerous products?
  

At present, the answers to these questions raise little confidence in me that EHRevent.org is "the national database" being called for by true watchdogs, e.g., those truly interested in ensuring the safest, most effective EHR medical devices, and the weeding out of dangerous and deficient EHR medical devices.

I'm going to go a step further.

I am making the following request: that EHRevent.org make available online, in a de-identified (as to people and organization) and searchable format the event reports about the EHR medical devices they receive.

Finally, regarding infant mortality related to health IT, perhaps Dr. Victoroff should read cases #2 and #3 at the post "Babies' deaths spotlight safety risks linked to computerized systems" at this link.

-- SS