Amid all the dog-bites-man type health IT news, here are some not-so-positive EMR/EHR stories that have been reported:
– An EMR in Lifespan hospital group gave incorrect prescriptions to some 2000 patients. The article in the Providence Journal says that
The hospitals have placed calls to nearly all the affected patients, although not all have called back, Cooper said. Most patients reached had already obtained the correct medication because the error was noticed by someone at the hospital, or a pharmacist or doctor outside, she said. So far, Cooper said, there is no evidence that any- one was harmed.
Thank goodness for that.
– Incorrectly calculated MU thresholds (GE Centricity). I’m not going to rehash the story, but you can check out Neil Versel’s article in InformationWeek, the spirited discussion on my previous EMR and EHR blog post and John’s EMR and HIPAA blog post.
It might be just be my skewed viewpoint, but GE Centricity related issues are nowhere on par with people being prescribed the wrong prescription. In one case, a few practices may not be able to demonstrate Meaningful Use. Wrong medication could actually be life-threatening to you. So if I had to rank my problems, I’d rather be short by 44K than worry about my EMR inadvertently killing my patients off.
What we need is a governing body, similar to the National Transportation Safety Board, to police EMRs, says Paul Cerrato in a recent InformationWeek Healthcare article.
Cerrato writes:
“An NTSB-like organization for EHRs would at the very least provide a reporting mechanism to keep track of incidents and life-threatening consequences of misusing e-records. More importantly, it could police vendors and healthcare providers who repeatedly ignore these dangers.”
Cerrato goes on to say there are only 120 EHR-specific problems reported to the FDA over the last 18 years. That figure, if correct, to me shows:
- EMR users don’t know how/where they can report EMR related errors or don’t expect any action to be taken – this certainly is credible, because from all quarters, it seems as if the focus is just to get the healthcare field into electronic data capture, not on whether the experience delivers any tangible and useful benefits
- Maybe they’re willing to give EMRs a pass assuming the healthcare IT to be in infancy
- They’re too overwhelmed with the EMRs’ capabilities/inabilities to really see what’s going on
For a national database of EMR problems to be truly relevant, here’s the information I would look for, on problems I’m facing:
- How critical was the error? How many people did it affect, and in what ways – medically, financially?
- How was it handled?
- How common is it – are there others who’ve faced similar problems?
- If the problem was not sorted, what raps on the fingers did the vendors face?
Read the article here.
In answer to your headline’s question, I say “these guys”
http://searchhealthit.techtarget.com/news/2240024712/Public-private-coalition-announces-EHR-adverse-event-reports-site
don fluckinger,
I’ve seen that group before, but after their launch I hadn’t heard anything about them again. I’m not sure they’re going to have high enough profile to be able to really collect the reports. Basically, a reporting system is great, but if no one knows to report something there, then it’s not worth much. Plus, if someone reports something but the organization doesn’t do anything with that information, it’s not very meaningful (pun intended) is it. Maybe they’ll surprise me.
why not charge the same entity that’s responsible for misuse/abuse of physicians’ hardcopy records systems with monitoring/managing EMR/EHR?
oh, right, there isn’t one
FDA gathers adverse events for medical devices. The question that it’s debating is whether software should be treated as a device. In some respects, this is already the case where a device uses both hardware and software.
Since the FDA has systems for dealing with adverse events already, it makes I think both economic and reporting sense for them to include adverse EMR events as well.
As to an NTSB approach, for better or worse this is what the National Institute of Standards and Technology is tasked to do. As with NTSB, NIST is not a regulatory agency, but develops policies. They don’t have NTSB’s investigative powers.
“Need a governing body”?! You’ve got it exactly backwards. It’s the governing bodies that have hospitals and groups scrambling to buy immature clunky error-prone software. As I’ve said before, if EMRs worked, we’d already be using them, no stimulus needed.
Brian,
I wouldn’t say it’s a governing body. I’d say it’s a place for issues with EMR to be reported and made public. I’m not sure the right way to do it since it’s fraught with challenges. Although, I do like the idea of holding EMR vendors accountable. Maybe the first step is making EMR switching costs extremely low.
Carl sent me this Washington Post article today which talks about a report that calls for the FDA to monitor the safety of health IT: http://www.washingtonpost.com/national/health-science/report-calls-for-new-agency-to-monitor-safety-of-health-it/2011/11/08/gIQAnCoo2M_story.html?wpisrc=emailtoafriend
[…] week I wrote wondering who will police EMRs and EHRs. With the release of IOM’s report recommending the creation of a different federal agency to […]
Technically, it doesn’t call for the FDA to regulate EMR safety. It calls for ONC to lead voluntary efforts as a carrot at first…and then have the FDA developing a regulatory framework in the background. If ONC feels the health care industry (and the IOM comes down harder on vendors than end users), ONC can throw up its hands and green light the FDA to take over
http://searchhealthit.techtarget.com/healthitexchange/healthitpulse/10-things-you-need-to-know-from-the-iom-hit-safety-report/
http://searchhealthit.techtarget.com/news/2240110836/IOM-report-poised-to-shape-EHR-safety-regulation