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ONC Annual Meeting – Who’s Going?

Posted on January 28, 2015 I Written By

When Carl Bergman isn't rooting for the Washington Nationals or searching for a Steeler bar, he’s Managing Partner of EHRSelector.com, a free service for matching users and EHRs. For the last dozen years, he’s concentrated on EHR consulting and writing. He spent the 80s and 90s as an itinerant project manger doing his small part for the dot com bubble. Prior to that, Bergman served a ten year stretch in the District of Columbia government as a policy and fiscal analyst.

ONC’s Agenda – February 2-3, Washington, DC

Next Monday, ONC holds its annual meeting in downtown DC. I’m going, one small advantage of living here. Here’s the agenda. To see day two, click on the agenda header.

I’m particularly interested in these topics:

  • Adverse event reporting,
  • Interoperability standards,
  • Meaningful Use program’s future, and
  • Usability.

Looking at the agenda, I should stay busy with one exception. There isn’t much on usability. The word’s only on the agenda once. Not a surprise since ONC has pretty much relinquished any role to the vendors.

How important do you think the ONC meeting and also the ONC run Healthdatapalooza now that meaningful use has kind of run its course? Will these two meeting gain steam and influence or will organizations start to go other places? I’ll be interested to watch that trend as I attend the event.

If you can’t attend, you can follow on various webcasts and twitter. If you do plan to attend, I’d love to see you there. To email me, click on my name in my profile blurb, or at carl@ehrselector.com.

Adverse Event Reporting: What Is It?

Posted on December 3, 2014 I Written By

When Carl Bergman isn't rooting for the Washington Nationals or searching for a Steeler bar, he’s Managing Partner of EHRSelector.com, a free service for matching users and EHRs. For the last dozen years, he’s concentrated on EHR consulting and writing. He spent the 80s and 90s as an itinerant project manger doing his small part for the dot com bubble. Prior to that, Bergman served a ten year stretch in the District of Columbia government as a policy and fiscal analyst.

Eric Duncan’s Ebola death in Dallas was, to say the least, an adverse event (AE). Famously now, when he had a high fever, pronounced pain, etc., he went to Texas Health’s Presbyterian Hospital’s ER, and was sent home with antibiotics. Three days later much worse, he came back by ambulance.

In the aftermath of Duncan’s death, the hospital’s EHR, EPIC, came in for blame, though it was later cleared. Many questions have come from Duncan’s death including how our medical system handles such problems. Articles often use the term adverse event, but rarely mention reporting. I think it’s important to take a direct look at our adverse event reporting systems and where EHR and AEs are headed. This blog post looks at AE systems. The next will look at where EHRs fit in.

The FDA: Ground Zero for Adverse Event Reports

HHS’ Food and Drug Administration has prime, but not exclusive, jurisdiction over adverse reports breaking them into three classes:

  • Medicines
  • Medical Devices, and
  • Vaccines.

Four FDA systems cover these classes:

  • FAERS. This is FDA’s system for drug related adverse reports. It collects information for FDA’s post marketing for drug and biologic product surveillance. For example, if there’s a problem with Prozac, it’s reported here.
  • MAUDE. The Manufacturer and User Facility Device Experience reporting system. If an X-Ray machine malfunctions or lab equipment operates defectively, this is where the report goes.
  • VAERS. Vaccine adverse reports are collected here.
  • MEDSUN. This is voluntary, device reporting system gathers more detailed information than MAUD. It’s run by as a collaboration of the FDA and several hundred hospitals, clinics, etc. (Disclosure: My wife was MAUD project system developer.) MEDSUN captures details and incidents, such as close calls or events that may have had a potential for harm, but did not cause any. MEDSUN has two subsystems, HeartNet, which is for electrophysiology labs and KidNet for neonatal and pediatric ICUs.
DSC04388

MEDSUN Reporting Poster

State Adverse Event Reporting Systems

Several states require Adverse Event reporting in addition to FDA reports. Twenty-seven states and DC require Adverse Event reports, with varying coverage and reporting requirements. Some states, such as Pennsylvania, have an extensive, public system for reporting and analysis.

Patient Safety Organizations

Added to federal and state organizations are many patient safety organizations (PSOs) with an Adverse Event interest. Some are regional or state groups. Others, are national non profits, such as the ECR Institute.

The Safety Reporting Paradox

If you delve into an Adverse Event reporting systems, you’ll quickly see some institutions are more present than others. That doesn’t necessarily mean they are prone to bad events. In fact, these may be the most safety conscious who report more of their events than others. Moreover, high reporters often have policies that encourage AE reporting to find systemic problems without punitive consequences.

Many safety prevention systems work this way. Those in charge recognize it’s important to get all the facts out. They realize adopting a punitive approach drives behavior underground.

For example, the FAA has learned this the hard way. Recently on vacation, I met two air traffic controllers who contrasted the last Bush administration’s approach to now. Under Bush’s FAA errors were subject to public shaming. The result was that many systemic problems were hidden. Now, the FAA encourages reporting and separates individual behavior. The result is that incidents are more reported and more analyzed. If individual behavior is culpable, it’s addressed as needed.

In the next part, I’ll look at how EHRs fit into the current system and the congressional efforts to exempt them from reporting AEs, a move that I think is akin to putting pennies in a fuse box.