This is a continuation of a two-part interview with Seth Pazinski, Office of the National Coordinator for Health IT's (ONC) division director for planning and operations on the agency's recently published EHR incentives for helping patient safety. Part one of the interview can be found here.
The ONC's EHR incentive plan states that "HHS will consider issuing public notices related to serious adverse events or unsafe conditions involving EHR technology." Can you give more detail on that at this time?
Pazinski: One of the findings from the IOM (Institute of Medicine) report is, at this time we don't have sufficient information about the scope and breadth of health IT events. The main focus of this plan is trying to set up and use existing patient safety reporting mechanisms to learn what [are] the patient safety health IT events that are occurring. One of the things that we would consider is putting out alerts.
It's all in a draft stage now, so we know a lot can change between now and the final edition. At this point, what can you say about corrective actions that ONC might take when significant health IT adverse events occur toward providers, vendors or both?
Pazinski: Primarily, there are patient safety programs like the PSO [patient safety organizations] program where you report an adverse event and the PSO will work with the provider group to do some analysis and figure out how to correct that type of event in the future. I think we're talking about building the capacity within those programs to recognize and take steps to mitigate health IT-related safety events.
How does reporting of adverse health IT events jibe with other mandatory reporting programs providers already participate in (meaningful use and other quality-based programs)? Something like a subset of those things they already do?
Next year we hope to put out health IT safety guides to give an idea of what key areas during implementing systems you should be focused on -- and what are some steps you can take to do that in a safe way.
division director for planning and operations, ONC
Pazinski: Right. The way that we focused this was -- the IOM report found that less than 1% of events are indicated to having any relation to health IT. So how can we use existing programs instead of setting up entirely new programs to look at health IT-related events? The AHRQ [Agency for Healthcare Research and Quality] common formats are really one way to do that because they create a standardized reporting mechanism, and one of the types of events those common formats look at is health IT. It helps us parse the role of health IT with regard to reported events.
So in sum, we know a lot of adverse events are happening, but we don't really know how to ascribe some of them to health IT, because we don't have that bucket right now. This safety plan attempts to take what we already know and classify it in a meaningful way that can be researched with future prevention in mind.
Pazinski: Right. How can we use these existing safety programs where we already have people looking at patient safety events, and start to identify events related to health IT, but also how can we use health IT to improve patient safety overall? Just the idea of being able to report patient safety events in a standardized way has the potential to improve all patient safety.
How does ONC see vendor responsibility for adverse events? What if, for example, you have a contrarian vendor who doesn't participate in the voluntary code of conduct to pave the way for collecting adverse event data related to their products in use?
Pazinski: A couple ways we're trying to reach the vendor community with this plan: One, we've already done in our 2014 edition standards certification criteria. We have criteria related to user-centered design and good manufacturing practices, so we're trying to build safe ways of developing products. [Two,] as a part of our certification program providers will occasionally report safety-related issues to their vendor. You'll see some things in our plan that will provide some guidance to vendors on keeping a record and making those records available to the certification body. That will give us visibility into what events are occurring.
What else should vendors and providers know about in regards to EHR safety that ONC is working on?
Pazinski: We have an effort, a contract starting to look at health IT safety priority areas and mitigation steps around those. Next year we hope to put out health IT safety guides to give an idea of what key areas during implementing systems you should be focused on, and what are some steps you can take to do that in a safe way.
Why is tracking EHR safety so hard, to the point where other private sector efforts such as EHRevent.org have failed?
Pazinski: Health care is complex, and determining the cause of [an adverse event is tough]. Between the technology and the individual - it's all part of the process. Trying to piece out the exact cause is challenging.