Providers have been lashing out against subpar electronic health record design for years. They gripe that not only do poorly designed systems impede workflow and cost too much, they also create new patient safety problems and don't share data with other systems to coordinate care, as promised. Still, the industry hasn't done much to address these concerns.
However, maybe now they'll have to. New evidence released this week bolsters what the providers have been saying all along: EHRs, as currently designed, adversely impact patient safety.
First, there's the new study of adverse patient safety events at the Veterans Affairs Department (VA), which operates a voluntary, non-punitive reporting program of such incidents. Three-fourths of the 100 EHR-patient safety issues studied related to design issues. Moreover, a whopping 94 percent of the safety concerns were traced back to just four problems, all of them design flaws, including:
- Unmet data display needs, such as small print or a "poor fit" between information needs and the clinician's task on hand
- Problems with software upgrades and modifications, which created configuration errors
- System-to-system interface problems
- "Hidden dependencies" within the EHR, such as use of matching algorithms that created errors and delays.
Then there's the U.S. Food and Drug Administration (FDA), which just posted a blog post about its new pilot program, Mini-Sentinel. The surveillance system uses claims and EHR data from 18 large healthcare organizations so the agency can monitor the safety of FDA-regulated medical products, help answer important drug safety questions and improve public health.
But in the post, Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research, lamented that the EHRs' lack of interoperability is a fundamental design defect, implying that it could negatively impact the pilot program's success. Woodcock said that lack of interoperability was a "challenge" to research and negatively impacted public health efforts. She also said "we need to further standardize the data and the way it is exchanged," as well as use standard terms for "adverse events" or "treatments" so that EHRs can "better talk'" to each other.
Sure, user error causes some adverse patient safety incidents. But as the VA study points out, the number of events attributable to user error drops as users become more experienced with their systems.
But users can't correct design errors.
How should they be redesigned? For starters, consider the roadmap the VA study provides. The researchers offer several suggestions to improve EHR design, such as making hidden dependencies explicit, testing software changes with the full range of clinical content, testing information displays in the context of "real world" tasks and using unambiguous words in system messages.
There are other steps that also can be considered. Patient outcomes is a large part of Stage 3 of Meaningful Use, but perhaps we should go farther. For instance, Health IT Now has recommended that EHR vendors who thwart interoperability and drag their feet on patient safety improvements should be investigated and decertified.
The Office of the National Coordinator for Health IT may also want to make EHR design a priority for the agency's new health IT safety center.