EHRs Can Be Dangerous. Are New Guidelines Necessary?

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Electronic health records (EHRs) may be designed with usability in mind, but when those systems enter the real world, they often fail to match their performance in the lab, and the results can have major health implications for patients.

That’s the premise of a new review from the Pew Charitable Trusts, MedStar Health’s National Center for Human Factors in Healthcare and the American Medical Association.

“Research has shown a clear link between system usability and patient safety,” Ben Moscovitch, M.A., project director for health information technology at Pew, told Healthcare Analytics News™.

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Usability and other issues are the subject of federal guidelines and regulations. The problem is that those regulations are enforced during the design and development stage, Moscovitch and colleagues note. Thus, there’s no backstop to ensure EHRs meet the same standards once they’ve been put into use in a clinical setting. That’s troubling because the precise operations of EHRs are often customized at the healthcare organization level, and employee training also varies depending on the site.

For instance, the study notes, if a customization causes laboratory tests to be displayed without the date and time, clinicians could end up making decisions based on data that are no longer relevant. Likewise, if an EHR system’s alerts and warnings aren’t working correctly, a physician might miss information on a drug interaction.

Moscovitch said the organizations Pew partnered with set out to come up with better guidelines to help healthcare organizations and regulators understand how to keep safety at the forefront.

“With input from more than two dozen stakeholders — including representatives from EHR developers, healthcare providers and government — we identified steps that can be taken to improve health IT safety throughout the product lifecycle, including during development and after implementation within facilities,” he said.

Among the report’s recommendations are a number of proposed changes to test case scenarios used to validate EHR usability.

They argue that test case scenarios should better represent how each member of a healthcare team uses EHRs, as staffers in different roles might interact differently with the systems.

Testing should also be designed to include known areas of risk, and such cases should be designed around the specific audience that will be using the end product, the authors wrote.

The new guidelines don’t have the force of law. For now, they’re merely suggestions. However, Moscovitch and colleagues suggest that the Office of the National Coordinator for Health Information Technology could use the guidelines as alternatives to its current regulations. Conversely, healthcare organizations and EHR vendors could voluntarily adopt the guidelines.

“Healthcare facilities can begin implementing the best practices identified and use safety-based test case scenarios to understand the potential risks associated with their unique workflows and customizations,” Moscovitch said.

He said healthcare organizations could use the test case scenarios offered in his report to evaluate whether their EHR system has safety or efficiency flaws.

“The Joint Commission, which accredits healthcare providers, also has an opportunity to adopt some of the best practices into its initiatives to ensure that hospitals and other facilities are factoring health IT safety and usability into their practices,” he said.

Moscovitch offered, for instance, that the Joint Commission could require organizations seeking certification to prove that they monitor for harm associated with “high-risk customization.”

The report, “Ways to Improve Electronic Health Record Safety,” was published last month and can be read in full on Pew’s website.

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