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The largest healthcare provider in the Baltimore-Washington metropolitan area is urging Congress to take action when it comes to the link between electronic health record usability and patient safety.

MedStar Health has drafted a letter to Senate and House committees calling on lawmakers to “address safety-related usability challenges” and to implement a key provision of the 21st Century Cures Act.

While Congress has taken steps to address this problem, MedStar’s letter contends that “success depends upon effective implementation by the Office of the National Coordinator for Health Information Technology” of Section 4002 of the Cures Act, which directs the “creation of an EHR Reporting Program, where ONC would collect and disseminate data on core EHR features, including usability.”

“If developed effectively, this program can give providers, patients, the public and even EHR vendors better information on how these systems operate to address any challenges—including usability and safety,” the MedStar letter adds.

The not-for-profit health system, which operates 10 hospitals in the Baltimore-Washington region, is asking healthcare stakeholders to sign the letter to Congress by February 28 to lend support to the initiative.

“Poor EHR usability promotes certain types of medical errors as physicians, nurses, and other clinicians use these systems to care for patients, and there is increasing evidence showing the association between usability issues and safety,” states the letter.

Also See: EHR usability issues pose safety risk to pediatric patients

The American Medical Informatics Association issued a statement supporting the effort and urged other industry stakeholders to sign the letter to Congress.

“We have a fractured and loosely connected system to understand when health IT negatively impacts patient care, how such harms could have been avoided, and what changes to usability, design and implementation are necessary to mitigate such shortcomings in the future,” said Doug Fridsma, MD, AMIA’s president and CEO. “This inability to understand how health IT impacts safety across settings of care is why AMIA supports the establishment of a national public/private center, or collaborative, on health IT safety meant to convene, analyze and disseminate information to improve the safety and safe use of health IT.”

Raj Ratwani, director of the MedStar Health National Center for Human Factors in Healthcare, which authored the letter to Congress, contends that a central reporting system is needed “so that clinicians, patients, and any other stakeholder that sees an EHR usability and safety issue can report it into that database.”

On Monday, a viewpoint article co-authored by Ratwani was published in JAMA calling for the creation of a national reporting system much like the Food and Drug Administration’s Manufacturer and User Facility Device Experience database for medical devices.

“To create such a reporting system, clinicians must be permitted to report and illustrate various types of usability issues, and resources must be allocated by the ONC, HIT vendors and healthcare organizations for appropriate investigation into root causes of these issues so they can be resolved,” states the article. “The 21st Century Cures Act, passed with bipartisan support in 2016, may provide the legal authority and regulatory framework to establish this database through ONC, which should be accessible by the public and allow anyone to report issues.”

According to Ratwani, this kind of data must be available for analysis but he charges that “gag clauses” in contracts between EHR vendors and provider organizations “has prevented open discussion of these kinds of issues and challenges.”

However, in a written statement, the Electronic Health Record Association pointed out that EHR developers have a longstanding commitment to patient safety.

“The principles of the 2016 EHR Developer Code of Conduct promote patient safety,” according to the group. “EHRA also actively monitors, contributes and is committed to engagement with federal agencies, PSOs, trade associations, professional societies, liability carriers, academics and other stakeholders to collaborate on efforts to promote a culture of safety in health IT and evolve a non-punitive national learning system.”

Nonetheless, MedStar and the American Medical Association have made available for the first time videos from the clinician’s point of view that the provider organizations say demonstrate the risks and challenges caused by poor EHR usability.

The videos are posted on a website, EHRSeeWhatWeMean.org, based on recent MedStar research in partnership with the AMA regarding the EHR usability of the two major health IT vendors with the largest market share—Cerner and Epic. In the study, emergency medicine physicians from four health systems—two using Cerner and two using Epic—were given common tasks to perform in standardized clinical scenarios mimicking real patient cases.

What we found was huge variability in the time and error rates while completing those tasks,” said MedStar’s Ratwani. “We presented that information in a journal publication in 2018, and now we’re showing the video snippets of those usability challenges.”

Ratwani added that MedStar asked permission from the Cerner sites to show the actual video, which the vendor granted. “We approached Epic in the same way and sought their permission—which they denied,” he noted, adding that the vendor expressed concerns over intellectual property. “While we’re certainly respectful of their decision, we disagree with it. And, so, we have instead created a simulated EHR and mimicked the usability issues that we observed in Epic to show what was found in those products.”

Epic did not provide a comment on the videos or the MedStar-AMA research. However, Cerner acknowledged in a written statement that it volunteered to participate in the study, while making the case that the company is actively engaged in addressing physician burnout as an industry challenge.

“We’re focused on engaging physicians in each step of the design of EHR workflows to better reflect how they deliver care,” read Cerner’s statement. “Through the use of analytics, research and feedback we are able to continuously optimize solutions to deliver a more personalized and intuitive care delivery experience.”

For its part, the Office of the National Coordinator for Health IT provided a written statement emphasizing that the agency appreciates the efforts of MedStar and the AMA on this issue.

“If designed and implemented appropriately, health IT can improve overall patient safety,” said the ONC spokesperson. “We also recognize that there are examples of health IT-related adverse events and the importance of reporting these events. Many of those are intercepted by clinicians before patients are impacted.”

“As the report says, the 21st Century Cures Act directs HHS to report on patient safety organization activities that address health IT safety and directs ONC to improve the interoperability of health information,” added the agency’s spokesperson. “And, as the report notes, part of that includes addressing what is known as ‘information blocking’—which may include efforts by EHR developers to deny the sharing of information about their EHRs, including potential adverse events.”


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