Electronic health records products that have been certified by a federal agency may be causing issues that could lead to patient harm, according to a new analysis published in JAMA.
Among the examples of safety issues identified: an EHR deleted a decimal point from a drug dosage entry so 2.5 milligrams was changed to 25 milligrams.
"That could be a significant overdose, depending on the medication," said Raj Ratwani, Ph.D., an EHR safety researcher and co-author of the research letter published in the Journal of the American Medical Association.
Other issues the researchers flagged include vaccines wrongly coded in the EHR, inaccurate medication codes, and laboratory results failing to import into the EHR properly.
Ratwani, the director of the MedStar Health National Center for Human Factors in Healthcare, led the research team in examining EHR surveillance data collected by The Office of the National Coordinator for Health Information Technology (ONC) between January 2016 and June 2019.
ONC may perform surveillance on EHR vendor products in response to a reported issue or by randomly selecting products for investigation, according to the research letter.
The researchers examined more than 350 reports of EHR issues perceived to violate the federal certification program, as defined by the U.S. Department of Health and Human Services (HHS). These reported issues may be related to the design, functionality or security of the product, as well as required disclosures about the product.
Their research findings indicate there is a real possibility for EHR platforms to cause patient harm, Ratwani said. Close to 4% of all certified EHRs, or a total of 275 systems, had an issue with the potential for patient harm, the study found.
Those products with potential safety issues stem from nine vendors and the researchers estimate 786 hospitals and 37,365 individual providers may have used the products with these potential patient safety issues.
"The product may have been fixed before rigorous use," Ratwani said. "But the reach here can be pretty substantial. If there is an issue in one of these EHRs technologies, it may not be happening at one site, it may be happening across the country. We don’t know if patients have been harmed but there is the potential for it."
He said the research reinforces the need for an EHR safety reporting program. Unlike other industries, the health IT industry currently does not have a method for clinicians or patients to openly report safety issues with EHR software, he said.
"While innovations in medications and medical devices are guided by strict surveillance programs in the U.S., no such rigor exists to evaluate the safety of the electronic health record systems that U.S. providers constantly rely upon,” he said.
MedStar's research shows the limitations in surveillance and challenges in reporting and widely addressing incidents, he said. "This research highlights the need for proactive safety surveillance. We need to develop algorithms to identify safety issues before the issues reach patients," he said.
The majority of the discovered EHR problems were turned up by ONC's reactive surveillance, according to researchers.
The rigor of safety and usability testing for health IT products needs substantial improvement, Ratwani said, noting that test case scenarios used in EHR certification often don't resemble "true clinical cases."
And often health IT products and EHRs are customized and configured during implementation. "We call that the 'reality gap'—the implemented product is different than what was certified," he said.
One way to address that is to call on the Joint Commission to develop accreditation standards focused on health IT safety. The Centers for Medicare and Medicaid Services (CMS) also could play a role by developing health IT safety requirements, Ratwani said.
Maryland-based MedStar and the American Medical Association (AMA) have teamed up on an advocacy campaign to raise awareness about the patient safety risks associated with poor EHR usability. MedStar and other industry leaders are calling for federal lawmakers to address safety-related usability challenges through oversight of the administration’s implementation of key provisions from the 21st Century Cure Act.
As part of the Cures Act, ONC is charged with creating an EHR Reporting Program and many stakeholders are advocating that this program include safety as part of usability criteria.