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Researchers from MedStar Health National Center for Human Factors in Healthcare and Georgetown University School of Medicine analyzed electronic health records (EHR) surveillance data collected by The Office of the National Coordinator (ONC) for safety issues that could lead to patient harm. The ONC collects data to determine whether EHR systems, which were certified as meeting specific design, functionality, and security standards set forth by the ONC, still meet those standards when implemented and used.
The research team included Raj Ratwani, PhD and Aaron Z. Hettinger, MD from MedStar Health National Center for Human Factors in Healthcare; and Thomas B. Pacheco, BS from Georgetown University School of Medicine, Washington, D.C.,
The ONC may perform surveillance on EHR vendor products in response to a reported issue (reactive) or by randomly selecting products for investigation (randomized). The researchers examined the surveillance data from January 2016 through June 2019 to determine whether identified issues had the potential for patient harm, and the frequency of these issues. The research focused on nonconformity issues that may have patient safety implications.
The analysis surveilled 697 EHR systems and 358 of all vendor products examined had a certified capability nonconformity issue. The study found that close to 4% (275 EHR systems), had an issue with the potential for patient harm. Most surveillance was reactive, with 352 product IDs having a certified capability nonconformity issue and 273 were coded as being associated with possible patient harm. With most issues being identified through reactive surveillance, 41.8% of product IDs were classified as having a possible patient harm issue.
The study concluded the need for an EHR safety reporting program. To date, the health information technology industry does not have a method for clinicians or patients to openly report safety issues with EHR software. “This research highlights the need for proactive safety surveillance. We need to develop algorithms to identify safety issues before the issues reach patients, “ said Raj Ratwani, Ph.D.
Dr. Ratwani is supported by AHRQ grants R01HS023701 and R01HS025136. Dr. Hettinger is supported by Agency for Healthcare Research and Quality (AHRQ) grant R01HS025136. Mr. Pacheco is supported by the Frank S. Pellegrini, MD Medical Student Research Scholarship Endowment.
JAMA, 2019. DOI: 10.1001/jama.2019.17242