Electronic medical record products may have patient safety issues––even if they’re certified, according to a new study published in JAMA.
HHS’ Office of the National Coordinator (ONC) can conduct EHR surveillance to determine whether EHR systems meet specific, certified design, functionality and security standards. Certified EHR products receive a unique product ID.
Researchers from Georgetown University School of Medicine and MedStar Health National Center for Human Factors sought to estimate the extent of lack of adherence to certification standards and the potential for patient harm among vendor products.
Researchers analyzed publicly available surveillance data from Jan. 28, 2016, to June 24, 2019, including surveillance activity and any identified issues, called nonconformities. They then classified nonconformities into either possible patient harms or unlikely patient harms. In total, they looked at 697 out of 7,415 active certified IDs. The analyzed portion came from 195 vendors.
Some of the potential patient harms include serious errors that could have dire consequences. For example, a missing decimal point on a dosage entry or the EHR not properly recording CVX codes in specific circumstances. Unlikely patient harms included blank entries on the audit log or other electronic clinical quality measures, among others.
More than half of the surveilled product IDs––358, or 51.4%––had a certified capability noncomformity issue. In addition, 275, or 39.5% of all products surveilled, from 9 vendors were coded as being associated with possible patient harm.
“These findings begin to estimate the extent of vendor lack of adherence to certification standards and the potential for patient harm, with 3.7% of total product IDs having a nonconformity issue that could be a contributing factor to a patient harm event,” first author Thomas B. Pacheco, BS, of the Georgetown University School of Medicine, et al. wrote.
The study pointed out that most surveillance was reactionary, and randomized surveillance was rarely performed. Researchers didn’t analyze whether patients were actually harmed from the EHRs.
“Although products associated with possible patient harm issues are widely used by health care facilities, it is unknown whether these issues resulted in actual patient harm,” Pacheco et al. wrote.