A viewpoint article published in JAMA Pediatrics calls for a rigorous certification program for electronic health records used in pediatric care.
Authors Raj Ratwani of MedStar Health's National Center for Human Factors in Healthcare and Ben Moscovitch and Josh Rising of Pew Charitable Trusts argue that children are especially vulnerable to patient safety risks such as incorrect medication doses that arise from poor EHR design.
The article offers several recommendations to the federal government for making the health IT systems safer for children, including new requirements for vendors.
A provision in the 21st Century Cures Act, passed by Congress in 2016, directs the Office of the National Coordinator for Health Information Technology (ONC) in HHS to develop a voluntary program to certify EHRs in a way that accounts for unique issues in pediatric care.
Progress has been slow on the development of regulations around key EHR challenges including interoperability and security. Facing mounting political pressure in Congress to ensure the intent of the Cures Act is followed, ONC in late August issued a request for information to the health IT industry for input on issues such as product integration as a path toward interoperability.
EHRs are now used nearly universally by clinicians across the United States to prescribe medication, gain clinical decision support, view health histories and complete numerous other tasks essential to safe, high-quality care. Yet, according to the viewpoint authors, differences in care for pediatric patients and adults have not been recognized.
The problem can lead to harm when, for example, medication dosages for children are based on weight. Confusing EHR displays have resulted in medication overdoses being given to children because of difficulty in entering a child’s correct weight, the authors said.
Another big issue: Age-appropriate vaccinations can be overlooked because an EHR failed to notify the clinician of a needed vaccine, or the wrong vaccination may be given when the EHR recommends a vaccine that is inappropriate for the child’s age.
The authors make five recommendations for a certification program:
- Require EHR vendors to provide evidence that they are employing a user-centered design process.
- Require that usability test participants represent the clinical end users.
- Define and require the use of rigorous test cases to assess usability and safety.
- Recognize that EHR implementation is crucial to safety, and consider the entire EHR lifecycle, not just the development phase, when granting certification.
- Encourage transparency in sharing usability and safety challenges to improve safety and EHR product.