- A new report from AMA, Pew Charitable Trusts, and MedStar Health outlines recommendations on how stakeholders can improve EHR usability and safety throughout the entire EHR life cycle, as well as criteria for rigorous safety tests.
The 57-page report also includes sample test case scenarios based on reported EHR safety challenges to help promote improvements in EHR usability and safety during implementation and customization.
The organizations collaborated to develop the report in response to persistent safety hazards and challenges associated with EHR usability.
“These challenges can stem not only from the layout of EHRs, but also from how the technology is implemented and operated in health care facilities; how clinicians are trained to use it; and how the EHR is maintained, updated, and customized,” explained authors in the report.
“Each stage of EHR development and use — the software life cycle from development through implementation and use in a health care environment — can affect the usability and safety of the technology,” they concluded.
In addition to contributing to patient safety threats, problems with EHR usability can also negatively affect clinical efficiency.
While the ONC Health IT Certification Program includes some usability testing, the program’s requirements do not adequately assess whether a health IT product poses a threat to patient safety.
The certification program largely fails to assess a product’s effect on patient safety because it does not account for system customizations made during the EHR implementation process.
“Instead, current rules focus only on the design and development stage of the EHR,” wrote report authors. “While federal regulations mandate the testing of certain safety-related features — such as medication-allergy checks — the requirements do not focus on whether those functions operate in a safe way.”
The Health IT Certification Program also lacks requirements and guidance for testing clinicians on how they interact with EHR technology.
Through literature review and expert panel discussions about existing best practices, criteria, and factors that affect EHR usability and safety, the organizations identified several usability and safety optimization opportunities for each stage of the EHR life cycle.
Specifically, criteria focused on optimizing a culture of safety, EHR product design and development, acquisition, customization and configuration, implementation and system upgrades, and EHR use training.
The organizations provided separate recommendations for EHR developers and healthcare organizations.
“By focusing on the entire EHR life cycle and having specific criteria in place to improve usability and safety, the voluntary certification framework can augment the current certification process,” wrote report authors. “Adherence to these recommendations by EHR developers and health care providers can reduce the likelihood of unintended patient harm from clinician use of this technology.”
The organizations also offered test case scenarios demonstrating how clinicians can best interact with EHR systems to overcome usability and safety challenges.
Usability scenarios currently part of the certification program may lack rigor, authors suggested.
“They were simple, did not reflect realistic clinical conditions, or included prescriptive instructions that may not be present in a clinical setting — making it more difficult to identify challenges that may arise when using the technology for actual care,” stated report authors.
To improve the rigor of test case scenarios moving forward, EHR developers, clinicians, researchers, and other stakeholders part of the expert panel recommended scenarios be representative, contain concrete goals and measures, test areas of risk or inefficiency, and define the audience the test case is for.
Overall, the suggested comprehensive certification framework focused on the entire EHR life cycle presented by the organizations is intended to engage both EHR developers and providers in ensuring the safety and usability of health IT.
“Once adopted, the test cases should be evaluated for their ability to detect safety events, assessed for challenges that arise in their use, and adjusted accordingly,” authors wrote.
The organizations offered four potential avenues EHR developers and providers could take to adopt the voluntary criteria:
First, the organizations suggested ONC could recognize elements of this certification as an alternative to its current requirements.
The organizations also recommended EHR developers and healthcare organizations could voluntarily adopt criteria as an indication that they prioritize safety.
Third, the organizations advised that providers that already prioritize health IT safety could integrate the comprehensive framework into their existing programs.
Finally, the organizations suggested healthcare organizations that have a role in overseeing healthcare facilities — including the Joint Commission — may be able to motivate healthcare providers to incorporate the recommendations and pressure health IT companies into also utilizing best practices.