Safety-Enhanced Design: Summative Usability Evaluations

User-Centered Design Makes for Effective, Efficient, and Satisfied Users

EHR vendors seeking ONC Safety-Enhanced Design (170.315 G3) Certification (as required for MACRA, MIPS reimbursements) need to follow the requirements for Electronic Health Records (EHRs) issued by The Office of the National Coordinator for Health Information Technology (ONC). Every vendor must include proof of user-centered design and user testing results for the Medical IT user experience from their EHR computer interface in their certification submission. Vendors are also required to follow a formal User Centered Design (UCD) process and perform summative usability testing i.e., Safety-Enhanced Design, on specific product areas.

Your resource for expert usability evaluations of your companies EHR: The Usability People

We recommend that EHR vendors follow the ISO 9241-11 standard. ISO-9241 Part 11: (1998) pertains to the extent to which a product can be used by specified users to achieve specified goals with Effectiveness (Task completion by users), Efficiency (Task on time) and Satisfaction (responded by user in term of experience) in a specified context of use (users, tasks, equipment & environments). NIST 7741 provides a fantastic framework for implementing 9241-11.

Summative testing

Summative usability testing is an industry standard usability methodology (see ) During the testing a trained user experience professional works with the EHR vendor to create a series of representative tasks and then measures the amount of time it takes to complete the task (time on task), how many and what type of errors occur (error rates), and satisfaction with the task interaction (user satisfaction). The results — as measured by things like task times, assisted and un-assisted completion rates and standardized satisfaction scores — can be benchmarked against current industry standards.

In a public comment regarding the certification process, The Drummond Group (an ONC ATCB) stated that "from our experience .. the usability test effort is not a small undertaking for EHR vendors. In fact, it was essentially one of the most difficult criteria to complete.”

EHR developers can and should perform many iterations of user testing for the Medical IT user experience. These early iterations are often called Formative testing. We also recommend that an Expert (Heuristic) review be performed before any of the more formal EHR usability testing.

This is a cost-saving measure that can significantly reduce the number of iterations required and ultimately reduce the number of “items needed improvement” presented in the ONC submission. The Public submission that is ultimately provided for testing and certification may be the expression of a final iteration in which few areas for improvement would be identified. See Please don’t air our dirty laundry!

How should the Results Presented?

Results from the summative study should be created and presented using the Customized Common Industry Format (CCIF) Template for EHR Usability Testing (NISTIR 7742 see ) These reports typically include an Executive Summary, an introduction, a method section, discussion of the results and any appendices

For more information on the Safety-enhanced Design portion of the ONC HealthIT certification see provided by The Usability People