ONC Meaningful Use and Usability Testing

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User-Centered Design: Helping users become Effective, Efficient, and Satisfied

For Stage 2 of meaningful use, The Office of the National Coordinator for Health Information Technology (ONC) released a set of certification and meaningful use requirements for electronic health records (EHRs). These requirements have been expanded for the ONC 2015 Edition certification (MACRA,MIPS). These require that EHR vendors include evidence of user-centered design and user test results in their certification submission. To be able to obtain the ONC 2014 or 2015 Edition certification, EHR vendors must follow a formal User Centered Design (UCD) process and perform summative usability testing on specific areas of the product.

In a public comment on the certification process, Drummond (one of the ONC ATCB's) stated that

"...the usability test effort is not a small undertaking for EHR vendors. In fact, it {is} essentially one of the most difficult criteria to complete."

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).

Summative testing

Summative usability testing is an industry standard usability methodology (see http://bit.ly/13WYqTU ) 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.

EHR developers can and should perform many iterations of user testing. These early iterations are often called Formative testing. We also recommend that an Expert (Heuristic) review be performed before any of the more formal usability testing. ( see also: Please don’t air our dirty laundry! ) 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 submission that is ultimately provided for testing and certification should be the expression of a final iteration in which few areas for improvement would be identified.

How should the Results Presented?

Results from the summative study should be created and presented to the ONC using the Customized Common Industry Format (CCIF) Template for EHR Usability Testing (NISTIR 7742 see http://1.usa.gov/gAZFDt )These reports typically include an Executive Summary, an introduction, a method section, discussion of the results and any appendices

The following are required for the 2014 Edition submission to ONC:
• Name and version of the product
• Date and location of the test
• Test environment
• Description of the intended users
• Total number of participants
• Description of participants: their experience and demographic characteristics
• Description of the user tasks that were tested
• List of the specific metrics captured during the testing for effectiveness, efficiency and satisfaction
• Data scoring
• Results of the test and data analysis
• Major test findings
• Identified area(s) of improvement(s)

For more information on the ONC Test Procedure for §170.314(g)(3) Safety-enhanced design see http://bit.ly/YLwrPO

For expert Usability evaluations of your companies EHR: Contact The Usability People

Usability reports produced by The Usability People adhere to the NISTIR 7742 CCIF format suitable for submission to an ONC-ACB. We can also provide a set of prioritized, detailed, and actionable feedback that you can take directly to your design and development teams for implementation.