The Office of the National Coordinator for Health Information Technology (ONC)

released a set of certification and requirements for electronic health records (EHRs). 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 2014 or 2015 edition ONC certification, EHR vendors must follow a formal User Centered Design (UCD) process and perform summative usability testing on specific areas of the product.

We conduct and report summative usability evaluations suitable for ONC certification.

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

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) and examine the NISTIR 7741 Guidelines.

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 formal usability testing begins. 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 public ONC submission. The submission that is ultimately provided for testing and certification would 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
.

For the 2015 Edition certification, the following are required for 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 as follows:
  • Sex
  • Age
  • Education
  • Occupation/role
  • Professional experience
  • Computer experience
  • Product experience
• Description of the user tasks that were tested and association of each task to corresponding certification criteria
• List of the specific metrics captured during the testing
  • Task Success (%)
  • Task Failures (%)
  • Task Standard Deviations (%)
  • Task Performance Time
  • User Satisfaction Rating (Scale with 1 as very difficult and 5 as very easy)
• Test results for each task using metrics listed above
• Results and data analysis narrative:
  • Major test finding
  • Effectiveness
  • Efficiency
  • Satisfaction
  • Areas for improvement

Usability Starts with "U"

Click here to sign up for Summative Safety-enhanced Design testing for your EHR:

The Usability People create and report summative usability evaluations using the NISTIR 7742 Customized Common Industry Format Template for EHR Usability Testing. We help EHR vendors receive their ONC 2014 or 2015 Edition certification by providing testing and reporting on the Safety-enhanced Design criteria to your ONC-ATCB (such as Drummond, Infogard, etc.)