Safety Enhanced Design Important Part Of MU Stage 2 Certification

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A major advantage of a great EHR is it’s potential to increase client safety through preventing and detecting human errors. In Meaningful Use Stage 2 (the ONC 2014 Certified Solution) there is a requirement for Safety Enhanced Design (170.314(g)(3). This requirement focuses on user-centered design processes for eight different areas (listed below). The report is mandatory for a complete EHR certification and is published on the ONC’s website.

Safety enhanced design uses a multi-disciplinary process. End-user feedback is taken at each stage of the product design and development process. It’s based upon a set of user-focused tasks (for example prescribe Abilify for client X) and integrates those changes back into the solution. However, it starts before the product design and development processes begin with a solid foundation and understanding of human factors. As part of our dedication to our clients and their clients, we have a user-experience (UX) team that includes members with a Master’s Degree in HCI, Human Factors and Psychology. The UX team works with our clients, product management, engineering and consulting as part of the multi-disciplinary team.

Instead of calling it a usability study, ONC put safety first…thus the name of the requirement: Safety Enhanced Design. Usability is looked at from three perspectives:

  1. Effectiveness. The accuracy and the completeness by which users achieve specified goals.
  2. This pulls together a look at the resources utilized in relation to the accuracy and completeness of the goals outlined under effectiveness.
  3. The comfort and acceptability of users utilizing the system.

Safety enhanced design for Meaningful Use Stage 2 testing is pass/fail. To pass, you need to produce a report in the correct format. The bar was set very low on this critical test. However, the information available to you as a result of this requirement is huge. You can easily tell who takes this seriously. We do. Our Clients do.  

The 8 areas for testing:

1. Computerized Provider Order Entry System (CPOE) (§ 170.314(a)(1));
2. Drug- drug, drug-allergy interaction checks (§ 170.314(a)(2));
3. Medication list (§ 170.314(a)(6));
4. Medication allergy list (§ 170.314(a)(7));
5. Clinical decision support (§ 170.314(a)(8));
6. Electronic medication administration record (§ 170.314(a)(16));
7. Electronic prescribing (§ 170.314(b)(3));
8. Clinical information reconciliation (§ 170.314(b)(4)).

The format of the report is designed around the NISTIR (National Institute of Standards and Technology Interagency/Internal Report) 7742 form and includes 12 sections.

  • 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)”

To find the report, search for a specific solution on the ONC website. Once you’ve found the solution in the Product Column, click on the product name. Your last click is where it says “Click Here for test summary result”. This opens a pdf that includes a number of interesting documents, including one on safety-enhanced design.

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