What is Safety Enhanced Design?

Safety in healthcare is a hot-button topic today, and with good reason. One of the major advantages of electronic health records is their potential to increase patient safety by preventing, detecting and aiding in the recovery from human errors. In order to turn that potential into reality, the ONC has set certification standards for safety-enhanced design (SED), making patient safety a primary focus in the design of an EHR.

Certification requires that designers follow two major steps:

  1. Use a formal User Centered Design (UCD) process during development
  2. Perform Summative Usability Testing on specific areas of the product.

UCD procedures have been specified in detail in several ISO standards, listed below. These are not the only acceptable standards, but the point is that a formal UCD procedure must be followed during design and development, and the procedure must be identified or described as part of the certification process.

The essential document to read and follow is NISTIR 7742 Customized Common Industry Format Template for EHR Usability Testing. It outlines how the ONC requires documentation of the results of summative usability testing.

The Central Requirement: Summative Testing

The second step, summative usability testing, is described in detail in “Test Procedure for §170.314(g)(3) Safety-enhanced design” . In addition, ONC provides a handy, elaborate template, NISTIR 7742 Customized Common Industry Format Template for EHR Usability Testing for summative testing. We consider NISTIR-7742 extremely useful, if not essential, in seeking certification.

In the test procedure, real users run the EHR with a series of fundamental tasks. The goal is to measure the usability and safety of the EHR by documenting (1) its effectiveness in performing each task (2) its efficiency in performing that task, and (3) the user’s satisfaction from performing the task.

Each task is a fundamental EHR capability, and each must be tested and reported separately. The tasks cover these capabilities (areas of focus):

  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)).

Other Requirements/Tips for Success:

Developers should familiarize themselves with required government standards related to SED (listed below). Reading these standards, as you probably know, will require some time and concentration, but understanding them is necessary for preparing your report. For one thing, you will be expected to specify the standards used in the design process of your EHR system.

  • ISO 9241-11
  • ISO 9241-210
  • ISO/TR 16982
  • IEC/ISO 62366
  • ISO/IEC 25062
  • NISTIR 7741 & 7742 (described previously)
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