Safety Enhanced Design (SED)
SED Summary
- FULL USABILITY REPORT:
- https://www.drummondgroup.com/pdfs/CloudCraft-NISTIR7742Final_01.28.2020.pdf
- DESCRIPTION OF INTENDED USERS:
- Users at a healthcare office or facility.
- DATE SED TESTING WAS COMPLETED:
- Dec 17, 2019
SED Tested Certification Criteria & Associated UCD Processes
| Certification Criteria | UCD Process | UCD Process Details |
|---|---|---|
| 170.315 (a)(1) | ||
| 170.315 (a)(2) | ||
| 170.315 (a)(3) | ||
| 170.315 (a)(4) | NISTIR 7741 | NISTIR 7741 was used. |
| 170.315 (a)(5) | ||
| 170.315 (a)(9) | ||
| 170.315 (a)(14) | ||
| 170.315 (b)(2) |
SED Testing Tasks
- Access CPOE Medication Order
- Access UDI, Device Description, Identifiers and Attributes
- Access the following attributes for one of the triggered CDS interventions/resources: bibliographic citation, developer, funding source, release/revision date
- Add a CDS intervention and/or reference resource for each of the required elements: Problem List, Medication List, Medication Allergy List, at least one Demographic, Laboratory Test, Vital Signs, and a Combination of at least 2 of the elements above
- Adjust the severity level of a displayed drug-drug interaction
- Change CPOE Medication Order
- Change Imaging order via CPOE
- Change Lab order via CPOE
- Change UDI Status
- Change a patient’s demographics
- Display a patient’s demographics
- Display changed CPOE Imaging order
- Display changed CPOE Lab order
- Generate a new CCDA with reconciled data
- Incorporate a CCDA and conduct reconciliation of the medications, medication allergies, and problems in the CCDA with the information currently in the patient's record
- Record CPOE Medication Order
- Record Imaging order via CPOE
- Record Lab order via CPOE
- Record UDI
- Record a patient’s demographics
- Trigger the CDS interventions/resources added using the applicable data elements from each of the required elements
- Trigger the CDS interventions/resources based on data elements in the problem list, medication list, and medication allergy list by incorporating patient information from a transition of care/referral summary
- Using CPOE, trigger a drug-allergy interaction by entering a new medication order
- Using CPOE, trigger a drug-drug interaction by entering a new medication order
- View the intervention/resource information using the Infobutton standard for data elements in the problem list, medication list, and demographics