Safety-enhanced design (MU3))

Overview

Working with Columbia HIT.

UCD Process

NIST 7741

Criteria that are testing

• a1: Computerized provider order entry (CPOE) – medications (task 2)
• a2: CPOE – laboratory (task 4)
• a5: Demographics (task 1)
• a9: Clinical decision support (task 1)
• a14: Implantable device list (task 3)

Research

Actual rule:

• https://www.healthit.gov/test-method/safety-enhanced-design

Example reports:

• https://content-main.ul.com/sites/g/files/qbfpbp306/files/2020-08/BlueEHR-2.0-SED-Report.pdf
• https://slicompliance.com/wp-content/uploads/2022/01/Prime-Clinical-EHR-Usability-Test-Report.pdf
• https://slicompliance.com/wp-content/uploads/2022/01/FreeChiro_18_SED_Report.pdf
• https://slicompliance.com/wp-content/uploads/2021/12/Strateq_EHR_UsabilityReport_08Dec2021.pdf

Usability official testing demos

• These are duplicate official testing demos that contain 1 patient (Ed Smith with one encounter) with one lab option (PSA) and with ICD10 code set installed and one provider (the admin user with name of Frank Johnson). Official testing demos completely reset daily at around 1:00 am pacific time; when official testing demos completely reset, they are rebuilt on top of most recent codebase. Official testing demos use private credentials (ie. public will not be able to access them) that are only known to the official testers.

• Usability Official Testing Demo D4
• Usability Official Testing Demo E5
• Usability Official Testing Demo F6

• Steps to manually reset the official testing demo so can retest would require the following changes to patient Ed Smith:

• Revert demographic changes (change Gender Identity and Sexual Orientation to Unassigned; change DOB to 1999-12-30).
• Delete the prescription, implantable device and lab order.

Usability training demos

• The point of these training demos is to allow training by multiple users, which pick a Ed* Smith* patient to run through the below training guides on.
• These are duplicate training demos that contain 9 patients (named Ed1 Smith1...Ed9 Smith9 each with one encounter) with one lab option (PSA) and with ICD10 code set installed and one provider (the admin user with name of Frank Johnson). Training demos completely reset daily at around 1:00 am pacific time; when training demos completely reset, they are rebuilt on top of most recent codebase.
• Training demos use public credentials, which are username:admin password:Administrator1!

• Usability Training Demo 1
• Usability Training Demo 2
• Usability Training Demo 3
• Usability Training Demo 4

Usability testing scenario

• Ed Smith is a patient in the user's clinic. In this scenario, the user will modify this patient's demographics, enter in a medication order for this patient, add a implantable device for this patient, and order a lab for this patient.

• The following is the testing guide that will be used during testing by the users: Usability Testing Guide

• The task material below is for user training.

Task 1: Enter and modify demographics.

• Test:

• Edit demographics for 'Ed Smith'

• Gender Identity choose 'Identifies as Male'
• Sexual Orientation choose 'Straight or Heterosexual'
• DOB change to '1968-12-30'

• After saving above demographic changes, clinical decision support will display window with new due reminders based off age (including Colon Cancer Screening).

• Specific testing steps:

Enter 'Smith' in patient selector at top right and then click the search icon/button.

Click the 'Smith, Ed' patient.

Click the edit icon/button for Demographics.

Gender Identity set 'Identifies as Male'. Sexual Orientation set 'Straight or Heterosexual'. DOB change to '1968-12-30'. Then click 'Save'.

Click 'OK'.

Task 2: Enter in medication order.

• Test:

• Add prescription for 'Ed Smith'

• Lipitor 20mg tabs Per Oris q.d. with quantity of 30

• Specific testing steps:

Scroll to bottom of patient summary screen and click the edit icon/button for Prescriptions.

Click 'Add'

Enter 'Lipitor' in the textbox and then select the Lipitor entry.

Enter Quantity 30. Enter Medicine Units 20 mg. Enter Directions 1 in tablet Per Oris q.d. Then click 'Save'.

Click 'Quit'.

Task 3: Add a implantable device.

• Test:

• Add Implantable Device for 'Ed Smith'

• UDI is (01)00889095205923(11)141231(17)150707(10)A213B1(21)1234

• Specific testing steps:

Click 'Issues' at top of patient summary screen.

Click 'Add' at Medical Devices.

Paste following into UDI textbox: (01)00889095205923(11)141231(17)150707(10)A213B1(21)1234
Then click 'Process UDI'.

This is what screen looks like after clicking 'Process UDI'.

Then scroll down and click 'Save'.

Task 4: Order a lab.

• Test:

• Order lab for 'Ed Smith'

• PSA

• Specific testing steps:

Click 'Visit Past Encounters' at top of screen.

Click '2022-01-18 Office Visit' from dropdown.

In encounter menu, click 'Administrative', then click 'Procedure Order'.

Click Procedure Test textbox.

Enter 'PSA' and click 'Search'.

Click 'psa_level_order'.

Click 'Save'.