EHR Usability Test Report of My Vision Express, 2018 - UL.com

 
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EHR Usability Test Report of My Vision Express, 2018 - UL.com
EHR Usability Test Report of My Vision Express, 2018
Report based on NISTIR 7742 Customized Common Industry Format Template for
Electronic Health Record Usability Testing

My Vision Express, 2018

Date of Usability Test: 10/31/2017
Date of Report: 11/1/2017
Report Prepared By: Dr. Disha Biala & Dr. Jasmine Pattanayak

                                                                             1
TABLE OF CONTENTS

1. Executive Summary…………………………………………..3
2. Introduction…………………………………………….....…16
3. Method
       3.1Participants.................................................................16
       3.2 Study Design.............................................................17
       3.3 Tasks………………………………………………..18
       3.4 Procedure…………………………………………...19
       3.5 Test Location……………………….………...…….20
       3.6 Test Environment……………………….……….…20
       3.7 Test Forms and Tools…………….………..……….21
       3.8 Participant Instructions…………….……….………21
       3.9 Usability Metrics…………………………………....22
       3.10 Data Scoring……………………………………….23
4. Results
       4.1 Data Analysis………………………………………..24
       4.2 Discussion of the findings…………………………...25
       4.3 Major Findings………………………………………30
       4.4 Areas for Improvement........................................…...30
5. Appendices
       5.1 Appendix 1- Participant Demographics……………...31
       5.2 Appendix 2- Informed Consent Form………………..33
       5.3 Appendix 3- Non- Disclosure Agreement……………35
       5.3 Appendix 4- Usability Instructions…….……………..36
       5.4 Appendix 4- Safety Enhanced Design Test Scenarios...40
       5.5 Appendix 5- Post-Test Questionnaire………………….68

                                                                                            2
EXECUTIVE SUMMARY

A usability test of My Vision Express, 2018, an ambulatory electronic health record
software; was conducted from 10/25/2017 to 10/31/2017 from our office in India by
My Vision Express Software employees. The purpose of this test was to test and
validate the usability of the current user interface, and provide evidence of usability
in the My Vision Express Software. During the usability test, 10 healthcare
providers and/or other healthcare personnel matching the target demographic criteria
and representing a cross section of our typical user base, served as participants and
used the EHR under test (EHRUT) in simulated, but representative tasks.

This study collected performance data on a series of tasks related to safety-enhanced
design, typically conducted on an EHR. The tasks are correlated to the twelve
certification criteria in 45 CFR Part 170 Subpart C of the Health Information
Technology: 2015 Edition Health Information Technology (Health IT) Certification
Criteria, 2015 Edition Base Electronic Health Record (EHR) Definition, and ONC
Health IT Certification Program Modifications:

   •   §170.315(a)(1) Computerized Provider Order Entry – Medications
   •   §170.315(a)(2) Computerized Provider Order Entry – Laboratory
   •   §170.315(a)(3) Computerized Provider Order Entry – Diagnostic Imaging
   •   §170.315(a)(4) Drug-Drug, Drug-Allergy Interactions Checks
   •   §170.315(a)(5) Demographics
   •   §170.315(a)(6) Problem List
   •   §170.315(a)(7) Medication List
   •   §170.315(a)(8) Medication Allergy List
   •   §170.315(a)(9) Clinical Decision Support
   •   §170.315(a)(14) Implantable Device List
   •   §170.315(b)(2) Clinical Information Reconciliation and Incorporation

During the 60 minutes, one-on-one usability test, each participant was greeted by the
administrator and asked to review and sign an informed consent & Non- Disclosure
Agreement, shown in Appendix 2 & 3 respectively. The participants were instructed
that they could withdraw at any time. All participants were current users of My
Vision Express, so they had prior experience with some version of the EHR. The
administrator introduced the test, and instructed participants to complete a series of
tasks (given one at a time) using the EHRUT. During the testing, the administrator

                                                                                          3
timed the test and, along with the data logger recorded user performance data on
paper and electronically. The administrator did not give the participant assistance in
how to complete the task except in areas of elucidation or paraphrasing of
instructions when the directions seemed uncertain.

The following types of data were collected for each participant:
   • Number of tasks successfully completed within the allotted time without
       assistance
   • Time to complete the tasks
   • Number and types of errors
   • Path deviations
   • Participant’s satisfaction rating of the system

All participant data was de-identified – no correspondence could be made from the
identity of the participant to the data collected. Following the conclusion of the
testing, participants were asked to complete a post-test questionnaire. Various
recommended metrics, in accordance with the examples set forth in the NIST Guide
to the Processes Approach for Improving the Usability of Electronic Health Records,
were used to evaluate the usability of My Vision Express, 2018.

Following is a summary of the performance and rating data collected on
My Vision Express, 2018:
                                                                                                                                                                                         Standard Deviation for Task Time

                                                                                                                                                                                                                                                                                                                                                                                                    Task Rating Standard Deviation
                                                                             Task Success- Standard Deviation %

                                                                                                                                                                                                                                                                                                                  Task Errors-Standard Deviation %
                                                                                                                                                                                                                            Task Time Deviation-Mean Observed
                                                                                                                   Observed # of Steps-Mean
                                                   Task Success - Mean (%)

                                                                                                                                              Optimal number of steps

                                                                                                                                                                                                                                                                                         Task Errors - Mean (%)
                                                                                                                                                                                                                                                                Optimal Time for Tasks

                                                                                                                                                                                                                                                                                                                                                     Task Rating Scale Type

                                                                                                                                                                                                                                                                                                                                                                              Task Rating - Mean
                        Task Description

                                                                                                                                                                        Mean Task Time
Task Identifier

                                                                                                                                                                                                                                        Seconds
                                           N (#)

                  Record a CPOE
                    medication
                                                                                                                                                                                                                                                                                                                                                     Likert Scale

                    order- Tab
(a)(1).(1)

                  Tylenol 325mg
                                           10      100                          0                                 12.1                        12                        44                  7                                         8                         36                       0.8                      26                                                          4.7                  0.48
                  Once Daily for
                    One month
                  RxNorm code-
                     209387

                                                                                                                                                                                                                                                                                                                                                                                                                                     4
Standard Deviation for Task Time

                                                                                                                                                                                                                                                                                                                                                                                                    Task Rating Standard Deviation
                                                                              Task Success- Standard Deviation %

                                                                                                                                                                                                                                                                                                                  Task Errors-Standard Deviation %
                                                                                                                                                                                                                            Task Time Deviation-Mean Observed
                                                                                                                   Observed # of Steps-Mean
                                                    Task Success - Mean (%)

                                                                                                                                              Optimal number of steps

                                                                                                                                                                                                                                                                                         Task Errors - Mean (%)
                                                                                                                                                                                                                                                                Optimal Time for Tasks

                                                                                                                                                                                                                                                                                                                                                     Task Rating Scale Type

                                                                                                                                                                                                                                                                                                                                                                              Task Rating - Mean
                         Task Description

                                                                                                                                                                        Mean Task Time
Task Identifier

                                                                                                                                                                                                                                        Seconds
                  Change a CPOE             N (#)
                     medication

                                                                                                                                                                                                                                                                                                                                                     Likert Scale
(a)(1).(2)

                     order- Tab
                  Hydrochlorothiaz          10      100                          0                                   7                          7                       38                  3                                         7                         31                         0                         0                                                        4.5                  0.71
                   ide- 25mg OD
                    FOR 1month
                  RxNorm- 310798

                  Display changed
                       CPOE

                                                                                                                                                                                                                                                                                                                                                     Likert Scale
                     medication
(a)(1).(3)

                     order- Tab
                                            10      100                          0                                   1                          1                        3                  1                                         1                           2                        0                         0                                                        4.9                  0.32
                  Hydrochlorothiaz
                   ide- 25mg OD
                    FOR 1month
                  RxNorm- 310798

                  Record a CPOE

                                                                                                                                                                                                                                                                                                                                                     Likert Scale
                     lab order-
(a)(2).(1)

                  Creatinine 24H
                                            10      100                          0                                   7                          7                       27                  6                                   11                              16                         0                         0                                                        4.5                  0.97
                  renal clearance
                  panel, LOINC®
                   code: 34555-3

                                                                                                                                                                                                                                                                                                                                                     Likert Scale
                  Change a CPOE
(a)(2).(2)

                   lab order- Cell
                                            10      100                          0                                   3                          3                        9                  1                                         2                           7                        0                         0                                                        4.7                  0.48
                    count panel,
                  LOINC- 34556-1                                                                                                                                                                                                                                                                                                                     Likert Scale

                  Display changed
(a)(2).(3)

                  CPOE lab order-
                                            10      100                          0                                   1                          1                        3                  1                                         2                           1                        0                         0                                                        4.8                  0.63
                  Cell count panel,
                  LOINC- 34556-1
                                                                                                                                                                                                                                                                                                                                                     Likert Scale

                  Record a CPOE
(a)(3).(1)

                   image order-
                                            10      100                          0                                 7.1                          7                       23                  3                                         6                         17                       1.4                      44                                                          4.4                  0.97
                   Fundus Photo
                    CPT- 92250

                     Change the
                                                                                                                                                                                                                                                                                                                                                     Likert Scale
(a)(3).(2)

                    CPOE image
                   order- Corneal           10      100                          0                                   3                          3                       12                  2                                         4                           8                        0                         0                                                        4.7                  0.48
                    Topography
                    CPT- 92025

                                                                                                                                                                                                                                                                                                                                                                                                                                     5
Standard Deviation for Task Time

                                                                                                                                                                                                                                                                                                                                                                                                      Task Rating Standard Deviation
                                                                               Task Success- Standard Deviation %

                                                                                                                                                                                                                                                                                                                    Task Errors-Standard Deviation %
                                                                                                                                                                                                                              Task Time Deviation-Mean Observed
                                                                                                                     Observed # of Steps-Mean
                                                     Task Success - Mean (%)

                                                                                                                                                Optimal number of steps

                                                                                                                                                                                                                                                                                           Task Errors - Mean (%)
                                                                                                                                                                                                                                                                  Optimal Time for Tasks

                                                                                                                                                                                                                                                                                                                                                       Task Rating Scale Type

                                                                                                                                                                                                                                                                                                                                                                                Task Rating - Mean
                          Task Description

                                                                                                                                                                          Mean Task Time
Task Identifier

                                                                                                                                                                                                                                          Seconds
                  Display changed            N (#)

                                                                                                                                                                                                                                                                                                                                                       Likert Scale
(a)(3).(3)

                    CPOE image
                   order- Corneal            10      100                          0                                    1                          1                        2                  0                                         1                           1                        0                         0                                                        4.8                  0.63
                    Topography
                    CPT- 92025

                     Using CPOE,
                    trigger a drug-
                   drug interaction
                     by entering a

                                                                                                                                                                                                                                                                                                                                                       Likert Scale
(a)(4).(1)

                  new medication -
                  Amoxicillin 500            10      100                          0                                    5                          5                       44                  9                                         3                         41                         0                         0                                                        4.5                  0.53
                    MG; RxNorm
                    code: 262073,
                   Orally, Twice a
                  day for 30 days.
                     {2 capsules}
                    Using CPOE,
                   trigger a drug-
                       allergy
                   interaction by

                                                                                                                                                                                                                                                                                                                                                       Likert Scale
                   entering a new
(a)(4).(2)

                  medication order
                                             10      100                          0                                    4                          4                       30                  3                                   10                              20                         0                         0                                                        4.6                  0.52
                   - Glucosamine
                   {Glucosamine
                      Sulphate}
                  100MG Capsule,
                   Orally, Once a
                  day for 15 days.
                                                                                                                                                                                                                                                                                                                                                       Likert Scale

                      Adjust the
(a)(4).(3)

                   severity level of
                                             10      100                          0                                    2                          2                       15                  3                                         7                           8                        0                         0                                                        4.4                  1.26
                  a displayed drug-
                   drug interaction

                       Record
                    demographics
                  • Record Date of
                        Birth,
                                                                                                                                                                                                                                                                                                                                                       Likert Scale
(a)(5).(1)

                     06/02/1965
                    • Record Sex,            10      100                          0                                 16.2                        16                        66                  3                                         4                         62                       1.3                      41                                                            4                  1.15
                       Female
                   • Record Race,
                  American Indian
                  (OMB- 1002-5)

                                                                                                                                                                                                                                                                                                                                                                                                                                       6
Standard Deviation for Task Time

                                                                                                                                                                                                                                                                                                                                                                                                     Task Rating Standard Deviation
                                                                              Task Success- Standard Deviation %

                                                                                                                                                                                                                                                                                                                   Task Errors-Standard Deviation %
                                                                                                                                                                                                                             Task Time Deviation-Mean Observed
                                                                                                                    Observed # of Steps-Mean
                                                    Task Success - Mean (%)

                                                                                                                                               Optimal number of steps

                                                                                                                                                                                                                                                                                          Task Errors - Mean (%)
                                                                                                                                                                                                                                                                 Optimal Time for Tasks

                                                                                                                                                                                                                                                                                                                                                      Task Rating Scale Type

                                                                                                                                                                                                                                                                                                                                                                               Task Rating - Mean
                         Task Description

                                                                                                                                                                         Mean Task Time
Task Identifier

                                                                                                                                                                                                                                         Seconds
                        • Record            N (#)
                        Ethnicity,
                   Hispanic Latino
                   (OMB- 2135-2)
                        • Record
                        Preferred
                       Language,
                         English
                   • Record Sexual
                      Orientation,
                        Bisexual
                  • Record Gender
                    Identity, Male-
                       to-Female
                  (MTF)/Transgen
                           der
                         Change
                     demographics
                  • Change Date of
                          Birth,
                       06/02/1987
                     • Change Sex,
                          Male
                   • Change Race,
                     White (OMB-
                         2106-3)
                        • Change
                        Ethnicity,                                                                                                                                                                                                                                                                                                                    Likert Scale
(a)(5).(2)

                       Declined to
                                            10      100                          0                                 14.1                        14                        49                  5                                         9                         40                       0.7                      22                                                          4.4                  0.97
                         specify
                        • Change
                        Preferred
                       Language,
                         Spanish
                  • Change Sexual
                      Orientation,
                  Straight/Heterose
                           xual
                  • Change Gender
                        Identity,
                      Identifies as
                          Male

                                                                                                                                                                                                                                                                                                                                                                                                                                      7
Standard Deviation for Task Time

                                                                                                                                                                                                                                                                                                                                                                                                     Task Rating Standard Deviation
                                                                               Task Success- Standard Deviation %

                                                                                                                                                                                                                                                                                                                   Task Errors-Standard Deviation %
                                                                                                                                                                                                                             Task Time Deviation-Mean Observed
                                                                                                                    Observed # of Steps-Mean
                                                     Task Success - Mean (%)

                                                                                                                                               Optimal number of steps

                                                                                                                                                                                                                                                                                          Task Errors - Mean (%)
                                                                                                                                                                                                                                                                 Optimal Time for Tasks

                                                                                                                                                                                                                                                                                                                                                      Task Rating Scale Type

                                                                                                                                                                                                                                                                                                                                                                               Task Rating - Mean
                          Task Description

                                                                                                                                                                         Mean Task Time
Task Identifier

                                                                                                                                                                                                                                         Seconds
                      Display the            N (#)
                  patient’s changed
                        preferred

                                                                                                                                                                                                                                                                                                                                                      Likert Scale
(a)(5).(3)

                  language, date of
                   birth, birth sex,         10      100                          0                                   1                          1                        3                  0                                         1                           2                        0                         0                                                        4.9                  0.32
                   race, ethnicity,
                          sexual
                      orientation,
                   gender identity
                        Record a
                    problem to the
                     problem list-

                                                                                                                                                                                                                                                                                                                                                      Likert Scale
                  Non proliferative
(a)(6).(1)

                         diabetic
                                             10      100                          0                                   7                          7                       19                  1                                         4                         15                         0                         0                                                        3.8                  1.55
                      retinopathy
                       (disorder).
                  ICD10- E11.329
                      SNOMED-
                      390834004
                        Change a
                   problem on the

                                                                                                                                                                                                                                                                                                                                                      Likert Scale
                     problem list-
(a)(6).(2)

                   Resolve Internal
                                             10      100                          0                                   3                          3                        4                  1                                         2                           2                        0                         0                                                        4.5                  0.97
                      hordeolum
                  ICD10- H00.021
                      SNOMED-
                      414521009
                      Display the
                   active problem
                            list
                                                                                                                                                                                                                                                                                                                                                      Likert Scale

                   a. (Active) Non
(a)(6).(3)

                     proliferative
                                             10      100                          0                                   1                          1                        3                  0                                         2                           1                        0                         0                                                        4.8                  0.42
                         diabetic
                     retinopathy.
                  ICD10- E11.329
                      SNOMED-
                      390834004
                      Display the
                        historical
                     problem list
                                                                                                                                                                                                                                                                                                                                                      Likert Scale

                   a. (Active) Non
(a)(6).(4)

                     proliferative
                                             10      100                          0                                   1                          1                        3                  1                                         2                           1                        0                         0                                                        4.5                  1.27
                         diabetic
                     retinopathy.
                  ICD10- E11.329
                      SNOMED-
                      390834004

                                                                                                                                                                                                                                                                                                                                                                                                                                      8
Standard Deviation for Task Time

                                                                                                                                                                                                                                                                                                                                                                                                      Task Rating Standard Deviation
                                                                               Task Success- Standard Deviation %

                                                                                                                                                                                                                                                                                                                    Task Errors-Standard Deviation %
                                                                                                                                                                                                                              Task Time Deviation-Mean Observed
                                                                                                                     Observed # of Steps-Mean
                                                     Task Success - Mean (%)

                                                                                                                                                Optimal number of steps

                                                                                                                                                                                                                                                                                           Task Errors - Mean (%)
                                                                                                                                                                                                                                                                  Optimal Time for Tasks

                                                                                                                                                                                                                                                                                                                                                       Task Rating Scale Type

                                                                                                                                                                                                                                                                                                                                                                                Task Rating - Mean
                          Task Description

                                                                                                                                                                          Mean Task Time
Task Identifier

                                                                                                                                                                                                                                          Seconds
                     b. (Resolved)           N (#)
                         Internal
                       hordeolum
                  ICD10- H00.029
                      SNOMED-
                      414521009
                        Record a
                  medication to the

                                                                                                                                                                                                                                                                                                                                                       Likert Scale
                    medication list-
(a)(7).(1)

                    Keflex 750 mg,
                                             10      100                          0                                 11.1                        11                        51                  5                                         6                         45                       0.9                      28                                                          4.8                  0.42
                  Oral, twice daily
                      for 15 days.
                    RxNorm Code-
                         637175
                        Change a
                     medication on

                                                                                                                                                                                                                                                                                                                                                       Likert Scale
(a)(7).(2)

                    the medication
                   list- Discontinue         10      100                          0                                    6                          6                       24                  3                                         4                         20                         0                         0                                                        4.6                  0.70
                   Diamox Sequels
                  500 mg Rx Norm
                     code- 876439
                      Display the
                  active medication
                           list-

                                                                                                                                                                                                                                                                                                                                                       Likert Scale
(a)(7).(3)

                       a. (Active)
                    Keflex 750 mg,           10      100                          0                                    1                          1                        3                  1                                         2                           1                        0                         0                                                        4.8                  0.42
                  Oral, twice daily
                      for 15 days.
                    RxNorm Code-
                         637175
                      Display the
                        historical
                    medication list
                       a. (Active)
                    Keflex 750 mg,
                                                                                                                                                                                                                                                                                                                                                       Likert Scale

                  Oral, twice daily
(a)(7).(4)

                      for 15 days.
                    RxNorm Code-             10      100                          0                                    1                          1                        3                  1                                         2                           1                        0                         0                                                        4.9                  0.32
                         637175

                  b. (Discontinued)
                  Diamox Sequels
                  500 mg Rx Norm
                    code- 876439

                                                                                                                                                                                                                                                                                                                                                                                                                                       9
Standard Deviation for Task Time

                                                                                                                                                                                                                                                                                                                                                                                                     Task Rating Standard Deviation
                                                                               Task Success- Standard Deviation %

                                                                                                                                                                                                                                                                                                                   Task Errors-Standard Deviation %
                                                                                                                                                                                                                             Task Time Deviation-Mean Observed
                                                                                                                    Observed # of Steps-Mean
                                                     Task Success - Mean (%)

                                                                                                                                               Optimal number of steps

                                                                                                                                                                                                                                                                                          Task Errors - Mean (%)
                                                                                                                                                                                                                                                                 Optimal Time for Tasks

                                                                                                                                                                                                                                                                                                                                                      Task Rating Scale Type

                                                                                                                                                                                                                                                                                                                                                                               Task Rating - Mean
                          Task Description

                                                                                                                                                                         Mean Task Time
Task Identifier

                                                                                                                                                                                                                                         Seconds
                       Record a              N (#)
                      medication

                                                                                                                                                                                                                                                                                                                                                      Likert Scale
                      allergy- Rx
(a)(8).(1)

                     Norm Code-
                                             10      100                          0                                 11                         11                        30                  4                                         7                         23                         0                         0                                                        4.4                  0.53
                  202589 Cytoxan,
                       Reaction-
                       diarrhea,
                   Severity- Severe
                       Change a
                      medication
                   allergy- Inactive

                                                                                                                                                                                                                                                                                                                                                      Likert Scale
(a)(8).(2)

                       Codeine;
                    RxNorm code:             10      100                          0                                   4                          4                        7                  2                                         3                           4                        0                         0                                                        4.6                  0.52
                   2670; Reaction:
                     Diarrhea and
                  Abdominal Pain,
                   Severity- Severe
                      Display the
                  active medication
                      allergy list

                                                                                                                                                                                                                                                                                                                                                      Likert Scale
(a)(8).(3)

                   a. (Active) Rx
                    Norm Code-               10      100                          0                                   1                          1                        2                  1                                         1                           1                        0                         0                                                        4.9                  0.32
                  202589 Cytoxan,
                      Reaction-
                      diarrhea,
                  Severity- Severe
                     Display the
                      historical
                     medication
                     allergy list
                   a. (Active) Rx
                    Norm Code-
                  202589 Cytoxan,
                                                                                                                                                                                                                                                                                                                                                      Likert Scale
(a)(8).(4)

                      Reaction-
                      diarrhea,              10      100                          0                                   1                          1                        2                  0                                         0                           2                        0                         0                                                        4.9                  0.32
                  Severity- Severe
                    b. (Inactive)
                   RxNorm code:
                   2670 Codeine;
                     Reaction:
                    diarrhea and
                  Abdominal Pain,
                  Severity- Severe

                                                                                                                                                                                                                                                                                                                                                                                                                                      10
Standard Deviation for Task Time

                                                                                                                                                                                                                                                                                                                                                                                                      Task Rating Standard Deviation
                                                                               Task Success- Standard Deviation %

                                                                                                                                                                                                                                                                                                                    Task Errors-Standard Deviation %
                                                                                                                                                                                                                              Task Time Deviation-Mean Observed
                                                                                                                     Observed # of Steps-Mean
                                                     Task Success - Mean (%)

                                                                                                                                                Optimal number of steps

                                                                                                                                                                                                                                                                                           Task Errors - Mean (%)
                                                                                                                                                                                                                                                                  Optimal Time for Tasks

                                                                                                                                                                                                                                                                                                                                                       Task Rating Scale Type

                                                                                                                                                                                                                                                                                                                                                                                Task Rating - Mean
                          Task Description

                                                                                                                                                                          Mean Task Time
Task Identifier

                                                                                                                                                                                                                                          Seconds
                     Add a CDS               N (#)
                     intervention
                   and/or reference
                  resource for each
                    of the required
                      elements,-
                   a. Problem List-
                  Non proliferative
                        diabetic
                      retinopathy.
                  ICD10- E11.329
                      SNOMED-
                      390834004

                                                                                                                                                                                                                                                                                                                                                       Likert Scale
(a)(9).(1)

                    b. Medication
                  Allergy List (Rx                                                                                                                                                                                                                                19
                                             10      100                          0                                 65.2                        65                        242              23                                     43                                                       0.3                         9                                                        3.5                  1.58
                     Norm Code-                                                                                                                                                                                                                                   9
                  202589 Cytoxan)
                  c. Medication list
                  (RxNorm Code-
                    637175 Keflex
                        750 mg)
                           d.
                   Demographics-
                       (Ethnicity-
                      Hispanic or
                         Latino)
                  e. Combination-
                    Age>50 and
                  Vitals- BMI- >25
                  Trigger the CDS
                  interventions/res
                    ources added
                       using the
                   applicable data
                   elements from
                                                                                                                                                                                                                                                                                                                                                       Likert Scale

                      each of the
(a)(9).(2)

                        required                                                                                                                                                                                                                                  10
                                             10      100                          0                                 37.1                        37                        113                 7                                   13                                                       0.3                         9                                                        4.4                  0.70
                       elements-                                                                                                                                                                                                                                  0
                    Problem List-
                  Non proliferative
                        diabetic
                     retinopathy.
                  ICD10- E11.329
                     SNOMED-
                     390834004

                                                                                                                                                                                                                                                                                                                                                                                                                                       11
Standard Deviation for Task Time

                                                                                                                                                                                                                                                                                                                                                                                                     Task Rating Standard Deviation
                                                                               Task Success- Standard Deviation %

                                                                                                                                                                                                                                                                                                                   Task Errors-Standard Deviation %
                                                                                                                                                                                                                             Task Time Deviation-Mean Observed
                                                                                                                    Observed # of Steps-Mean
                                                     Task Success - Mean (%)

                                                                                                                                               Optimal number of steps

                                                                                                                                                                                                                                                                                          Task Errors - Mean (%)
                                                                                                                                                                                                                                                                 Optimal Time for Tasks

                                                                                                                                                                                                                                                                                                                                                      Task Rating Scale Type

                                                                                                                                                                                                                                                                                                                                                                               Task Rating - Mean
                          Task Description

                                                                                                                                                                         Mean Task Time
Task Identifier

                                                                                                                                                                                                                                         Seconds
                      Medication             N (#)
                   Allergy List (Rx
                      Norm Code-
                  202589 Cytoxan)
                    Medication list
                   (RxNorm Code-
                    637175 Keflex
                         750 mg)
                    Demographics-
                       (Ethnicity-
                      Hispanic or
                         Latino)
                     Combination-
                      Age>50 and
                  Vitals- BMI- >25
                        View the
                  intervention/reso
                  urce information
                        using the

                                                                                                                                                                                                                                                                                                                                                      Likert Scale
(a)(9).(3)

                       Infobutton
                  standard for data          10      100                          0                                   3                          3                       10                  1                                         2                           8                        0                         0                                                        4.9                  0.32
                    elements in the
                      problem list,
                    medication list,
                            and
                     demographics
                  Trigger the CDS
                  interventions/res
                   ources based on
                   data elements in
                   the problem list,
                                                                                                                                                                                                                                                                                                                                                      Likert Scale

                    medication list,
(a)(9).(4)

                    and medication
                                             10      100                          0                                 10                         10                        76                  5                                         6                         70                         0                         0                                                        4.9                  0.32
                     allergy list by
                     incorporating
                          patient
                  information from
                     a transition of
                      care/referral
                        summary.
                       Access the
                        following
                   attributes for the
                                                                                                                                                                                                                                                                                                                                                      Likert Scale
(a)(9).(5)

                      Problem list
                    triggered CDS            10      100                          0                                   1                          1                        2                  0                                         0                           2                        0                         0                                                          5                  0.00
                  interventions/res
                  ources: developer
                      and funding
                          source.

                                                                                                                                                                                                                                                                                                                                                                                                                                      12
(b)(2).(2)              (b)(2).(1)      (a)(14).(3)     (a)(14).(2)           (a)(14).(1)              Task Identifier

                                                                                                            Task Description

                                                                   (UDI)

                                                device

                             conduct
                                               attributes

                           medication
                           CCDA and
                                             description,

                           information

        CCDA with
                                             Access UDI,
                                                                                    Record UDI-

                          Incorporate a

                          allergies, and
                                                               of the Unique

                                            identifiers and

      reconciled data
                         currently in the

      Generate a new
                         problems in the
                        CCDA with the
                                                                                   213B1(21)1234

                        patient’s record.
                        the medications,
                        reconciliation of
                                                                                  (01)1088452106

                                                                                  17)150707(10)A

                                                              Device Identifier
                                                                                  2856(11)141231(

                                                              Change the status

           10
                                 10
                                                  10
                                                                    10
                                                                                        10
                                                                                                                   N (#)

                                                                                                        Task Success - Mean (%)

           100
                                 100
                                                  100
                                                                    100
                                                                                        100

           0
                                 0
                                                  0
                                                                    0
                                                                                        0

                                                                                                    Task Success- Standard Deviation %

           4
                                                  1
                                                                    5
                                                                                        6

                                 11
                                                                                                       Observed # of Steps-Mean

           4
                                                  1
                                                                    5
                                                                                        6

                                 11
                                                                                                        Optimal number of steps

                                                  2
                                                                    8

                                 82

           18
                                                                                        84

                                                                                                            Mean Task Time

                                 5

           4
                                                  1
                                                                    0
                                                                                        12

                                                                                                    Standard Deviation for Task Time

                                                                                                      Task Time Deviation-Mean Observed

                                 9

          9
                                                  1
                                                                    2
                                                                                        30

                                                                                                                  Seconds

           9
                                                  1
                                                                    6

                                 73
                                                                                        54

                                                                                                        Optimal Time for Tasks

                                 0

           0
                                                  0
                                                                    0
                                                                                        0

                                                                                                        Task Errors - Mean (%)
                                 0

           0
                                                  0
                                                                    0
                                                                                        0

                                                                                                     Task Errors-Standard Deviation %

     Likert Scale            Likert Scale    Likert Scale     Likert Scale         Likert Scale         Task Rating Scale Type
                                                  5

                                                                                                          Task Rating - Mean

           4.7
                                 4.7
                                                                    4.6
                                                                                        3.5

                                                                                                    Task Rating Standard Deviation
           0.67
                                 0.48
                                                  0.00
                                                                    0.97
                                                                                        1.27

13
Overall Ease of Use and Satisfaction of Tasks Performed During the
Study

Ease of Use
   • Overall the subjective ease of use mean was 3.47 out of 5.
   • Overall the percentage of ease of use was 69.4%

Satisfaction
    • Overall the subjective satisfaction mean was 4.5 out of 5.
    • Overall the percentage satisfaction of use was 90%

Major Findings

During the testing process, it was observed that the participants performed the
majority of tasks within expected number of steps. However, it was revealed that
some of the participants exceeded the optimal range of steps and time while
performing certain tasks under CPOE Medication order, Image order, CDS,
Implantable device list and Demographics.
Participants found that adding a new CDS intervention was slightly difficult as they
struggled while saving the CDS interventions. Recording and changing the
demographics details were perceived to be slightly troublesome by the participants.
With no search option and a cumbersome selection process, participants struggled to
select the correct ethnicity and race fields.

The implantable device list interface proved to be the higher risk area, since the
implantable device list is a newly added module to the EHR. The participants were
not familiar with its functionality. The attributes pertaining to the UDI can be
accessed only after making a precise entry, as the information is dependent on a
third party. Also, manual entry of the UDI, makes it a tedious task for the
participants.

Overall, the testing process evidenced that the participants were exceeding the
optimal time and the presence of path deviations. However, the participants were
able to perform all the tasks without any error. The performance of the participants
during the testing process, depicts zero error; which describes the usability of the
software.

                                                                                       14
Areas for Improvement

The first area of improvement belongs to CDS, since most of the participants faced
difficulty while configuring the interventions. There was also some confusion as to
where the alert would be shown while interacting with the product. Therefore, it
will require a thorough review during the end user training, to improve the user
experience. The second area of improvement identified was the Implantable device
list. This is a newly added module, so most users were unsure of how to add the UDI
code. They spent extra time trying to enter the UDI into the text box on the main
page, when the UDI needed to be entered after they had pressed the add button.
This will need to be addressed within the end user training.

                                                                                      15
INTRODUCTION

The EHR under test for this study was My Vision Express, 2018. Tailored to present
medical information to healthcare providers in the ophthalmology field. My Vision
Express, 2018, provides care planning, patient education, prescription writing, and
others as the core electronic health record (EHR) capabilities along with practice
management services.
My Vision Express also provides important data security capabilities including
automatic backup and logoff, encrypted data transfer, recovery protection, secure
remote access, password protection, and unique user IDs. The usability testing
attempted to represent realistic exercises and conditions.

The purpose of this study was to test and validate the usability of the current user
interface and provide evidence of usability in My Vision Express, 2018. To this end,
measures of effectiveness, efficiency and user satisfaction such as task time,
deviations and success rate were captured during the usability testing.

METHOD

Participants

A total of 10 participants were tested on My Vision Express, 2018. Participants in
the test were health care providers and other health care personnel. Participants were
recruited by My Vision Express Staff, and were not compensated for their time. In
addition, participants did not have a direct connection to the development of or to
the organization producing My Vision Express, 2018. Participants were not from the
testing or supplier organization. Participants were given the opportunity to have the
same orientation and level of training as the actual end users would have received.

Recruited participants had a mix of backgrounds and demographic characteristics,
representing the cohort of intended users. The following is the table of participants
by characteristics, including demographics, professional experience, and computer
experience. Participant names were replaced with Participant IDs, so that
individuals’ data cannot be tied back to individual identities. No assistive
technologies were used for any of the participants.

                                                                                         16
Assistive Technology?
                                                                                                             Computer Experience
                                                                                        Product Experience
                                                       Occupation/Role
 Participant ID

                                                                         Professional
                                                                         Experience
                                       Education
                   Age

                            Sex
                                   Master's         Business
MVE01             20-29   Female                                            28             3                 144                   No
                                   Degree           Analyst

                                   Master's
MVE02             30-39   Male                     Test Lead              120           24                   120                   No
                                   Degree

                                                     Senior
                                   Master's
MVE03             20-29   Female                    Business                70             6                 192                   No
                                   Degree
                                                    Analyst

                                   Bachelor's        QA
MVE04             20-29   Female                                            60          12                   120                   No
                                    Degree          Analyst

                                   Master's
MVE05             30-39   Female                   Technician               48             8                 132                   No
                                   Degree

                                   Master's
MVE06             40-49   Male                     Manager                180           12                   180                   No
                                   Degree

                                   Bachelor's
MVE07             30-39   Female                    Optician                96             6                 180                   No
                                    Degree

                                   Associate
MVE08             30-39   Male                      Optician              240              8                 336                   No
                                    Degree

                                                                                                                                                           17
Customer
                             Master's
MVE09     20-29    Female                Support     72       9      110      No
                             Degree
                                        Executive

                            Associate
MVE10     30-39     Male                Technician   144     10      192      No
                             Degree

Ten participants matching the description of intended users were recruited, and all
ten participated in the usability test. No participants failed to show up for the study.

Participants were scheduled for 1 session of 60 minutes with time after the session
for an overview by the administrator and data logger and to reset systems to proper
test conditions. A spreadsheet was used to keep track of the participant schedule and
included each participant’s demographic characteristics.

Study Design

Overall, the objective of this test was to uncover areas where the application
performed well – that is, effectively, efficiently, and with satisfaction – and areas
where the application failed to meet the needs of the participants. The data from this
test may serve as a baseline for future tests with an updated version of My Vision
Express, 2018. In short, this testing serves as both a means to record or benchmark
current usability, but also to identify areas where improvements must be made.

During the usability test, participants interacted with My Vision Express, 2018. Each
participant used the system in the same location, and was provided with the same
instructions. The system was evaluated for effectiveness, efficiency and satisfaction
as defined by measures collected and analyzed for each participant:

   •    Number of tasks successfully completed within the allotted time without
        assistance
   •    Time to complete the tasks
   •    Number and types of errors
   •    Task deviations
   •    Participant’s satisfaction ratings of the system

                                                                                           18
Additional information about the various measures can be found in the Usability
Metrics section of this report.

Tasks

A number of tasks were constructed that would be realistic and representative of the
kinds of activities a user might do with My Vision Express, including:

   •    Computerized Physician Order Entry (Medication, Laboratory &
   •    Diagnostic imaging)
   •    Drug-Drug and Drug-Allergy interaction checks
   •    Patient Demographic Changes
   •    Problem list
   •    Medication list
   •    Medication allergy list
   •    Clinical Decision Support (CDS)
   •    Implantable device list
   •    Clinical Information Reconciliation and Incorporation

These tasks were selected based on the twelve ONC CEHRT2015 certification
criteria, considering frequency of user interactions, potential risks of user errors &
criticality of function.
(See Appendix 5: Safety Enhanced Design Test Scenarios).

Procedure

Upon arrival, participants were greeted. Their identity was verified and matched to
the names on the participant schedule. Participants were then assigned a participant
ID. Each participant had already reviewed, signed and returned the informed consent
and non-disclosure agreement shown in Appendix 2 & 3 respectively. A
representative from the test team witnessed the participant’s signature.

                                                                                         19
To ensure that the test ran smoothly, two staff members participated in this test—
the usability administrator and the data logger. The usability testing staff members
conducting the test were experienced usability practitioners.

The administrator moderated the session including administering instructions and
tasks. The administrator also monitored task times, obtained post-task rating data,
provided clarifications of directions as appropriate and took notes on participant
comments. A second person served at the data logger and took notes on task success,
task deviations and task failures.

Participants were instructed to perform the tasks:

   •   As quickly as possible making as few errors and deviations as possible.
   •   Without assistance; administrators were allowed to give immaterial guidance
       and clarification on tasks but not instructions for use without reductions in
       ratings.
   •   Without using a think aloud technique

The administrator read the tasks aloud to the participants and then instructed them to
initiate performing the tasks. The participants had the written copies of just the tasks.
Exact details of the procedures used and tasks performed are shown in Appendix 5.
The task time was stopped once the participant indicated they had successfully
completed the task. At the end of each task, the participant rated the question on a
scale of 1 – 5 with 5 being the easiest and 1 the most difficult.

Time was recorded from the declaration to begin until the participant either
completed the task successfully or failed the task.

Following the session, the administrator gave the participant the post-test
questionnaire (e.g., the System Usability Scale, see Appendix 6) and thanked each
individual for their participation.

Participants’ demographic information, task success rate, task performance time,
task failure, task standard deviations and post-test questionnaire were recorded into a
spreadsheet.

                                                                                            20
Test Location

The test facility included a testing room with a table, computer for the participant,
and recording computer for the administrator. The participant, the administrator and
the data logger viewed the screen simultaneously.

To ensure that the environment was comfortable for users, noise levels were kept to
a minimum with the ambient temperature within a normal range. All of the safety
instruction and evacuation procedures were valid, in place, and visible to the
participants.

Test Environment

The My Vision Express Software would typically be used in a healthcare office or
facility. For testing, the computer used was Lenovo running Windows 7 using a
testing database having de-identified patient data. The participants logged in via
GoToMeeting from their respective workstations. Participants used the mouse and
keyboard when interacting with My Vision Express, 2018.

My Vision Express can function on a variety of screen sizes and resolutions. In order
to display well on all monitors, a resolution of 1366 x 768 was used.

My Vision Express, 2018 was set up by the in-house Information Technology staff
members as it would be for a typical installation. It was connected to the Internet
wired connection.

Test Forms and Tools

During the usability test, various documents and instruments were used, including:

   1. Informed Consent & Non- Disclosure Agreement
   2. Usability Instructions
   3. Post-test Questionnaire

Examples of these documents can be found in the Appendices section.
Prior to the commencement of the test, the participants were provided with the
informed consent and non- disclosure agreement shown in Appendix 2 & 3

                                                                                        21
respectively. All participants signed and returned the form. Also prior to the test,
participants were given the rating metrics, so they would have them available during
testing for reference. Rating metrics sent were:

1 – Very Difficult
2 – Difficult
3 – Neither Difficult nor Easy
4 – Easy
5 – Very Easy

Immediately following the test, participants were asked the questions on the post-
test questionnaire shown in Appendix 6.

Participant Instructions

At the beginning of each testing session the administrator read the following
instructions aloud to each participant:

Thank you for participating in this study. Your input is very important. Our session
today will last about 60 minutes. During that time, you will use an instance of an
electronic health record, My Vision Express. I will ask you to complete a few tasks
using this system and answer some questions. You should complete the tasks as
quickly as possible making as few errors as possible. Please try to complete the tasks
on your own following the instructions very closely. Please note that we are not
testing you, we are testing the system; therefore, if you have difficulty, all this
means is that something needs to be improved in the system. I will be here in case
you need specific help, but I am not able to instruct you or provide help in how to
use the application.

Overall, we are interested in how easy (or how difficult) this system is to use, what
in it would be useful to you, and how we could improve it. Please be honest with
your opinions. All of the information that you provide will be kept confidential and
your name will not be associated with your comments at any time. Should you feel it
necessary, you are able to withdraw at any time during the testing.

                                                                                         22
Following the procedural instructions, participants were shown the EHR and were
given 30 minutes of instruction on using the EHR. Once the training was completed,
the administrator gave the following instructions:

For each task, I will read the description to you and say “Begin.” At that point,
please perform the task and say “Done” once you believe you have successfully
completed the task. I would like to request you not talk aloud or verbalize while you
are doing the tasks. I will ask for your impressions about the task once you are done.

Participants were then given a series of tasks to complete. Tasks are listed in
Appendix 5.

Usability Metrics

According to the NIST Guide to the Processes Approach for Improving the Usability
of Electronic Health Records, EHRs should support a process that provides a high
level of usability for all users. The goal is for the users to interact with the system
effectively, efficiently and with an acceptable level of satisfaction.

To this end metrics for effectiveness, efficiency and user satisfaction were captured
during the usability testing. The goals of the test were to assess:

   •   The effectiveness of My Vision Express, 2018, by measuring participant
       success rates and errors
   •   The efficiency of My Vision Express, 2018, by measuring the average task
       time and path deviations
   •   The satisfaction with My Vision Express, 2018, by measuring ease of use
       Ratings

Data Scoring

The following table unveils the details of how tasks were scored, the errors were
evaluated and the time data was analyzed,

Measures         Rationale and Scoring

                                                                                          23
Effectiveness:   Task success was determined by assigning numeric weights for
                 various levels of task success, as follows:
Task Success     • Success (without assistance) = 1.0
                 • Partial success = 0.5
                 • Failure = 0.0
                 A task was counted as a “Success” if the participant was able to
                 achieve the correct outcome, without assistance, within the time
                 allotted on a per task basis. A ‘Partial success’ if the participant was
                 able to achieve the correct outcome with minimal assistance.
                 The total number of successes were calculated for each task and
                 then divided by the total number of times that task was attempted.
                 The results were provided as a percentage.
                 Task times were recorded for successes. The amount of time a task
                 took minus the optimal time expected was recorded as the Task
                 Time Deviation (in seconds) and was used to help determine partial
                 success.
Effectiveness:   If the participant abandoned the task, did not reach the correct
                 answer, performed it incorrectly, or reached the end of the allotted
Task Failures    time before successful completion, the task was counted as a
                 failure. No task times for failed tasks or tasks that exceeded the
                 target task time were used in calculations.
                 Participants were not asked to attempt the task more than once.
                 The total number of errors was calculated by averaging the number
                 of errors counted for each task. Not all deviations were counted as
                 errors. Task failures were also expressed as the mean number of
                 failed tasks per participant.
                 A qualitative account of the observed errors and error types was
                 collected.
Efficiency:      The participant’s navigation path (i.e., steps) through the
                 application was recorded.
Task             Deviations occur if the participant, for example, went to a wrong
Deviations       screen, clicked on an incorrect menu item, followed an incorrect
                 link, or interacted incorrectly with an on-screen control. This path
                 was compared to the optimal path. The Optimal time was subtracted
                 from the observed time to provide the deviation time.
                 Path deviations are reported on a qualitative level for use in
                 recommendations for improvement.
Efficiency:      Each task was timed from when the administrator said “Begin”
                 until the participant said “Done.” If the participant failed to say
Task Time        “Done,” the time was stopped when the participant ceased
                 performing the task. Only task times for tasks that were
                 successfully completed and tasks that were completed at or under
                 the target time were included in the average task time analysis.

                                                                                            24
Average time per task and variance measures were calculated for
                each task for use in the result analysis.
Satisfaction:   Participant’s subjective impression of the ease of use of the
                application was measured by administering both a simple post-task
Task Rating     question as well as a post-session questionnaire. After each task, the
                participant was asked to rate, “Overall this task was,” on a scale of
                1 (Very Difficult) to 5 (Very Easy). These data are averaged across
                participants.

Results

Data Analysis and Reporting

The results of the usability test of specific safety –design related tasks were
calculated according to the methods specified in the Usability Metrics section above.

The usability testing results for My Vision Express are detailed below. A numerical
summary enclosing all the tasks covered is shown in a tabular form in the Executive
Summary section of this report. The results should be seen in light of the objectives
and goals outlined in the Study Design section. The data yielded actionable results
that, when corrected, will yield a material, positive impact on user performance.

Discussion of the Findings

The test findings are discussed below:

1. (a.1) CPOE- Medication Order
Effectiveness- The success score for changing a medication order and displaying the
changed order was 100%. However, some of the participants faced slight difficulty
while recording the medication orders. The success rate for recording a medication
order via CPOE was 95%.

Efficiency- Though the participants exceeded the optimal time while performing the
tasks, all the participants completed the tasks within the optimal number steps, as
suggested by the number of steps taken by expert users.

                                                                                         25
Satisfaction- The participants were familiar with these tasks and gave an average
satisfaction rating of 4.7 out of 5 points on a Likert scale.

2. (a.2) CPOE Laboratory Order

Effectiveness- The success score for each of the tasks under CPOE Lab order was
observed to be 100%.

Efficiency- Most of the participants exceeded the optimal time for each task,
however they successfully performed the tasks within the optimal number of steps,
as suggested by the number of steps taken by expert users.

Satisfaction- The participants were familiar with these tasks and gave an average
satisfaction rating of 4.6 out of 5 points on a Likert scale.

3. (a.3) CPOE Imaging Order

Effectiveness- The success score for changing a CPOE image order and displaying
the changed order was 100%. However, some of the participants faced slight
difficulty while recording the image orders. The success rate for recording an image
order via CPOE was 95%.

Efficiency- The participants completed the tasks successfully within the optimal
number of steps; however, they exceeded the optimal time while performing the
tasks without any error.

Satisfaction- The participants had an average satisfaction rating of 4.6 out of 5
points on a Likert scale. Most of the participants were familiar with these tasks.

4. (a.4) Drug-Drug and Drug-Allergy Interaction Checks

Effectiveness- The participants were able to successfully trigger a drug-drug, drug-
allergy interaction and adjust the severity levels, yielding a task success score of
100%.

                                                                                       26
Efficiency- The participants completed the tasks successfully within optimal time
for each task and with either fewer steps or the same number of steps as expert users.

Satisfaction- The participants were familiar with these tasks and gave an average
satisfaction rating of 4.5 out of 5 points on a Likert scale.

5. (a.5) Demographics

Effectiveness- The success score for recording the demographic details was
observed to be 90% and changing the demographic details was 95%.
The participants were able to successfully record, change and display the changed
entries made under demographics, resulting into a success score of 100%.

Efficiency- All the participants completed the tasks within the same number of steps
as expert users. Some of the participants exceeded the optimal time while
performing the tasks; however, they completed the tasks successfully without any
errors.

Satisfaction- The participants gave an average satisfaction rating of 4.4 out of 5
points on a Likert scale.

6. (a.6) Problem List

Effectiveness- All the participants successfully recorded a new problem, changed the
status of the problem and displayed the active & the historical problem list; with a
success score of 100%.

Efficiency- All the participants successfully completed the tasks of displaying the
historical medication list within the optimal time and with optimal number of steps.
However, the participants exceeded the time while recording & changing a problem
to the problem list and displaying active problem list.

Satisfaction- Participants had an average satisfaction rating of 4.4 out of 5 points on
a Likert scale.

7. (a.7) Medication List

                                                                                          27
Effectiveness- The success score for recording a medication to the medication list
was observed to 95%. However, the participants successfully completed the rest of
the tasks, changing and displaying the active & historical medication list, with a
success score of 100%.

Efficiency- The participants completed the tasks of changing a medication on the
medication list and displaying the active & historical medication list within the
optimal time and optimal number of steps. However, the participants exceeded the
optimal time and steps while recording a medication to the medication list.

Satisfaction- The participants had an average satisfaction of 4.7 out of 5 points on a
Likert scale. Most participants were familiar with these tasks and found the tasks
easy to complete.

8. (a.8) Medication Allergy List

Effectiveness- All the participants were able to successfully record & change the
medication allergy and display the active & historical medication allergy list with a
success score of 100%.

Efficiency- All the participants were able to successfully record a medication allergy
and display the active & historical medication allergy list within the optimal time
and optimal number of steps. Participants exceeded the optimal time while changing
the medication allergy; however, they completed the tasks without any errors.

Satisfaction- The participants had an average satisfaction of 4.7 out of 5 points on a
Likert scale. Most participants were familiar with these tasks and found the tasks
easy to complete.

9. (a.9) Clinical Decision Support

Effectiveness- The participants were having little trouble with adding CDS
interventions and triggering the CDS interventions from the required elements; as
revealed by the success score of 90% and 95% respectively. The success score for
viewing the resource information using the Info button standard, triggering the CDS
interventions during reconciliation and accessing the attributes of the triggered CDS
intervention alert for Problem List, was identified to be 100%.

                                                                                         28
Efficiency- Participants exceeded the optimal time and optimal number of steps
while adding CDS interventions for the required elements. However, all the
participants were able to trigger the CDS interventions, view the intervention
information and access the attributes; successfully within optimal number of steps
and optimal time, as suggested by timings and steps by expert users.

Satisfaction- The participants gave an average satisfaction rating of 4.5 out of 5
points on a Likert scale.

10. (a.14) Implantable Device List

Effectiveness- The success score for each of the tasks was 100%. Participants were
able to record the UDI, change the UDI status and access UDI, device description,
identifiers, and attributes successfully.

Efficiency- All the participants were able to perform the tasks within optimal
number of steps and time. The participants exceeded the time while recording
unique device identifier, however completed the task without any error.

Satisfaction- Since, it was a newly added EHR component, the participants were
unfamiliar with the tasks. They had an average satisfaction rating of 4.3 out of 5 on a
Likert scale. However, the participants performed the tasks easily.

11. (b.2) Clinical Information Reconciliation and Incorporation

Effectiveness- The success score for incorporating a CCDA & conducting
reconciliation as well as generating a new CCDA with reconciled data was observed
to be 100%.

Efficiency- All the participants exceeded the optimal number of steps and time while
incorporating a CCDA & conducting reconciliation and generating a new CCDA
with reconciled data. However, the participants completed the tasks successfully
without any errors.

                                                                                          29
Satisfaction- The participants had an average satisfaction of 4.7 out of 5 points on a
Likert scale. Most participants were familiar with these tasks and found the tasks
easy to complete.

Major Findings

During the testing process, it was observed that the participants performed the
majority of tasks within expected number of steps. However, it was revealed that
some of the participants exceeded the optimal range of steps and time while
performing certain tasks under CPOE Medication order, Image order, CDS,
Implantable device list and Demographics.
Participants found that adding a new CDS intervention was slightly difficult as they
struggled while saving the CDS interventions. Recording and changing the
demographics details were perceived to be slightly troublesome by the participants.
With no search option and a cumbersome selection process, participants struggled to
select the correct ethnicity and race fields.

The implantable device list interface proved to be the higher risk area, since the
implantable device list is a newly added module to the EHR. The participants were
not familiar with its functionality. The attributes pertaining to the UDI can be
accessed only after making a precise entry, as the information is dependent on a
third party. Also, manual entry of the UDI, makes it a tedious task for the
participants.

Overall, the testing process evidenced that the participants were exceeding the
optimal time and the presence of path deviations. However, the participants were
able to perform all the tasks without any error. The performance of the participants
during the testing process, depicts zero error; which describes the usability of the
software.

Areas for Improvement

The first area of improvement belongs to CDS, since most of the participants faced
difficulty while configuring the interventions. There was also some confusion as to

                                                                                         30
where the alert would be shown while interacting with the product. Therefore, it
will require a thorough review during the end user training, to improve the user
experience. The second area of improvement identified was the Implantable device
list. This is a newly added module, so most users were unsure of how to add the UDI
code. They spent extra time trying to enter the UDI into the text box on the main
page, when the UDI needed to be entered after they had pressed the add button.
This will need to be addressed within the end user training.

APPENDICES-

   1.   Participant Demographics
   2.   Informed Consent
   3.   Non- Disclosure Agreement
   4.   Usability Instructions
   5.   Safety Enhanced Design Test Scenarios
   6.   Post- Test Questionnaire

APPENDIX 1- PARTICIPANT DEMOGRAPHICS

Below is a summary of participant demographics for this study

   1. Participant Gender

Participant
Gender             (N=10)       %
Male                 4          40
Female               6          60

   2. Participant Age

Participant Age    (N=10)       %
20-29                4          40
30-39                5          50
40-49                1          10

   3. Participant Education

                                                                                      31
Participant Education               (N=10)       %
Associate’s Degree                    2          20
Bachelor's Degree                     2          20
Master's Degree                       6          60

   4. Participant Roles

Participant Role                    (N=10)       %
Business Analyst                      1          10
Test Lead                             1          10
Senior Business Analyst               1          10
QA Analyst                            1          10
Technician                            2          20
Manager                               1          10
Optician                              2          20
Customer Support
Executive                               1        10

   5. Participant Professional Experience

Participant
Professional
Experience                N=10      Months   Years
                          Mean      105.8    8.81

   6. Participant Computer Experience

Participant
Computer
Experience                N=10     Months    Years
                          Mean     170.6     14.21

   7. Participant Product Experience

Participant Product
Experience                N=10     Months    Years
                          Mean      9.8      0.81

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APPENDIX 2- INFORMED COSENT FORM

My Vision Express would like to thank you for participating in this study. The
purpose of this study is to evaluate an electronic health records system. If you decide
to participate, you will be asked to perform several tasks using the prototype and
give your feedback. The study will last about approximately 60minutes.

Agreement

I understand and agree that as a voluntary participant in the present study conducted
by My Vision Express, I am free to withdraw consent or discontinue participation at
any time.

I understand and agree that the purpose of this study is to make software
applications more useful and usable in the future.

I understand and agree that the data collected from this study may be shared outside
of My Vision Express and My Vision Express clients. I understand and agree that
data confidentiality is assured, because only de- identified data – i.e., identification
numbers not names – will be used in analysis and reporting of the results.

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I agree to immediately raise any concerns or areas of discomfort with the study
administrator. I understand that I can leave at any time.

Please check one of the following:

[ ] YES, I have read the above statement and agree to be a participant.

[ ] NO, I choose not to participate in this study.

Participant’s printed name- ………………………………………..……………

Signature- …………………………………………………………………...…..
Date- ………………..……………………………………………………………
Email Address- …………………………………………………………………..

APPENDIX 3- NON- DISCLOSURE AGREEMENT

This agreement is entered into as of _____________, 2017, between
___________________________ (“the Participant”) and My Vision Express.

The Participant acknowledges his or her voluntary participation in today’s usability
study may bring the Participant into possession of Confidential Information. The
term "Confidential Information" means all technical and commercial information of
a proprietary or confidential nature which is disclosed by My Vision Express, or
otherwise acquired by the Participant, in the course of today’s study.

By way of illustration, but not limitation, confidential information includes trade
secrets, processes, formulae, data, know-how, products, designs, drawings, computer
aided design files and other computer files, computer software, ideas, improvements,
inventions, training methods and materials, marketing techniques, plans, strategies,
budgets, financial information, or forecasts.

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Any information the Participant acquires relating to this product during this study is
confidential and proprietary to Test Company and is being disclosed solely for the
purposes of the Participant’s participation in today’s usability study. By signing this
form the Participant acknowledges that s/he will not receive any monetary
compensation for feedback and will not disclose this confidential information
obtained today to anyone else or any other organizations.

Participant’s printed name- …………………………………………………………

Signature- ……………………………………………………………………………
Date- ………………………………………………………………………………….

APPENDIX 4- USABILITY INSTRUCTIONS
Usability Instructions (MM/DD/YYYY)
Administrator
Data Logger
Date
Time
Participant ID

Orientation

We express our gratitude towards you for participating in this study. You will be
helping us evaluate the workflows pertaining to the ONC’s EHR vendor certification
requirements. Our session today will last approximately 60 minutes. During that
you will be provided with an overview in relation to My Vision Express and the
modules involved under this testing.

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The product you will be using today is My Vision Express, which you are already
familiar with. It is, however, a non-production version, so all patients are fake.
As you go through the workflows, please keep in mind that it is My Vision Express
under review here, not you.
During this study, you will be asked to complete a few tasks using My Vision
Express and answer some questions.         We are interested in obtaining feedback
regarding the ease of use of this product, what in the product you find most useful,
and feedback as to how it can be improved.

You will be asked to complete these tasks on your own, trying to do them as quickly
as possible with the fewest possible errors and deviations.

Please save your detailed comments until the end of a task or the end of the session
as a whole, when we can discuss freely. Please feel free to be honest with your
opinions.

All of the information that you provide will be kept confidential and your name will
not be associated with your comments at any time.

Do you have any questions or concerns?

Preliminary Questions

Okay, now we need to ask you a few questions about yourself. What is your:

Education

Occupation/Role

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Professional
Experience
Computer Experience

Product Experience

On a scale of 1 to 5, with 5 being “most familiar”, how would you rate your
knowledge of the following:

   Computerized Physician Order Entry

   Drug-Drug and Drug-Allergy
   interaction checks

   Patient Demographic

   Problem list

   Medication list

   Medication allergy list

   Clinical Decision Support (CDS)

   Implantable device list

   Clinical Information Reconciliation
   and Incorporation

   Electronic prescribing

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APPENDIX 5- SAFETY ENHANCED DESIGN TEST SCENARIOS
The tasks are prioritized in accordance with the risks associated with user errors.

1. (a.9) Clinical Decision Support
{User Interaction- Moderate, Risk- Moderate}

Tasks
   1. Add a CDS intervention and/or reference resource for each of the required
      elements,-
      a. Problem List- Non proliferative diabetic retinopathy. ICD10- E11.329
         SNOMED- 390834004
      b. Medication Allergy List (Rx Norm Code- 202589 Cytoxan)
      c. Medication list (RxNorm Code-637175 Keflex 750 mg)
      d. Demographics- (Ethnicity- Hispanic or Latino)
      e. Combination- Age>50 and Vitals- BMI- >25

Expected Task Time
Actual Task Time

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Optimal Path:
    Correct
    Deviations
      If any, no. of deviations observed________

Observed errors:

 Rating:
On a scale of 1 to 5, with 5 being “very easy to use”, how would you rate the ease of
use for completing this task?
     1
     2
     3
     4
     5

   2. Trigger the CDS interventions/resources added using the applicable data
      elements from each of the required elements-
          a. Problem List- Non proliferative diabetic retinopathy. ICD10-
             E11.329 SNOMED- 390834004
          b. Medication Allergy List (Rx Norm Code- 202589 Cytoxan)
          c. Medication list (RxNorm Code-637175 Keflex 750 mg)
          d. Demographics- (Ethnicity- Hispanic or Latino)
          e. Combination- Age>50 and Vitals- BMI- >25

Expected Task Time
Actual Task Time

Optimal Path:
    Correct
    Deviations
     If any, no. of deviations observed________

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