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Test Results Summary for 2014 Edition EHR Certification 14-2710-R-0092-PRA V1.2 May 4, 2017 ©2017 InfoGard. May be reproduced only in its original entirety, without revision Page 1 of 13 ONC HIT Certification Program Test Results Summary for 2014 Edition EHR Certification Part 1: Product and Developer Information 1.1 Certified Product Information Product Name: PowerSoftMD Certified Product Version: MU2B Domain: Ambulatory Test Type: Complete EHR 1.2 Developer/Vendor Information Developer/Vendor Name: Data Tec, Inc. Address: PO Box 31576 Des Peres, MO 63131 Website: www.powersoftmd.com Email: [email protected] Phone: (636) 256-7401 Developer/Vendor Contact: Hal Goodall Part 2: ONC-Authorized Certification Body Information 2.1 ONC-Authorized Certification Body Information ONC-ACB Name: InfoGard Laboratories, Inc. Address: 709 Fiero Lane Suite 25 San Luis Obispo, CA 93401 Website: www.infogard.com Email: [email protected] Phone: (805) 783-0810 ONC-ACB Contact: Adam Hardcastle This test results summary is approved for public release by the following ONC-Authorized Certification Body Representative: Adam Hardcastle EHR Certification Body Manager ONC-ACB Authorized Representative Function/Title 5/4/17 Signature and Date
Transcript
Page 1: ONC HIT Certification Program Test Results Summary for ...connect.ul.com/rs/365-LEA-623/images/14-2710-R-0092-PRA-V1.1-Data... · Part 3 of this test results summary is approved for

Test Results Summary for 2014 Edition EHR Certification 14-2710-R-0092-PRA V1.2 May 4, 2017

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ONC HIT Certification Program Test Results Summary for 2014 Edition EHR Certification

Part 1: Product and Developer Information

1.1 Certified Product Information

Product Name: PowerSoftMD Certified Product Version: MU2B Domain: Ambulatory Test Type: Complete EHR

1.2 Developer/Vendor Information

Developer/Vendor Name: Data Tec, Inc. Address: PO Box 31576

Des Peres, MO 63131 Website: www.powersoftmd.com Email: [email protected] Phone: (636) 256-7401 Developer/Vendor Contact: Hal Goodall

Part 2: ONC-Authorized Certification Body Information

2.1 ONC-Authorized Certification Body Information

ONC-ACB Name: InfoGard Laboratories, Inc. Address: 709 Fiero Lane Suite 25

San Luis Obispo, CA 93401 Website: www.infogard.com Email: [email protected] Phone: (805) 783-0810 ONC-ACB Contact: Adam Hardcastle

This test results summary is approved for public release by the following ONC-Authorized Certification Body Representative:

Adam Hardcastle

EHR Certification Body Manager ONC-ACB Authorized Representative Function/Title

5/4/17 Signature and Date

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2.2 Gap Certification The following identifies criterion or criteria certified via gap certification

§170.314 (a)(1) (a)(17) (d)(5) (d)(9)

(a)(6) (b)(5)* (d)(6) (f)(1)

(a)(7) (d)(1) (d)(8)

*Gap certification allowed for Inpatient setting only

No gap certification

2.3 Inherited Certification The following identifies criterion or criteria certified via inherited certification

§170.314 (a)(1) (a)(14) (c)(3) (f)(1) (a)(2) (a)(15) (d)(1) (f)(2) (a)(3) (a)(16) Inpt. only (d)(2) (f)(3) (a)(4) (a)(17) Inpt. only (d)(3) (f)(4) Inpt. only (a)(5) (b)(1) (d)(4)

(f)(5) Optional & Amb. only (a)(6) (b)(2) (d)(5)

(a)(7) (b)(3) (d)(6) (f)(6) Optional &

Amb. only (a)(8) (b)(4) (d)(7) (a)(9) (b)(5) (d)(8) (g)(1) (a)(10) (b)(6) Inpt. only (d)(9) Optional (g)(2) (a)(11) (b)(7) (e)(1) (g)(3) (a)(12) (c)(1) (e)(2) Amb. only (g)(4)

(a)(13) (c)(2) (e)(3) Amb. only

No inherited certification

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Part 3: NVLAP-Accredited Testing Laboratory Information

Report Number: 14-2710-R-0092 V1.3 Test Date(s): July 27, 2014 – February 27, 2015 Location of Testing: InfoGard and Vendor Site

3.1 NVLAP-Accredited Testing Laboratory Information

ATL Name: InfoGard Laboratories, Inc.

Accreditation Number: NVLAP Lab Code 100432-0

Address: 709 Fiero Lane Suite 25 San Luis Obispo, CA 93401

Website: www.infogard.com

Email: [email protected]

Phone: (805) 783-0810

ATL Contact: Milton Padilla

For more information on scope of accreditation, please reference http://ts.nist.gov/Standards/scopes/1004320.htm

Part 3 of this test results summary is approved for public release by the following Accredited Testing Laboratory Representative:

Milton Padilla

EHR Test Body Manager ATL Authorized Representative Function/Title

5/4/17 Signature and Date

3.2 Test Information

3.2.1 Additional Software Relied Upon for Certification

Additional Software Applicable Criteria Functionality provided by Additional Software

NewCrop (a)2, (a)8, a(10), (b)1, (b)2, (b)3, (b)4, (b)7, (e)1, (e)3

Ordering Medication and Patient Portal

No additional software required

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3.2.2 Test Tools

Test Tool Version Cypress 2.0.4 ePrescribing Validation Tool 1.0.4 HL7 CDA Cancer Registry Reporting Validation Tool HL7 v2 Electronic Laboratory Reporting (ELR) Validation Tool

HL7 v2 Immunization Information System (IIS) Reporting Validation Tool 1.8.0

HL7 v2 Laboratory Results Interface (LRI) Validation Tool 1.7.0 HL7 v2 Syndromic Surveillance Reporting Validation Tool 1.7.0 Transport Testing Tool 179 Direct Certificate Discovery Tool 3.0.2

No test tools required

3.2.3 Test Data

Alteration (customization) to the test data was necessary and is described in Appendix [insert appendix letter]

No alteration (customization) to the test data was necessary

3.2.4 Standards

3.2.4.1 Multiple Standards Permitted The following identifies the standard(s) that has been successfully tested where more than one standard is permitted

Criterion # Standard Successfully Tested

(a)(8)(ii)(A)(2)

§170.204(b)(1) HL7 Version 3 Implementation Guide: URL-Based Implementations of the Context-Aware Information Retrieval (Infobutton) Domain

§170.204(b)(2) HL7 Version 3 Implementation Guide: Context-Aware Knowledge Retrieval (Infobutton) Service-Oriented Architecture Implementation Guide

(a)(13)

§170.207(a)(3) IHTSDO SNOMED CT® International Release July 2012 and US Extension to SNOMED CT® March 2012 Release

§170.207(j) HL7 Version 3 Standard: Clinical Genomics; Pedigree

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Criterion # Standard Successfully Tested

(a)(15)(i)

§170.204(b)(1) HL7 Version 3 Implementation Guide: URL-Based Implementations of the Context-Aware Information Retrieval (Infobutton) Domain

§170.204(b)(2) HL7 Version 3 Implementation Guide: Context-Aware Knowledge Retrieval (Infobutton) Service-Oriented Architecture Implementation Guide

(a)(16)(ii) §170.210(g)

Network Time Protocol Version 3 (RFC 1305)

§170. 210(g) Network Time Protocol Version 4 (RFC 5905)

(b)(2)(i)(A)

§170.207(i) The code set specified at 45 CFR 162.1002(c)(2) (ICD-10-CM) for the indicated conditions

§170.207(a)(3) IHTSDO SNOMED CT® International Release July 2012 and US Extension to SNOMED CT® March 2012 Release

(b)(7)(i)

§170.207(i) The code set specified at 45 CFR 162.1002(c)(2) (ICD-10-CM) for the indicated conditions

§170.207(a)(3) IHTSDO SNOMED CT® International Release July 2012 and US Extension to SNOMED CT® March 2012 Release

(e)(1)(i) Annex A of the FIPS Publication 140-2 • SHA256 RSA 2048bit

(e)(1)(ii)(A)(2) §170.210(g)

Network Time Protocol Version 3 (RFC 1305)

§170. 210(g) Network Time Protocol Version 4 (RFC 5905)

(e)(3)(ii) Annex A of the FIPS Publication 140-2 • Sha256RSA(2048 bits)

Common MU Data Set (15)

§170.207(a)(3) IHTSDO SNOMED CT® International Release July 2012 and US Extension to SNOMED CT® March 2012 Release

§170.207(b)(2) The code set specified at 45 CFR 162.1002(a)(5) (HCPCS and CPT-4)

None of the criteria and corresponding standards listed above are applicable

3.2.4.2 Newer Versions of Standards The following identifies the newer version of a minimum standard(s) that has been successfully tested

Newer Version Applicable Criteria

No newer version of a minimum standard was tested

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3.2.5 Optional Functionality

Criterion # Optional Functionality Successfully Tested

(a)(4)(iii) Plot and display growth charts

(b)(1)(i)(B) Receive summary care record using the standards specified at §170.202(a) and (b) (Direct and XDM Validation)

(b)(1)(i)(C) Receive summary care record using the standards specified at §170.202(b) and (c) (SOAP Protocols)

(b)(2)(ii)(B) Transmit health information to a Third Party using the standards specified at §170.202(a) and (b) (Direct and XDM Validation)

(b)(2)(ii)(C) Transmit health information to a Third Party using the standards specified at §170.202(b) and (c) (SOAP Protocols)

(f)(3) Ambulatory setting only – Create syndrome-based public health surveillance information for transmission using the standard specified at §170.205(d)(3) (urgent care visit scenario)

Common MU Data Set (15)

Express Procedures according to the standard specified at §170.207(b)(3) (45 CFR162.1002(a)(4): Code on Dental Procedures and Nomenclature)

Common MU Data Set (15)

Express Procedures according to the standard specified at §170.207(b)(4) (45 CFR162.1002(c)(3): ICD-10-PCS)

No optional functionality tested

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3.2.6 2014 Edition Certification Criteria* Successfully Tested

Criteria # Version

Criteria # Version

TP** TD*** TP TD (a)(1) (c)(3) 1.7.1 2.0.4 (a)(2) (d)(1)

(a)(3) (d)(2) 1.4 (a)(4) (d)(3) 1.3 (a)(5) (d)(4) (a)(6) (d)(5) (a)(7) (d)(6) (a)(8) 1.2 (d)(7) (a)(9) (d)(8) (a)(10) (d)(9) Optional (a)(11)

(e)(1) 1.7 (a)(12) (e)(2) Amb. only 1.2 (a)(13) (e)(3) Amb. only 1.3 (a)(14) (f)(1) (a)(15) 1.5 (f)(2) 1.3 1.8.0 (a)(16) Inpt. only (f)(3) 1.3 1.7.0 (a)(17) Inpt. only (f)(4) Inpt. only

(b)(1) 1.6 1.4 (f)(5) Optional &

Amb. only (b)(2) 1.4 1.6

(b)(3) (f)(6) Optional &

Amb. only (b)(4) 1.3 1.4

(b)(5) 1.4 1.7.0 (g)(1) (b)(6) Inpt. only (g)(2) 1.6 1.9 (b)(7) 1.4 1.7 (g)(3) 1.3

(c)(1) 1.7.1 2.0.4 (g)(4) 1.2

(c)(2) 1.7.1 2.0.4

*For a list of the 2014 Edition Certification Criteria, please reference http://www.healthit.gov/certification (navigation: 2014 Edition Test Method) **Indicates the version number for the Test Procedure (TP) ***Indicates the version number for the Test Data (TD)

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3.2.7 2014 Clinical Quality Measures*

Type of Clinical Quality Measures Successfully Tested: Ambulatory Inpatient No CQMs tested

*For a list of the 2014 Clinical Quality Measures, please reference http://www.cms.gov (navigation: 2014 Clinical Quality Measures)

Ambulatory CQMs CMS ID Version CMS ID Version CMS ID Version CMS ID Version

2 90 136 155 22 117 137 156 V3 50 V3 122 138 V3 157 52 123 V3 139 158 56 124 140 159 61 125 141 160 62 126 142 161 64 127 V3 143 163 65 128 144 164 66 129 145 165 68 V4 130 146 166 69 131 V3 147 167 74 132 148 169 75 V3 133 149 177 77 134 153 179 82 135 154 V3 182

Inpatient CQMs CMS ID Version CMS ID Version CMS ID Version CMS ID Version

9 71 107 172 26 72 108 178 30 73 109 185 31 91 110 188 32 100 111 190 53 102 113

55 104 114 60 105 171

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3.2.8 Automated Numerator Recording and Measure Calculation

3.2.8.1 Automated Numerator Recording

Automated Numerator Recording Successfully Tested (a)(1) (a)(9) (a)(16) (b)(6)

(a)(3) (a)(11) (a)(17) (e)(1)

(a)(4) (a)(12) (b)(2) (e)(2)

(a)(5) (a)(13) (b)(3) (e)(3)

(a)(6) (a)(14) (b)(4)

(a)(7) (a)(15) (b)(5)

Automated Numerator Recording was not tested

3.2.8.2 Automated Measure Calculation

Automated Numerator Recording Successfully Tested (a)(1) (a)(9) (a)(16) (b)(6)

(a)(3) (a)(11) (a)(17) (e)(1)

(a)(4) (a)(12) (b)(2) (e)(2)

(a)(5) (a)(13) (b)(3) (e)(3)

(a)(6) (a)(14) (b)(4)

(a)(7) (a)(15) (b)(5)

Automated Measure Calculation was not tested

3.2.9 Attestation

Attestation Forms (as applicable) Appendix Safety-Enhanced Design* A Quality Management System** B Privacy and Security C

*Required if any of the following were tested: (a)(1), (a)(2), (a)(6), (a)(7), (a)(8), (a)(16), (b)(3), (b)(4) **Required for every EHR product

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Appendix A: Safety-Enhanced Design

An inaccurate description of the summative usability testing measures used for Effectiveness, Efficiency, and Satisfaction was provided in the "Results" section of the report. The information provided in the table of results data did not match the results as described for measures of Effectiveness, Efficiency, and Satisfaction.

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PO Box 31576, Des Peres, MO 63131

Voice (636) 256-7401 Fax (636) 230-6801 www.powersoftmd.com ________________________________________________________________________________________________________

October 27, 2015

To Infogard:

PowerSoftMD utilizes the NISTIR 7741 standard to design the following measures:

• §170.314(a)(1) Computerized provider order entry

• §170.314(a)(2) Drug-drug, drug-allergy interaction checks

• §170.314(a)(6) Medication list

• §170.314(a)(7) Medication allergy list

• §170.314(a)(8) Clinical decision support

• §170.314(b)(3) Electronic prescribing

• §170.314(b)(4) Clinical information reconciliation

Sincerely,

Peter Goodall

Data Tec, Inc.

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Mar 2014

EHR Usability Test Report of PowerSoftMD Certified Version MU2

Report based on ISO/IEC 25062:2006 Common Industry Format for Usability Test Reports

PowerSoftMD Certified Version MU2 by Data Tec, Inc.

Date of Usability Test: March 31st through April 8th Date of Report: April 9th Report Prepared By: Data Tec, Inc.

Peter Goodall, Manager, Data Tec, Inc. (636)256-7401 [email protected] PO Box 31576, Des Peres, MO 63131

Table of Contents 1 EXECUTIVE SUMMARY 2

2 INTRODUCTION 6

3 METHOD 6

3.1 PARTICIPANTS 6

3.2 STUDY DESIGN 7 3.3 TASKS 8

3.4 PROCEDURE 9 3.5 TEST LOCATION 10

3.6 TEST ENVIRONMENT 11 3.7 TEST FORMS AND TOOLS 11

3.8 PARTICIPANT INSTRUCTIONS 12 3.9 USABILITY METRICS 13

4 RESULTS 16

4.1 DATA ANALYSIS AND REPORTING 16 4.2 DISCUSSION OF THE FINDINGS 17

4.3 PARTICIPANT DEMOGRAPHICS 18

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Mar 2014

EXECUTIVE SUMMARY

A usability test of PowerSoftMD Certified, MU2, Ambulatory Complete EHR was

conducted between the dates of Mach 31st through November 16th in Des

Peres, MO, by Data Tec, Inc. The purpose of this test was to test and

validate the usability of the current user interface, and provide evidence

of usability in the EHR Under Test (EHRUT).

During the usability test, 3 healthcare providers, 1 medical assistant

and 1 office worker matching the target demographic criteria served as participants

and used the EHRUT in simulated, but representative tasks.

This study collected performance data on 9 tasks typically conducted

on an EHR:

• First Impressions • Review Computerized Orders • Create New Medication Orders • Create New Laboratory Orders • Create New Radiology Orders • Mark Orders Complete • Electronic Prescriptions • Build Medication List • Build Allergy List • Clinical Information Reconciliation • Clinical Decision Support Rule • Drug-Drug, Drug-Allergy Interactions

During the 120 minute one-on-one usability test, each

participant was greeted by the administrator and asked to review and

sign an informed consent/release form (included in Appendix 3); they

were instructed that they could withdraw at any time. Participants between no experience to several years prior experience with 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 timed the test and, along with the data logger(s) recorded user performance data on paper and electronically. The administrator did not give the participant assistance in how to complete the task.

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Mar 2014

Participant screens, head shots and audio were recorded for subsequent

analysis.

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 verbalizations

• Participant’s satisfaction ratings 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 and were compensated with $50 per hour compensation] for their time. 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 the EHRUT. Following is a summary of the performance and rating data collected on the EHRUT.

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Mar 2014

Chart of Task Attempts, Successes and Failures: Task # of

attempts

Task Success - Mean

Path Deviation, n

Task Time – Mean, in seconds

Task Time – mean of Deviations, in Seconds

Errors, n

Task Rating, (mean) 1=Very Easy

1. First Impressions

5 1 0 36 N/A N/A N/A

2. Review Computerized Orders

5 1 0 50 0 0 1.2

3. Create New Medication Orders

5 1 3 156 48 3 1.4

4. Create New Laboratory Orders

5 1 1 96 4 1 1.4

5. Create New Radiology Orders

5 1 1 78 0 0 1.4

6. Mark Orders Complete

5 1

1 54 12 1 1.2

7. Electronic Prescriptions

5 0.8 4 184 94 5 1.6

8. Build Medication List

5 1 1 54 12 1 1.2

9. Build Allergy List

5 1 0 32 0 0 1

10. Clinical Information Reconciliation

3 3 0 200 86.67 1 1.33

11. Clinical Decision Support Rule

2 2 2 1200 1200 2 4

12. Drug-Drug Drug-Allergy Interaction

2 2 0 600 600 1 1

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The results from the System Usability Scale scored the subjective

satisfaction with the system based on performance with these tasks to

be a mean of: 1.52.5

In addition to the performance data, the following qualitative observations

were made:

- Major findings

Overall, the subjects found the software easy to use once they acclimated to it. Most responded that once they knew or were shown how to do a task, they did not have to be shown again. They

found the flashing arrow and prompts very helpful. Some subjects were confused by the difference

between medications and prescriptions in e-scripts, but once they understood the meaning of the

terms, were able to find the correct information.

- Areas for improvement

Several subjects had difficulty remembering to click the “Select to Move to Current Meds” button once they had select the correct med, suggesting removal of this in a future update, if possible. In general, some subjects were uncomfortable with the slight interface change between PowerSoft and the e-scripts window, although they quickly adapted.

Subjects took a long time with the Clinical Decision Support Rule, and

appeared to get hung up on the many options available.

5 See Tullis, T. & Albert, W. (2008). Measuring the User Experience. Burlington, MA: Morgan Kaufman (p. 149). Broadly interpreted, scores under 60 represent systems with poor usability; cores over 80 would be considered above average.

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Mar 2014

INTRODUCTION

The EHRUT tested for this study was Software engineering — Software product Quality Requirements and Evaluation(SQuaRE) — Common Industry Format (CIF) for usability test reports (ISO/IEC 25062:2006(E)) Designed to present medical information to healthcare

providers in Ambulatory settings, the EHRUT consists of

timed, task-oriented trials. 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 the EHR

Under Test (EHRUT). . To this end, measures of effectiveness,

efficiency and user satisfaction, such as the time taken for each task, and the ease of completion were captured during the usability testing.

METHOD

PARTICIPANTS

A total of 5 participants were tested on the EHRUT(s). Participants in

the test was a medical assistant, a former office manager, 2 current medical office managers and a medical doctor. Participants were recruited

by Data Tec, Inc. and were compensated $50 per hour (typically 1 hour) for their time. In addition, participants had no direct connection to the development of or organization producing the EHRUT(s). Participants were not from the testing or supplier organization. Participants were not given the opportunity to have the same orientation and level of training as the actual end users

would have received. They were seeing several of these features for the

first time. For the test purposes, end-user characteristics were identified

and translated into a recruitment screener used to solicit potential

participants; an example of a screener is provided in Appendix 1.

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Recruited participants had a mix of backgrounds and demographic

characteristics conforming to the recruitment screener. The following is a

table of participants by characteristics, including demographics,

professional experience, computing experience and user needs for

assistive technology. Participant names were replaced with Participant

IDs so that an individual’s data cannot be tied back to individual

identities.

5 participants (matching the demographics in the section on Participants) were recruited and 5 participated in the usability test. Z e r o participants failed to show for the study.

Participants were scheduled for 120 minute sessions with

1 minute in between each session for debrief by the administrator(s) and

data logger(s), 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 as

provided by the recruiting firm.

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

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the participants. The data from this test may serve as a baseline for

future tests with an updated version of the same EHR and/or comparison

with other EHRs provided the same tasks are used. 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 01 EHR. 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

• Path deviations

• Participant’s verbalizations (comments)

• Participant’s satisfaction ratings of the system

Additional information about the various measures can be found in

Section 3.9 on Usability Metrics. TASKS

A number of tasks were constructed that would be realistic and

representative of the kinds of activities a user might do with this EHR,

including:

• First Impressions • Review Computerized Orders • Create New Medication Orders • Create New Laboratory Orders • Create New Radiology Orders • Mark Orders Complete • Electronic Prescriptions • Build Medication List

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• Build Allergy List • Clinical Information Reconciliation • Clinical Decision Support Rule • Drug-Drug, Drug-Allergy Interactions

Tasks were selected based on their frequency of use, criticality of

function, and those that may be most troublesome for users.6 Tasks

should always be constructed in light of the study objectives.

PROCEDURES Upon arrival, participants were greeted; their identity was verified and matched with a name on the participant schedule. Participants were then

assigned a participant ID. 7 Each participant reviewed and signed an

informed consent and release form (See Appendix 3). A representative

from the test team witnessed the participant’s signature.

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 conducting the test was experienced usability practitioners

with Peter Peter Goodall, a bachelor of political science from the University of Missouri, with 7 years experience in the medical software field.

The administrator moderated the session including administering

instructions and tasks. The administrator also monitored task times,

obtained post-task rating data, and took notes on participant comments.

A second person served as the data logger and took notes on task

success, path deviations, number and type of errors, and comments.

Participants were instructed to perform the tasks (see specific

instructions below):

• As quickly as possible making as few errors and deviations as

possible.

6 Constructing appropriate tasks is of critical importance to the validity of a usability test. These are the actual functions, but most tasks

contain larger and more fleshed out context that aligns with the sample data sets available in the tested EHR. Please consult usability references for guidance on how to construct appropriate tasks.

7 All participant data must be de-identified and kept confidential.

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• Without assistance; administrators were allowed to give

immaterial guidance and clarification on tasks, but not

instructions on use.

• Without using a think aloud technique.

For each task, the participants were given a written copy of the task.

Task timing began once the administrator finished reading the question.

The task time was stopped once the participant indicated they had

successfully completed the task. Scoring is discussed below in Section

3.9.

Following the session, the administrator gave the participant the post-test

questionnaire (e.g., the System Usability Scale, see Appendix 5),

compensated them for their time, and thanked each individual for their

participation.

Participants' demographic information, task success rate, time on task,

errors, deviations, verbal responses, and post-test questionnaire were

recorded into a spreadsheet.

Participants were thanked for their time and compensated. Participants

signed a receipt and acknowledgement form (See Appendix 6) indicating

that they had received the compensation. TEST LOCATION

The test facility included a waiting area and a quiet testing room with a

table, computer for the participant, and recording computer for the

administrator. Only the participant and administrator were in the test

room. All observers and the data logger worked from a separate room

where they could see the participant’s screen and face shot, and listen to

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the audio of the session. 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 EHRUT would be typically be used in a healthcare office or facility.

In this instance, the testing was conducted in an office building. For

testing, the computer used an Intel-based computer running Windows 8.

The participants used a mouse and keyboard

when interacting with the EHRUT.

The test subject used a 17” monitor at 1366x768 resolution with 16 million colors. The application was set up by Data Tec, Inc. according to the vendor’s documentation describing the system set-up and preparation. The application itself was running on a Windows 8 Computer using a test database on a LAN connection. Technically, the system performance (i.e., response time) was representative to what actual users would experience in a field implementation. Additionally, participants were instructed not to change any of the default system settings (such as control of font size).

TEST FORMS AND TOOLS

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

including:

1. Informed Consent

2. Moderator’s Guide

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3. Post-test Questionnaire

4. Incentive Receipt and Acknowledgment Form

Examples of these documents can be found in Appendices 3-6

respectively. The Moderator’s Guide was devised so as to be able to

capture required data.

The participant’s interaction with the EHRUT was captured and recorded

digitally with screen capture software running on the test machine. A

web camera recorded each participant’s facial expressions synced

with the screen capture, and verbal comments were recorded

with a microphone. 8 The test session were electronically transmitted to a

nearby observation room where the data logger observed the test

session.

PARTICIPANT INSTRUCTIONS

The administrator reads the following instructions aloud to the each

participant (also see the full moderator’s guide in Appendix [B4]):

Thank you for participating in this study. Your input is very important. Our session today will last about 120 minutes. During that time you will use an instance of an electronic health record. 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

8 There are a variety of tools that record screens and transmit those recordings across a local area network for remote observations.

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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.

Following the procedural instructions, participants were shown the EHR

and as their first task, were given time (10 minutes) to explore the

system and make comments. Once this task was complete, 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 that you not talk aloud or verbalize while you are doing the tasks. 9 I will ask you your impressions about the task once you are done.

Participants were then given 9 tasks to complete. Tasks are listed in

the moderator’s guide in Appendix [B4].

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 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:

1. Effectiveness of the test by measuring participant success rates and errors

2. Efficiency of the test by measuring the average task time and path deviations

9 Participants should not use a think-aloud protocol during the testing. Excessive verbalization or attempts to converse with the moderator during task performance should be strongly discouraged. Participants will naturally provide commentary, but they should do so, ideally, after the testing. Some verbal commentary may be acceptable between tasks, but again should be minimized by the moderator.

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3. Satisfaction with the test by measuring ease of use ratings DATA SCORING

The following table (Table [x]) details how tasks were scored, errors

evaluated, and the time data analyzed. 10

Measures Rationale and Scoring Effectiveness:

Task Success 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.

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 are provided as a percentage.

Task times were recorded for successes. Observed task times divided by the optimal time for each task is a measure of optimal efficiency.

Optimal task performance time, as benchmarked by expert performance under realistic conditions, is recorded when constructing tasks. Target task times used for task times in the Moderator’s Guide must be operationally defined by taking multiple measures of optimal performance.

Effectiveness:

Task Failures If the participant abandoned the task, did not reach the correct answer or performed it incorrectly, or reached the end of the allotted time before successful completion, the task was counted as an “Failures.” No task times were taken for errors.

The total number of errors was calculated for each task and then divided by the total number of times that task was attempted. Not all deviations would be counted as errors.11 This should also be expressed as the mean number of failed tasks per participant.

On a qualitative level, an enumeration of errors and error types should be collected.

Efficiency:

Task Deviations The participant’s path (i.e., steps) through the application was recorded. Deviations occur if the participant, for example, went to a wrong 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 number of steps in the observed path is divided by the number of optimal steps to provide a ratio of path deviation.

10 An excellent resource is Tullis, T. & Albert, W. (2008). Measuring the User Experience. Burlington, MA: Morgan Kaufman. Also see 11 Errors have to be operationally defined by the test team prior to testing.

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It is strongly recommended that task deviations be reported. Optimal paths (i.e., procedural steps) should be recorded when constructing tasks.

Efficiency:

Task Time Each task was timed from when the administrator said “Begin” until the participant said, “Done.” If he or she failed to say “Done,” the time was stopped when the participant stopped performing the task. Only task times for tasks that were successfully completed were included in the average task time analysis. Average time per task was calculated for each task. Variance measures (standard deviation and standard error) were also calculated.

Satisfaction:

Task Rating Participant’s subjective impression of the ease of use of the application was measured by administering both a simple post-task 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. 12

Common convention is that average ratings for systems judged easy to use should be 3.3 or above.

To measure participants’ confidence in and likeability of the test overall, the testing team administered the System Usability Scale (SUS) post-test questionnaire. Questions included, “I think I would like to use this system frequently,” “I thought the system was easy to use,” and “I would imagine that most people would learn to use this system very quickly.” See full System Usability Score questionnaire in Appendix 5.13

Details of how observed data were scored.

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RESULTS

DATA ANALYSIS AND REPORTING

The results of the usability test were calculated according to the methods

specified in the Usability Metrics section above. Participants who failed to

follow session and task instructions had their data excluded from the

analyses

12 See Tedesco and Tullis (2006) for a comparison of post-task ratings for usability tests. Tedesco, D. & Tullis, T. (2006) A comparison of methods for eliciting post-task subjective ratings in usability testing. Usability Professionals association Conference, June 12 – 16, Broomfield, CO. 13 The SUS survey yields a single number that represents a composite measure of the overall perceived usability of the system. SUS scores have a range of 0 to 100 and the score is a relative benchmark that is used against other iterations of the system.

The usability testing results for the EHRUT are detailed below14. The

results should be seen in light of the objectives and goals outlined in

Section 3.2 Study Design. The data should yield actionable

results that, if corrected, yield material, positive impact on user

performance.

The results from the SUS (System Usability Scale) scored the subjective

satisfaction with the system based on performance with these tasks to

be a mean of : 2.94.15

DISCUSSION OF THE FINDINGS

14 Note that this table is an example. You will need to adapt it to report the actual data collected. 15 See Tullis, T. & Albert, W. (2008). Measuring the User Experience. Burlington, MA: Morgan Kaufman (p. 149).

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EFFECTIVENESS It appeared that the subjects only pressed the buttons they needed to, and mostly ignored anything they didn’t use, although it is reasonable to think that less buttons would lead to less hesitation. EFFICIENCY

Most users found they had several options from each of the screens and they could easily jump to any screen they wanted to from any other screen. Again, if they did not need a particular button or option, most would simply ignore it. If they did need it, they were happy it was there. Overall, they found it very efficient. SATISFACTION

The subjects were very impressed with the software and reported finding it very easy-to-use. Most would recommend it to others and those that don’t use this EMR in an office setting would be happy to give it a try. Moreover, they would be happy to receive additional training and learn more about the software, if they knew nothing about it in the first place. MAJOR FINDINGS

Overall, the subjects found the software easy to use once they acclimated to it. Most responded that once they knew or were shown how to do a task, they did not have to be shown again. They found the flashing arrow and prompts very helpful. Some subjects were confused by the difference between medications and prescriptions in e-scripts, but once they understood the meaning of the terms, were able to find the correct information.

AREAS FOR IMPROVEMENT

Several subjects had difficulty remembering to click the “Select to Move to Current Meds” button once they had select the correct med, suggesting removal of this in a future update, if possible. In general, some subjects were uncomfortable with the slight interface change between PowerSoft and the e-scipts window, although they quickly adapted.

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PARTICIPANT DEMOGRAPHICS The report should contain a breakdown of the key participant demographics. A representative list is

shown below. Following is a high-level overview of the participants in this study.

Gender Men [2 ] Women [3 ] Total (participants) [5 ]

Occupation/Role RN/BSN [0 ] Physician [1 ] Admin Staff [4 ] Total (participants) [5 ]

Years of Experience Years experience [0 ] Facility Use of EHR All paper [0 ] Some paper, some [5 ] electronic All electronic [0 ] Total (participants) [5 ]

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Usability Test Report of NewCrop, LLC

170.314(g)(3) NewCropCoreVersion: 13.05DateofUsabilityTest:/DateofReport: 07/25/2013UsabilityTestConducted: 07/25/2013ReportPrepared: 07/25/2013ReportPrepartedby: NewCrop,LLC

[email protected] 903.445.7079Newcrop,LLC1800BeringDr.#600Houston,TX77057

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Table of Contents 

1.EXECUTIVESUMMARY.......................................................................................................................3

2.METHOD....................................................................................................................................................4

2.1PARTICIPANTS...............................................................................................................................4

2.2TASKS..................................................................................................................................................5

2.3USABILITYMETRICS....................................................................................................................8

3.RESULTS....................................................................................................................................................8

3.1DATAANALYSISANDREPORTING........................................................................................8

3.2DISCUSSIONOFFINDINGS.........................................................................................................9

4.APPENDICES............................................................................................................................................9

4.1Appendix1:PARTICIPANTDEMOGRAPHICS....................................................................9

4.2Appendix2:INFORMEDCONSENTFORM.......................................................................10

4.3Appendix3:FINALQUESTIONS...........................................................................................12

4.4Appendix4:SYSTEMUSABILITYSCALEQUESTIONNAIRE.....................................12

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1. EXECUTIVE SUMMARY A usability test of NewCrop Core 13.05 was conducted on 07/25/2013 by online meeting via GoToMeeting by Jennifer Harvey. The purpose of this test was to test and validate the usability of the current user interface, and provide evidence of usability in the EHR Under Test (EHRUT). During the usability test, one healthcare provider and one nurse matching the target demographic criteria served as participants and used the EHRUT in simulated, but representative tasks.

This study collected performance data on 18 tasks typically conducted on NewCrop Core 13.05:

CPOE (314.a.1)

Record Medication Order Change Medication Order Access Medication Order Record Laboratory Order Change Laboratory Order Access Laboratory Order Record Radiology/Imaging Order Change Radiology/Imaging Order Access Radiology/Imaging Order

Drug-drug, drug-allergy interactions checks (314.a.2)

Create drug-drug and drug-allergy interventions prior to CPOE completion Adjustment of severity level of drug-drug interventions

Medication list (314.a.6) Record Medication List Change Medication List Access Medication List

Medication allergy list (314.a.7) Record Medication List Change Medication List Access Medication List

Formulary Checking (314.a.7)

Electronic prescribing (314.b.3) – Create prescriptions

Clinical Messaging

Compose Clinical message View Unread Clinical Message View Sent Clinical Message

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2. METHOD During the 60 minute usability test, participants were greeted by the administrator and asked to review and sign an informed consent/release form (included in Appendix 2); they were instructed that they could withdraw at any time. Participants had prior experience with NewCrop Core 13.05 through their EHR application. Testing was completed in a Pre-Production environment, using a direct log in to NewCrop Core 13.05. The administrator introduced the test, and instructed participants to complete a series of tasks (given one at a time). During the testing, the administrator recorded user performance data on paper and electronically. The administrator did not give the participant assistance in how to complete the task. �

The following types of data were collected for each participant:

• Number of tasks successfully completed

• Number and types of errors

• Path deviations

• Participant’s verbalizations

• Participant’s satisfaction ratings of the system �

Following the conclusion of the testing, the practice was asked to complete a post- test questionnaire. Following is a summary of the performance and rating data collected on the EHRUT.

2.1 PARTICIPANTS Participants for the test consisted of the following subjects

• 1 Doctor of Internal Medicine with 5 years of experience with EHR software. • 1 Licensed Practical Nurse with 5 years of experience with EHR Software.

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2.2 TASKS 

Task Ratings 1= Very Easy 2= Easy 3= Neither Easy, Nor Difficult 4= Difficult 5= Very Difficult

Physician Results:

Task Path Deviation Number of errors

Type of Error Task Rating

Record Medication Order

None 0 0 1-Very Easy

Change Medication Order

None 0 0 1-Very Easy

Access Medication Order

None 0 0 1-Very Easy

Record Laboratory Order

None 0 0 1-very easy

Change Laboratory Order

Clicked “Validate order” prior to modifying the order

0 0 1-very easy

Access Laboratory Order

None 0 0 1-very easy

Record Radiology/Imaging Order

None 0 0 1-very easy

Change Radiology/Imaging Order

None 0 0 1-very easy

Access Radiology/Imaging Order

None 0 0 1-very easy

Access Formulary Checking

None 0 0 1-very easy

Create Drug-Drug Intervention

None 0 0 1-very easy

Create Drug-Allergy Intervention

None 0 0 1-very easy

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Adjust Severity of Drug-Drug Intervention

None 0 0 1-very easy

Adjust Severity of Drug-Allergy Intervention

None 0 0 1-very easy

Record Medication Allergy List

None 0 0 1-very easy

Change Medication Allergy List

None 0 0 1-very easy

Access Medication Allergy List

None 0 0 1-very easy

Create Electronic Prescription

None 0 0 1-very easy

Compose Clinical Message

None 0 0 1-Very Easy

View Unread Clinical Message

No deviations, but test subject stated that the layout was cluttered and appeared to be one solid link rather than individual links for Compose, Inbox, and Sent, prompting him to give a rating of 2-Easy

0 0 2-Easy

View Sent Message

No deviations, but test subject stated that the layout was cluttered and appeared to be one solid link rather than individual links for Compose, Inbox, and Sent, prompting him to give a rating of 2-Easy

0 0 2-Easy

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Nurse Results:

Task Path Deviation Number of errors

Type of Error Task Rating

Record Medication Order

None 0 0 1-Very Easy

Change Medication Order

None 0 0 1-Very Easy

Access Medication Order

None 0 0 1-Very Easy

Record Laboratory Order

None 0 0 1-very easy

Change Laboratory Order

None 0 0 1-very easy

Access Laboratory Order

None 0 0 1-very easy

Record Radiology/Imaging Order

None 0 0 1-very easy

Change Radiology/Imaging Order

None 0 0 1-very easy

Access Radiology/Imaging Order

None 0 0 1-very easy

Access Formulary Checking

None 0 0 1-very easy

Create Drug-Drug Intervention

None 0 0 1-very easy

Create Drug-Allergy Intervention

None 0 0 1-very easy

Adjust Severity of Drug-Drug Intervention

None 0 0 1-very easy

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Adjust Severity of Drug-Allergy Intervention

None 0 0 1-very easy

Record Medication Allergy List

None 0 0 1-very easy

Change Medication Allergy List

None 0 0 1-very easy

Access Medication Allergy List

None 0 0 1-very easy

Create Electronic Prescription

None 0 0 1-very easy

Compose Clinical Message

None 0 0 1-Very Easy

View Unread Clinical Message

No deviations, but test subject stated that the layout was cluttered and appeared to be one solid link rather than individual links for Compose, Inbox, and Sent, prompting him to give a rating of 2-Easy

0 0 2-Easy

View Sent Message

No deviations, but test subject stated that the layout was cluttered and appeared to be one solid link rather than individual links for Compose, Inbox, and Sent, prompting him to give a rating of 2-Easy

0 0 2-Easy

2.3 USABILITY METRICS 1= Very Easy 2= Easy 3= Neither Easy, Nor Difficult 4= Difficult 5= Very Difficult

3. RESULTS 

3.1 DATA ANALYSIS AND REPORTING The results of the usability test were calculated according to the Task Ratings specified above.

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3.2 DISCUSSION OF FINDINGS 

SATISFACTION

The test subjects were satisfied with the workflow of commonly used features such as writing and transmitting new medications, discontinuing medications, formulary checking, drug-drug interaction checking, drug-allergy interaction checking. They were also satisfied with new features such as clinical messaging and lab ordering, though feedback was given regarding areas for improvement in clinical messaging.

MAJOR FINDINGS

Overall, the test subjects navigated the system with ease. There was a slight deviation in changing the lab order the first time where the test doctor clicked “validate” before adding a new lab and validating the order. This was the only actual error in 18 tasks tested.

AREAS FOR IMPROVEMENT

In the course of testing, the subjects indicated that they would like to see a confirmation for drug-drug interaction checking that involved actually clicking an acknowledgement of the interaction, rather than simply viewing it on the screen. The subjects also indicated that the separate links for Compose, Inbox, and Sent messages in the clinical messaging portion of the system are too close together and give the impression of being one link. This led to some confusion in the messaging portion of the test, but no errors or deviations were recorded due to this confusion.

In the imaging and laboratory portion of the test, the physician recommended that the drop down box for lab location selection be renamed lab/imaging facility because it could cause confusion if taken literally, as imaging orders aren’t sent to a “lab.” It did not cause errors or deviations with either subject.

4. APPENDICES The following appendices include supplemental data for this usability test report. Following is a list of the appendices provided:

1.ParticipantDemographics2.InformedConsentForm3.FinalQuestions4.SystemUsabilityScaleQuestionnaire

4.1 Appendix 1: PARTICIPANT DEMOGRAPHICS Following is a high-level overview of the participants in this study.

Gender

Men [1] Women [1] Total (participants) [2]

Occupation/Role

LPN [1] Physician [1] Admin Staff [0] Total (participants) [2]

Years of Experience

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Facility Use of EHR [5]�All paper [8] Some paper, some electronic [3]

All electronic [2] Total (participants) [2]

Detailed Participant Overview

The intended users, of NewCrop Core 13.05, include Physicians, Mid-level Prescribers, Nurses, and Clinical Staff. For this case study, one Physician and one Nurse performed all tests.

 

4.2 Appendix 2: INFORMED CONSENT FORM

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4.3 Appendix 3: FINAL QUESTIONS What was your overall impression of this system? Overall impression is very good, nice interface and easy to understand and intuitive

What aspects of the system did you like most? eRx we have done and works great, appreciate adding interface for lab ordering

What aspects of the system did you like least? messaging, once a message is sent the message should leave the screen

Were there any features that you were surprised to see? yes, surprised to see the lab feature with a Medication company

What features did you expect to encounter but did not see? That is, is there anything that is missing in this application? not sure as I have not seen everything but the question is if this is solely lab ordering or what I'd like to see is also interface of receiving lab as structured data

Compare this system to other systems you have used. Would you recommend this system to your colleagues? Only using MacPractice that does not really have this feature yet

4.4 Appendix 4: SYSTEM USABILITY SCALE QUESTIONNAIRE  Please answer the following questions with a response of strongly agree, agree, neither agree nor disagree, disagree, or strongly disagree

1. I think that I would like to use this system frequently. strongly agree

2. I found the system unnecessarily complex. strongly disagree

3. I thought the system was easy to use. strongly agree

4. I think that I would need the support of a technical person to be able to use this system. strongly disagree

5. I found the various functions in this system were well integrated. strongly agree

6. I thought there was too much inconsistency in this system. strongly disagree

7. I would imagine that most people would learn to use this system very quickly. strongly agree

8. I found the system very cumbersome to use. strongly disagree

9. I felt very confident using the system. strongly agree

10. I needed to learn a lot of things before I could get going with this system. strongly disagree

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Test Subjects Demographics Chart

PartID

Gender

Age Education

ProfessionalExperience

ComputerExperience

ProductExperience

AssistiveTechnologyNeeds

1 Subject 1

female

Notcollected

Notcollected

20 yearsmedical officemanager

Notcollected

7 years Notcollected

2 Subject 2

female

Notcollected

Notcollected

7 yearsmedicalassistant

Notcollected

none Notcollected

3 Subject 3

female

Notcollected

Notcollected

6 yearsmedical officemanager

Notcollected

6 years Notcollected

4 Subject 4

male Notcollected

Notcollected

39 years as aphysician

Notcollected

5 years Notcollected

5 Subject 5

male Notcollected

Notcollected

12 years as amedical officemanager

Notcollected

Notcollected

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Addendum To DATA SCORING

Qualitative Evaluation of Errors:

Task 1) First Impressions - errors not applicable

Task 2) Review Computerized Orders - zero errors total

Task 3) Create New Medication Orders - 3 errors totalError 1) Subject 2 tried to click on existing orders instead of new orders as the“create new order” button is below the list of existing ordersError 2) Subject 3 did not know to press “complete meds” button once theyhad selected medsError 3) Subject 4 added to the meds list, but also transmitted the medicationto the pharmacy as if it was a prescription

Task 4) Create new lab orders - 1 error totalError 1) Subject 3 did not hit the “save & exit” button after composing the order

Task 5) Create New Radiology Orders - zero errors total

Task 6) Mark Orders Complete - 1 error totalError 1) Subject 4 marked multiple orders complete instead of just 1

Task 7) Electronic Prescriptions - 5 errors totalError 1) Subject 1 ignored the warnings for contraindicationError 2) Subject 2 made a spelling error, could not find the drug and could notfigure out how to search againError 3) Subject 3 got to the review page and thought she was finished, butshe still needed to send the prescriptionsError 4) Subject 4 decided to send the drug, even with the contraindicationwarningError 5) Subject 5 had trouble viewing the screen, had to wait for each screen

Task 8) Build medication List - 1 error totalError 1) Subject 2 added an order instead of medication list, then started overand left that order pending

Task 9) Build Allergy List - zero error total

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Test Results Summary for 2014 Edition EHR Certification 14-2710-R-0092-PRA V1.2 May 4, 2017

©2017 InfoGard. May be reproduced only in its original entirety, without revision Page 11 of 13

Appendix B: Quality Management System

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Quality Management System Attestation Form-EHR-37-V03

InfoGard Laboratories, Inc. Page 1

For reporting information related to testing of 170.314(g)(4).

Vendor and Product Information

Vendor Name Data Tec, Inc.

Product Name PowerSoftMD Certified

Quality Management System

Type of Quality Management System (QMS) used in the development, testing, implementation, and maintenance of EHR product.

Based on Industry Standard (for example ISO9001, IEC 62304, ISO 13485, etc.). Standard:

A modified or “home-grown” QMS.

No QMS was used.

Was one QMS used for all certification criteria or were multiple QMS applied?

One QMS used.

Multiple QMS used.

Description or documentation of QMS applied to each criteria:

Not Applicable.

Statement of Compliance

I, the undersigned, attest that the statements in this document are completed and accurate.

Vendor Signature by an Authorized Representative

Date Dec. 5, 2014

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Appendix C: Privacy and Security

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Privacy and Security Attestation Form-EHR-36-V04

InfoGard Laboratories, Inc. Page 1

Vendor and Product Information

Vendor Name Data Tec, Inc.

Product Name PowerSoftMD Certified

Privacy and Security

170.314(d)(2) Auditable events and tamper-resistance

Not Applicable (did not test to this criteria)

Audit Log:

Cannot be disabled by any user.

Audit Log can be disabled.

The EHR enforces that the audit log is enabled by default when initially configured

Audit Log Status Indicator:

Cannot be disabled by any user.

Audit Log Status can be disabled

The EHR enforces a default audit log status. Identify the default setting (enabled or disabled):

There is no Audit Log Status Indicator because the Audit Log cannot be disabled.

Encryption Status Indicator (encryption of health information locally on end user device):

Cannot be disabled by any user.

Encryption Status Indicator can be disabled

The EHR enforces a default encryption status. Identify the default setting (enabled or disabled):

There is no Encryption Status Indicator because the EHR does not allow health information to be stored locally on end user devices.

Identify the submitted documentation that describes the inability of the EHR to allow users to disable the audit logs, the audit log status, and/or the encryption status: PowerSoftMD does not allow the Audit Logs to be disabled. Therefore, there is no Audit Log Status indication because it is always active. PowerSoftMD does not ever give users access to Audit Log Files or Data Bases; only the ability for authorized user to view reports. PowerSoftMD Certified is designed to not store any electronic health information on workstations or end user devices. Since, even when in use, no electronic health information is stored on the device, there is not any electronic health information on the workstations or end user device to encrypt. You can also see AuditLogsAndEncryptionAffidavit.pdf

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Privacy and Security Attestation Form-EHR-36-V04

InfoGard Laboratories, Inc. Page 2

Identify the submitted documentation that describes the method(s) by which the EHR protects 1) recording of actions related to electronic health information, 2) recording of audit log status, and 3) recording of encryption status from being changed, overwritten, or deleted by the EHR technology: Actual logs are never presented for users, when requested, only copies of logs are presented. Logs are not stored in user editable format. No options to view, change, overwrite, or delete log files exist in the PowerSoftMD Certified software. Also refer to our AuditLogsAndEncryptionAffidavit.pdf.

Identify the submitted documentation that describes the method(s) by which the EHR technology detects whether the audit log has been altered: The Audit Log is not accessible by users. Refer to our AuditLogsAndEncryptionAffidavit.pdf.

170.314(d)(7) End-user device encryption

Storing electronic health information locally on end-user devices (i.e. temp files, cookies, or other types of cache approaches).

Not Applicable (did not test to this criteria)

The EHR does not allow health information to be stored locally on end-user devices.

Identify the submitted documentation that describes the functionality used to prevent health information from being stored locally: There are no functions in the PowerSoftMD software for storing patient health information on end user devices. Also refer to our AuditLogsAndEncryptionAffidavit.pdf.

The EHR does allow health information to be stored locally on end user devices.

Identify the FIPS 140-2 approved algorithm used for encryption:

Identify the submitted documentation that describes how health information is encrypted when stored locally on end-user devices:

The EHR enforces default configuration settings that either enforces the encryption of locally stored health information or prevents health information from being stored locally.

Identify the default setting: The default, and only setting, is for health information to not be stored on any end user devices Also refer to our AuditLogsAndEncryptionAffidavit.pdf.

170.314(d)(8) Integrity

Not Applicable (did not test to this criteria)

Identify the hashing algorithm used for integrity (SHA-1 or higher): SHA1

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Privacy and Security Attestation Form-EHR-36-V04

InfoGard Laboratories, Inc. Page 3

170.314(e)(1) View, Download, and Transmit to 3rd Party

Not Applicable (did not test to this criteria)

Identify the FIPS 140-2 approved algorithm used for encryption:

AES256

Identify the FIPS 140-2 approved algorithm used for hashing:

SHA1

170.314(e)(3) Secure Messaging

Not Applicable (did not test to this criteria)

Identify the FIPS 140-2 approved algorithm used for encryption:

AES256

Identify the FIPS 140-2 approved algorithm used for hashing:

SHA1

Statement of Compliance

I, the undersigned, attest that the statements in this document are accurate.

Vendor Signature by an Authorized Representative

Date Dec. 5, 2014

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Test Results Summary for 2014 Edition EHR Certification 14-2710-R-0092-PRA V1.2 May 4, 2017

©2017 InfoGard. May be reproduced only in its original entirety, without revision Page 13 of 13

Test Results Summary Document History

Version Description of Change Date V1.0 Initial release March 9, 2015

V1.1 Updated Safety-Enhanced Design report March 2, 2016

V1.2 Removed specific participant info from Safety-Enhanced Design report

May 4, 2017

END OF DOCUMENT


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