Usability Veracity Attestation (170.315.g.3) - Usability Veracity Attestation (170.315.g.3) Debbie McKay,

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  • Usability Veracity Attestation (170.315.g.3) Debbie McKay, RN, BHS, JD Senior Solutions Manager – Regulatory Sunrise Business Unit Allscripts Healthcare Solutions 222 Merchandise Mart Plaza, Suite 2024 Chicago, IL 60654 1.800.334.8534 For public release: Allscripts attests that the usability standard/process and usability report submitted for the certification of Sunrise Clinical Manager (Allscripts 'Sunrise Acute Care', and Allscripts 'Sunrise Ambulatory Care' EHRs) is accurate and complete per the requirements of the ONC criterion 170.315(g)(3). I hereby attest that all above statements are true, as an authorized signing authority on behalf of my organization.

    Debbie McKay, RN, BHS, JD Sr Solutions Manager-Regulatory 11/17/2016

  • User-Centered Design Process Template (170.315.g.3) Debbie McKay, RN, BHS, JD Senior Solutions Manager – Regulatory Sunrise Business Unit Allscripts Healthcare Solutions 222 Merchandise Mart Plaza, Suite 2024 Chicago, IL 60654 1.800.334.8534 For public release: Allscripts used the following usability design in developing and designing their health IT module, Sunrise Clinical Manager (Allscripts 'Sunrise Acute Care', and Allscripts 'Sunrise Ambulatory Care' EHRs): NISTIR 7741. National Institute of Standards and Technology. (2010). NIST Guide to the Processes Approach for Improving the Usability of Electronic Health Records (NISTIR 7741). Gaithersburg, MD. www.nist.gov/manuscript-publication-search.cfm?pub_id=907313. According to the National Institute of Standards and Technology (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 goals are for users to interact with the system safely, effectively, efficiently, and with an acceptable level of satisfaction. To this end, design to optimize for safety, effectiveness, efficiency and user satisfaction was utilized throughout the design and development cycle. I hereby attest that all above statements are true, as an authorized signing authority on behalf of my organization.

    Debbie McKay, RN, BHS, JD Sr Solutions Manager-Regulatory 11/17/2016

    http://www.nist.gov/manuscript-publication-search.cfm?pub_id=907313

  • Allscripts Sunrise Acute Care 16.3

    Customized Common Industry

    Format Template for Electronic

    Health Record Usability Testing

    A User-Centred Design (UCD) Activity

    www.allscripts.com Copyright © 2016 Allscripts Healthcare Solutions, Inc.

  • Solution Design Document 22-Dec-16 Page 2 of 208

    Copyright Notice

    Copyright © 2016 Allscripts Healthcare Solutions, Inc.

    Confidentiality and Proprietary Rights

    This document is the confidential property of Allscripts Healthcare Solutions, Inc. It

    is furnished under an agreement with Allscripts Healthcare Solutions, Inc. and may

    only be used in accordance with the terms of that agreement. The use of this

    document is restricted to customers of Allscripts Healthcare Solutions, Inc. and their

    employees. The user of this document agrees to protect the Allscripts Healthcare

    Solutions, Inc. proprietary rights as expressed herein. The user further agrees not to

    permit access to this document by any person for any purpose other than as an aid

    in the use of the associated system. In no case will this document be examined for

    the purpose of copying any portion of the system described herein or to design

    another system to accomplish similar results. This document or portions of it may

    not be copied without written permission from Allscripts Healthcare Solutions, Inc.

    The information in this document is subject to change without notice.

  • Solution Design Document 22-Dec-16 Page 3 of 208

    Contents

    1 Executive summary ................................................................................... 5

    1.1 Data Summary ................................................................................... 6

    1.2 Major Findings and Areas for Improvement ................................................ 16

    2 Introduction ........................................................................................... 25

    3 Method .................................................................................................. 26

    3.1 Participants ...................................................................................... 26

    3.2 Study Design .................................................................................... 33

    3.3 Tasks ............................................................................................. 34

    3.4 Procedures....................................................................................... 35

    3.5 Test Location .................................................................................... 36

    3.6 Test Environment ............................................................................... 36

    3.7 Test Forms and Tools .......................................................................... 37

    3.8 Participant Instructions ......................................................................... 37

    3.8.1 Participant Instructions ...................................................................... 37

    3.9 Usability Metrics ................................................................................ 40

    3.10 Data Scoring .................................................................................. 40

    4 Results: §170.315(a)(1) Computerized Provider Order Entry (CPOE) – Medications 44

    4.1 Task Mapping ................................................................................... 44

    4.2 Task Participant and Instructions ............................................................ 45

    4.3 Data Analysis and Reporting.................................................................. 45

    4.4 Discussion of the Findings .................................................................... 47 5 Results: §170.315(a)(2) Computerized Provider Order Entry (CPOE) – Laboratory .. 50

    5.1 Task Mapping ................................................................................... 50

    5.2 Task Participant and Instructions ............................................................ 51

    5.3 Data Analysis and Reporting.................................................................. 51

    5.4 Discussion of the Findings .................................................................... 53

    6 Results: §170.315(a)(3) Computerized Provider Order Entry (CPOE) – Diagnostic

    Imaging ...................................................................................................... 55

    6.1 Task Mapping ................................................................................... 55

    6.2 Task Participant and Instructions ............................................................ 56

    6.3 Data Analysis and Reporting.................................................................. 56

    6.4 Discussion of the Findings .................................................................... 58

    7 Results: §170.315(a)(4) Drug-Drug, Drug-Allergy Interaction Checks - Clinical ...... 60

    7.1 Task Mapping ................................................................................... 60

    7.2 Task Participant and Instructions ............................................................ 61

    7.3 Data Analysis and Reporting - Clinical ...................................................... 62

    7.4 Discussion of the Findings .................................................................... 63

    8 Results: §170.315(a)(4) Drug-Drug, Drug-Allergy Interaction Checks - Configuration

    66 8.1 Task Mapping ................................................................................... 66

    8.2 Task Participant and Instructions ............................................................ 67

    8.3 Data Analysis and Reporting - Configuration............................................... 67

    8.4 Discussion of the Findings .................................................................... 68

  • Solution Design Document 22-Dec-16 Page 4 of 208

    9 Results: 170.315(a)(5) Demographics - Clinical .............................................. 71

    9.1 Task Mapping ................................................................................... 71

    9.2 Task Participant and Instructions ............................................................ 72

    9.3 Data Analysis and Reporting - Clinical ...................................................... 72

    9.4 Discussion of the Findings .................................................................... 73

    10 Results: 170.315(a)(5) Demographics - Registration ........................................ 76

    10.1 Task Mapping ................................................................................. 76

    10.2 Task Participant and Instructions .......................................................... 77

    10.3 Data Analysis and Reporting ............................................................... 78

    10.4 Discussion of the Findings ................................................