2024 Real World Testing: Wellsoft

Wellsoft

GENERAL INFORMATION

Developer Name: Wellsoft Corporation, a Division of Medsphere Systems Corporation

Plan Report ID Number: 20231025wel

Product Name(s): Wellsoft EDIS

Version Number(s): 11

Product List (CHPL) ID(s): 15.05.05.2538.WLST.01.01.1.180703

ONC-ACB Certification ID: 15.05.05.2538.WLST.01.01.1.180703

Developer Real World Testing Page URL:

https://www.medsphere.com/certifications/RealWorldTesting/Wellsoft

JUSTIFICATION FOR REAL WORLD TESTING APPROACH

At this time, Wellsoft EDIS is marketed as an Emergency Department Solution. Therefore, the Real World Testing plan will apply to this care setting. We feel that having the ability to capture data and transmit data related to communicable diseases to public health agencies as required in 170.315(f)(2) Transmission to public health agencies – syndromic surveillance, is a key piece of interoperability if that information becomes available during an emergency visit. Our Real World Testing approach will help us determine the usability rating and outcomes of these types of transmissions.

STANDARDS UPDATES (INCLUDING STANDARDS VERSION ADVANCEMENT PROCESS (SVAP) AND UNITED STATES CORE DATA FOR INTEROPERABILITY (USCDI))

This product utilizes all standards associated with the 2015 Cures Update methods.

Standard (and version)Not applicable
Date of ONC-ACB notificationNot applicable
Date of customer notification (SVAP only)Not applicable
USCDI-updated certification criteria (and USCDI version)None

MEASURES USED IN OVERALL APPROACH

The following outlines our measures that have been identified to best demonstrate how our product is in and maintains conformance to 170.315(f)(2) Transmission to Public Health Agencies-Syndromic Surveillance

Measure 1 (Message Transmission status to Public Health Agency)

This measure will capture the success/failure rates of HL7 messages being transmitted. Specifically, we will extract ADT messages to analyze error rates for public health agencies. (ADT-04, ADT-08)

Certification CriteriaAssociated CriteriaRelied Upon Software
170.315(f)(2) Transmission to Public Health Agencies – Syndromic SurveillanceTransmit ADT message to public health agency.N/A

Rationale: Wellsoft EDIS gives clinicians the ability to transmit certain information to external entities using HL7 standards. These message types are transmitted through an HL7 engine and logged in the system. When an instance arises around communicable diseases, the data is captured within the system, these data elements

are parsed into an HL7 message and transmitted to the respective external entity. This will provide an analytical view of the success rates of transmission.

Test Approach 1: (in the event that we have clients set up to exchange messages with a public health agency) System logs will be used to extract certain message types related to syndromic surveillance activities. Success rates of ADT messages being delivered to public health agencies will be reviewed and trended over time.

Expected Outcome(s): It is expected that clients will be able to transmit HL7 messages without limitations and in compliance with the certification criteria, including the technical standards and vocabulary code sets. We do anticipate some clients will experience some delay on first attempt due to network connectivity so we anticipate that 90% of messages will be successfully transmitted and the 10% error rate accounts for issues with network.

Test Approach 2: (in the event that we do not have clients set up to exchange messages with a public health agency) System logs will be used to extract certain message types related to immunization and syndromic surveillance activities. Success rates of ADT messages being delivered to a test entity will be conducted on a quarterly basis.

Expected Outcome(s): It is expected that standard ADT message types will be able to be created within a test environment and transmitted to an external test entity without limitations and in compliance with the certification criteria, including the technical standards and vocabulary code sets. Success/error rates will be captured to determine that the system is functioning as certified.

Care Setting(s)

Wellsoft EDIS is only marketed to emergency department settings, therefore, only emergency departments will be used for Real World Testing.

SCHEDULE OF KEY MILESTONES

Key MilestoneDate/Timeframe
Begin collection of data laid out by plan March 2024
Data Collection and ReviewQuarterly
End of Real World Testing for all measures.December, 2024
Final data review and analytics, create results reportJanuary 2025
Submit Real World Testing Results Report to ACBJanuary 2025

ATTESTATION

This Real World Testing plan is complete with all required elements, including measures that address all certification criteria and care settings. All information in this plan is up to date and fully addresses the health IT developer’s Real World Testing requirements.

Authorized Representative Name: Nicki Anderson, Director, Compliance
Authorized Representative Email: nicki.anderson@medsphere.com
Authorized Representative Phone:      760.979.6531
Authorized Representative Signature:               Nicki Anderson
Date:  October 9, 2023