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GENERAL INFORMATION
Developer Name: Wellsoft, a Division of Medsphere Systems Corporation
Plan Report ID Number: 20221022wel
Product Name(s): Wellsoft EDIS
Version Number(s): Wellsoft v.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 certification methods.
| Standard (and version) | Not applicable |
| Date of ONC-ACB notification | Not 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 Criteria | Associated Criteria | Relied Upon Software |
| 170.315(f)(2) Transmission to Public Health Agencies – Syndromic Surveillance | Transmit 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 Milestone | Date/Timeframe |
| Begin collection of data laid out by plan | March 2023 |
| Update Certification for 170.315 (b)(10) | Q3-Q4 |
| Data Collection and Review | Quarterly |
| End of Real World Testing for all measures. | December, 2023 |
| Final data review and analytics, create results report | January 2024 |
| Submit Real World Testing Results Report to ACB | January 2024 |
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 10, 2022 |
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