Medaxion Pulse Real World Testing Plan for § 170.315(b)(10) Electronic Health Information Export - 2025
General Information
- Developer Name: Medaxion, Inc.
- Product Name(s): Medaxion Pulse
- Version Number(s): Platform
- Certified Health IT Product List (CHPL) Product Number(s): 15.05.05.2797.MEDX.01.01.0.211207
- Developer Real World Testing Page URL: https://www.medaxion.com/rwt
Introduction
Consistent with the ONC's recommendation that "Real World Testing verifies that deployed Certified Health IT continues to perform as intended by conducting and measuring observations of interoperability and data exchange," this test plan focuses on capturing and documenting instances in which the certified EHI export capability is successfully utilized in the real world. Medaxion will demonstrate the required certified capability in a semi-controlled setting that closely approximates real-world usability.
It is important to note that Real-World Testing is only one component of the Health IT Certification program that demonstrates compliance with program requirements. Real-world testing augments and supports the testing conducted before certification without duplicating the methods or results previously demonstrated. This plan is designed to show that the certified capabilities have been successfully deployed and are available for providers to use at their discretion in live clinical settings.
Justification for Real-World Testing Approach
This Real-World Testing plan focuses on ensuring that the Medaxion Pulse EHR’s Electronic Health Information Export functionality (§ 170.315(b)(10)) operates as intended in live clinical environments. This capability enables the transition of care between electronic health systems, the sharing of patient data with external systems, and the movement of bulk patient data between systems. Real-world testing will validate that this functionality complies with ONC’s interoperability and data export standards.
Approach:
- Real Patient Data: Testing will occur in production environments using actual patient data in multiple care settings.
- Clinical Settings: The test will cover ambulatory surgery centers and in-patient (hospital) facilities.
- Focus on Key Export Types: Single-patient and multi-patient data exports will be timed and inspected for completeness.
- Manual Testing and User Tracking: Since the certified EHI export functionality is not used daily, testing will be conducted manually. The users performing the test will track and document all test activities, including the volume of exports, accuracy, and success rate of each operation. This ensures that the process accurately reflects real-world conditions.
Standards Updates
- No SVAP standards updates
Care Settings for Testing
Real World Testing will be conducted in the following settings where Medaxion Pulse is marketed:
- Ambulatory Surgery Centers
- Inpatient (Hospital) Facilities
Testing Methodology
Key Metrics and Measures
1. Success Rate of EHI Exports
- Measure: The percentage of successful exports out of total export attempts.
- Goal: Achieve a 95% or higher success rate.
- Method: Logs will track and document all EHI export attempts, noting successes and failures.
- Justification: Accuracy of data in exports is a critical factor in technology adoption.
2. Time to Complete Export
- Measure: The time to complete an export for single and multi-patient (bulk) exports.
- Goal: Individual patient exports should be completed within 5 minutes, and bulk population exports should be completed within 1 hour per 1000 patient records.
- Method: The user will use a stopwatch time from export initiation to completion for manual single-patient exports. For bulk exports, the user will record the time the export was requested and the timestamp on the email notification to measure the indication of the export's completion.
- Justification: Verify that a trained user can promptly export electronic health information for one patient record and the patient population, timeliness of data access is critical factor in technology adoption.
3. User Feedback on EHI Export
- Measure: User satisfaction ratings and qualitative feedback regarding the export feature's ease of use and reliability.
- Goal: Average rating of 3.5 or higher on a 5-point scale.
-Method: User surveys and interviews will be conducted post-testing.
- Justification: Ease-of-use is a critical factor in technology adoption.
Milestones and Timeline
1. Q1: Identify test participants from diverse clinical environments, finalize test scenarios and train users.
2. Q2–Q3: Conduct testing in live environments, capturing export success rates, time to completion, and user feedback.
3. Q4: Analyze results, resolve any issues encountered, and prepare the Real World Testing report for submission to the ONC-ACB.
Expected Outcomes
- Interoperability: Demonstrate that Medaxion Pulse’s EHI export functionality enables seamless data exchange with external systems.
- Timeliness: Exports will be completed in a situationally appropriate time interval.
- User Satisfaction: Users will report high satisfaction with the export feature's ease of use and functionality.
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.
/s/ John Toups
info@medaxion.com
615-537-5500
11/14/2024, 11:00 CDT
Plan Report ID # 20241115mdx