Real-World Testing

Developer Information:

  • Developer Name: Xcelrate UDI

  • Product Name(s): UDIVERIFY

  • Version Number(s): 1.0, 1.1

  • Certified Health IT Product List (CHPL) ID: 15.04.04.1234.XCEL.01.01.0.210331

  • Developer Real World Testing Plan Page URL: https://www.xcelrateudi.com/rwt-plan

1. General Information:

  • Plan Report ID Number:

  • Developer Name: Xcelrate UDI

  • Product Name(s): UDIVERIFY

  • Version Number(s): 1.0, 1.1

  • CHPL Product Number(s): 15.04.04.1234.XCEL.01.01.0.210331

  • Developer Real World Testing Plan URL: https://www.xcelrateudi.com/rwt-plan

2. Justification for Real World Testing Approach:

UDIVERIFY’s real-world testing is designed to validate the interoperability, functionality, and compliance of the application within actual production environments. The focus is on medical devices, biologics, supplies, and implantable devices, ensuring that UDIVERIFY meets certification criteria and supports essential clinical workflows. This approach includes real-time GUDID validation, patient safety checks (such as alerts for expired or recalled products), and system reliability, even during unexpected downtimes. The system's ability to manage implantable device lists, including critical MRI safety information and other device-specific data, is also a key testing component.

3. Standards Updates:

Any SVAP standards implemented by August 31 of this year will be included in this Real World Testing Plan. UDIVERIFY ensures that all standards are properly addressed, and appropriate conformance measures are applied to demonstrate compliance.

  • Standard (and Version): HL7 FHIR STU3

  • Updated Certification Criteria and Associated Product: §170.315(a)(14) – Implantable Device List

  • Health IT Module CHPL ID: 15.04.04.1234.XCEL.01.01.0.210331

  • Method Used for Standard Update: SVAP

  • Date of ONC-ACB Notification: 10/01/2024

  • Date of Customer Notification: 10/15/2024

  • Conformance Measure: Measure 4 – FHIR-Based UDI Data Exchange

4. Measures Used in Overall Approach:

  • Measure 1 – UDI Validation and Integration:

    • Description of Measurement/Metric: This measure tracks UDIVERIFY’s ability to validate UDIs against the FDA’s GUDID and integrate the data into the EHR, including parsing both machine-readable (barcode) and human-readable data. It also includes populating the 13 required fields, such as MRI safety and GMDN.

    • Associated Certification Criteria: §170.315(a)(14) – Implantable Device List

    • Relied Upon Software: None

    • Justification for the Measurement/Metric: This measure ensures that UDIVERIFY meets ongoing interoperability and functionality requirements while maintaining patient safety and compliance with FDA regulations.

    • Expected Outcomes: Successful UDI validation, real-time data integration into the EHR, and seamless operation even during hospital system downtimes.

    • Care Setting(s): Testing will be conducted in hospitals and surgery centers, specifically within surgical and procedure departments.

  • Measure 2 – Patient Safety Alerts:

    • Description of Measurement/Metric: This measure evaluates UDIVERIFY’s ability to trigger real-time alerts for expired or recalled products based on UDI scans.

    • Associated Certification Criteria: §170.315(a)(14) – Implantable Device List

    • Relied Upon Software: None

    • Justification for the Measurement/Metric: Ensuring patient safety through timely warnings about product status is critical to maintaining the integrity of clinical care.

    • Expected Outcomes: Immediate alerts for expired or recalled products, preventing their use in patient care.

    • Care Setting(s): Testing will be conducted in hospitals and surgery centers, particularly in surgical and procedure departments.

  • Measure 3 – Implantable Device List Management:

    • Description of Measurement/Metric: This measure tracks UDIVERIFY’s ability to accurately manage and track implantable devices, ensuring that all relevant information, including UDI, MRI safety, and expiration dates, is properly documented and associated with patient records.

    • Associated Certification Criteria: §170.315(a)(14) – Implantable Device List

    • Relied Upon Software: None

    • Justification for the Measurement/Metric: This measure ensures that UDIVERIFY supports the comprehensive management of implantable devices, maintaining accurate records for patient safety and regulatory compliance.

    • Expected Outcomes: Accurate tracking of implantable devices from inventory to patient implantation, with all necessary data integrated into the EHR.

    • Care Setting(s): Testing will be conducted in hospitals and surgery centers, particularly within surgical and procedure departments.

5. Key Milestones:

  • Milestone 1: Completion of real-time GUDID validation testing in a hospital setting

    • Date/Timeframe: 05/15/2024

    • Care Setting: Hospitals and surgery centers, surgical and procedure departments

  • Milestone 2: Stress testing during peak operational hours in a large healthcare system

    • Date/Timeframe: 05/01/2024

    • Care Setting: Hospitals and surgery centers, surgical and procedure departments

  • Milestone 3: Finalization of patient safety feature validation, including expiration and recall warnings

    • Date/Timeframe: 05/20/2024

    • Care Setting: Hospitals and surgery centers, surgical and procedure departments

  • Milestone 4: Implantable device list management validation

    • Date/Timeframe: 06/15/2024

    • Care Setting: Hospitals and surgery centers, surgical and procedure departments