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Real World Testing Plan 2023

Executive Summary


This is the Real World Testing plan for CY 2023 for Carefluence’s certified R4 Open API solution.

As ONC has stated in its rule, “The objective of real-world testing is to verify the extent to which a certified health IT deployed in operational production settings is demonstrating continued compliance to certification criteria and functioning with the intended use cases as part of the overall maintenance of a health IT’s certification.” In accordance with the ONC’s recommendation, Carefluence intends to conduct Real World Testing to verify that its Certified health IT product continues to perform as intended with regard to interoperability and data exchange criteria.

This test plan focuses on demonstrating that certified capability is utilized in real world care settings.
Health IT Developers have been given maximum flexibility to develop innovative plans and measures for Real World Testing. As we develop a plan to execute Real World Testing, the overall complexity of the workflows and use cases within the care settings are being consider in which Carefluence’s Health IT products are deployed.

Carefluence has included its milestones and timeline for completing Real World Testing in 2023 below.

Developer 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: Aditya Ayyagari
Authorized Representative Email: aditya.ayyagari@carefluence.com
Authorized Representative Phone: (248) 686-2600 x1003
Authorized Representative Signature: auth signature
Date: 10/26/2022

General Information

General Information
Plan Report ID Number: CF_RWT_2022
Developer Name: Carefluence
Product Name(s): Carefluence Open API
Version Number(s): R4
Certified Health IT Product List (CHPL) ID(s): 15.04.04.2657.Care.R4.01.0.220629
CHPL Product Number CHPL URL
15.04.04.2657.Care.R4.01.0.220629 https://chpl.healthit.gov/#/listing/10922

Timeline and Key Milestones in 2023

1.     Develop list of clients to assist with Real World Testing – Q1, 2023
2.     Preparation and scheduling testing with clients – Q2, 2023
3.     Collection of information as laid out by the plan – Q2 and Q3, 2023
4.     CY 2023 Real World Testing plan will be completed according to ONC and ONC-ACB requirements and expectations – Q4, 2023
5.     Document our CY 2023 test results – January 2024
6.     Submit Real World Testing Report to ONC-ACB – By Feb 01, 2024

Standards Updates – FHIR and USCDI

Standard (and version) FHIR R4 and USCDI 1.0 N/A
Updated certification criteria and associated product N/A
Health IT Module CHPL ID 15.04.04.2657.Care.R4.01.0.220629 N/A
Method used for standard update N/A
Date of ONC-ACB notification July 1 2022 N/A
Date of customer notification (SVAP only) July 1 2022 N/A
Conformance measure N/A N/A
USCDI-updated certification criteria (and USCDI version) USCDI 1.0 N/A

Justification for Real World Testing

Real World Testing is intended to verify that the deployed Certified Health IT continues to perform as intended by demonstrating that certified capability for interoperability and data exchange is successfully utilized in the real world.

All measures reasonably align with the elements within the Real World Testing plan, the scope of the certification, the types of settings in which the certified health IT is marketed, and other factors relevant to the implementation of the certified Health IT Module(s). Each element within the plan is relevant to the overall strategy for meeting the Real World Testing condition and maintenance of Certification requirements.

In each measurement description, we elaborate specifically on our justification for choosing this measure and the expected outcomes. Each measurement was chosen to best evaluate compliance with the certification criteria and interoperability of exchanging electronic health information (EHI) within the certified EHR.

Measures Used in Overall Approach

For each measurement/metric, describe the elements below:

  • Associated certification criteria
  • Description of each measurement/metric
  • Justification for each measurement/metric
  • Expected Outcomes for each measurement/metric
  • Care Settings Targeted will be ambulatory care settings

We will be using reporting methods and screenshots to capture and demonstrate compliance. This methodology uses the logging or reporting capabilities to examine functionality performed in the system over a given interval. This measurement was chosen to best evaluate compliance with the certification criteria and interoperability of exchanging electronic health information (EHI).

In instances where no or little evidence exists due to lack of adoption of a certified measure or other reasons, we will demonstrate the requirements in a semi-controlled setting in a production site, otherwise known as a “real world” environment.

Care Settings Targeted

Carefluence is an Open API platform that supports HIT Vendors in fulfilling interoperability requirements for medical clinics in ambulatory and acute care settings. All measures outlined in the Real World Testing are designed for and will be performed within the ambulatory care settings through HIT Applications.


Real World Testing: Application Programming Interfaces

Measure 1

Associated Certification Criteria: 170.315 (g)(7): Application Access – Patient Selection
Measurement: Count the number of API queries for a patient search made in a real world setting.
Description: During the testing period, a report will be generated which tracks how many patient searches have been done by OpenAPI queries in the real world.
Justification: OpenAPI queries result in the selection of a patient and demonstrate the audit log of search or selection of patient.
Expected Outcomes: Demonstrate our compliance with the certification criteria and report the OpenAPI queries in selecting patients in a real world setting.

Measure 2

Associated Certification Criteria: 170.315 (g)(9): Application Access – All Data Request (Cures Update)
Measurement: Count the number of API queries for all-data request made in a real world setting.
Description: During the testing period, a report will be generated which tracks how many all-data requests have been done by OpenAPI queries
Justification: OpenAPI queries result in the selection of a patient and demonstrate the audit log of search or selection of patient and make all-data request.
Expected Outcomes: Demonstrate our compliance with the certification criteria and synchronize the OpenAPI query for a patient as a subject, to fetch all-data request in real world setting.

Measure 3

Associated Certification Criteria: 170.315 (g)(10): Standardized API for Patient and Population Services (Cures Update)
Measurement: Count the number of API queries for the category of clinical data set made in a real life setting.
Description: During the testing period, a report will be generated which tracks and log the OpenAPI queries made for specific data category requests in the real world.
Justification: Demonstrate Audit log report of OpenAPI queries with a patient as a subject and fetch that patient-specific data by category.
Expected Outcomes: Demonstrate our compliance with the certification criteria and report the OpenAPI queries with a patient as a subject in real world setting.

Metrics and Outcomes: RWT Result – Year 2023

Real World Environment: Carefluence OpenAPI platform R4 is licensed to its EHR vendors to host the integrated API to run in Production on the servers of EHR’s Infrastructure.  Real World Testing results reported here are from one of the EHR vendor’s hosted instance of Carefluence OpenAPI R4 in Production.

Associated Certification CriteriaOutcomes,Methodology and Key findingsMeasurement/Metric (Count the Queries)
170.315 (g)(10): Standardized API for Patient and Population Services (Cures Update)HIPAA compliant secure chat application was registered as Client application on our OpenAPI R4 management console of our EHR vendor.  Patient registration for Chat application queried Patient endpoint and uploaded all the secure Chat transcripts as PDF via DocumentReference end point.  This is just one of the use cases  where we measured no of queries in Production328
170.315 (g)(9): Application Access – All Data Request (Cures Update)CCDA 2.1 file generation in an EHR in a real-world setting was using Carefluence OpenAPI to request a bundle of FHIR resources with the selected patient as a subject in query and generate a CCDA 2.1 file.  This request is launched typically in transition of care by providers, or view, download, transmit from patient portal. Further, a patient portal on iOS app connecting to an EHR was generating the CCDA file using the same set of queries before writing to Health App. This workflow helped us measure the number of all data request queries for the associated certification criteria within the report period.1994
170.315 (g)(7): Application Access – Patient SelectionHIPAA compliant secure chat application was registered as Client application on our OpenAPI R4 management console of our EHR vendor.  Patient registration for Chat application queried Patient endpoint 328