Real World Test Plan - 2022 | Elation Health
21st Century Cures Real World Test Plan
Background & Instructions
Under the ONC Health IT Certification Program (Program), Health IT Developers are required to conduct Real World Testing of their Certified Health IT (45 CFR 170.556 and 170.523(i)). The Office of the National Coordinator for Health Information Technology (ONC) issues Real World Testing resources to clarify Health IT Developers’ responsibilities for conducting Real World Testing, to identify topics and specific elements of Real World Testing that ONC considers a priority, and to assist Health IT Developers to develop their Real World Testing plans.
Health IT Developers have maximum flexibility to develop innovative plans and measures for Real World Testing. As developers are planning for how they will execute Real World Testing, they should consider the overall complexity of the workflows and use cases within the care settings in which they market their Certified Health IT to determine which approaches they will take. This Real World Testing plan template was created to assist Health IT Developers in organizing the required information that must be submitted for each element in their Real World Testing plan. Health IT Developers must submit one plan for each year of Real World Testing (see resources listed below for specific timelines and due dates). ONC does not encourage updating plans outside the submission timeline and will not post updates on the Certified Health IT Product List (CHPL). If adjustments to approaches are made throughout Real World Testing, the Health IT Developer should reflect these adjustments in their Real World Testing results report. ONC would expect that the Real World Testing results report will include a description of these types of changes, the reasons for them, and how intended outcomes were more efficiently met as a result. This resource should be read and understood in conjunction with the following companion resources, which describe in detail many of the Program requirements referenced in this resource.
- Real World Testing–What It Means for Health IT Developers – Fact Sheet
- Real World Testing Resource Guide – Coming Soon
- Real World Testing Certification Companion Guide
Health IT Developers should also review the following regulatory materials, which establish the core requirements and responsibilities for Real World Testing under the Program.
- 21st Century Cures Act: Interoperability, Information Blocking, and the ONC Health IT Certification Program final rule, 85 FR 25642 (May 1, 2020) (Century Cures final rule)
General Information
Plan Report ID Number: [For ONC-Authorized Certification Body use only]
Developer Name: Elation Health, Inc
Product Name(s): Elation EMR
Version Number(s): Version 3
Certified Health IT Product List (CHPL) ID(s): 15.04.04.2717.Elat.03.00.1.181231
Developer Real World Testing Page URL: https://www.elationhealth.com/real-world-test-plan
Justification for Real World Testing Approach
Consistent with the ONC’s recommendation that “Real World Testing verify 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 the number of instances that certified capability is successfully utilized in the real world. In instances where no evidence exists due to zero adoption of a certified capability or the inability to capture evidence of successful use for other reasons, we will demonstrate the required certified capability in a semi-controlled setting as close to a “real world” implementation as possible.
It is important to note that Real World Testing is only one component of the Health IT Certification program used to demonstrate compliance with the program requirements. Real World Testing should augment and support testing that was conducted prior to certification being granted. It is not intended to duplicate the methods or results previously demonstrated. Instead, this test plan was developed to demonstrate that the certified capabilities have been successfully deployed for providers to use at their discretion in live settings.
We are using a 2-fold approach to demonstrate successful real-world implementations.
- Summative Testing
- Interactive Testing
Summative Assessment Metrics
The following metrics will be measured by viewing audit logs and reporting systems available to track the behavior of the certified Health IT module during a given time frame. All metrics are designed to reflect the core elements of the criteria, demonstrate interoperability, and demonstrate the success rate of the certified capability being used. In most cases we elected to record these metrics over a 90-day period to reflect the reporting periods typically required for compliance with the federal incentive programs.
The continued measurable use of certified capabilities will provide implicit evidence of successful implementation of the required certified capability. This is especially meaningful in cases where interoperability with outside systems is demonstrated. In cases where it is not possible to determine “success” via an explicit confirmation by a receiving system, success will be defined as a transmission was made where no error was received from the destination system or its intermediaries. Additionally, we will review internal customer and vendor issue tracking systems for reports of failures or unsatisfactory performance in the field. None of the following criteria were updated to the Cures Update version of criteria prior to August 31, 2021. As a result, all testing is scheduled to be conducted against the 2015 Edition version of the criteria.
| Criterion | Metric | Care Setting | Justification and Expected Outcome |
|---|---|---|---|
| 170.315 (b)(1) Transition of care | Over a 90-day period: 1) Number of CCDAs created 2) Number of CCDAs sent via edge protocols 3) Number of CCDAs received via edge protocols |
Primary Care | This criterion requires the ability of a certified Health IT module to create CCDAs according to specified standards and vocabulary code sets, as well as send and receive CCDAs via edge protocols... |
| 170.315 (b)(2) Clinical information reconciliation and incorporation | Over a 90-day period: 1) Number of times a user reconciled medication list data from a received CCDA 2) Number of times a user reconciled allergies and intolerance list data from a received CCDA 3) Number of times a user reconciled problem list data from a received CCDA |
Primary Care | This criterion requires the ability of a certified Health IT module to take a CCDA received via an outside system and match it to the correct patient; reconcile the medication, allergy, and problem lists... |
| 170.315(b)(3) – Electronic prescribing | Over a 90-day period: 1) Number of prescriptions created 2) Number of prescriptions changed 3) Number of prescriptions canceled 4) Number of prescriptions renewed |
Primary Care | This criterion requires the ability of a certified Health IT module to perform prescription-related electronic transactions (eRx) using required standards... |
| 170.315(b)(6) Data export | Over a 90-day period: 1) Number of times a data export was performed |
Primary Care | This criterion requires the ability of a certified Health IT module to export a summary of a patient’s record in CCDA format according to specified standards... |
| 170.315(b)(9) Care Plan | Over a 90-day period: 1) Number of care plans recorded 2) Number of care plans changed 3) Number of care plans accessed 4) Number of care plans created 5) Number of care plans received |
Primary Care | This criterion requires the ability of a certified Health IT module to record, change, access, create, and receive care plan information... |
| 170.315(c)(1-3) Clinical quality measures (CQMs) | Over a 90-day period: 1) Number of measures recorded during the period 2) Number of QRDA Category 1 files exported 3) Number of QRDA Category 1 files imported (if applicable) 4) Number of QRDA Category 3 aggregate report(s) created over the period |
Primary Care | These criteria will be tested together... |
| 170.315(e)(1) View, download, and transmit to 3rd party | Over a 90-day period: 1) Number of views of health information by a patient or authorized representative 2) Number of downloads of health information by a patient or authorized representative 3) Number of transmissions of health information by a patient or authorized representative |
Primary Care | This criterion requires the ability of a certified Health IT module to provide patients access to a patient portal with the ability to view, download, and send their health care records... |
Interactive Testing
The following test plans will be executed to demonstrate Real World certified capabilities for criteria where metrics are not available...
| Criterion | Interactive Test Plan | Care Setting | Justification and Expected Outcome |
|---|---|---|---|
| 170.315(b)(9) Care Plan | Elation Health will work with a provider to perform a real life test in production with live patient data... | ||
| 170.315(f)(1) Transmission to immunization registries | Elation Health will work with a practice to perform a real life test in production with live patient data... | ||
| 170.315(f)(2) Transmission to public health agencies — syndromic surveillance | Elation Health will work with a practice to perform a real life test in production with live patient data... |
Schedule of Key Milestones
Real World test planning will commence in the first quarter of 2022. Each phase is expected to take 90 days to complete, with report writing to occur end of 2022/early 2023.
| Key Milestones | Care Setting | Date/Time Frame |
|---|---|---|
| Data instrumentation | Primary Care | 90 days |
| Data collection | Primary Care | 90 days |
| Review and collate data | Primary Care | 90 days |
| Writing report | Primary Care | 90 days |
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.