EHR Real World Testing Plan 2023
Professional Imaging PI EMR v2.0
Real World Testing Plan - 2023
Justification for Real World Testing Approach
The overall approach for our Real World Testing includes extraction and analysis of data on ongoing activity and simulated testing where there is no ongoing use of relevant certified functionality.
The PI EMR v2.0 Certified Health IT Module is self-developed. It is not available for sale. It is only used by Professional Imaging LLC and its affiliates. As a self-developer with a very narrow practice scope, resources for implementing RWT must, by necessity, be limited to mitigate negative financial impact.
The care setting in which this module is used is an ambulatory interaction with Nursing Facilities. For some of the criteria covered in the Real World Testing plan, testing will be conducted using simulated environments utilizing a pass/fail metric due to the absence of real world use. The affected criteria in this regard are those related to Care Coordination, Public Health, Application Program Interfaces and Electronic Exchange. As there is no ongoing activity in these cases, it is not possible to measure ongoing compliance.
The circumstances for this are as follows:
As yet, no Nursing Facilities have requested use of the interoperability functionality being tested. This is due to the fact that Nursing Facilities are not required to use an EHR as doing so is not seen as a benefit.
No Nursing Facility, patient, patient representative or providing clinician has ever requested access to our API.
We are either unqualified for or unable to (due to unavailability of agencies prepared to receive the data) perform the activities covered by criteria related to Transmission to public health Agencies.
In the cases mentioned above, our Real World Testing approach measures success through demonstrating conformance and interoperability through simulated testing. Testing will be conducted to confirm and document that each data point transmitted and received is accurate and complete as required by the relevant certification criteria.
For certified functionality that we do have ongoing activity, the records of that activity will be analyzed regarding the successful transmission and receipt of relevant information. Documentation of that analysis will be provided.
The RWT plan may also utilize data transfer with an affiliate practice. The affiliate practice, which provides the same type of specialized service as Professional Imaging, has been selected due to their ongoing relationship with our practice and their availability for this testing.
Where applicable, several certification criteria may be tested simultaneously.
Criteria to be Tested
§ 170.315(b)(1) Transitions of care
§ 170.315(b)(2) Clinical information reconciliation and incorporation
§ 170.315(c)(1) Record and export
§ 170.315(c)(2) Import and calculate
§ 170.315(c)(3) Report
§ 170.315(e)(1) View, download, and transmit to 3rd party.
§ 170.315(f)(2) Syndromic surveillance
§ 170.315(f)(7) Health care surveys
§ 170.315(g)(7) Application access— patient selection R
§ 170.315(g)(9) Application access— all data request
§ 170.315(h)(1) Direct Project
Schedule of Key Milestones
1Q-2023: Begin communication with affiliate practice to schedule participation in real-world testing.
2Q-3Q 2023: During the 2nd and 3rd quarter, real world testing will be scheduled and performed. It is expected that a preparatory call will be made with the affiliate practice to prepare them for testing activities. Capture and analysis of data relevant to functionality will be conducted. Test results will be documented and ultimately used to build the test report. If any non-compliances are observed, we will notify the ONC-ACB of the findings and make the necessary changes required.
4Q-2023: During the last quarter of the year, the CY 2024 real-world test plan will be completed according to ONC and ONC-ACB requirements and expectations. The test plan will be prepared and submitted per the deadline requirements.
February 2024: Document our CY 2022 test results into our RWT Test Report and submit to our ONC-ACB.
Care Coordination
The following outlines the measure that has been identified to best demonstrate conformance to thecertification criteria concerning Care Coordination (170.315(b)(1) and 170.315(b)(2)).
Measure Description
The metric used for testing functionality covered by these criteria is the successful secure transmission, receipt, re-incorporation and data verification of the required transition of care documentation. Direct messaging will be conducted using MaxMD (Version N/A) third party software
Measure Justification
The stated metric was selected as it provides full testing of the functionality.
Expected Outcome
The expected outcome is that the data transmitted will be identical with that of the data received. This will be confirmed by the reconciliation process covered under (b)(2) and the received data is successfully imported and applied to the target patient.The resulting patient record will also be validated using the 2023 ONC Cures Update R2.1 and USCDI v1 Validator Tool.
Test Methodology
· As self-developers, our practice does not use CCDA R2.1 documents in a real world setting to send or receive patient health records with outside providers. As such, we will conduct testing using synthetic patient data.
· For the b1 criteria, we will generate both a Continuity of Care and a Referral Note CCDA R2.1 document using a representative synthetic patient. Both CCDA xml files will be validated using the 2023 ONC Cures Update R2.1 and USCDI v1 Validator Tool (at https://ett.healthit.gov/ett/#/validators/ccdar2).
· For the b2 criteria will be tested using a representative synthetic patient. First, we will import an initial patient record (CCDA R2.1 xml) file. Next, we will import an updated patient record for the same patient containing new medications, problems and alerts and reconcile (merge) it with the medications, problems and alerts in the initial patient record. To simulate a referral from another practice, we will generate the initial and updated patient records (CCDA R2.1 files) at a practice at one location and then transmit the CCDA files to a 2nd practice at a different location using a secure messaging system. Importing, reconciliation and incorporation of the initial and updated CCDA files will then be performed at the 2nd practice. The resulting patient record will be exported in CCDA R2.1 format and validated using the 2023 ONC Cures Update R2.1 and USCDI v1 Validator Tool (at https://ett.healthit.gov/ett/#/validators/ccdar2).
Clinical Quality Measures
The following outlines the measure that has been identified to best demonstrate conformance to multiple certification criteria concerning Critical Quality Measures (170.315(c)(1), 170.315(c)(2) and 170.315(c)(3).
Measure Description
The metric used for testing functionality covered by these criteria is the successful recording, exporting, importing, calculation and reporting of CQM (QRDA I & QRDA III) data and the subsequent validation of that data. As self-developers, our practices were not required to submit CQM data to CMS in 2022. Consequently, we conducted our RWT using the appropriate Cypress test tool. As we do not yet know whether we will be required to do so in 2023, the Test Methodologies described below include both actual submission of CQM data to CMS and use of the appropriate Cypress test tool.
Measure Justification
The stated metric was selected as it provides full testing of the functionality.
Expected Outcome
If we are required to submit CQM data to CMS in 2023, the expected outcome is as follows. The measurement will count and list of CQMs submitted to CMS for MIPs during 2023. We will report on the number CQMs successfully reported on to CMS which reveals compliance to the associated criteria listed above. A successful measure submission indicates compliance to the underlying ONC criteria. It will show that the EHR can do calculations on the CQM and that they are accepted by CMS. Successfully completing this measure also confirms general understanding of the EHR functional operations for this EHR Module and an overall support for the user experience while not completing this measure may indicate lack of understanding or possibly lack of use or need for this functionality. We will use the measure result to establish a historic baseline of expected interoperability use so it can be used in subsequent real world testing efforts.
If we are not required to submit CQM data to CMS in 2023, the expected outcome is that the QRDA I and QRDA III test data generated by our EHR is valid based on the current QRDA 1 and QRDA III standards and that the calculations and reporting of the resulting CQM QRDA III data accurately reflects the content of a representative sample of QRDA I test data.
Test Methodology
If we are required to submit CQM data to CMS in 2023, the test methodology will be as follows. Analysis of use logs associated with transmission of CQM data to CMS for MIPS. In addition, for QRDA category I data, we will import the data sent to CMS (using PI EMR v2.0) to a test database and confirm that all intended patient data has been successfully transmitted.
If we are not required to submit CQM data to CMS in 2023, testing for these criteria will be performed using CVU+ test products provided by the 2023 Cypress test tool. Note that Cypress CVU+ test products allow vendors to upload and validate QRDA I and QRDA III test data for one or more CMS measures.
Patient Engagement
The following outlines the measure that has been identified to best demonstrate conformance to the certification criteria concerning Patient Engagement (170.315(e)(1)).
Measure Description
This use case is tracking and counting how patients are given access to their portal account over the course of the reporting period. Third party software employed for testing includes MaxMD (Version N/A) for direct messaging, Meinberg NTP (Version 4.2.8p12) for NTP compliance and time server synchronization and WebSupergoo ABCpdf (Version 10117) for zipping files requested for download or transmission.
Measure Justification
This use case measure will provide a numeric value to indicate both how often this interoperability feature is being used as well as its compliance to the requirement. An increment to this measure indicates that the EHR can create a new patient portal account and give the patient access to it. A survey can often provide more information on the impact and value of an interoperability element than a standard software test evaluation. The patient portal is intended to support patient engagement with their health records and the ability to transmit their patient data as a C-CDA or human readable copy.
Expected Outcome
We will get reporting values on patient portal access as well as patients use of the portal’s interoperability features. Measure #1: Report the number of new patient accounts created over a three (3) month period. The measurement will produce numeric results over a given interval. We will utilize various reports and audit logsto determine our measure count. A successful measure increment indicates compliance to the underlying ONC criteria.
Testing Methodology:
We will use analysis of the usage logs from our patient portals to provide total counts of documents added to our portals and total counts of documents viewed and downloaded. At our practice's request the option to transmit patient records has not been enabled. To test the transmission of patient records we will transmit a representative sample of synthetic patient records in CCDA R2.1 format from our EHR to our HISP provider. A representative sample of downloaded and transmitted CCDA R2.1 files will be validated using the 2023 ONC Cures Update R2.1 and USCDI v1 Validator Tool (at https://ett.healthit.gov/ett/#/validators/ccdar2).
Public Health –
The following outlines the measure that has been identified to best demonstrate conformance to the certification criteria concerning Transmission to Public Health Agencies (170.315(f)(2) and 170.315(f)(7).
Measure Description
The metric used for testing functionality covered by these criteria is the successful secure transmission, receipt, verification and processing of the required public health data. Third party software employed for testing includes MaxMD (Version N/A) for direct messaging.
Measure Justification
The stated metric was selected as it provides full testing of the functionality.
Expected Outcome
The expected outcome is that the data transmitted will be identical with that of the data received and the data will be successfully processed by the receiving entity. This will be confirmed by the validation websites.
Test Methodology -
f2: Generate NIST HL7v2 Syndromic Surveillance xml files for a representative sample of synthetic patient data based on our actual patient cases. This process may produce as many as 30 synthetic patient files. Confirm the accuracy and completion of these test files then use the NIST HL7v2 Syndromic Surveillance validation website for validation.
f7: generate a NHCS xml survey file for a representative sample of synthetic patient data based on our actual patient cases. This process may produce as many as 30 synthetic patient files. Confirm the accuracy and completion of these test files, then use the NHCS validation website to validate the generated xml test files.
Application Programming Interfaces
The following outlines the measure that has been identified to best demonstrate conformance to the certification criteria concerning APIs (170.315(g)(7) and 170.315(g)(9).
Measure Description
The metric used for testing functionality covered by these criteria is the successful secure retrieval and verification of the applicable data by a simulated patient.
Measure Justification
The stated metric was selected as it provides full testing of the functionality.
Expected Outcome
The expected outcome is that the data received by the simulated patient will be identical with that of the data transmitted. This will be confirmed by the comparison between the data sets.
Testing Methodology
We will use an in-house developed application named PI_EHR_API_Test that demonstrates use of our certified EHR API.
We will test g7 by generating an encrypted api key that allows access to a specific representative synthetic patient (name RWT_PT PATIENT_01, DOB 1960-05-01).
Testing of g9 will be performed by downloading a CCDA R2.1 document for the aforementioned synthetic patient. This file will be validated using the 2023 ONC Cures Update R2.1 and USCDI v1 Validator Tool (at https://ett.healthit.gov/ett/#/validators/ccdar2).
Electronic Exchange
The following outlines the measure that has been identified to best demonstrate conformance to the certification criteria concerning Electronic Exchange (170.315(h)(1)).
Measure Description
The metric used for testing functionality covered by these criteria is the successful secure retrieval and verification of the applicable data for a simulated patient. Third party software employed for testing includes MaxMD (Version N/A) for direct messaging.
Measure Justification
The stated metric was selected as it provides full testing of the functionality.
Expected Outcome
The expected outcome is that the data received by the simulated patient will be identical with that of the data transmitted. This will be confirmed by the comparison between the data sets.
Testing Methodology
Send 2 Direct messages to a test Direct address, one message with an attachment and one with no attachment. Then we will recover the Direct message replies to these messages, again one with an attachment and one with no attachment. This will be done by sending the message to a HISP provider test address then verifying the contents of the received messages on the HISP provider user website match our EHR.
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 Real World Testing requirements.
2022 EHR Real World Testing Plan
Authorized Representative Name: Michael Goforth
Authorized Representative Email: mike@proimagetx.com
Authorized Representative Phone: 360-359-3690
Authorized Representative Signature:
