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Bug/Issue
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Resolution: Answered
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Major
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Guidance from ONC is to perform the certification as per the current test procedure.
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Implementation Problem
This is a re-post of a comment I made to the project-cypress-talk list regarding comments from Rob Dingwell on using of Cypress vs 2.2 and requiring the EHR to create multiple QRDA Cat I files per patient per measure. This guidance for using Cypress v2.2 to test criteria 314.c.1 in my belief violates the ONC regulation, QRDA specification and the testing precedent used for Cypress v2.0, 2.0.1 and 2.1.
To confirm my understanding the approach shared on the project-cypress-talk list, it is indicating that the EHR must create QRDA Cat I files per measure/per patient. Thus, the EHR certifying for measures 0028 (Tobacco) and 0059 (Diabetes) which has patient Jane Doe, who is in the IPP for both measures, is expected to be able to create one QRDA Cat I file for Jane Doe’s 0028 measure, containing only data relevant to 0028 measure, and then create a second QRDA Cat I file, distinctly different from the first QRDA Cat I file, for Jane Doe’s 0059 measure, containing only data relevant to the 0059 measure. If that what is being expected, that is not correct per the regulations or the QRDA spec.
First for 314.c.1.ii (Export), it requires the EHR technology to export a QRDA Cat I file that includes “all of the data captured for each and every CQM to which EHR technology was certified”. There is nothing in the regulation or the Final Rule preamble to require or expect an EHR to have functionality of exporting QRDA files multiple times for the same patient divided according to measures to be certified. Criteria 314.c.3 requires submission of both Cat III aggregate results as well as individual Cat I patient data because of the flexibility needed by EPs/EHs in CMS reporting. Therefore, this approach would expect the EHRs to have capability of switching its QRDA Cat I export to 1.) be by measures/patient for 314.c.1 and then 2.) switch to just patient-only (all relevant measures reported) to satisfy 314.c.3.
Second, you reference the scoop and filter philosophy in 3.2.3 of the DTSU, but the previous section 3.2.2 states that a “QRDA Category I instance contains data on a single patient for one or more QDM-based eMeasures” and that “a QRDA Category I instance may contain data elements for multiple measures”. There is nothing in the QRDA Cat I spec to support sub-dividing QRDA files per patient per individual measure.
Third, we did not enforce this “requirement” in the previous 2.0/2.0.1/2.1 implementations of Cypress using the QRDA test deck. There, we had a large patient record produced covering multiple measures, but the EHRs were not expected to produce separate QRDA files for each measure but rather just a single QRDA Cat I file for validation.
Given the current design of Cypress v2.2, we will need to upload the same QRDA file multiple times based on the measures which that patient is associated. From doing that with the test deck, it appears we only get XML warning notices which is acceptable, especially given the reason for doing this.