Source: https://www.healthit.gov/test-method/clinical-quality-measures-cqms-import-and-calculate
Timestamp: 2019-04-26 10:38:55+00:00

Document:
Removed note to test one of the two alternatives and renumbered steps for paragraph (c)(2)(ii).
Added numbers to the Execute Any Time section for paragraph (c)(2)(i) and continued the numbering for the next sections (Setup and Import).
Updated the numbering to restart at 1 for the SUT section of Calculate under paragraph (c)(2)(ii).
Added a continued number to the section of Alternative: Cypress Certification API under the TLV of paragraph (c)(2)(ii).
In paragraph (c)(2)(ii), updated the Alternative section to align with the correct steps a tester would take if using the Cypress Certification API.
Updated ‘step #’ to reference the actual step description and added clarifying language in the Alternative API section.
Import. Enable a user to import a data file in accordance with the standard specified in §170.205(h)(2) for one or multiple patients and use such data to perform the capability specified in paragraph (c)(2)(ii) of this section. A user must be able to execute this capability at any time the user chooses and without subsequent developer assistance to operate.
Calculate each and every clinical quality measure for which it is presented for certification.
The health IT developer supplies documentation outlining how a user can execute the import capability described in (c)(2)(i) any time the user chooses and without subsequent developer assistance to operate.
Using the "Cypress Gold Standard Test Data" a user demonstrates the importing of reports formatted in accordance with the standard specified at § 170.205(h)(2) HL7 CDA® R2 Implementation Guide for: Quality Reporting Document Architecture – Category I (QRDA I); Release 1, DSTU Release 3, Volume 1 for all of the data needed to calculate each of the clinical quality measures (CQMs) presented for testing, for one or multiple patients.
The tester verifies that the health IT developer supplied documentation outlines that a user can perform an import as specified in (c)(2)(i) any time the user chooses and without subsequent developer assistance to operate.
The tester creates the "Cypress Gold Standard Test Data" based upon the information provided by the health IT developer, in Cypress, which will create a new (c)(2) test instance.
Using visual inspection, the tester verifies that the Health IT Module can demonstrate the importing of CQM data specified in accordance to the standard at § 170.205(h)(2).
The user calculates the aggregate reports for each of the CQMs for which they are seeking certification, based upon the imported and de-duplicated data set.
The Health IT Module submits an aggregate report for each of the CQMs to be certified.
The tester verifies that the Health IT Module can use the imported CQM data to calculate the aggregate data and display the report in accordance at a minimum to the standard at § 170.205(k)(1) Quality Reporting Document Architecture Category III, Implementation Guide for CDA Release 2 and § 170.205(k)(2) Errata to the HL7 Implementation Guide for CDA® Release 2: Quality Reporting Document Architecture—Category III, DSTU Release 1 using visual inspection.
all of the data generated by the Health IT Module.
A tester may use the Cypress Certification API to upload the data file submitted by the Health IT Module. The tester can verify the results in Cypress as normal, however, the tester should manually verify that the Health IT Module can use the imported CQM data to calculate the aggregate data and display the report appropriately as well as the accuracy of the submitted CQM results for at least one CQM to ensure this functionality is present. The tester should still generate a test artifact containing the test data and all data generated by the Health IT Module into a single archive file, as usual. Testers are permitted to randomly select, at their discretion, which individual patient from the batch entry recording will be used to export a QRDA Category I file in order to demonstrate the functionality is present. The tester instructs the health IT developer to export the selected patient and confirms that this patient was exported.
Included clarifications regarding testing and certification to versions of standards associated with the CMS annual measure updates, de-duplication, and testing for calculation.
Revised to include clarification about testing, certification, and surveillance expectations for paragraph (c)(2)(i).
Privacy and Security: This certification criterion was adopted at § 170.315(c)(2). As a result, an ONC-ACB must ensure that a product presented for certification to a § 170.315(c) “paragraph (c)” criterion includes the privacy and security criteria (adopted in § 170.315(d)) within the overall scope of the certificate issued to the product.
Certain CMS programs require or provide the option for electronic CQM (eCQM) reporting. These programs include the EHR Incentive Program, the Physician Quality Reporting System, the Hospital Inpatient Quality Reporting Program, the Comprehensive Primary Care (CPC) initiative, CPC Plus, and the Value-Based Payment Modifier Program. Each year, CMS issues annual updates to eCQMs (herein referred to as the “CMS annual measure update(s)”) which are published on the Electronic Clinical Quality Improvement (eCQI) Resource Center. The CMS annual measure updates rely upon a specific version of the Quality Reporting Document Architecture (QRDA) Category I standard. Each year’s QRDA Category I standard is referenced in the corresponding CMS QRDA Implementation Guide (IG) associated with that program year and CMS annual measure update. The CMS QRDA IG also contains additional programmatic form and manner requirements necessary for reporting to CMS programs, which make it necessary for the corresponding testing tool to keep pace with these measure updates and CMS reporting requirements. Thus, health IT developers are permitted to be tested and certified to the applicable CMS annual measure update and use the corresponding version of QRDA Category I standard referenced in the CMS QRDA IG. Note that for this criterion at § 170.315(c)(2), the testing tools are only capable of validating the correct calculation of CQMs for reports submitted in the corresponding QRDA Category III format. ONC will evaluate the need for future rulemaking to align the version of QRDA Category I standard required for this certification criterion with the version of QRDA Category I standard in the CMS annual measure update.
After technology is certified to specific CQMs for this 2015 Edition certification criterion at § 170.315(c)(2), technology is not required to recertify to the annual measure specification updates CMS issues to maintain 2015 Edition certification unless that product is relabeled. Said another way, other programs, such as the EHR Incentive Programs, may require developers upgrade their technology to the newest CQM specifications, but the technology is not required to be retested or recertified, unless explicitly specified in other program requirements. [ONC FAQ #42] It is expected that all systems will test all measure and standards updates as a best practice. The testing tools are available for each CMS annual measure update and when there are late standards errata or CMS requirement changes to facilitate additional testing.
Technical outcome – A user can import a data file formatted in accordance with HL7 QRDA Category I Release 3 or the corresponding version of the QRDA standard for the CMS annual measure update being certified for one or multiple patients in order to perform calculations on the CQMs presented for certification.
We would expect that health IT must be able to de-duplicate patient records, but do not prescribe how systems would demonstrate de-duplication. Developers have the discretion to determine the most suitable method for deduplication. [see also 80 FR 62651] De-duplication testing will require systems to identify two files with the same or similar patient identifiers but different QRDA document identifiers and adjudicate information which is identical and combine information which is not.
Technical outcome – The health IT must be able to calculate each CQM presented for certification.
The testing tools are only capable of validating the correct calculation of CQMs for reports submitted in the QRDA Category III format.

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