Summary
- This is the Real World Testing Results document for 2022 by Roji Health Intelligence LLC.
- These Real World Testing Results are for the following Certification Criteria:
- 45 CFR § 170.315(c)(2) Clinical quality measures (CQMs) – import and calculate
- 45 CFR § 170.315(c)(3) Clinical quality measures (CQMs) – report
- As per the 21st Century Cures Act: Interoperability, Information Blocking, and the ONC Health IT Certification Program final rule, 85 FR 25642 (https://www.govinfo.gov/content/pkg/FR-2020-05-01/pdf/2020-07419.pdf) (May 1, 2020) (ONC Cures Act Final Rule), Section VII.B.5 “Real World Testing”.
Audience
- Drummond Group LLC as an ONC Authorized Certification Body (ACB) and ONC Authorized Testing Lab (ACL).
- The Office of the National Coordinator for Health Information Technology (ONC) and its ONC Health IT Certification Program for the purposes of Real World Testing and posting publicly on the ONC Certified Health IT Product List (CHPL).
General Information
- Plan Report ID Number: (For ONC-Authorized Certification Body use only)
- Developer Name: Sheila Kelley, Roji Health Intelligence LLC
- Product Name(s): Roji Clinical Data Registry
- Version Number(s): 2016
- Certified Health IT Product List (CHPL) ID(s): 15.04.04.2951.Roji.16.00.0.170202
- Developer Real World Testing Page URL: https://rojihealthintel.com/real-world-testing/
- Developer Real World Testing Results Report Page URL: https://rojihealthintel.com/real-world-testing-results-2022/
Changes to Original Plan
Summary of Change | Reason | Impact |
For Measure 1, rather than testing monthly, Roji LLC tested the import of QRDA I once, at the end of the year. | Client was transitioning to a new EHR system and sent QRDA I data only at the end of the year, rather than monthly. | No discernible impact. Roji was able to import QRDA I documents for 100% of cases, as expected. |
Summary of Testing Methods and Key Findings
The focus of Roji Health Intelligence’s Real World Testing measures was squarely on the import of data from clients and the capacity to create QRDA documents from that data. Measure 1 tests Roji’s ability to successfully import QRDA documents from clients. Measure 2 tests Roji’s ability to generate QRDA III documents from the data that a client has provided.
As expected, Roji Health Intelligence was able to successfully import QRDA I documents and generate QRDA III documents in 100% of cases in which this was attempted. This success demonstrates that Roji is a. compliant with the certification criteria; b. is exchanging electronic health information (EHI) in the care and practice settings for which it is marketed for use; and c. that EHI is received by and used in the certified health IT.
Measures used in overall approach
RWT Measure 1
- Description of the measurement/metric: Test a random subset of the patients per client every month.
- The numerator will be the number of distinct patients that valid QRDA I documents successfully imported.
- The denominator will be the number of distinct patients this was attempted for.
- Associated certification criteria:
- 45 CFR § 170.315(c)(2) Clinical quality measures (CQMs) – import and calculate
- Justification for selected measurement/metric: Some clients can give us patient-level QRDA I documents that we normalize into our database. Other clients give us raw data that we normalize into our database. A successful import will allow us to perform calculations.
- Care setting(s) that is addressed: A random subset should cover a variety of clinical variables.
- Expected outcomes: We expect to be able to successfully import and parse QRDA I documents for 100% of the cases.
RWT Results for Measure 1
Numerator: 179076
Denominator: 179076
Roji was able to successfully import and parse QRDA I documents for 100% of cases.
RWT Measure 2
- Description of the measurement/metric: Test a subset of the practice & provider combinations per client every month.
- The numerator will be the number of distinct client-practice-provider combos that a valid QRDA III document was generated.
- The denominator will be the number of distinct client-practice-provider combos this was attempted for.
- Report the particular CQMs applicable to the subset.
- Associated certification criteria:
- 45 CFR § 170.315(c)(2) Clinical quality measures (CQMs) – import and calculate
- 45 CFR § 170.315(c)(3) Clinical quality measures (CQMs) – report
- Justification for selected measurement/metric: We should be able to generate valid QRDA III documents regardless of the CQMs.
- Care setting(s) that is addressed: Clients, practices, and providers only report on applicable CQMs.
- Expected outcomes: We expect to be able to generate a QRDA III document for 100% of the cases.
RWT Results for Measure 2
Numerator: 306
Denominator: 306
Roji was able to generate QRDA III documents for 100% of cases.
Standards Updates (Including Standards Version Advancement Process (SVAP) and United States Core Data for Interoperability (USCDI))
- Yes, I have products certified with voluntary SVAP or USCDI standards.
- No, none of my products include these voluntary standards.
Update 1
- Standard (and version): CMS Implementation Guide for Quality Reporting Document Architecture: Category I; Hospital Quality Reporting; Implementation Guide for 2020 (https://ecqi.healthit.gov/sites/default/files/QRDA-HQR-2020-CMS-IG-v1.1-508.pdf)
- Updated certification criteria and associated product:
- Certification Criteria: 45 CFR § 170.315(c)(2) Clinical quality measures (CQMs) – import
- Product: Roji Clinical Data Registry
- Health IT Module CHPL ID: 15.04.04.2951.Roji.16.00.0.170202
- Method used for standard update: Update code in Roji QRDA Parser and CQM Engine.
- Conformance measure: RWT Measure 2
Update 2
- Standard (and version): CMS Implementation Guide for Quality Reporting Document Architecture: Category III; Eligible Clinicians and Eligible Professionals Programs; Implementation Guide for 2020 (https://ecqi.healthit.gov/sites/default/files/2020-CMS-QRDA-III-Eligible-Clinicians-and-EP-IG-v1.2.1-508.pdf)
- Updated certification criteria and associated product:
- Certification Criteria: 45 CFR § 170.315(c)(3) Clinical quality measures (CQMs) – report
- Product: Roji Clinical Data Registry
- Health IT Module CHPL ID: 15.04.04.2951.Roji.16.00.0.170202
- Method used for standard update: Update code in Roji QRDA Generator and CQM Engine.
- Conformance measure: RWT Measure 2
Care Setting(s)
Measure 1 and Measure 2 in Roji Health Intelligence’s Real World Testing Plan are not specific to a care setting. The clinical settings of the data involved may include ambulatory, inpatient, outpatient, and emergency department.
Schedule of Key Milestones
Key Milestone | Timeframe |
Collect data for Roji RWT Measures | 2022-06 to 2022-09 |
Conduct testing | 2022-10 to 2022-12 |
Collation and finalization of results | 2023-01 |
Attestation
These Real World Testing results are complete with all required elements, including measures that address all certification criteria and care settings. All information in this document is up to date and fully addresses the health IT developer’s Real World Testing requirements.
- Authorized Representative Name: Sheila Kelley
- Authorized Representative Signature:
- Authorized Representative Email: [email protected]
- Authorized Representative Phone: (312) 258-8004 x708
- Date: January 27, 2023