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Guidance for reporting diagnostic test data in the Diagnostic Study Performed (V4) template of QRDA Category I files

The Centers for Medicare & Medicaid Services (CMS) and The Joint Commission (TJC) released guidance for reporting diagnostic test data in the Diagnostic Study Performed (V4) template of Quality Reporting Document Architecture (QRDA) Category I files. This affects the electronic clinical quality measure (eCQM) CMS31v6 - Hearing Screening Prior To Hospital Discharge only. The 2018 CMS QRDA Category I Implementation Guide (IG) for Hospital Quality Reporting allows for two ways of reporting the result of a diagnostic test in the Diagnostic Study Performed (V4) template:

  1. Using the element “value” inherited from its parent template Procedure Activity Observation (V2), or
  2. Using the contained template Result Observation (V3).

For 2018 reporting, CMS has aligned with TJC to only use the first option. Result data for the Diagnostic Study Performed template must be in the value element in order to be processed by CMS.

Result data provided in the template Result Observation (V3) will not be used by the QualityNet data receiving system during measure calculation of CMS31v6. The QRDA file will not be rejected, nor will a warning be returned, if the Result Observation (V3) template is used, and that the measure outcome of CMS31v6 from CMS may not match what is expected.

CMS QRDA Pre-Submission Validation Tools Guide

The CMS Quality Reporting Document Architecture (QRDA) Pre-Submission Validation Tools Guide is a resource which offers multiple QRDA validation tools that are available to submitters. It is intended to give users a single point of reference for these tools and assist them in selecting the most appropriate tool to meet their individual needs. The tool covers:

  • Cypress QRDA Validation Utility
  • Pre-Submission Validation Application (PSVA)
  • CMS Data Receiving System, within the QualityNet Secure Portal

CMS QualityNet Data Receiving Systems Edits Document

The eCQM Data Receiving System Edits Document provides a list of all the error messages and system edits generated by the CMS data receiving system, via the Quality-Net Secure Portal, for the current reporting period when test and production Quality Reporting Document Architecture (QRDA) Category I patient-level files are submitted to the CMS Quality-Net Secure Portal.

QRDA Category I files are submitted by hospitals to fulfill a portion of the aligned mandatory electronic clinical quality measure (eCQM) reporting requirements for the CMS Hospital Inpatient Quality Reporting (IQR) and Promoting Interoperability Programs. Hospitals reporting on eCQMs are encouraged to use this resource to support successful reporting.

eCQI Resource Center

The eCQI Resource Center is a website which provides eCQI resources and connections with the community of professionals who are dedicated to electronic clinical quality improvement for better health. It provides eCQM electronic specifications along with tool and resource links. It serves as “the one-stop shop for the most current resources to support electronic clinical quality improvement.”

eCQM Calculations Libraries and Technical Services

The eCQM Calculations Libraries and Technical Services are open source libraries which provide support for loading and calculating eCQMs, generating Quality Data Model (QDM) types, and other libraries related to Clinical Quality Language (CQL) and Fast Healthcare Interoperability Resources (FHIR). Many of the libraries listed below are used within the Bonnie and Cypress tools and are actively supported. 

CQM Models: A software library containing auto generated models based off of QDM.
CQM Execution: NPM module for calculating eCQMS written in CQL, using the CQM-Models library
CQM Reports: A library for import and export of reports for use with eCQMs.
CQM Parsers : A library for parsing CQL-based HQMF documents and parsing Measure Authoring Tool (MAT) eCQM packages into models based off of the CQM-Models library.
CQM Validators: A library for QRDA validation. It contains Schematron validators, and validators for QRDA-specific features (measure IDs, performance rates, result extraction, etc).
CQM Execution Service: A Dockerized Node-based service for calculating eCQMs which uses the CQM Execution module.
CQL Execution: A JavaScript CQL Execution framework that can execute CQL artifacts expressed as JSON ELM.
CQL to ELM Translation Service: A microservice wrapper for the CQL to ELM conversion library.
CQL Exec FHIR: A FHIR-based data source module for use with the CQL Execution Engine.


The HL7 Quality Reporting Document Architecture Category I Implementation Guide (HL7 QRDA I IG) describes constraints on HL7's Clinical Document Architecture Release 2 (CDA R2) to create a QRDA I document. QRDA Category I is for reporting quality data at the individual patient level.


The HL7 Quality Reporting Document Architecture Category III Implementation Guide (HL7 QRDA III IG) describes constraints on HL7's Clinical Document Architecture Release 2 (CDA R2) to create a QRDA III document. QRDA Category III is for reporting aggregated quality measure data.