HL7 Implementation Guide for Clinical Document Architecture (CDA) Release 2: Quality Reporting Document Architecture (QRDA)

General Information

Technologies must be operated and maintained in accordance with Federal and Department security and privacy policies and guidelines. More information on the proper use of the TRM can be found on the TRM Proper Use Tab/Section.

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Description:	QRDA is a document format that provides a standard structure with which to report quality measure data to organizations that will analyze and interpret the data. Quality measurement in health care is complex. Accurate, interpretable data efficiently gathered and communicated is key in correctly assessing that quality care is delivered. This is addressed within two-volume implementation guides (IGs). A QRDA Category I report is an individual-patient-level quality report. Each report contains quality data for one patient for one or more quality measures, where the data elements in the report are defined by the particular measure(s) being reported on. A QRDA Category I report contains raw applicable patient data. When pooled and analyzed, each report contributes the quality data necessary to calculate population measure metrics. This two-volume implementation guide (IG) describes constraints on the Clinical Document Architecture Release 2 (CDA R2) header and body elements for Quality Reporting Document Architecture (QRDA) documents. A QRDA Category III report is an aggregate quality report. Each report contains calculated summary data for one or more measures for a specified population of patients within a particular health system over a specific period of time. Data needed to generate QRDA Category III reports must be included in the collected QRDA Category I reports, as the processing entity will not have access to additional data sources. The QRDA Category III Implementation Guide directs implementers on how to construct QRDA Category III instances to report aggregated results for electronic clinical quality measures (eCQMs). CMS publishes QRDA implementation guides (IGs), schematrons, and sample files annually to provide technical guidance for implementing the HL7 QRDA I and III standards for reporting to CMS quality reporting programs. The CMS IGs further constrain the HL7 QRDA standards to support CMS specific requirements, such as requiring CMS program names. The CMS IGs also provide submission guidance for a specific performance/reporting period. Schematron files contain a list of assertion rules used to validate that the generated QRDA reports conform to the requirements specified in the IGs.
Technology/Standard Usage Requirements:	Users must ensure their use of this technology/standard is consistent with VA policies and standards, including, but not limited to, VA Handbooks 6102 and 6500; VA Directives 6004, 6513, and 6517; and National Institute of Standards and Technology (NIST) standards, including Federal Information Processing Standards (FIPS). Users must ensure sensitive data is properly protected in compliance with all VA regulations. Prior to use of this technology, users should check with their supervisor, Information Security Officer (ISO), Facility Chief Information Officer (CIO), or local Office of Information and Technology (OI&T) representative to ensure that all actions are consistent with current VA policies and procedures prior to implementation.
Section 508 Information:
Decision:	View Decisions

Decision Source:	TRM Mgmt Group
Decision Process:	One-VA TRM v23.6
Decision Date:	06/28/2023 at 21:50:19 UTC
Aliases:	QRDA
Introduced By:	TRM Request
Standards Body:	HL7

Vendor Release Information

The Vendor Release table provides the known releases for the TRM Industry Standard, obtained from the vendor (or from the release source).

Version	Release Date	Vendor End of Life Date	Vendor Desupport Date
QRDA I STU R3	06/01/2015
QRDA III STU2.1	06/01/2017
QRDA III R1 (2023)	09/01/2021
QRDA I STU5.3 errata	12/01/2022

Current Decision Matrix (06/09/2023)

Users must ensure their use of this technology/standard is consistent with VA policies and standards, including, but not limited to, VA Handbooks 6102 and 6500; VA Directives 6004, 6513, and 6517; and National Institute of Standards and Technology (NIST) standards, including Federal Information Processing Standards (FIPS). Users must ensure sensitive data is properly protected in compliance with all VA regulations. Prior to use of this technology, users should check with their supervisor, Information Security Officer (ISO), Facility Chief Information Officer (CIO), or local Office of Information and Technology (OI&T) representative to ensure that all actions are consistent with current VA policies and procedures prior to implementation.

The VA Decision Matrix displays the current and future VA IT position regarding different releases of a TRM entry. These decisions are based upon the best information available as of the most current date. The consumer of this information has the responsibility to consult the organizations responsible for the desktop, testing, and/or production environments to ensure that the target version of the technology will be supported. Any major.minor version that is not listed in the VA Decision Matrix is considered unapproved for use.

Legend:

White	Approved: The technology/standard has been approved for use.
Yellow	Approved w/Constraints: The technology/standard can be used within the specified constraints located below the decision matrix in the footnote[1] and on the General tab.
Gray	Unapproved: This technology or standard can be used only if a POA&M review is conducted and signed by the Authorizing Official Designated Representative (AODR) as designated by the Authorizing Official (AO) or designee and based upon a recommendation from the POA&M Compliance Enforcement, has been granted to the project team or organization that wishes to use the technology.
Orange	Divest: VA has decided to divest itself on the use of the technology/standard. As a result, all projects currently utilizing the technology/standard must plan to eliminate their use of the technology/standard. Additional information on when the entry is projected to become unapproved may be found on the Decision tab for the specific entry.
Black	Prohibited: The technology/standard is not (currently) permitted to be used under any circumstances.
Blue	Planning/Evaluation Constraint:The period of time this technology is currently being evaluated, reviewed, and tested in controlled environments. Use of this technology is strictly controlled and not available for use within the general population. If a customer would like to use this technology, please work with your local or Regional OI&T office and contact the appropriate evaluation office displayed in the notes below the decision matrix. The Local or Regional OI&T office should submit an inquiry to the TRM if they require further assistance or if the evaluating office is not listed in the notes below.

Release/Version Information:

VA decisions for specific versions may include a ‘.x’ wildcard, which denotes a decision that pertains to a range of multiple versions.

For example, a technology approved with a decision for 7.x would cover any version of 7.(Anything) - 7.(Anything). However, a 7.4.x decision would cover any version of 7.4.(Anything), but would not cover any version of 7.5.x or 7.6.x on the TRM.

VA decisions for specific versions may include ‘+’ symbols; which denotes that the decision for the version specified also includes versions greater than what is specified but is not to exceed or affect previous decimal places.

For example, a technology approved with a decision for 12.6.4+ would cover any version that is greater than 12.6.4, but would not exceed the .6 decimal ie: 12.6.401 is ok, 12.6.5 is ok, 12.6.9 is ok, however 12.7.0 or 13.0 is not.

<Past

CY2022

CY2023

CY2024

Future>

Release

Q1

Q2

Q3

Q4

Q1

Q2

Q3

Q4

Q1

Q2

Q3

Q4

QRDA I STU R3

Unapproved

Approved w/Constraints
[2]

QRDA III STU2.1

Unapproved

Approved w/Constraints
[2]

QRDA III R1 (2023)

Unapproved

Approved w/Constraints
[1, 2]

QRDA I STU5.3 errata

Unapproved

Approved w/Constraints
[1, 2]

Decision Constraints


[1]	This Industry Standard is currently being evaluated, reviewed, and tested in controlled environments. Use of this technology is strictly controlled and not available for use within the general population.

[2]	IGs, schematrons, and sample files may be updated after initial publication to address stakeholder or policy requirements. Revisit https://ecqi.healthit.gov/qrda for updated resources prior to use. Please contact the VHA Office of Standards & Interoperability (Mailgroup: vhas&iresponseteam@va.gov) prior to implementation to obtain guidance and the VHA-endorsed version of this standard.

Note:

CMS publishes QRDA implementation guides (IGs), schematrons, and sample files annually to provide technical guidance for implementing the HL7 QRDA I and III standards for reporting to CMS quality reporting programs. The CMS IGs further constrain the HL7 QRDA standards to support CMS specific requirements, such as requiring CMS program names. The CMS IGs also provide submission guidance for a specific performance/reporting period. Schematron files contain a list of assertion rules used to validate that the generated QRDA reports conform to the requirements specified in the IGs. IGs, schematrons, and sample files may be updated after initial publication to address stakeholder or policy requirements. Revisit https://ecqi.healthit.gov/qrda for updated resources prior to use. Please contact the VHA Office of Standards & Interoperability (Mailgroup: vhas&iresponseteam@va.gov) prior to implementation to obtain guidance and the VHA-endorsed version of this standard.

References

The following reference(s) are associated with this entry:
Type	Name	Source	Description
Policy	Standards Version Advancement Process	ONC	The Standards Version Advancement Process (SVAP) permits health IT developers to voluntarily update health IT products certified under the ONC Health IT Certification Program (Certification Program) to newer versions of adopted standards as part of the “Real World Testing” Condition and Maintenance of Certification requirement (§ 170.405) of the 21st Century Cures Act. <br><br> All the standards in this guidance are currently available for voluntary certification under the Certification Program. The approved SVAP versions for 2020 went into effect in the Certification Program beginning March 12, 2021. The 2022 approved SVAP versions were announced June 28, 2022 and went into effect on August 29, 2022. Once effective, any newer versions of approved standards replaced existing approved standards from previous years.
Best Practice	CMS Implementation Guide for Quality Reporting Document Architecture Category I Hospital Quality Reporting Implementation Guide for 2022	Centers for Medicare and Medicaid Services	This guide is a CMS Quality Reporting Document Architecture Category I (QRDA I) implementation guide to the HL7 Implementation Guide for CDA Release 2: Quality Reporting Document Architecture Category I, Release 1, STU Release 5.2, and any subsequent errata update, referred to as the HL7 QRDA I STU R5.2 in this guide. This guide describes additional conformance statements and constraints for EHR data submissions that are required for reporting information to the CMS for the Hospital Inpatient Quality Reporting Program 2022 Reporting Period. The purpose of this guide is to serve as a companion to the base HL7 QRDA I STU R5.2 for entities such as Eligible Hospitals (EH), Critical Access Hospitals (CAHs), and vendors to submit QRDA I data for consumption by CMS systems including for Hospital Quality Reporting (HQR). Each QRDA Category I report contains quality data for one patient for one or more quality measures, where the data elements in the report are defined by the particular measure(s) being reported on. A QRDA Category I report contains raw applicable patient data. When pooled and analyzed, each report contributes the quality data necessary to calculate population measure metrics.
Best Practice	CMS Implementation Guide for Quality Reporting Document Architecture Category III Eligible Clinicians and Eligible Professionals Programs Implementation Guide for 2022	Centers for Medicare and Medicaid Services	This guide is a CMS Quality Reporting Document Architecture Category III (QRDA III) implementation guide to the HL7 QRDA III STU R2.1. Templates defined in this implementation guide are conformant with HL7 QRDA III STU R2.1. The CMS Eligible Clinicians and Eligible Professionals Programs QRDA III templates address aggregate reporting requirements for: Primary Care First (PCF), Merit-Based Incentive Payment System (MIPS), APM Performance Pathway (APP) <br><br> A QRDA III report is an aggregate quality report. Each QRDA III report contains calculated summary data for one or more measures for a specified population of patients within a particular health system over a specific period of time. Summary data in the QRDA III report are defined based on the specified measures in HL7 Health Quality Measures Format (HQMF), which standardizes the representation of a health quality measure as an electronic document. Other summary data provided in the QRDA III report include Promoting Interoperability measures, formerly Advancing Care Information measures, and Improvement Activities.
Requirement	170.315(c)(3) Clinical quality measures (CQMs) — report	ONC	This Certification Companion Guide (CCG) is an informative document designed to assist with health IT product development. The CCG is not a substitute for the 21st Century Cures Act: Interoperability, Information Blocking, and the ONC Health IT Certification Program Final Rule (ONC Cures Act Final Rule). It extracts key portions of the rule’s preamble and includes subsequent clarifying interpretations. To access the full context of regulatory intent please consult the ONC Cures Act Final Rule or other included regulatory reference. The CCG is for public use and should not be sold or redistributed.
Requirement	170.315(c)(1) Clinical quality measures (CQMs) — record and export	ONC	This Certification Companion Guide (CCG) is an informative document designed to assist with health IT product development. The CCG is not a substitute for the 2015 Edition final regulation. It extracts key portions of the rule’s preamble and includes subsequent clarifying interpretations. To access the full context of regulatory intent please consult the 2015 Edition final rule or other included regulatory reference. The CCG is for public use and should not be sold or redistributed.
Requirement	170.315(c)(2) Clinical quality measures (CQMs) — import and calculate	ONC	This Certification Companion Guide (CCG) is an informative document designed to assist with health IT product development. The CCG is not a substitute for the 2015 Edition final regulation. It extracts key portions of the rule’s preamble and includes subsequent clarifying interpretations. To access the full context of regulatory intent please consult the 2015 Edition final rule or other included regulatory reference. The CCG is for public use and should not be sold or redistributed.
Vendor Provided*	QRDA - Quality Reporting Document Architecture	ONC	The Quality Reporting Document Architecture (QRDA) is the data submission standard used for a variety of quality measurement and reporting initiatives. It is based on the Health Level Seven International® (HL7®) Clinical Document Architecture (CDA). QRDA creates a standard method to report quality measure results in a structured, consistent format and can be used to exchange eCQM data between systems.
Policy	170.205(h) Clinical quality measure data import, export and reporting - Standards (2) and (3)	Code of Federal Regulations	HL7 CDA R2 Implementation Guide: Quality Reporting Document Architecture—Category I (QRDA I); Release 1, DSTU Release 3 (US Realm), Volume 1—Introductory Material HL7 CDA R2 Implementation Guide: Quality Reporting Document Architecture—Category I (QRDA I); Release 1, DSTU Release 3 (US Realm), Volume 2—Templates and Supporting Material (incorporated by reference in § 170.299). CMS Implementation Guide for Quality Reporting Document Architecture: Category I; Hospital Quality Reporting; Implementation Guide for 2020 (incorporated by reference in § 170.299).
Policy	170.205(k)(3) Clinical quality measure aggregate reporting	Code of Federal Regulations	CMS Implementation Guide for Quality Reporting Document Architecture: Category III; Eligible Clinicians and Eligible Professionals Programs; Implementation Guide for 2020 (incorporated by reference in § 170.299)
Policy	170.315(c)(1) - Clinical quality measures (CQMs) — record and export	Code of Federal Regulations	Record. For each and every CQM for which the technology is presented for certification, the technology must be able to record all of the data that would be necessary to calculate each CQM. Data required for CQM exclusions or exceptions must be codified entries, which may include specific terms as defined by each CQM, or may include codified expressions of “patient reason,” “system reason,” or “medical reason.” Export. A user must be able to export a data file at any time the user chooses and without subsequent developer assistance to operate: (A) Formatted in accordance with the standard specified in § 170.205(h)(2); (B) Ranging from one to multiple patients; and (C) That includes all of the data captured for each and every CQM to which technology was certified under paragraph (c)(1)(i) of this section.
Policy	170.315(c)(2) - Clinical quality measures (CQMs) — import and calculate	Code of Federal Regulations	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.
Policy	170.315(c)(3) - Clinical quality measures (CQMs) — report	Code of Federal Regulations	Enable a user to electronically create a data file for transmission of clinical quality measurement data: In accordance with the applicable implementation specifications specified by the CMS implementation guides for Quality Reporting Document Architecture (QRDA), category I, for inpatient measures in § 170.205(h)(3) and CMS implementation guide for QRDA, category III for ambulatory measures in § 170.205 (k)(3); or In accordance with the standards specified in § 170.205(h)(2) and § 170.205(k)(1) and (2) for the period before December 31, 2022.
Policy	Information Blocking (21st Century Cures Act)	ONC	Most clinical information is digitized, accessible, and shareable thanks to several technology and policy advances making interoperable, electronic health record systems widely available. In 2016, the 21st Century Cures Act (Cures Act) made sharing electronic health information the expected norm in health care by authorizing the Secretary of Health and Human Services (HHS) to identify `reasonable and necessary activities that do not constitute information blocking.` ONC``s 2020 Cures Act Final Rule established information blocking exceptions to implement the law.
*NOTE: Vendor provided information is subject to the accuracy of the manufacturer.

Standard Components

Note: This list may not be complete. No component, listed or unlisted, may be used outside of the technology in which it is released. The usage decision for a component is found in the Decision and Decision Constraints.
Source	Name	Description
HL7	HL7 CDA R2 Implementation Guide: Quality Reporting Document Architecture - Category I (QRDA I) - US Realm	This two-volume implementation guide (IG) describes constraints on the Clinical Document Architecture Release 2 (CDA R2) header and body elements for Quality Reporting Document Architecture (QRDA) documents. The Institute of Medicine (IOM) definition of quality is: “The degree to which health services for individuals and populations increase the likelihood of desired health outcomes and are consistent with current professional knowledge.” For care quality to be evaluated, it must be standardized and communicated to the appropriate organizations. QRDA is a document format that provides a standard structure with which to report quality measure data to organizations that will analyze and interpret the data. Quality measurement in health care is complex. Accurate, interpretable data efficiently gathered and communicated is key in correctly assessing that quality care is delivered. A QRDA Category I report is an individual-patient-level quality report. Each report contains quality data for one patient for one or more quality measures, where the data elements in the report are defined by the particular measure(s) being reported on. A QRDA Category I report contains raw applicable patient data. When pooled and analyzed, each report contributes the quality data necessary to calculate population measure metrics. This two-volume implementation guide (IG) describes constraints on the Clinical Document Architecture Release 2 (CDA R2) header and body elements for Quality Reporting Document Architecture (QRDA) documents. A QRDA Category I report is an individual-patient-level quality report. Each report contains quality data for one patient for one or more quality measures, where the data elements in the report are defined by the particular measure(s) being reported on. A QRDA Category I report contains raw applicable patient data. When pooled and analyzed, each report contributes the quality data necessary to calculate population measure metrics. This two-volume implementation guide (IG) describes constraints on the Clinical Document Architecture Release 2 (CDA R2) header and body elements for Quality Reporting Document Architecture (QRDA) documents.
HL7	HL7 CDA® R2 Implementation Guide: Quality Reporting Document Architecture (QRDA III), Release 1 - US Realm	A QRDA Category III report is an aggregate quality report. Each report contains calculated summary data for one or more measures for a specified population of patients within a particular health system over a specific period of time. Data needed to generate QRDA Category III reports must be included in the collected QRDA Category I reports, as the processing entity will not have access to additional data sources. The QRDA Category III Implementation Guide directs implementers on how to construct QRDA Category III instances to report aggregated results for electronic clinical quality measures (eCQMs).

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Domain Area	Category	Customer Guidance	Category Locked By ELT Date
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General Analysis

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