October 7, 2012

The QRDA Category 1 XML Standard

The Quality Reporting Document Architecture (QRDA) Category 1 standard is a new XML standard designed for communicating patient-level clinical data that will be used to calculate Clinical Quality Measures (CQMs). This is an HL7 XML standard that is part of the Clinical Document Architecture  (CDA), which is an overall framework for expressing healthcare data in XML that is also stewarded by HL7.  

The QRDA Category 1 XML standard was created because systems needing to calculate Clinical Quality Measures (CMSs) could not guarantee that patient-level data would appear in the existing continuity of care standards such as the HITSP C32, HL7 Consolidated CDA (CCDA), and the ASTM Continuity of Care Record (CCR).  The QRDA Category 1 standard has been designed so that all of the clinical information needed for each specific CQM will need to be expressed within the QRDA Category 1 XML document. 

The QRDA Category 1 is a clinical document representing a single patient. It defines sections containing measure information and patient data that meets criteria for a measure. It also contains information on the reporting period. The markup for the patient data is the same as a CCDA document.  

In a nutshell, the QRDA Category 1 XML standard will include the templates needed for each attribute in each CQM that a patient could provide clinical data to be used to calculate any number of CQMs.  Additionally, more than one CQM can be included in the request for the clinical data associated with one patient.  

If you view the illustration below, you can see that an Electronic Health Record (EHR) system may be requested to generate QRDA Category 1 XML for patients to be used to drive the calculation of the Diabetes Blood Pressure Management CQM AND the Diabetes LDL Test CQM.  In that case, all clinical data that could be used to drive the calculation of either of those CQMs must appear in the QRDA Category 1 for each patient in the EHR.  Further, additional clinical information associated with each patient is not required, and will result in warnings (but not errors) in the QRDA Category 1 for each patient.

c32/ccda vs qrda category 1
The C32/CCDA vs QRDA Category 1
Only relevant data is expressed in the QRDA Category 1
based on the need for specific CQMs
I personally feel that the QRDA Category 1 reflects the failures of the CCR, C32, and CCDA standards.  It is difficult to explain why a single standard for expressing patient-level data that is interoperable and can provide sufficient fidelity of data for calculating CQMs does still not exist.  It's 2012.

Where problems are identified with a CQM when the CCR... the C32... the CCDA do not provide sufficient information for calculating MU CQMs, CQMs could be adjusted to be simpler, and conform to data that must exist in the CCR... the C32... the CCDA.  This lack of a good continuity of care standard for a single patient record is what I feel is the root cause of all of this work.  

Knowing that the QRDA Category 1 isn't going away anytime soon, I have found that the use of the QRDA Category 1 XML standard has been difficult due to lack of validation tests and example QRDA Category 1 XML files.  However, I suspect that these two shortcomings will be addressed in time.

The objective of using the QRDA Category 1 XML standard as a mechanism to present clinical quality data associated with a patient should unambiguously define clinical attributes so that there’s no confusion about what is expected of an EHR system's ability to export in XML artifacts.  Time will tell if this objective is realized in EHR systems... I remain skeptical.  I think we will know a lot more by 2013, when this standard is officially introduced into the Meaningful Use Stage 2 program.

This work is licensed under a Creative Commons Attribution-NonCommercial-NoDerivs 3.0 Unported License. © Rob McCready, 2012.
Creative Commons License