|Submitted By: Joel Andress / Centers for Medicare and Medicaid Services (CMS) Center for Clinical Standards and Quality (CCSQ)|
|Data Element Information|
|Use Case Description(s)|
|Use Case Description||Diagnostic studies and exams performed with results are key data elements currently used in CMS eCQMs across hospital and clinician reporting programs. These data are necessary to confirm appropriate care is received for patients across different populations. Similar to labs and vital signs, it is clinically relevant from a care perspective and a quality measurement perspective to have access to and use diagnostic study/exam results for care decision making. This information can support surveillance of appropriate use and adherence to care guidelines for value-based care of patients.
Diagnostic study/exam concepts represented in measures include and eye/disc/macular exams and ejection fraction studies. Results for these types of studies and exams are available in structured fields and exchanged for quality measurement purposes.
|Estimated number of stakeholders capturing, accessing using or exchanging||1 million providers currently capture, access and exchange this diagnostic study/exam information. This information is currently electronically submitted by providers and hospitals to CMS for quality measurement purposes, including QPP.
eCQI resource center, includes measure specifications for CMS program eCQMs (i.e. CMS 143, 135): https://ecqi.healthit.gov/ecqms
|Link to use case project page||https://ecqi.healthit.gov/ecqms|
|Use Case Description||Data exchange of diagnostic study/exam information is critical for clinical care. Clinician’s need to be aware of recent tests completed to both ensure the patient is receiving appropriate care and reduce duplicity which drives up healthcare costs.
Diagnostic study and exam information including studies/exams performed, result, and the type of test completed via standard terminology can be exchanged via C-CDA for patient care coordination.
|Estimated number of stakeholders capturing, accessing using or exchanging||Majority or hospital and clinical providers are capturing, accessing and exchanging this information.|
|Link to use case project page||http://www.hl7.org/implement/standards/product_brief.cfm?product_id=492|
|Maturity of Use and Technical Specifications for Data Element|
|Applicable Standard(s)||LOINC (i.e. OID: 2.16.840.1.113883.3.526.3.1251)
|Additional Specifications||HL7 FHIR QI Core Implementation Guide STU4 based on FHIR R4, Observation Profile (category= exam) : http://hl7.org/fhir/us/qicore/StructureDefinition-qicore-observation.html and DiagnosticReport profiles
CMS Quality Data Model (QDM) version 5.5 Guidance https://ecqi.healthit.gov/sites/default/files/QDM-v5.5-Guidance-Update-May-2020-508.pdf
HL7 FHIR US Core Implementation Guide v3.1.0 based on FHIR R4, includes Observation-lab Profile, which can be built out further to also identify exams and studies performed. https://www.hl7.org/fhir/us/core/StructureDefinition-us-core-observation-lab.html
|Current Use||This data element has been used at scale between multiple different production environments to support the majority of anticipated stakeholders|
These diagnostic studies and exams performed are regularly captured by EHR systems across hospitals, providers, and other healthcare stakeholders, and used for CQM quality measurement (eCQMs).
|Number of organizations/individuals with which this data element has been electronically exchanged||5 or more. This data element has been tested at scale between multiple different production environments to support the majority of anticipated stakeholders.|
Diagnostic studies and exams performed are electronically exchanged from organization’s EHR systems to CMS for reporting and payment quality measurement programs, via QRDA files.
Diagnostic study/exams can also be electronically exchanges with external organizations via C-CDA.
|Restrictions on Standardization (e.g. proprietary code)||No challenges anticipated. This data is available in standard terminology that can be publicly accessed via the VSAC and HL7.|
|Restrictions on Use (e.g. licensing, user fees)||We are not aware of any restrictions.|
|Privacy and Security Concerns||This data, like any patient data should be exchanged securely. Current processes exist, governed by CMS and ONC, to securely transfer this data.|
|Estimate of Overall Burden||Diagnostic study and exam performance is regularly captured as part of EHR systems. Most hospitals, including critical access hospitals, and providers are already capturing and exchanging these data for quality measurement to CMS.
Some additional efforts may be necessary to build out Observation profile or additional resources in FHIR US Core Implementation Guide, though base resources exist in FHIR and profiles exist in QI Core Implementation Guide.
|Other Implementation Challenges||N/A|
Includes non-imaging and non-laboratory tests performed on a patient that results in structured or unstructured (narrative) findings specific to the patient, such as electrocardiogram (ECG), visual acuity exam, macular exam, or graded exercise testing (GXT), to facilitate the diagnosis and management of conditions.
The name of the non-imaging or non-laboratory test performed on a patient.
Applicable Vocabulary Standard(s)