|Submitted By: Joel Andress / Centers for Medicare and Medicaid Services (CMS) Center for Clinical Standards and Quality (CCSQ)|
|Data Element Information|
|Rationale for Separate Consideration||Clinical notes for this concept are required by USCDI v1. Recommending expanding the concept to include specification of the type of imagining study and its performance completed, using standardized terminology.|
|Use Case Description(s)|
|Use Case Description||Imagining diagnostic studies performed are key data elements currently used in CMS eCQMs across hospital and clinician reporting programs. The confirmation of completion of a study is necessary to confirm appropriate care is received for patients across different populations, for example if a bone density screening was completed for an at-risk cancer patient. Similar to labs and vital signs, it is clinically relevant from a care perspective and a quality measurement perspective to confirm the completion of diagnostic studies for patients. This information can support surveillance of appropriate use and adherence to care guidelines for value-based care of patients.
Imaging diagnostic study concepts represented in CMS quality measures include DXA/DEXA, bone scans, and mammograms. Actual results, which are not always in structured fields, do not need to be exchanged for measurement, but the study/exam performance is documented in standardized terminology and exchangeable to confirm the study was performed.
|Estimated number of stakeholders capturing, accessing using or exchanging||More than 4,000 hospitals and 1 million providers currently capture, access and exchange this imaging diagnostic study performance. This information is currently electronically submitted by providers and hospitals to CMS for quality measurement purposes, including in IQR and QPP.|
|Link to use case project page||https://ecqi.healthit.gov/ecqms|
|Use Case Description||Data exchange of imagining diagnostic study performance 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.
Studies performed, 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: 2.16.840.1.113883.3.526.3.320)
|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
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||Extensively used in production environments|
Types of diagnostic studies performed are regularly captured by EHR systems across hospitals, providers, and other healthcare stakeholders, and used for CQM quality measurement (eCQMs). The results or interpretations of some studies may only be available in clinical notes, however that is already included in USCDI v1.
https://ecqi.healthit.gov/ecqms (for example, CMS 129) https://ecqi.healthit.gov/sites/default/files/ecqm/measures/CMS129v9.html)
|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.|
Imaging diagnostic studies performed are electronically exchanged from organization’s EHR systems to CMS for reporting and payment quality measurement programs, via QRDA files.
Diagnostic study performance can also be electronically exchanges with external organizations via C-CDA, and is included in ONC’s exchange criteria as part of the Medical Imagining Format for Data Exchange and Distribution.
|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 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|
|ONC Evaluation Details
Each submitted Data Element has been evaluated based on the following 4 criteria. The overall Level classification is a composite of the maturity based on these individual criteria. This information can be used to identify areas that require additional work to raise the overall classification level and consideration for inclusion in future versions of USCDI
|Maturity – Standards/Technical Specifications||Level 1/2 - Must be represented by a vocabulary standard or an element of a published technical specification|
|Maturity - Current Use||Level 2 - Used at scale in more than 2 different production environments|
|Maturity - Current Exchange||Level 2 - Demonstrates exchange between 4 or more organizations with different EHR/HIT systems|
|Breadth of Applicability - # Stakeholders Impacted||Level 2 - Used by a majority of patients, providers or events requiring its use|