Non-imaging and non-laboratory tests performed that result in structured or unstructured findings specific to the patient to facilitate the diagnosis and management of conditions. (e.g., electrocardiogram (ECG), visual acuity exam, macular exam, or graded exercise testing (GXT))
Logical Observation Identifiers Names and Codes (LOINC®) version 2.73
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
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.
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.
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.
There was much interest from the Task Force in adding clinical variables beyond laboratory to USCDI. This is a suggested starting set. We would suggest that users would not be required to use these specific codes listed under a given panel verbatim. They could drop codes that did not fit and add other LOINC codes as appropriate. This starter set should get the ball rolling to deliver richer clinical data that has been available for years and is in high demand by clinicians and patients.
2021 03 29 Some clinical measure tests panels available from LOINC just some to explore.docx
CMS agrees with the need to make this additional clinical data available via inclusion in the USCDI. We agree LOINC terminology is an appropriate applicable standard to accompany the data element. CMS identified some critical diagnostic studies/exams including cardiac exams (ejection fraction from echocardiography tests), and colonoscopy; many of these align with the exams provided in this document.
There was much interest from the Task Force in adding clinical variables beyond laboratory to USCDI. This is a suggested starting set. We would suggest that users would not be required to use these specific codes listed under a given panel verbatim. They could drop codes that did not fit and add other LOINC codes as appropriate. This starter set should get the ball rolling to deliver richer clinical data that has been available for years and is in high demand by clinicians and patients.
Submitted by JAndress316 on 2021-04-16
Response to Comment on Diagnostic studies and exams with results
There was much interest from the Task Force in adding clinical variables beyond laboratory to USCDI. This is a suggested starting set. We would suggest that users would not be required to use these specific codes listed under a given panel verbatim. They could drop codes that did not fit and add other LOINC codes as appropriate. This starter set should get the ball rolling to deliver richer clinical data that has been available for years and is in high demand by clinicians and patients. 2021 03 29 Some clinical measure tests panels available from LOINC just some to explore.docx CMS agrees with the need to make this additional clinical data available via inclusion in the USCDI. We agree LOINC terminology is an appropriate applicable standard to accompany the data element. CMS identified some critical diagnostic studies/exams including cardiac exams (ejection fraction from echocardiography tests), and colonoscopy; many of these align with the exams provided in this document.