QI-Core Implementation Guide: STU 4 (v4.0.0 for FHIR 4.0.0)

QI-Core Implementation Guide, Clinical Quality Improvement WG - CI build for vesion 4.0.0). This version is based on the current content of https://github.com/cqframework/qi-core/ and changes regularly. See the Directory of published versions

7.9.0 Diagnostic Study

The content on this page was updated based on review by the CQI Workgroup Conference call on April 6, 2018 with reference to QDM 5.3. The content presented here is updated to QDM version 5.4. QDM version 5.4 removed the "method" attribute from "Diagnostic Study, Order" and "Diagnostic Study, Recommended" but retained the "method" attribute for "Diagnostic Study, Performed". There are no other changes in QDM version 5.4 as compared to QDM version 5.3.

QDM defines Diagnostic Study as any kind of medical test performed as a specific test or series of steps to aid in diagnosing or detecting disease (e.g., to establish a diagnosis, measure the progress or recovery from disease, confirm that a person is free from disease). The QDM differentiates diagnostic studies from laboratory tests in that diagnostic studies are those that are not performed in organizations that perform testing on samples of human blood, tissue, or other substance from the body. Diagnostic studies may make use of digital images and textual reports. Such studies include but are not limited to imaging studies, cardiology studies (electrocardiogram, treadmill stress testing), pulmonary-function testing, vascular laboratory testing, and others.

Thus far, consensus opinion suggests that the FHIR Observation Resource best fits the diagnostic study use case for querying clinical data to retrieve information about the event and/or the result of the study. Individual studies may use the US-Core DiagnosticReport-note (http://hl7.org/fhir/us/core/StructureDefinition-us-core-diagnosticreport-note.html) to provide information about an individual study (e.g., a cardiac ultrasound, MRI, etc.) although some have considered use of other reporting resources and artifacts. Since new studies regularly become available and the nature of existing studies change over time, a complete list of studies to reference a desired result cannot be assured. Therefore, a quality measure or clinical decision support (CDS) artifacts seeking a specific result value should use the Observation resource to request a retrieve of the result value desired. This practice will enable implementers to determine which is the best source for the desired observation. LOINC observable entities may indicate specific methods for determination of results. Measure and CDS developers can reference direct reference codes or value sets using the such LOINC codes to specify the type of testing considered acceptable to provide sufficient fidelity to their requests.

7.9.1 Diagnostic Study, Performed

QDM Context QI-Core R4 Comments
Diagnostic Study, Performed Observation
Observation.partOf A larger event of which this particular Observation is a component or step. For example, an observation as part of a procedure.
Observation.status Constrain status to - final, amended, corrected, appended
QDM Attributes
code Observation.code
id Observation.id
method Observation.method
facility location N/A
Observation.bodySite
negation rationale Observation.dataAbsentReason The Observation.status value set does not include a "not-done" option. Therefore, the Observation.dataAbsentReason with status="unknown" or "cancelled" might be used. Consider extension for status="not-done"
Observation.issued Issued - the date and time this version of the observation was made available to providers, typically after the results have been reviewed and verified. Consider if QI-Core should include an extension to manage timing of the dataAbsentReason.
reason Observation.basedOn the Observation.basedOn concept indicates the plan, proposal or order that the observation fulfills. This concept is not consistent with the QDM concept of "reason" for the study to be performed.
result Observation.value[x]
Observation.interpretation
result dateTime Observation.issued
Relevant dateTime Observation.issued
Relevant Period Observation.effective[x] Period
Status Observation.status Constrain status to - final, amended, corrected, appended
Author dateTime Observation.issued Issued - the date and time this version of the observation was made available to providers, typically after the results have been reviewed and verified. Consider if QI-Core should include an extension to manage timing of the dataAbsentReason.
Component Observation.component Components not present in US-Core-R4 DiagnosticReport but the report references Observation for results; thus it seems reasonable to re-use observation concepts for the components of a DiagnosticReport
Observation.component.id
Component code Observation.component.code
Component result Observation.component.value[x]
Observation.component.interpretation
Observation.component.dataAbsentReason
Performer Observation.performer

7.9.2 Diagnostic Study, Order

To address the QDM attribute Diagnostic Study, Order see Service Request

7.9.3 Diagnostic Study, Recommended

To address the QDM attribute Diagnostic Study, Recommended see Service Request