STU 2 Ballot

This page is part of the Data Access Framework (v1.6.0: STU 2 Ballot 1) based on FHIR v1.6.0. . For a full list of available versions, see the Directory of published versions

D.10.0 U.S. Data Access Framework (DAF) Results Profile

D.10.0.1 Scope and Usage

This profile sets expectations for use of the Observation resource to record results associated with a patient within the DAF FHIR IG. This profile identifies which core elements, extensions, vocabularies and value sets must be Supported by DAF actors. For the definition of Supported please refer to DAF FHIR IG. The data elements identified by the profile are based on ONC 2014 Edition S&CC and DAF use cases.

This DAF Observation profile supports the various kinds of result values that are generated by Laboratories, Radiology systems, and Ask at Order Entry ('AOE') questions. This profile supports:

  • Coded results (valueCodeableConcept). For example, this profile could be used to record a Chlamydia trachomatis RNA PCR result of "Not Detected"
  • Quantitative or numeric results (valueQuantity) with required units and reference ranges. For example, valueQuantity would be used to record a Blood Glucose level measurement of 80 mg/dL.
  • Quantitative results that are expressed as ranges with required reference ranges (valueRange). For example, valueRange would be used to record white blood cells (WBCs) in a urine analysis with a value range of 10-20 WBC/HPF.
  • Ratios for titers with required reference ranges (valueRatio). For example, valueRatio would be used to record an adenovirus total antibody of <1:8
  • Other result value types
    • valueAttachment
    • valueDateTime
    • valuePeriod
    • valueSampleData
    • valueString
    • valueTime
    For example, the other result value types would be used to record a free text entry of a cytology observation, or to record the date of last menstrual period for an ask at order entry question for a pap smear report.
  • This profile may also be used for a panel/battery. A panel observation lists the set component observations from a panel or battery in the Observation.related element and does not have its own Observation.value. For example a Chyamydia trachomatis + Neisseria gonorrhoeae RNA PCR (GC/CT) panel would have two references to related observations for the Chlamydia trachomatis RNA PCR result and the Neisseria gonorrhoeae RNA PCR result.

This profile is referenced in the DAFDiagnosticReport profile for one or more test results. They are also referenced for Ask at Order Entry ("AOE") questions, other clinically relevant questions and for reporting prior results when requesting a test order using the DAFDiagnosticRequest. Although not specified in this implementation, it may be used in other resources as well.

The mappings between the ONC 2014 Edition S&I data elements and DAF data elements are captured in the table below, where the first column identifies the ONC 2014 Edition S&I data element name, the second column maps the ONC 2014 Edition S&I data elements to DAF data elements which are derived from ONC 2014 Edition S&I standards and DAF use cases and lastly the third column identifies the mapping to FHIR resources and attributes.

D.10.0.2 Meaningful Use Data Element Mapping

The DAFResults profile mapping to Meaningful Use data elements and FHIR Resources are as shown below. For an overview of how the DAF profiles and data elements were derived from ONC 2014 Edition S&CC please refer to DAF FHIR IG data mapping section.


Meaningful Use Data Element Name Mapping to Priority DAF Data Elements FHIR Resource Mapping
Laboratory Result Value(s)
Lab Test Name Observation.name.coding.code
Lab Test Result Observation.value[x](Code,SimpleQuantity,Ratio or other)
Lab Test Specimen collection date Observation.effective[x]
Lab Test Result Available Date Observation.issued
Lab Test Result Interpretation Observation.interpretation
Lab Test Result Reference Range Observation.referenceRange
Body Site used to collect specimen Observation.Specimen.collection.bodySite

D.10.0.3 Boundaries and Relationships

This profile relies on the following other profiles:

D.10.0.4 Content

Profiles:
DAF-ResultObsUS Realm DAF result observation

D.10.0.4.1 Search Parameters

The full list of supported search parameters are can be accessed at DAF Requestor conformance expectations and DAF Responder conformance expectations.

D.10.0.4.2 Example Usage Scenarios

The following are example usage scenarios for the DAF-Results profile:

  • Query for lab results belonging to a Patient
  • Query for all patients who have had a specific lab result available
  • Query for lab results based on type of lab test
  • Query for all patients with a lab test (e.g HbA1c) beyond the acceptable reference range

D.10.0.4.3 Profile specific implementation guidance

Implementers need to be mindful of the following during their implementation

    Accessing Results: Typically results are grouped by a DAF-DiagnosticReport and access to observatations SHOULD be through the a DiagnosticReport. Access directly to observations is appropriate when a DiagnosticReport is not maintained.

    Representing No Known Lab Results: No Known Lab Results will be represented using the DAF-ResultList profile with no entries.

    See DAF FHIR IG for implementation guidance common to all profiles.