HL7 FHIR Implementation Guide: Breast Cancer Data, Release 1 - US Realm (Draft for Comment 2)
This page is part of the Breast Cancer Data Logical Models and FHIR Profiles (v0.2.0: STU 1 Draft) based on FHIR R3. . For a full list of available versions, see the Directory of published versions 
The official URL for this logical model is:
http://hl7.org/fhir/us/breastcancer/StructureDefinition/oncology-OncotypeDxInvasiveRecurrenceScore-model
The Oncotype DX test for invasive breast cancer examines the activity of 21 genes in a patient’s breast tumor tissue to provide personalized information for tailoring treatment based on the biology of their individual disease. The value from 0 to 100 indicates the estimated risk of recurrence, with the highest risk indicated by a score greater than 31. No LOINC code currently exists for this test. We are seeking feedback on the value of separating OncotypeDx scores for DCIS and invasive breast carcinomas. Does it make more sense to report the OncotypeDx as a single score, regardless of the type of cancer?
This logical model was published on Fri Aug 17 00:00:00 AEST 2018 as a draft by The HL7 Cancer Interoperability Group sponsored by Clinical Interoperability Council Work Group (CIC).
View the corresponding OncotypeDxInvasiveRecurrenceScoreProfile profile.
| Name | Flags | Card. | Type | Description & Constraints |
|---|---|---|---|---|
  oncology-OncotypeDxInvasiveRecurrenceScore-model | 0..* | |||
  personOfRecord | 1..1 | Reference(BC PersonOfRecord Logical Model) | The person this entry belongs to. | |
 laboratoryObservationTopic | 1..1 | BackboneElement | The topic composition for laboratory observations. A specimen is required, anatomical location is excluded (since the specimen indicates the collection body site). Also includes a diagnostic service (indicating the type of laboratory), not present in general observations. | |
 topicCode | 1..1 | Coding | The concept representing the finding or action that is the topic of the statement. | |
 extension | 0..* | Extension | Additional Content defined by implementations Slice: Unordered, Open by value:url | |
 system | Σ | 1..1 | uri | Identity of the terminology system Fixed Value: http://ncimeta.nci.nih.gov |
| version | Σ | 0..1 | string | Version of the system - if relevant |
| code | Σ | 1..1 | code | Symbol in syntax defined by the system Fixed Value: C1709318 |
| display | Σ | 0..1 | string | Representation defined by the system |
 userSelected | Σ | 0..1 | boolean | If this coding was chosen directly by the user |
| findingMethod | 0..1 | Coding | The technique used to create the finding, for example, the specific imaging technical, lab test code, or assessment vehicle. Binding: http://loinc.org/vs (preferred) | |
| details | 0..1 | string | A text note containing additional details, explanation, description, comment, or summarization. Details can discuss, support, explain changes to, or dispute information. | |
| category | 1..* | Coding | A class or division of people or things having particular shared characteristics | |
| extension | 0..* | Extension | Additional Content defined by implementations Slice: Unordered, Open by value:url | |
| system | Σ | 1..1 | uri | Identity of the terminology system Fixed Value: http://hl7.org/fhir/observation-category |
| version | Σ | 0..1 | string | Version of the system - if relevant |
| code | Σ | 1..1 | code | Symbol in syntax defined by the system Fixed Value: laboratory |
| display | Σ | 0..1 | string | Representation defined by the system |
| userSelected | Σ | 0..1 | boolean | If this coding was chosen directly by the user |
| breastSpecimen | 1..1 | Reference(BC BreastSpecimen Logical Model) | Specimen resulting from biopsy or excision of breast and surrounding tissue. | |
 precondition | 0..* | Coding, Reference(BC Observation Logical Model) | A description of the conditions or context of an observation, for example, under sedation, fasting or post-exercise. Body position and body site are also qualifiers, but handled separately. A qualifier cannot modify the measurement type; for example, a fasting blood sugar is still a blood sugar. | |
 referenceRange | 0..* | http://hl7.org/fhir/us/breastcancer/StructureDefinition/cimi-topic-ReferenceRange-model | The usual or acceptable range for a test result. | |
| diagnosticService | 0..* | Coding | The service completing the observations, e.g. biochemistry, microbiology, blood bank. | |
 extension | 0..* | Extension | Additional Content defined by implementations Slice: Unordered, Open by value:url | |
| system | Σ | 1..1 | uri | Identity of the terminology system Fixed Value: http://hl7.org/fhir/v2/0074 |
| version | Σ | 0..1 | string | Version of the system - if relevant |
| code | Σ | 1..1 | code | Symbol in syntax defined by the system Fixed Value: PAT |
| display | Σ | 0..1 | string | Representation defined by the system |
| userSelected | Σ | 0..1 | boolean | If this coding was chosen directly by the user |
| observationContext | 1..1 | BackboneElement | Context for recording an evaluation result, used to indicate an evaluation has been made. | |
| contextCode | 1..1 | Coding | A code representing the ontological status of the statement, e.g., whether it exists, does not exist, is planned, etc. | |
| extension | 0..* | Extension | Additional Content defined by implementations Slice: Unordered, Open by value:url | |
| system | Σ | 1..1 | uri | Identity of the terminology system Fixed Value: http://snomed.info/sct |
| version | Σ | 0..1 | string | Version of the system - if relevant |
| code | Σ | 1..1 | code | Symbol in syntax defined by the system Fixed Value: 424975005 |
| display | Σ | 0..1 | string | Representation defined by the system |
| userSelected | Σ | 0..1 | boolean | If this coding was chosen directly by the user |
| encounter | 0..1 | http://hl7.org/fhir/us/breastcancer/StructureDefinition/cimi-encounter-Encounter-model | A description of an interaction between a patient and healthcare provider(s) for the purpose of providing healthcare service(s) or assessing the health status of a patient. | |
| interpretation | 0..1 | Coding | A clinical interpretation of a finding (applies to both assertions and observation). Binding: BC RecurrenceRiskScoreInterpretationVS ValueSet (required) | |
| findingStatus | 1..1 | code | Indicates whether the finding is preliminary, amended, final, etc. Binding: ObservationStatus (required) | |
| relevantTime | 0..1 | dateTime, http://hl7.org/fhir/us/breastcancer/StructureDefinition/shr-core-TimePeriod-model | The time or time period that the finding addresses. | |
| resultValue | 0..1 | http://hl7.org/fhir/us/breastcancer/StructureDefinition/shr-core-Quantity-model | The finding itself, such as the blood pressure value recorded. | |
| exceptionValue | 0..1 | Coding | Reason that a value associated with a test or other finding is missing. Binding: DataAbsentReason (extensible) | |
| deltaFlag | 0..1 | Coding | Indicator of significant change (delta) from the last or previous measurement. Binding: BC DeltaFlagVS ValueSet (required) | |
| issued | 0..1 | instant | The date and time this observation was made available to providers, typically after the results have been reviewed and verified. | |
| observer | 0..* | Reference(BC Practitioner Logical Model | BC Organization Logical Model | BC Patient Logical Model | BC RelatedPerson Logical Model) | The person or organization who observed or informed the reporter about the characteristic, potentially the clinician, the patient, or a related person. | |
| Documentation for this format | ||||
Downloads: StructureDefinition: (XML, JSON, TTL)
| Path | Name | Conformance | ValueSet |
| oncology-OncotypeDxInvasiveRecurrenceScore-model.laboratoryObservationTopic.findingMethod | ?ext | preferred | http://loinc.org/vs |
| oncology-OncotypeDxInvasiveRecurrenceScore-model.observationContext.interpretation | BC RecurrenceRiskScoreInterpretationVS ValueSet | required | RecurrenceRiskScoreInterpretationVS |
| oncology-OncotypeDxInvasiveRecurrenceScore-model.observationContext.findingStatus | ObservationStatus | required | ObservationStatus |
| oncology-OncotypeDxInvasiveRecurrenceScore-model.observationContext.exceptionValue | DataAbsentReason | extensible | DataAbsentReason |
| oncology-OncotypeDxInvasiveRecurrenceScore-model.observationContext.deltaFlag | BC DeltaFlagVS ValueSet | required | DeltaFlagVS |