HL7 FHIR® Implementation Guide: Breast Cancer Data, Release 1 - US Realm (Draft for Comment)
This page is part of the Breast Cancer Data Logical Models and FHIR Profiles (v0.1.0: 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-HER2ReceptorStatus-model
HER2 receptor status. HER2 is a member of the human epidermal growth factor receptor family of proteins and is encoded by the ERBB2 oncogene. HER2 is overexpressed in 20-30% of breast tumors,10 and is associated with an aggressive clinical course and poor prognosis. HER2 status (positive=present or overexpressed; negative=absent) is a factor in determining prognosis and treatment options.
We are seeking feedback if it is better to put the positive/negative status in Value or Interpretation. The current approach is that positive/negative designation is a value, even though that value is (in fact) an interpretation of evidence from HER2 by IHC and/or HER2 by ISH tests, not a direct observation.
This logical model was published on Sun Apr 01 00:00:00 AEDT 2018 as a draft by The HL7 Cancer Interoperability Group sponsored by Clinical Interoperability Council Work Group (CIC).
View the corresponding HER2ReceptorStatusProfile profile.
| Name | Flags | Card. | Type | Description & Constraints |
|---|---|---|---|---|
  oncology-HER2ReceptorStatus-model | 0..* | |||
  evaluationResultTopic | 1..1 | BackboneElement | The base class, independent of context, for evaluations (measurements, tests, or questions) and a value containing the result (answer). | |
 valueCodeableConcept | 0..1 | Coding | A set of codes drawn from different coding systems, representing the same concept. Binding: PositiveNegativeEquivocalVS (required) | |
 topicCode | 1..1 | TopicCodeModel | The concept representing the finding or action that is the topic of the statement. | |
 value | 1..1 | Coding | HER2 [Interpretation] in Tissue | |
  system | Σ | 1..1 | uri | Identity of the terminology system Fixed Value: http://loinc.org |
| 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: 48676-1 |
| display | Σ | 0..1 | string | Representation defined by the system |
| userSelected | Σ | 0..1 | boolean | If this coding was chosen directly by the user |
| interpretation | 0..1 | InterpretationModel | A clinical interpretation of a finding. | |
| category | 1..* | CategoryModel | A class or division of people or things having particular shared characteristics | |
| value | 1..1 | Coding | Code representing a class or division of people or things having particular shared characteristics | |
| 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 | 0..1 | BreastSpecimenModel | Specimen resulting from biopsy or excision of breast and surrounding tissue. | |
| deltaFlag | 0..1 | DeltaFlagModel | Indicator of significant change (delta) from the last or previous measurement. | |
| recordedContext | 1..1 | RecordedContextModel | Context for an evaluation result, used to indicate an evaluation has been made. | |
| encounter | 0..1 | EncounterModel | An abstract class that represents an encounter class. This class has been stubbed out to limit the scope of this implementation guide to classes relevant to this ballot concerning breast cancer. | |
| members | 0..1 | BackboneElement | Members represent the elements of a group of a related but independent evaluations. | |
| value | 0..1 | EvaluationResultRecorded representing members represent the elements of a group of a related but independent evaluations. | ||
 hER2byIHC | 0..* | Reference(BC HER2byIHC Logical Model) | HER2 receptor status as determined by Immunohistochemistry (IHC). | |
| hER2byISH | 0..* | Reference(BC HER2byISH Logical Model) | HER2 receptor status as determined by In Situ Hybridization (ISH). | |
| diagnosticService | 0..* | DiagnosticServiceModel | A code that classifies the clinical discipline, department or diagnostic service that created the report (e.g. cardiology, biochemistry, hematology, MRI). This is used for searching, sorting and display purposes. | |
| value | 1..1 | Coding | Code representing a code that classifies the clinical discipline, department or diagnostic service that created the report (e.g. cardiology, biochemistry, hematology, MRI). This is used for searching, sorting and display purposes. | |
| system | Σ | 1..1 | uri | Identity of the terminology system Fixed Value: http://hl7.org/fhir/us/breastcancer/CodeSystem/cimi-statement-DiagnosticServiceCS |
| 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: pathology |
| display | Σ | 0..1 | string | Representation defined by the system |
| userSelected | Σ | 0..1 | boolean | If this coding was chosen directly by the user |
| Documentation for this format | ||||
Downloads: StructureDefinition: (XML, JSON, TTL)
| Path | Name | Conformance | ValueSet |
| oncology-HER2ReceptorStatus-model.evaluationResultTopic.valueCodeableConcept | PositiveNegativeEquivocalVS | required | PositiveNegativeEquivocalVS |