HL7 FHIR Implementation Guide: Breast Cancer Data, Release 1 - US Realm (Draft for Comment 2)

BreastCancerGeneticAnalysisObservationModel

Definitions for oncology-BreastCancerGeneticAnalysisObservation-model.

1. oncology-BreastCancerGeneticAnalysisObservation-model
Definition

The status of genes known or suspected to play a role in breast cancer risk, for example, the tumor suppressor genes, BRCA1 and BRCA2.

Control0..*
2. oncology-BreastCancerGeneticAnalysisObservation-model.personOfRecord
Definition

The person this entry belongs to.

Control1..1
TypeReference(PersonOfRecordModel)
3. oncology-BreastCancerGeneticAnalysisObservation-model.laboratoryObservationTopic
Definition

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.

Control1..1
TypeBackboneElement
4. oncology-BreastCancerGeneticAnalysisObservation-model.laboratoryObservationTopic.topicCode
Definition

The concept representing the finding or action that is the topic of the statement.

For action topics, the TopicCode represents the action being described. For findings, the TopicCode represents the 'question' or property being investigated. For evaluation result findings, the TopicCode contains a concept for an observable entity, such as systolic blood pressure. For assertion findings, the TopicCode contains a code representing the condition, allergy, or other item being asserted. In all cases, the TopicCode describes the topic independent of the context of the action or the finding.

Control1..1
TypeCoding
5. oncology-BreastCancerGeneticAnalysisObservation-model.laboratoryObservationTopic.findingMethod
Definition

The technique used to create the finding, for example, the specific imaging technical, lab test code, or assessment vehicle.

Control0..0
BindingThe codes SHOULD be taken from http://loinc.org/vs
TypeCoding
6. oncology-BreastCancerGeneticAnalysisObservation-model.laboratoryObservationTopic.details
Definition

A text note containing additional details, explanation, description, comment, or summarization. Details can discuss, support, explain changes to, or dispute information.

Control0..1
Typestring
7. oncology-BreastCancerGeneticAnalysisObservation-model.laboratoryObservationTopic.media
Definition

A file that contains audio, video, image, or similar content.

Control0..0
Typehttp://hl7.org/fhir/us/breastcancer/StructureDefinition/shr-core-Media-model
8. oncology-BreastCancerGeneticAnalysisObservation-model.laboratoryObservationTopic.category
Definition

A class or division of people or things having particular shared characteristics

Control1..*
TypeCoding
9. oncology-BreastCancerGeneticAnalysisObservation-model.laboratoryObservationTopic.category.id
Definition

unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

Control0..1
Typestring
10. oncology-BreastCancerGeneticAnalysisObservation-model.laboratoryObservationTopic.category.extension
Definition

May be used to represent additional information that is not part of the basic definition of the element. In order to make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer is allowed to define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

Control0..*
TypeExtension
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

11. oncology-BreastCancerGeneticAnalysisObservation-model.laboratoryObservationTopic.category.system
Definition

The identification of the code system that defines the meaning of the symbol in the code.

Control1..1
Typeuri
Requirements

Need to be unambiguous about the source of the definition of the symbol.

Comments

The URI may be an OID (urn:oid:...) or a UUID (urn:uuid:...). OIDs and UUIDs SHALL be references to the HL7 OID registry. Otherwise, the URI should come from HL7's list of FHIR defined special URIs or it should de-reference to some definition that establish the system clearly and unambiguously.

Fixed Valuehttp://hl7.org/fhir/observation-category
12. oncology-BreastCancerGeneticAnalysisObservation-model.laboratoryObservationTopic.category.version
Definition

The version of the code system which was used when choosing this code. Note that a well-maintained code system does not need the version reported, because the meaning of codes is consistent across versions. However this cannot consistently be assured. and when the meaning is not guaranteed to be consistent, the version SHOULD be exchanged.

NoteThis is a business versionId, not a resource version id (see discussion)
Control0..1
Typestring
Comments

Where the terminology does not clearly define what string should be used to identify code system versions, the recommendation is to use the date (expressed in FHIR date format) on which that version was officially published as the version date.

13. oncology-BreastCancerGeneticAnalysisObservation-model.laboratoryObservationTopic.category.code
Definition

A symbol in syntax defined by the system. The symbol may be a predefined code or an expression in a syntax defined by the coding system (e.g. post-coordination).

Control1..1
Typecode
Requirements

Need to refer to a particular code in the system.

Fixed Valuelaboratory
14. oncology-BreastCancerGeneticAnalysisObservation-model.laboratoryObservationTopic.category.display
Definition

A representation of the meaning of the code in the system, following the rules of the system.

Control0..1
Typestring
Requirements

Need to be able to carry a human-readable meaning of the code for readers that do not know the system.

15. oncology-BreastCancerGeneticAnalysisObservation-model.laboratoryObservationTopic.category.userSelected
Definition

Indicates that this coding was chosen by a user directly - i.e. off a pick list of available items (codes or displays).

Control0..1
Typeboolean
Requirements

This has been identified as a clinical safety criterium - that this exact system/code pair was chosen explicitly, rather than inferred by the system based on some rules or language processing.

Comments

Amongst a set of alternatives, a directly chosen code is the most appropriate starting point for new translations. There is some ambiguity about what exactly 'directly chosen' implies, and trading partner agreement may be needed to clarify the use of this element and its consequences more completely.

16. oncology-BreastCancerGeneticAnalysisObservation-model.laboratoryObservationTopic.anatomicalLocation
Definition

A location or structure in the body, including tissues, regions, cavities, and spaces; for example, right elbow, or left ventricle of the heart.

Control0..0
Typehttp://hl7.org/fhir/us/breastcancer/StructureDefinition/cimi-element-AnatomicalLocation-model
17. oncology-BreastCancerGeneticAnalysisObservation-model.laboratoryObservationTopic.device
Definition

A specific durable physical device used in diagnosis or treatment. The value is the coding for a type of device, for example, a CPAP machine. The same device might be used on multiple patients.

Control0..0
TypeReference(DeviceModel)
18. oncology-BreastCancerGeneticAnalysisObservation-model.laboratoryObservationTopic.breastSpecimen
Definition

Specimen resulting from biopsy or excision of breast and surrounding tissue.

Control1..1
TypeReference(BreastSpecimenModel)
19. oncology-BreastCancerGeneticAnalysisObservation-model.laboratoryObservationTopic.precondition
Definition

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.

Control0..0
TypeChoice of: Coding, Reference(ObservationModel)
20. oncology-BreastCancerGeneticAnalysisObservation-model.laboratoryObservationTopic.referenceRange
Definition

The usual or acceptable range for a test result.

Control0..*
Typehttp://hl7.org/fhir/us/breastcancer/StructureDefinition/cimi-topic-ReferenceRange-model
21. oncology-BreastCancerGeneticAnalysisObservation-model.laboratoryObservationTopic.evaluationComponent
Definition

A simplified, non-separable evaluation consisting of a finding code (represented by the Concept), value (or exception value), reference range, and interpretation. The subject of the evaluation component is the same as in the parent evaluation.

Control1..1
22. oncology-BreastCancerGeneticAnalysisObservation-model.laboratoryObservationTopic.evaluationComponent.bRCA1Variant
Definition

Whether the patient has a mutation in the BRCA1 gene.

Control1..1
Typehttp://hl7.org/fhir/us/breastcancer/StructureDefinition/oncology-BRCA1Variant-model
23. oncology-BreastCancerGeneticAnalysisObservation-model.laboratoryObservationTopic.evaluationComponent.bRCA2Variant
Definition

Whether the patient has a mutation in the BRCA2 gene.

Control1..1
Typehttp://hl7.org/fhir/us/breastcancer/StructureDefinition/oncology-BRCA2Variant-model
24. oncology-BreastCancerGeneticAnalysisObservation-model.laboratoryObservationTopic.panelMembers
Definition

PanelMembers represent the elements of a group of a related but independent evaluations. Examples are the measurements that compose a complete blood count (CBC), or the elements of a pathology report. Each member is an independent evaluation, but the grouping reflects a composite lab order, shared specimen, or a single report author. Typically the Category and Reason are not given for individual findings that are part of the panel, but rather given at the level of the panel itself.

Control0..0
Typehttp://hl7.org/fhir/us/breastcancer/StructureDefinition/cimi-topic-PanelMembers-model
25. oncology-BreastCancerGeneticAnalysisObservation-model.laboratoryObservationTopic.diagnosticService
Definition

The service completing the observations, e.g. biochemistry, microbiology, blood bank.

Control0..*
TypeCoding
26. oncology-BreastCancerGeneticAnalysisObservation-model.laboratoryObservationTopic.diagnosticService.id
Definition

unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

Control0..1
Typestring
27. oncology-BreastCancerGeneticAnalysisObservation-model.laboratoryObservationTopic.diagnosticService.extension
Definition

May be used to represent additional information that is not part of the basic definition of the element. In order to make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer is allowed to define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

Control0..*
TypeExtension
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

28. oncology-BreastCancerGeneticAnalysisObservation-model.laboratoryObservationTopic.diagnosticService.system
Definition

The identification of the code system that defines the meaning of the symbol in the code.

Control0..0
Typeuri
Requirements

Need to be unambiguous about the source of the definition of the symbol.

Comments

The URI may be an OID (urn:oid:...) or a UUID (urn:uuid:...). OIDs and UUIDs SHALL be references to the HL7 OID registry. Otherwise, the URI should come from HL7's list of FHIR defined special URIs or it should de-reference to some definition that establish the system clearly and unambiguously.

29. oncology-BreastCancerGeneticAnalysisObservation-model.laboratoryObservationTopic.diagnosticService.version
Definition

The version of the code system which was used when choosing this code. Note that a well-maintained code system does not need the version reported, because the meaning of codes is consistent across versions. However this cannot consistently be assured. and when the meaning is not guaranteed to be consistent, the version SHOULD be exchanged.

NoteThis is a business versionId, not a resource version id (see discussion)
Control0..0
Typestring
Comments

Where the terminology does not clearly define what string should be used to identify code system versions, the recommendation is to use the date (expressed in FHIR date format) on which that version was officially published as the version date.

30. oncology-BreastCancerGeneticAnalysisObservation-model.laboratoryObservationTopic.diagnosticService.code
Definition

A symbol in syntax defined by the system. The symbol may be a predefined code or an expression in a syntax defined by the coding system (e.g. post-coordination).

Control1..1
Typecode
Requirements

Need to refer to a particular code in the system.

Fixed Valuegenetics
31. oncology-BreastCancerGeneticAnalysisObservation-model.laboratoryObservationTopic.diagnosticService.display
Definition

A representation of the meaning of the code in the system, following the rules of the system.

Control0..1
Typestring
Requirements

Need to be able to carry a human-readable meaning of the code for readers that do not know the system.

32. oncology-BreastCancerGeneticAnalysisObservation-model.laboratoryObservationTopic.diagnosticService.userSelected
Definition

Indicates that this coding was chosen by a user directly - i.e. off a pick list of available items (codes or displays).

Control0..1
Typeboolean
Requirements

This has been identified as a clinical safety criterium - that this exact system/code pair was chosen explicitly, rather than inferred by the system based on some rules or language processing.

Comments

Amongst a set of alternatives, a directly chosen code is the most appropriate starting point for new translations. There is some ambiguity about what exactly 'directly chosen' implies, and trading partner agreement may be needed to clarify the use of this element and its consequences more completely.

33. oncology-BreastCancerGeneticAnalysisObservation-model.observationContext
Definition

Context for recording an evaluation result, used to indicate an evaluation has been made.

Control1..1
Typehttp://hl7.org/fhir/us/breastcancer/StructureDefinition/cimi-context-ObservationContext-model
34. oncology-BreastCancerGeneticAnalysisObservation-model.observationContext.contextCode
Definition

A code representing the ontological status of the statement, e.g., whether it exists, does not exist, is planned, etc. Attribute aligns with the SNOMED CT Situation with Explicit Context (SWEC) Concept Model context attributes: 'Finding context (attribute)' (SCTID: 408729009) and 'Procedure context (attribute)' (SCTID: 408730004). The range allowed for this attribute shall be consistent with the SNOMED CT concept model specification for SWEC.

Control1..1
TypeCoding
35. oncology-BreastCancerGeneticAnalysisObservation-model.observationContext.contextCode.id
Definition

unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

Control0..1
Typestring
36. oncology-BreastCancerGeneticAnalysisObservation-model.observationContext.contextCode.extension
Definition

May be used to represent additional information that is not part of the basic definition of the element. In order to make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer is allowed to define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

Control0..*
TypeExtension
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

37. oncology-BreastCancerGeneticAnalysisObservation-model.observationContext.contextCode.system
Definition

The identification of the code system that defines the meaning of the symbol in the code.

Control1..1
Typeuri
Requirements

Need to be unambiguous about the source of the definition of the symbol.

Comments

The URI may be an OID (urn:oid:...) or a UUID (urn:uuid:...). OIDs and UUIDs SHALL be references to the HL7 OID registry. Otherwise, the URI should come from HL7's list of FHIR defined special URIs or it should de-reference to some definition that establish the system clearly and unambiguously.

Fixed Valuehttp://snomed.info/sct
38. oncology-BreastCancerGeneticAnalysisObservation-model.observationContext.contextCode.version
Definition

The version of the code system which was used when choosing this code. Note that a well-maintained code system does not need the version reported, because the meaning of codes is consistent across versions. However this cannot consistently be assured. and when the meaning is not guaranteed to be consistent, the version SHOULD be exchanged.

NoteThis is a business versionId, not a resource version id (see discussion)
Control0..1
Typestring
Comments

Where the terminology does not clearly define what string should be used to identify code system versions, the recommendation is to use the date (expressed in FHIR date format) on which that version was officially published as the version date.

39. oncology-BreastCancerGeneticAnalysisObservation-model.observationContext.contextCode.code
Definition

A symbol in syntax defined by the system. The symbol may be a predefined code or an expression in a syntax defined by the coding system (e.g. post-coordination).

Control1..1
Typecode
Requirements

Need to refer to a particular code in the system.

Fixed Value424975005
40. oncology-BreastCancerGeneticAnalysisObservation-model.observationContext.contextCode.display
Definition

A representation of the meaning of the code in the system, following the rules of the system.

Control0..1
Typestring
Requirements

Need to be able to carry a human-readable meaning of the code for readers that do not know the system.

41. oncology-BreastCancerGeneticAnalysisObservation-model.observationContext.contextCode.userSelected
Definition

Indicates that this coding was chosen by a user directly - i.e. off a pick list of available items (codes or displays).

Control0..1
Typeboolean
Requirements

This has been identified as a clinical safety criterium - that this exact system/code pair was chosen explicitly, rather than inferred by the system based on some rules or language processing.

Comments

Amongst a set of alternatives, a directly chosen code is the most appropriate starting point for new translations. There is some ambiguity about what exactly 'directly chosen' implies, and trading partner agreement may be needed to clarify the use of this element and its consequences more completely.

42. oncology-BreastCancerGeneticAnalysisObservation-model.observationContext.encounter
Definition

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.

Control0..1
Typehttp://hl7.org/fhir/us/breastcancer/StructureDefinition/cimi-encounter-Encounter-model
43. oncology-BreastCancerGeneticAnalysisObservation-model.observationContext.interpretation
Definition

A clinical interpretation of a finding (applies to both assertions and observation).

Control0..1
BindingThe codes SHALL be taken from Observation Interpretation Codes; other codes may be used where these codes are not suitable
TypeCoding
44. oncology-BreastCancerGeneticAnalysisObservation-model.observationContext.findingStatus
Definition

Indicates whether the finding is preliminary, amended, final, etc.

Control1..1
BindingThe codes SHALL be taken from ObservationStatus
Typecode
45. oncology-BreastCancerGeneticAnalysisObservation-model.observationContext.relevantTime
Definition

The time or time period that the finding addresses. The clinically relevant time is not necessarily when the information is gathered or when a test is carried out, but for example, when a specimen was collected, or the time period referred to by the question. Use a TimePeriod for a measurement or specimen collection continued over a significant period of time (e.g. 24 hour Urine Sodium).

Control0..1
TypeChoice of: dateTime, http://hl7.org/fhir/us/breastcancer/StructureDefinition/shr-core-TimePeriod-model
46. oncology-BreastCancerGeneticAnalysisObservation-model.observationContext.resultValue
Definition

The finding itself, such as the blood pressure value recorded.

Control0..0
TypeChoice of: http://hl7.org/fhir/us/breastcancer/StructureDefinition/shr-core-Quantity-model, Coding, string, boolean, http://hl7.org/fhir/us/breastcancer/StructureDefinition/shr-core-Range-model, http://hl7.org/fhir/us/breastcancer/StructureDefinition/shr-core-Ratio-model, time, dateTime, http://hl7.org/fhir/us/breastcancer/StructureDefinition/shr-core-TimePeriod-model
47. oncology-BreastCancerGeneticAnalysisObservation-model.observationContext.exceptionValue
Definition

Reason that a value associated with a test or other finding is missing.

Control0..0
BindingThe codes SHALL be taken from DataAbsentReason; other codes may be used where these codes are not suitable
TypeCoding
48. oncology-BreastCancerGeneticAnalysisObservation-model.observationContext.deltaFlag
Definition

Indicator of significant change (delta) from the last or previous measurement.

Control0..1
BindingThe codes SHALL be taken from BC DeltaFlagVS ValueSet
TypeCoding
49. oncology-BreastCancerGeneticAnalysisObservation-model.observationContext.issued
Definition

The date and time this observation was made available to providers, typically after the results have been reviewed and verified.

Control0..1
Typeinstant
50. oncology-BreastCancerGeneticAnalysisObservation-model.observationContext.observer
Definition

The person or organization who observed or informed the reporter about the characteristic, potentially the clinician, the patient, or a related person.

Control0..*
TypeReference(PractitionerModel | OrganizationModel | PatientModel | RelatedPersonModel)