AU Core Implementation Guide
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## Resource Profile: AU Core Diagnostic Result Observation

Official URL: http://hl7.org.au/fhir/core/StructureDefinition/au-core-diagnosticresult | Version: 1.1.0-preview
Standards status: Trial-use | Maturity Level: 2 | Computable Name: AUCoreDiagnosticResult
Copyright/Legal: Used by permission of HL7 International, all rights reserved Creative Commons License. HL7 Australia© 2022+; Licensed Under Creative Commons No Rights Reserved.

This profile sets minimum expectations for an Observation resource to record, search, and fetch diagnostic results associated with a patient. It is based on the AU Base Diagnostic Result profile and identifies the additional mandatory core elements, extensions, vocabularies and value sets that SHALL be present in the Observation when conforming to this profile. It provides the floor for standards development for specific uses cases in an Australian context.

See Comparison with other national and international IGs for a comparison between AU Core profiles and profiles in other implementation guides.

### Usage scenarios

The following are supported usage scenarios for this profile:

- Query for diagnostic results for a patient
- Query for category of diagnostic results (e.g. all cardiology results)
- Record or update a diagnostic result for a patient

### Profile specific implementation guidance

- `Observation.category` provides an efficient way of supporting system interactions, e.g. restricting searches. Implementers need to understand that data categorisation is somewhat subjective. The categorisation applied by the source may not align with a receiver’s expectations.
- The observations MAY have additional codes that translate or map to the Observation code or category codes. For example:
  - providing a local code
  - providing a more specific code
- The use of coding can vary significantly across systems, requesters need to understand that they may encounter codes they do not recognise and be prepared to handle those resources appropriately. Responders SHOULD populate `Observation.code.text` and/or `Observation.code.coding.display` so that the requester can at least display the observation even if the requester does not recognise the code supplied.
- The Observation resource can represent a result using a single value in `Observation.value`, or can represent a set of results using either `Observation.component.value` or `Observation.hasMember`.
  - Although all are marked as Must Support, responders are not required to support all choices, but they SHALL support at least one of these elements
  - A requester SHALL support all elements (`Observation.value`, `Observation.component.value`, `Observation.hasMember`)
  - for further guidance, see the Observation Grouping section in FHIR Specification.
- `Observation.identifier` may contain the same identifier as in the order or report connecting the resources that are related to a single request fulfilment workflow.
- Source system identifiers that identify the business process (order ids and reporting identifiers) MAY be included as AU Local Order Identifier and AU Local Report Identifier to support workflow and deduplication of Observation resources.
  - See guidance on the construction of an identifier on the relevant Identifier profile page and the section on Business Identifiers in AU Base.

Usage:

- Refer to this Resource Profile: AU Core Diagnostic Result Observation
- Examples for this Resource Profile: Observation/hearing-threshold-1 and Observation/observation-masked
- CapabilityStatements using this Resource Profile: AU Core Requester CapabilityStatement and AU Core Responder CapabilityStatement

Changes since version 1.0.0:

- The resource metadata has changed (description)

### Formal Views of Profile Content

Description of Profiles, Differentials, Snapshots and how the different presentations work.

- Differential Table
- Key Elements Table
- Snapshot Table
- Statistics/References
- All

This structure is derived from AUBaseDiagnosticResult

Name | Flags | Card. | Type | Description & Constraints
--- | --- | --- | --- | ---
Observation | C | 0..* | AUBaseDiagnosticResult | A diagnostic result observation in an Australian healthcare context au-core-obs-01: If there is no component or hasMember element then at least value or data absent reason shall be present
status | SO | 1..1 | code | registered | preliminary | final | amended +
Obligations | Actor
SHALL:populate-if-known | AU Core Responder
SHALL:no-error | AU Core Requester
category | SO | 1..* | CodeableConcept | Diagnostic service section
Obligations | Actor
SHALL:populate-if-known | AU Core Responder
SHALL:no-error | AU Core Requester
code | SO | 1..1 | CodeableConcept | Diagnostic procedure
Obligations | Actor
SHALL:populate-if-known | AU Core Responder
SHALL:no-error | AU Core Requester
subject | SO | 1..1 | Reference(AU Core Patient) | Who and/or what the observation is about
Obligations | Actor
SHALL:populate-if-known | AU Core Responder
SHALL:no-error | AU Core Requester
effective[x] | SO C | 1..1 | dateTime, Period, Timing, instant | Clinically relevant time/time-period for observation au-core-obs-02: Date shall be at least to day or, if not available, the Data Absent Reason extension shall be present
Obligations | Actor
SHALL:populate-if-known | AU Core Responder
SHALL:no-error | AU Core Requester
performer | SO | 0..* | Reference(AU Core Practitioner | AU Core PractitionerRole | AU Core Organization | AU Core Patient | AU Core RelatedPerson) | Who is responsible for the observation
Obligations | Actor
SHALL:populate-if-known | AU Core Responder
SHALL:no-error | AU Core Requester
value[x] | SO C | 0..1 | Quantity, CodeableConcept, string, boolean, integer, Range, Ratio, SampledData, time, dateTime, Period | Actual result
Obligations | Actor
SHALL:populate-if-known | AU Core Responder
SHALL:no-error | AU Core Requester
dataAbsentReason | SO C | 0..1 | CodeableConcept | Why the result is missing
Obligations | Actor
SHALL:populate-if-known | AU Core Responder
SHALL:no-error | AU Core Requester
bodySite | SO C | 0..1 | CodeableConcept | Observed body part Binding: Body Site (extensible) au-core-obs-04: If a coded body site is provided, at least one coding shall be from SNOMED CT
Obligations | Actor
SHALL:populate-if-known | AU Core Responder
SHALL:no-error | AU Core Requester
hasMember | SO | 0..* | Reference(AU Core Diagnostic Result Observation | AU Core Pathology Result Observation) | Individual observations in a group, study, or panel
Obligations | Actor
SHALL:populate-if-known | AU Core Responder
SHALL:no-error | AU Core Requester
component | SO C | 0..* | BackboneElement | Component results au-core-obs-03: The component shall at least have a value or a data absent reason
Obligations | Actor
SHALL:populate-if-known | AU Core Responder
SHALL:no-error | AU Core Requester
code | SO | 1..1 | CodeableConcept | Type of component observation (code / type)
Obligations | Actor
SHALL:populate-if-known | AU Core Responder
SHALL:no-error | AU Core Requester
value[x] | SO C | 0..1 | Quantity, CodeableConcept, string, boolean, integer, Range, Ratio, SampledData, time, dateTime, Period | Actual component result
Obligations | Actor
SHALL:populate-if-known | AU Core Responder
SHALL:no-error | AU Core Requester
dataAbsentReason | SO C | 0..1 | CodeableConcept | Why the component result is missing
Obligations | Actor
SHALL:populate-if-known | AU Core Responder
SHALL:no-error | AU Core Requester
Documentation for this format

#### Terminology Bindings (Differential)

Path | Conformance | ValueSet | URI
Observation.bodySite | extensible | BodySite `https://healthterminologies.gov.au/fhir/ValueSet/body-site-1` from https://tx.ontoserver.csiro.au/fhir

#### Constraints

Id | Grade | Path(s) | Details | Requirements
au-core-obs-01 | error | Observation | If there is no component or hasMember element then at least value or data absent reason shall be present : (component.empty() and hasMember.empty()) implies (dataAbsentReason.exists() or value.exists()) |
au-core-obs-02 | error | Observation.effective[x] | Date shall be at least to day or, if not available, the Data Absent Reason extension shall be present : (($this is dateTime implies $this.toString().length() >= 10) and extension('http://hl7.org/fhir/StructureDefinition/data-absent-reason').value.exists().not()) xor ($this is dateTime implies ($this.hasValue().not() and extension('http://hl7.org/fhir/StructureDefinition/data-absent-reason').value.exists())) |
au-core-obs-03 | error | Observation.component | The component shall at least have a value or a data absent reason : value.exists() or dataAbsentReason.exists() |
au-core-obs-04 | error | Observation.bodySite | If a coded body site is provided, at least one coding shall be from SNOMED CT : coding.exists() implies coding.where(system='http://snomed.info/sct').exists() |

Name | Flags | Card. | Type | Description & Constraints
--- | --- | --- | --- | ---
Observation | C | 0..* | AUBaseDiagnosticResult | A diagnostic result observation in an Australian healthcare context dom-2: If the resource is contained in another resource, it SHALL NOT contain nested Resources dom-3: If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource dom-4: If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated dom-5: If a resource is contained in another resource, it SHALL NOT have a security label dom-6: A resource should have narrative for robust management obs-6: dataAbsentReason SHALL only be present if Observation.value[x] is not present obs-7: If Observation.code is the same as an Observation.component.code then the value element associated with the code SHALL NOT be present inv-obs-0: A diagnostic result shall at least have value or data absent reason or a child observation with a value or data absent reason inv-obs-1: BodyStructure Reference extension shall only be present if the body site is not present au-core-obs-01: If there is no component or hasMember element then at least value or data absent reason shall be present
implicitRules | ?!Σ | 0..1 | uri | A set of rules under which this content was created ele-1: All FHIR elements must have a @value or children
Slices for extension |  |  |  | Content/Rules for all slices
extension:bodyStructure | C | 0..1 | Reference(BodyStructure) | Target anatomic location or structure URL: http://hl7.org/fhir/StructureDefinition/bodySite ele-1: All FHIR elements must have a @value or children ext-1: Must have either extensions or value[x], not both
modifierExtension | ?! | 0..* | Extension | Extensions that cannot be ignored ele-1: All FHIR elements must have a @value or children ext-1: Must have either extensions or value[x], not both
status | ?!SO Σ | 1..1 | code | registered | preliminary | final | amended + Binding: ObservationStatus (required): Codes providing the status of an observation. ele-1: All FHIR elements must have a @value or children
Obligations | Actor
SHALL:populate-if-known | AU Core Responder
SHALL:no-error | AU Core Requester
category | SO | 1..* | CodeableConcept | Diagnostic service section Binding: DiagnosticServiceSectionCodes (preferred) ele-1: All FHIR elements must have a @value or children
Obligations | Actor
SHALL:populate-if-known | AU Core Responder
SHALL:no-error | AU Core Requester
code | SO Σ | 1..1 | CodeableConcept | Diagnostic procedure Binding: Evaluation Procedure (example) ele-1: All FHIR elements must have a @value or children
Obligations | Actor
SHALL:populate-if-known | AU Core Responder
SHALL:no-error | AU Core Requester
subject | SO Σ | 1..1 | Reference(AU Core Patient) | Who and/or what the observation is about ele-1: All FHIR elements must have a @value or children
Obligations | Actor
SHALL:populate-if-known | AU Core Responder
SHALL:no-error | AU Core Requester
effective[x] | SO Σ C | 1..1 |  | Clinically relevant time/time-period for observation ele-1: All FHIR elements must have a @value or children au-core-obs-02: Date shall be at least to day or, if not available, the Data Absent Reason extension shall be present
Obligations | Actor
SHALL:populate-if-known | AU Core Responder
SHALL:no-error | AU Core Requester
effectiveDateTime |  |  | dateTime |
effectivePeriod |  |  | Period |
effectiveTiming |  |  | Timing |
effectiveInstant |  |  | instant |
performer | SO Σ | 0..* | Reference(AU Core Practitioner | AU Core PractitionerRole | AU Core Organization | AU Core Patient | AU Core RelatedPerson) | Who is responsible for the observation ele-1: All FHIR elements must have a @value or children
Obligations | Actor
SHALL:populate-if-known | AU Core Responder
SHALL:no-error | AU Core Requester
value[x] | SO Σ C | 0..1 |  | Actual result ele-1: All FHIR elements must have a @value or children
Obligations | Actor
SHALL:populate-if-known | AU Core Responder
SHALL:no-error | AU Core Requester
valueQuantity |  |  | Quantity |
valueCodeableConcept |  |  | CodeableConcept |
valueString |  |  | string |
valueBoolean |  |  | boolean |
valueInteger |  |  | integer |
valueRange |  |  | Range |
valueRatio |  |  | Ratio |
valueSampledData |  |  | SampledData |
valueTime |  |  | time |
valueDateTime |  |  | dateTime |
valuePeriod |  |  | Period |
dataAbsentReason | SO C | 0..1 | CodeableConcept | Why the result is missing Binding: DataAbsentReason (extensible): Codes specifying why the result (Observation.value[x]) is missing. ele-1: All FHIR elements must have a @value or children
Obligations | Actor
SHALL:populate-if-known | AU Core Responder
SHALL:no-error | AU Core Requester
bodySite | SO C | 0..1 | CodeableConcept | Observed body part Binding: Body Site (extensible) ele-1: All FHIR elements must have a @value or children au-core-obs-04: If a coded body site is provided, at least one coding shall be from SNOMED CT
Obligations | Actor
SHALL:populate-if-known | AU Core Responder
SHALL:no-error | AU Core Requester
hasMember | SO Σ C | 0..* | Reference(AU Core Diagnostic Result Observation | AU Core Pathology Result Observation) | Individual observations in a group, study, or panel ele-1: All FHIR elements must have a @value or children
Obligations | Actor
SHALL:populate-if-known | AU Core Responder
SHALL:no-error | AU Core Requester
component | SO Σ C | 0..* | BackboneElement | Component results ele-1: All FHIR elements must have a @value or children au-core-obs-03: The component shall at least have a value or a data absent reason
Obligations | Actor
SHALL:populate-if-known | AU Core Responder
SHALL:no-error | AU Core Requester
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized ele-1: All FHIR elements must have a @value or children ext-1: Must have either extensions or value[x], not both
code | SO Σ | 1..1 | CodeableConcept | Type of component observation (code / type) Binding: LOINCCodes (example): Codes identifying names of simple observations. ele-1: All FHIR elements must have a @value or children
Obligations | Actor
SHALL:populate-if-known | AU Core Responder
SHALL:no-error | AU Core Requester
value[x] | SO Σ C | 0..1 |  | Actual component result ele-1: All FHIR elements must have a @value or children
Obligations | Actor
SHALL:populate-if-known | AU Core Responder
SHALL:no-error | AU Core Requester
valueQuantity |  |  | Quantity |
valueCodeableConcept |  |  | CodeableConcept |
valueString |  |  | string |
valueBoolean |  |  | boolean |
valueInteger |  |  | integer |
valueRange |  |  | Range |
valueRatio |  |  | Ratio |
valueSampledData |  |  | SampledData |
valueTime |  |  | time |
valueDateTime |  |  | dateTime |
valuePeriod |  |  | Period |
dataAbsentReason | SO C | 0..1 | CodeableConcept | Why the component result is missing Binding: DataAbsentReason (extensible): Codes specifying why the result (Observation.value[x]) is missing. ele-1: All FHIR elements must have a @value or children
Obligations | Actor
SHALL:populate-if-known | AU Core Responder
SHALL:no-error | AU Core Requester
Documentation for this format

#### Terminology Bindings

Path | Conformance | ValueSet | URI
Observation.status | required | ObservationStatus `http://hl7.org/fhir/ValueSet/observation-status|4.0.1` from the FHIR Standard
Observation.category | preferred | DiagnosticServiceSectionCodes `http://hl7.org/fhir/ValueSet/diagnostic-service-sections` from the FHIR Standard
Observation.code | example | EvaluationProcedure `https://healthterminologies.gov.au/fhir/ValueSet/evaluation-procedure-1` from https://tx.ontoserver.csiro.au/fhir
Observation.dataAbsentReason | extensible | DataAbsentReason `http://hl7.org/fhir/ValueSet/data-absent-reason` from the FHIR Standard
Observation.bodySite | extensible | BodySite `https://healthterminologies.gov.au/fhir/ValueSet/body-site-1` from https://tx.ontoserver.csiro.au/fhir
Observation.component.code | example | LOINCCodes (a valid code from LOINC) `http://hl7.org/fhir/ValueSet/observation-codes` from the FHIR Standard
Observation.component.dataAbsentReason | extensible | DataAbsentReason `http://hl7.org/fhir/ValueSet/data-absent-reason` from the FHIR Standard

#### Constraints

Id | Grade | Path(s) | Details | Requirements
au-core-obs-01 | error | Observation | If there is no component or hasMember element then at least value or data absent reason shall be present : (component.empty() and hasMember.empty()) implies (dataAbsentReason.exists() or value.exists()) |
au-core-obs-02 | error | Observation.effective[x] | Date shall be at least to day or, if not available, the Data Absent Reason extension shall be present : (($this is dateTime implies $this.toString().length() >= 10) and extension('http://hl7.org/fhir/StructureDefinition/data-absent-reason').value.exists().not()) xor ($this is dateTime implies ($this.hasValue().not() and extension('http://hl7.org/fhir/StructureDefinition/data-absent-reason').value.exists())) |
au-core-obs-03 | error | Observation.component | The component shall at least have a value or a data absent reason : value.exists() or dataAbsentReason.exists() |
au-core-obs-04 | error | Observation.bodySite | If a coded body site is provided, at least one coding shall be from SNOMED CT : coding.exists() implies coding.where(system='http://snomed.info/sct').exists() |
dom-2 | error | Observation | If the resource is contained in another resource, it SHALL NOT contain nested Resources : contained.contained.empty() |
dom-3 | error | Observation | If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource : contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().as(canonical) | %resource.descendants().as(uri) | %resource.descendants().as(url))) or descendants().where(reference = '#').exists() or descendants().where(as(canonical) = '#').exists() or descendants().where(as(canonical) = '#').exists()).not()).trace('unmatched', id).empty() |
dom-4 | error | Observation | If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated : contained.meta.versionId.empty() and contained.meta.lastUpdated.empty() |
dom-5 | error | Observation | If a resource is contained in another resource, it SHALL NOT have a security label : contained.meta.security.empty() |
dom-6 | best practice | Observation | A resource should have narrative for robust management : text.`div`.exists() |
ele-1 | error | **ALL** elements | All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count()) |
ext-1 | error | **ALL** extensions | Must have either extensions or value[x], not both : extension.exists() != value.exists() |
inv-obs-0 | error | Observation | A diagnostic result shall at least have value or data absent reason or a child observation with a value or data absent reason : value.exists() or dataAbsentReason.exists() or hasMember.exists() or component.value.exists() or component.dataAbsentReason.exists() |
inv-obs-1 | error | Observation | BodyStructure Reference extension shall only be present if the body site is not present : bodySite.exists() implies extension('http://hl7.org/fhir/StructureDefinition/bodySite').empty() |
obs-6 | error | Observation | dataAbsentReason SHALL only be present if Observation.value[x] is not present : dataAbsentReason.empty() or value.empty() |
obs-7 | error | Observation | If Observation.code is the same as an Observation.component.code then the value element associated with the code SHALL NOT be present : value.empty() or component.code.where(coding.intersect(%resource.code.coding).exists()).empty() |

Name | Flags | Card. | Type | Description & Constraints
--- | --- | --- | --- | ---
Observation | C | 0..* | AUBaseDiagnosticResult | A diagnostic result observation in an Australian healthcare context obs-6: dataAbsentReason SHALL only be present if Observation.value[x] is not present obs-7: If Observation.code is the same as an Observation.component.code then the value element associated with the code SHALL NOT be present inv-obs-0: A diagnostic result shall at least have value or data absent reason or a child observation with a value or data absent reason inv-obs-1: BodyStructure Reference extension shall only be present if the body site is not present au-core-obs-01: If there is no component or hasMember element then at least value or data absent reason shall be present
id | Σ | 0..1 | id | Logical id of this artifact
meta | Σ | 0..1 | Meta | Metadata about the resource
implicitRules | ?!Σ | 0..1 | uri | A set of rules under which this content was created
language |  | 0..1 | code | Language of the resource content Binding: CommonLanguages (preferred): A human language.
Additional Bindings | Purpose
AllLanguages | Max Binding
text |  | 0..1 | Narrative | Text summary of the resource, for human interpretation
contained |  | 0..* | Resource | Contained, inline Resources
Slices for extension |  | 0..* | Extension | Extension Slice: Unordered, Open by value:url
extension:bodyStructure | C | 0..1 | Reference(BodyStructure) | Target anatomic location or structure URL: http://hl7.org/fhir/StructureDefinition/bodySite
modifierExtension | ?! | 0..* | Extension | Extensions that cannot be ignored
identifier | Σ | 0..* | Identifier | Business Identifier for observation
basedOn | Σ | 0..* | Reference(CarePlan | DeviceRequest | ImmunizationRecommendation | MedicationRequest | NutritionOrder | ServiceRequest) | Fulfills plan, proposal or order
partOf | Σ | 0..* | Reference(MedicationAdministration | MedicationDispense | MedicationStatement | Procedure | Immunization | ImagingStudy) | Part of referenced event
status | ?!SO Σ | 1..1 | code | registered | preliminary | final | amended + Binding: ObservationStatus (required): Codes providing the status of an observation.
Obligations | Actor
SHALL:populate-if-known | AU Core Responder
SHALL:no-error | AU Core Requester
category | SO | 1..* | CodeableConcept | Diagnostic service section Binding: DiagnosticServiceSectionCodes (preferred)
Obligations | Actor
SHALL:populate-if-known | AU Core Responder
SHALL:no-error | AU Core Requester
code | SO Σ | 1..1 | CodeableConcept | Diagnostic procedure Binding: Evaluation Procedure (example)
Obligations | Actor
SHALL:populate-if-known | AU Core Responder
SHALL:no-error | AU Core Requester
subject | SO Σ | 1..1 | Reference(AU Core Patient) | Who and/or what the observation is about
Obligations | Actor
SHALL:populate-if-known | AU Core Responder
SHALL:no-error | AU Core Requester
focus | Σ | 0..* | Reference(Resource) | What the observation is about, when it is not about the subject of record
encounter | Σ | 0..1 | Reference(Encounter) | Healthcare event during which this observation is made
effective[x] | SO Σ C | 1..1 |  | Clinically relevant time/time-period for observation au-core-obs-02: Date shall be at least to day or, if not available, the Data Absent Reason extension shall be present
Obligations | Actor
SHALL:populate-if-known | AU Core Responder
SHALL:no-error | AU Core Requester
effectiveDateTime |  |  | dateTime |
effectivePeriod |  |  | Period |
effectiveTiming |  |  | Timing |
effectiveInstant |  |  | instant |
issued | Σ | 0..1 | instant | Date/Time this version was made available
performer | SO Σ | 0..* | Reference(AU Core Practitioner | AU Core PractitionerRole | AU Core Organization | AU Core Patient | AU Core RelatedPerson) | Who is responsible for the observation
Obligations | Actor
SHALL:populate-if-known | AU Core Responder
SHALL:no-error | AU Core Requester
value[x] | SO Σ C | 0..1 |  | Actual result
Obligations | Actor
SHALL:populate-if-known | AU Core Responder
SHALL:no-error | AU Core Requester
valueQuantity |  |  | Quantity |
valueCodeableConcept |  |  | CodeableConcept |
valueString |  |  | string |
valueBoolean |  |  | boolean |
valueInteger |  |  | integer |
valueRange |  |  | Range |
valueRatio |  |  | Ratio |
valueSampledData |  |  | SampledData |
valueTime |  |  | time |
valueDateTime |  |  | dateTime |
valuePeriod |  |  | Period |
dataAbsentReason | SO C | 0..1 | CodeableConcept | Why the result is missing Binding: DataAbsentReason (extensible): Codes specifying why the result (Observation.value[x]) is missing.
Obligations | Actor
SHALL:populate-if-known | AU Core Responder
SHALL:no-error | AU Core Requester
interpretation |  | 0..* | CodeableConcept | High, low, normal, etc. Binding: ObservationInterpretationCodes (extensible): Codes identifying interpretations of observations.
note |  | 0..* | Annotation | Comments about the observation
bodySite | SO C | 0..1 | CodeableConcept | Observed body part Binding: Body Site (extensible) au-core-obs-04: If a coded body site is provided, at least one coding shall be from SNOMED CT
Obligations | Actor
SHALL:populate-if-known | AU Core Responder
SHALL:no-error | AU Core Requester
method |  | 0..1 | CodeableConcept | How it was done Binding: ObservationMethods (example): Methods for simple observations.
specimen |  | 0..1 | Reference(Specimen) | Specimen used for this observation
device |  | 0..1 | Reference(Device | DeviceMetric) | (Measurement) Device
referenceRange | C | 0..* | BackboneElement | Provides guide for interpretation obs-3: Must have at least a low or a high or text
id |  | 0..1 | string | Unique id for inter-element referencing
extension |  | 0..* | Extension | Additional content defined by implementations
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized
low | C | 0..1 | SimpleQuantity | Low Range, if relevant
high | C | 0..1 | SimpleQuantity | High Range, if relevant
type |  | 0..1 | CodeableConcept | Reference range qualifier Binding: ObservationReferenceRangeMeaningCodes (preferred): Code for the meaning of a reference range.
appliesTo |  | 0..* | CodeableConcept | Reference range population Binding: ObservationReferenceRangeAppliesToCodes (example): Codes identifying the population the reference range applies to.
age |  | 0..1 | Range | Applicable age range, if relevant
text |  | 0..1 | string | Text based reference range in an observation
hasMember | SO Σ C | 0..* | Reference(AU Core Diagnostic Result Observation | AU Core Pathology Result Observation) | Individual observations in a group, study, or panel
Obligations | Actor
SHALL:populate-if-known | AU Core Responder
SHALL:no-error | AU Core Requester
derivedFrom | Σ | 0..* | Reference(DocumentReference | ImagingStudy | Media | QuestionnaireResponse | Observation | MolecularSequence) | Related measurements the observation is made from
component | SO Σ C | 0..* | BackboneElement | Component results au-core-obs-03: The component shall at least have a value or a data absent reason
Obligations | Actor
SHALL:populate-if-known | AU Core Responder
SHALL:no-error | AU Core Requester
id |  | 0..1 | string | Unique id for inter-element referencing
extension |  | 0..* | Extension | Additional content defined by implementations
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized
code | SO Σ | 1..1 | CodeableConcept | Type of component observation (code / type) Binding: LOINCCodes (example): Codes identifying names of simple observations.
Obligations | Actor
SHALL:populate-if-known | AU Core Responder
SHALL:no-error | AU Core Requester
value[x] | SO Σ C | 0..1 |  | Actual component result
Obligations | Actor
SHALL:populate-if-known | AU Core Responder
SHALL:no-error | AU Core Requester
valueQuantity |  |  | Quantity |
valueCodeableConcept |  |  | CodeableConcept |
valueString |  |  | string |
valueBoolean |  |  | boolean |
valueInteger |  |  | integer |
valueRange |  |  | Range |
valueRatio |  |  | Ratio |
valueSampledData |  |  | SampledData |
valueTime |  |  | time |
valueDateTime |  |  | dateTime |
valuePeriod |  |  | Period |
dataAbsentReason | SO C | 0..1 | CodeableConcept | Why the component result is missing Binding: DataAbsentReason (extensible): Codes specifying why the result (Observation.value[x]) is missing.
Obligations | Actor
SHALL:populate-if-known | AU Core Responder
SHALL:no-error | AU Core Requester
interpretation |  | 0..* | CodeableConcept | High, low, normal, etc. Binding: ObservationInterpretationCodes (extensible): Codes identifying interpretations of observations.
referenceRange |  | 0..* | See referenceRange (Observation) | Provides guide for interpretation of component result
Documentation for this format

#### Terminology Bindings

Path | Conformance | ValueSet | URI
Observation.language | preferred | CommonLanguages `http://hl7.org/fhir/ValueSet/languages` from the FHIR Standard
Additional Bindings | Purpose
AllLanguages | Max Binding
Observation.status | required | ObservationStatus `http://hl7.org/fhir/ValueSet/observation-status|4.0.1` from the FHIR Standard
Observation.category | preferred | DiagnosticServiceSectionCodes `http://hl7.org/fhir/ValueSet/diagnostic-service-sections` from the FHIR Standard
Observation.code | example | EvaluationProcedure `https://healthterminologies.gov.au/fhir/ValueSet/evaluation-procedure-1` from https://tx.ontoserver.csiro.au/fhir
Observation.dataAbsentReason | extensible | DataAbsentReason `http://hl7.org/fhir/ValueSet/data-absent-reason` from the FHIR Standard
Observation.interpretation | extensible | ObservationInterpretationCodes `http://hl7.org/fhir/ValueSet/observation-interpretation` from the FHIR Standard
Observation.bodySite | extensible | BodySite `https://healthterminologies.gov.au/fhir/ValueSet/body-site-1` from https://tx.ontoserver.csiro.au/fhir
Observation.method | example | ObservationMethods `http://hl7.org/fhir/ValueSet/observation-methods` from the FHIR Standard
Observation.referenceRange.type | preferred | ObservationReferenceRangeMeaningCodes `http://hl7.org/fhir/ValueSet/referencerange-meaning` from the FHIR Standard
Observation.referenceRange.appliesTo | example | ObservationReferenceRangeAppliesToCodes `http://hl7.org/fhir/ValueSet/referencerange-appliesto` from the FHIR Standard
Observation.component.code | example | LOINCCodes (a valid code from LOINC) `http://hl7.org/fhir/ValueSet/observation-codes` from the FHIR Standard
Observation.component.dataAbsentReason | extensible | DataAbsentReason `http://hl7.org/fhir/ValueSet/data-absent-reason` from the FHIR Standard
Observation.component.interpretation | extensible | ObservationInterpretationCodes `http://hl7.org/fhir/ValueSet/observation-interpretation` from the FHIR Standard

#### Constraints

Id | Grade | Path(s) | Details | Requirements
au-core-obs-01 | error | Observation | If there is no component or hasMember element then at least value or data absent reason shall be present : (component.empty() and hasMember.empty()) implies (dataAbsentReason.exists() or value.exists()) |
au-core-obs-02 | error | Observation.effective[x] | Date shall be at least to day or, if not available, the Data Absent Reason extension shall be present : (($this is dateTime implies $this.toString().length() >= 10) and extension('http://hl7.org/fhir/StructureDefinition/data-absent-reason').value.exists().not()) xor ($this is dateTime implies ($this.hasValue().not() and extension('http://hl7.org/fhir/StructureDefinition/data-absent-reason').value.exists())) |
au-core-obs-03 | error | Observation.component | The component shall at least have a value or a data absent reason : value.exists() or dataAbsentReason.exists() |
au-core-obs-04 | error | Observation.bodySite | If a coded body site is provided, at least one coding shall be from SNOMED CT : coding.exists() implies coding.where(system='http://snomed.info/sct').exists() |
dom-2 | error | Observation | If the resource is contained in another resource, it SHALL NOT contain nested Resources : contained.contained.empty() |
dom-3 | error | Observation | If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource : contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().as(canonical) | %resource.descendants().as(uri) | %resource.descendants().as(url))) or descendants().where(reference = '#').exists() or descendants().where(as(canonical) = '#').exists() or descendants().where(as(canonical) = '#').exists()).not()).trace('unmatched', id).empty() |
dom-4 | error | Observation | If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated : contained.meta.versionId.empty() and contained.meta.lastUpdated.empty() |
dom-5 | error | Observation | If a resource is contained in another resource, it SHALL NOT have a security label : contained.meta.security.empty() |
dom-6 | best practice | Observation | A resource should have narrative for robust management : text.`div`.exists() |
ele-1 | error | **ALL** elements | All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count()) |
ext-1 | error | **ALL** extensions | Must have either extensions or value[x], not both : extension.exists() != value.exists() |
inv-obs-0 | error | Observation | A diagnostic result shall at least have value or data absent reason or a child observation with a value or data absent reason : value.exists() or dataAbsentReason.exists() or hasMember.exists() or component.value.exists() or component.dataAbsentReason.exists() |
inv-obs-1 | error | Observation | BodyStructure Reference extension shall only be present if the body site is not present : bodySite.exists() implies extension('http://hl7.org/fhir/StructureDefinition/bodySite').empty() |
obs-3 | error | Observation.referenceRange | Must have at least a low or a high or text : low.exists() or high.exists() or text.exists() |
obs-6 | error | Observation | dataAbsentReason SHALL only be present if Observation.value[x] is not present : dataAbsentReason.empty() or value.empty() |
obs-7 | error | Observation | If Observation.code is the same as an Observation.component.code then the value element associated with the code SHALL NOT be present : value.empty() or component.code.where(coding.intersect(%resource.code.coding).exists()).empty() |

This structure is derived from AUBaseDiagnosticResult

Summary

Mandatory: 3 elements
Must-Support: 14 elements

Structures

This structure refers to these other structures:

- AU Core Patient (http://hl7.org.au/fhir/core/StructureDefinition/au-core-patient)
- AU Core Practitioner (http://hl7.org.au/fhir/core/StructureDefinition/au-core-practitioner)
- AU Core PractitionerRole (http://hl7.org.au/fhir/core/StructureDefinition/au-core-practitionerrole)
- AU Core Organization (http://hl7.org.au/fhir/core/StructureDefinition/au-core-organization)
- AU Core RelatedPerson (http://hl7.org.au/fhir/core/StructureDefinition/au-core-relatedperson)
- AU Core Diagnostic Result Observation (http://hl7.org.au/fhir/core/StructureDefinition/au-core-diagnosticresult)
- AU Core Pathology Result Observation (http://hl7.org.au/fhir/core/StructureDefinition/au-core-diagnosticresult-path)

Maturity: 2

Differential View

This structure is derived from AUBaseDiagnosticResult

Name | Flags | Card. | Type | Description & Constraints
--- | --- | --- | --- | ---
Observation | C | 0..* | AUBaseDiagnosticResult | A diagnostic result observation in an Australian healthcare context au-core-obs-01: If there is no component or hasMember element then at least value or data absent reason shall be present
status | SO | 1..1 | code | registered | preliminary | final | amended +
Obligations | Actor
SHALL:populate-if-known | AU Core Responder
SHALL:no-error | AU Core Requester
category | SO | 1..* | CodeableConcept | Diagnostic service section
Obligations | Actor
SHALL:populate-if-known | AU Core Responder
SHALL:no-error | AU Core Requester
code | SO | 1..1 | CodeableConcept | Diagnostic procedure
Obligations | Actor
SHALL:populate-if-known | AU Core Responder
SHALL:no-error | AU Core Requester
subject | SO | 1..1 | Reference(AU Core Patient) | Who and/or what the observation is about
Obligations | Actor
SHALL:populate-if-known | AU Core Responder
SHALL:no-error | AU Core Requester
effective[x] | SO C | 1..1 | dateTime, Period, Timing, instant | Clinically relevant time/time-period for observation au-core-obs-02: Date shall be at least to day or, if not available, the Data Absent Reason extension shall be present
Obligations | Actor
SHALL:populate-if-known | AU Core Responder
SHALL:no-error | AU Core Requester
performer | SO | 0..* | Reference(AU Core Practitioner | AU Core PractitionerRole | AU Core Organization | AU Core Patient | AU Core RelatedPerson) | Who is responsible for the observation
Obligations | Actor
SHALL:populate-if-known | AU Core Responder
SHALL:no-error | AU Core Requester
value[x] | SO C | 0..1 | Quantity, CodeableConcept, string, boolean, integer, Range, Ratio, SampledData, time, dateTime, Period | Actual result
Obligations | Actor
SHALL:populate-if-known | AU Core Responder
SHALL:no-error | AU Core Requester
dataAbsentReason | SO C | 0..1 | CodeableConcept | Why the result is missing
Obligations | Actor
SHALL:populate-if-known | AU Core Responder
SHALL:no-error | AU Core Requester
bodySite | SO C | 0..1 | CodeableConcept | Observed body part Binding: Body Site (extensible) au-core-obs-04: If a coded body site is provided, at least one coding shall be from SNOMED CT
Obligations | Actor
SHALL:populate-if-known | AU Core Responder
SHALL:no-error | AU Core Requester
hasMember | SO | 0..* | Reference(AU Core Diagnostic Result Observation | AU Core Pathology Result Observation) | Individual observations in a group, study, or panel
Obligations | Actor
SHALL:populate-if-known | AU Core Responder
SHALL:no-error | AU Core Requester
component | SO C | 0..* | BackboneElement | Component results au-core-obs-03: The component shall at least have a value or a data absent reason
Obligations | Actor
SHALL:populate-if-known | AU Core Responder
SHALL:no-error | AU Core Requester
code | SO | 1..1 | CodeableConcept | Type of component observation (code / type)
Obligations | Actor
SHALL:populate-if-known | AU Core Responder
SHALL:no-error | AU Core Requester
value[x] | SO C | 0..1 | Quantity, CodeableConcept, string, boolean, integer, Range, Ratio, SampledData, time, dateTime, Period | Actual component result
Obligations | Actor
SHALL:populate-if-known | AU Core Responder
SHALL:no-error | AU Core Requester
dataAbsentReason | SO C | 0..1 | CodeableConcept | Why the component result is missing
Obligations | Actor
SHALL:populate-if-known | AU Core Responder
SHALL:no-error | AU Core Requester
Documentation for this format

#### Terminology Bindings (Differential)

Path | Conformance | ValueSet | URI
Observation.bodySite | extensible | BodySite `https://healthterminologies.gov.au/fhir/ValueSet/body-site-1` from https://tx.ontoserver.csiro.au/fhir

#### Constraints

Id | Grade | Path(s) | Details | Requirements
au-core-obs-01 | error | Observation | If there is no component or hasMember element then at least value or data absent reason shall be present : (component.empty() and hasMember.empty()) implies (dataAbsentReason.exists() or value.exists()) |
au-core-obs-02 | error | Observation.effective[x] | Date shall be at least to day or, if not available, the Data Absent Reason extension shall be present : (($this is dateTime implies $this.toString().length() >= 10) and extension('http://hl7.org/fhir/StructureDefinition/data-absent-reason').value.exists().not()) xor ($this is dateTime implies ($this.hasValue().not() and extension('http://hl7.org/fhir/StructureDefinition/data-absent-reason').value.exists())) |
au-core-obs-03 | error | Observation.component | The component shall at least have a value or a data absent reason : value.exists() or dataAbsentReason.exists() |
au-core-obs-04 | error | Observation.bodySite | If a coded body site is provided, at least one coding shall be from SNOMED CT : coding.exists() implies coding.where(system='http://snomed.info/sct').exists() |

Key Elements View

Name | Flags | Card. | Type | Description & Constraints
--- | --- | --- | --- | ---
Observation | C | 0..* | AUBaseDiagnosticResult | A diagnostic result observation in an Australian healthcare context dom-2: If the resource is contained in another resource, it SHALL NOT contain nested Resources dom-3: If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource dom-4: If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated dom-5: If a resource is contained in another resource, it SHALL NOT have a security label dom-6: A resource should have narrative for robust management obs-6: dataAbsentReason SHALL only be present if Observation.value[x] is not present obs-7: If Observation.code is the same as an Observation.component.code then the value element associated with the code SHALL NOT be present inv-obs-0: A diagnostic result shall at least have value or data absent reason or a child observation with a value or data absent reason inv-obs-1: BodyStructure Reference extension shall only be present if the body site is not present au-core-obs-01: If there is no component or hasMember element then at least value or data absent reason shall be present
implicitRules | ?!Σ | 0..1 | uri | A set of rules under which this content was created ele-1: All FHIR elements must have a @value or children
Slices for extension |  |  |  | Content/Rules for all slices
extension:bodyStructure | C | 0..1 | Reference(BodyStructure) | Target anatomic location or structure URL: http://hl7.org/fhir/StructureDefinition/bodySite ele-1: All FHIR elements must have a @value or children ext-1: Must have either extensions or value[x], not both
modifierExtension | ?! | 0..* | Extension | Extensions that cannot be ignored ele-1: All FHIR elements must have a @value or children ext-1: Must have either extensions or value[x], not both
status | ?!SO Σ | 1..1 | code | registered | preliminary | final | amended + Binding: ObservationStatus (required): Codes providing the status of an observation. ele-1: All FHIR elements must have a @value or children
Obligations | Actor
SHALL:populate-if-known | AU Core Responder
SHALL:no-error | AU Core Requester
category | SO | 1..* | CodeableConcept | Diagnostic service section Binding: DiagnosticServiceSectionCodes (preferred) ele-1: All FHIR elements must have a @value or children
Obligations | Actor
SHALL:populate-if-known | AU Core Responder
SHALL:no-error | AU Core Requester
code | SO Σ | 1..1 | CodeableConcept | Diagnostic procedure Binding: Evaluation Procedure (example) ele-1: All FHIR elements must have a @value or children
Obligations | Actor
SHALL:populate-if-known | AU Core Responder
SHALL:no-error | AU Core Requester
subject | SO Σ | 1..1 | Reference(AU Core Patient) | Who and/or what the observation is about ele-1: All FHIR elements must have a @value or children
Obligations | Actor
SHALL:populate-if-known | AU Core Responder
SHALL:no-error | AU Core Requester
effective[x] | SO Σ C | 1..1 |  | Clinically relevant time/time-period for observation ele-1: All FHIR elements must have a @value or children au-core-obs-02: Date shall be at least to day or, if not available, the Data Absent Reason extension shall be present
Obligations | Actor
SHALL:populate-if-known | AU Core Responder
SHALL:no-error | AU Core Requester
effectiveDateTime |  |  | dateTime |
effectivePeriod |  |  | Period |
effectiveTiming |  |  | Timing |
effectiveInstant |  |  | instant |
performer | SO Σ | 0..* | Reference(AU Core Practitioner | AU Core PractitionerRole | AU Core Organization | AU Core Patient | AU Core RelatedPerson) | Who is responsible for the observation ele-1: All FHIR elements must have a @value or children
Obligations | Actor
SHALL:populate-if-known | AU Core Responder
SHALL:no-error | AU Core Requester
value[x] | SO Σ C | 0..1 |  | Actual result ele-1: All FHIR elements must have a @value or children
Obligations | Actor
SHALL:populate-if-known | AU Core Responder
SHALL:no-error | AU Core Requester
valueQuantity |  |  | Quantity |
valueCodeableConcept |  |  | CodeableConcept |
valueString |  |  | string |
valueBoolean |  |  | boolean |
valueInteger |  |  | integer |
valueRange |  |  | Range |
valueRatio |  |  | Ratio |
valueSampledData |  |  | SampledData |
valueTime |  |  | time |
valueDateTime |  |  | dateTime |
valuePeriod |  |  | Period |
dataAbsentReason | SO C | 0..1 | CodeableConcept | Why the result is missing Binding: DataAbsentReason (extensible): Codes specifying why the result (Observation.value[x]) is missing. ele-1: All FHIR elements must have a @value or children
Obligations | Actor
SHALL:populate-if-known | AU Core Responder
SHALL:no-error | AU Core Requester
bodySite | SO C | 0..1 | CodeableConcept | Observed body part Binding: Body Site (extensible) ele-1: All FHIR elements must have a @value or children au-core-obs-04: If a coded body site is provided, at least one coding shall be from SNOMED CT
Obligations | Actor
SHALL:populate-if-known | AU Core Responder
SHALL:no-error | AU Core Requester
hasMember | SO Σ C | 0..* | Reference(AU Core Diagnostic Result Observation | AU Core Pathology Result Observation) | Individual observations in a group, study, or panel ele-1: All FHIR elements must have a @value or children
Obligations | Actor
SHALL:populate-if-known | AU Core Responder
SHALL:no-error | AU Core Requester
component | SO Σ C | 0..* | BackboneElement | Component results ele-1: All FHIR elements must have a @value or children au-core-obs-03: The component shall at least have a value or a data absent reason
Obligations | Actor
SHALL:populate-if-known | AU Core Responder
SHALL:no-error | AU Core Requester
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized ele-1: All FHIR elements must have a @value or children ext-1: Must have either extensions or value[x], not both
code | SO Σ | 1..1 | CodeableConcept | Type of component observation (code / type) Binding: LOINCCodes (example): Codes identifying names of simple observations. ele-1: All FHIR elements must have a @value or children
Obligations | Actor
SHALL:populate-if-known | AU Core Responder
SHALL:no-error | AU Core Requester
value[x] | SO Σ C | 0..1 |  | Actual component result ele-1: All FHIR elements must have a @value or children
Obligations | Actor
SHALL:populate-if-known | AU Core Responder
SHALL:no-error | AU Core Requester
valueQuantity |  |  | Quantity |
valueCodeableConcept |  |  | CodeableConcept |
valueString |  |  | string |
valueBoolean |  |  | boolean |
valueInteger |  |  | integer |
valueRange |  |  | Range |
valueRatio |  |  | Ratio |
valueSampledData |  |  | SampledData |
valueTime |  |  | time |
valueDateTime |  |  | dateTime |
valuePeriod |  |  | Period |
dataAbsentReason | SO C | 0..1 | CodeableConcept | Why the component result is missing Binding: DataAbsentReason (extensible): Codes specifying why the result (Observation.value[x]) is missing. ele-1: All FHIR elements must have a @value or children
Obligations | Actor
SHALL:populate-if-known | AU Core Responder
SHALL:no-error | AU Core Requester
Documentation for this format

#### Terminology Bindings

Path | Conformance | ValueSet | URI
Observation.status | required | ObservationStatus `http://hl7.org/fhir/ValueSet/observation-status|4.0.1` from the FHIR Standard
Observation.category | preferred | DiagnosticServiceSectionCodes `http://hl7.org/fhir/ValueSet/diagnostic-service-sections` from the FHIR Standard
Observation.code | example | EvaluationProcedure `https://healthterminologies.gov.au/fhir/ValueSet/evaluation-procedure-1` from https://tx.ontoserver.csiro.au/fhir
Observation.dataAbsentReason | extensible | DataAbsentReason `http://hl7.org/fhir/ValueSet/data-absent-reason` from the FHIR Standard
Observation.bodySite | extensible | BodySite `https://healthterminologies.gov.au/fhir/ValueSet/body-site-1` from https://tx.ontoserver.csiro.au/fhir
Observation.component.code | example | LOINCCodes (a valid code from LOINC) `http://hl7.org/fhir/ValueSet/observation-codes` from the FHIR Standard
Observation.component.dataAbsentReason | extensible | DataAbsentReason `http://hl7.org/fhir/ValueSet/data-absent-reason` from the FHIR Standard

#### Constraints

Id | Grade | Path(s) | Details | Requirements
au-core-obs-01 | error | Observation | If there is no component or hasMember element then at least value or data absent reason shall be present : (component.empty() and hasMember.empty()) implies (dataAbsentReason.exists() or value.exists()) |
au-core-obs-02 | error | Observation.effective[x] | Date shall be at least to day or, if not available, the Data Absent Reason extension shall be present : (($this is dateTime implies $this.toString().length() >= 10) and extension('http://hl7.org/fhir/StructureDefinition/data-absent-reason').value.exists().not()) xor ($this is dateTime implies ($this.hasValue().not() and extension('http://hl7.org/fhir/StructureDefinition/data-absent-reason').value.exists())) |
au-core-obs-03 | error | Observation.component | The component shall at least have a value or a data absent reason : value.exists() or dataAbsentReason.exists() |
au-core-obs-04 | error | Observation.bodySite | If a coded body site is provided, at least one coding shall be from SNOMED CT : coding.exists() implies coding.where(system='http://snomed.info/sct').exists() |
dom-2 | error | Observation | If the resource is contained in another resource, it SHALL NOT contain nested Resources : contained.contained.empty() |
dom-3 | error | Observation | If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource : contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().as(canonical) | %resource.descendants().as(uri) | %resource.descendants().as(url))) or descendants().where(reference = '#').exists() or descendants().where(as(canonical) = '#').exists() or descendants().where(as(canonical) = '#').exists()).not()).trace('unmatched', id).empty() |
dom-4 | error | Observation | If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated : contained.meta.versionId.empty() and contained.meta.lastUpdated.empty() |
dom-5 | error | Observation | If a resource is contained in another resource, it SHALL NOT have a security label : contained.meta.security.empty() |
dom-6 | best practice | Observation | A resource should have narrative for robust management : text.`div`.exists() |
ele-1 | error | **ALL** elements | All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count()) |
ext-1 | error | **ALL** extensions | Must have either extensions or value[x], not both : extension.exists() != value.exists() |
inv-obs-0 | error | Observation | A diagnostic result shall at least have value or data absent reason or a child observation with a value or data absent reason : value.exists() or dataAbsentReason.exists() or hasMember.exists() or component.value.exists() or component.dataAbsentReason.exists() |
inv-obs-1 | error | Observation | BodyStructure Reference extension shall only be present if the body site is not present : bodySite.exists() implies extension('http://hl7.org/fhir/StructureDefinition/bodySite').empty() |
obs-6 | error | Observation | dataAbsentReason SHALL only be present if Observation.value[x] is not present : dataAbsentReason.empty() or value.empty() |
obs-7 | error | Observation | If Observation.code is the same as an Observation.component.code then the value element associated with the code SHALL NOT be present : value.empty() or component.code.where(coding.intersect(%resource.code.coding).exists()).empty() |

Snapshot View

Name | Flags | Card. | Type | Description & Constraints
--- | --- | --- | --- | ---
Observation | C | 0..* | AUBaseDiagnosticResult | A diagnostic result observation in an Australian healthcare context obs-6: dataAbsentReason SHALL only be present if Observation.value[x] is not present obs-7: If Observation.code is the same as an Observation.component.code then the value element associated with the code SHALL NOT be present inv-obs-0: A diagnostic result shall at least have value or data absent reason or a child observation with a value or data absent reason inv-obs-1: BodyStructure Reference extension shall only be present if the body site is not present au-core-obs-01: If there is no component or hasMember element then at least value or data absent reason shall be present
id | Σ | 0..1 | id | Logical id of this artifact
meta | Σ | 0..1 | Meta | Metadata about the resource
implicitRules | ?!Σ | 0..1 | uri | A set of rules under which this content was created
language |  | 0..1 | code | Language of the resource content Binding: CommonLanguages (preferred): A human language.
Additional Bindings | Purpose
AllLanguages | Max Binding
text |  | 0..1 | Narrative | Text summary of the resource, for human interpretation
contained |  | 0..* | Resource | Contained, inline Resources
Slices for extension |  | 0..* | Extension | Extension Slice: Unordered, Open by value:url
extension:bodyStructure | C | 0..1 | Reference(BodyStructure) | Target anatomic location or structure URL: http://hl7.org/fhir/StructureDefinition/bodySite
modifierExtension | ?! | 0..* | Extension | Extensions that cannot be ignored
identifier | Σ | 0..* | Identifier | Business Identifier for observation
basedOn | Σ | 0..* | Reference(CarePlan | DeviceRequest | ImmunizationRecommendation | MedicationRequest | NutritionOrder | ServiceRequest) | Fulfills plan, proposal or order
partOf | Σ | 0..* | Reference(MedicationAdministration | MedicationDispense | MedicationStatement | Procedure | Immunization | ImagingStudy) | Part of referenced event
status | ?!SO Σ | 1..1 | code | registered | preliminary | final | amended + Binding: ObservationStatus (required): Codes providing the status of an observation.
Obligations | Actor
SHALL:populate-if-known | AU Core Responder
SHALL:no-error | AU Core Requester
category | SO | 1..* | CodeableConcept | Diagnostic service section Binding: DiagnosticServiceSectionCodes (preferred)
Obligations | Actor
SHALL:populate-if-known | AU Core Responder
SHALL:no-error | AU Core Requester
code | SO Σ | 1..1 | CodeableConcept | Diagnostic procedure Binding: Evaluation Procedure (example)
Obligations | Actor
SHALL:populate-if-known | AU Core Responder
SHALL:no-error | AU Core Requester
subject | SO Σ | 1..1 | Reference(AU Core Patient) | Who and/or what the observation is about
Obligations | Actor
SHALL:populate-if-known | AU Core Responder
SHALL:no-error | AU Core Requester
focus | Σ | 0..* | Reference(Resource) | What the observation is about, when it is not about the subject of record
encounter | Σ | 0..1 | Reference(Encounter) | Healthcare event during which this observation is made
effective[x] | SO Σ C | 1..1 |  | Clinically relevant time/time-period for observation au-core-obs-02: Date shall be at least to day or, if not available, the Data Absent Reason extension shall be present
Obligations | Actor
SHALL:populate-if-known | AU Core Responder
SHALL:no-error | AU Core Requester
effectiveDateTime |  |  | dateTime |
effectivePeriod |  |  | Period |
effectiveTiming |  |  | Timing |
effectiveInstant |  |  | instant |
issued | Σ | 0..1 | instant | Date/Time this version was made available
performer | SO Σ | 0..* | Reference(AU Core Practitioner | AU Core PractitionerRole | AU Core Organization | AU Core Patient | AU Core RelatedPerson) | Who is responsible for the observation
Obligations | Actor
SHALL:populate-if-known | AU Core Responder
SHALL:no-error | AU Core Requester
value[x] | SO Σ C | 0..1 |  | Actual result
Obligations | Actor
SHALL:populate-if-known | AU Core Responder
SHALL:no-error | AU Core Requester
valueQuantity |  |  | Quantity |
valueCodeableConcept |  |  | CodeableConcept |
valueString |  |  | string |
valueBoolean |  |  | boolean |
valueInteger |  |  | integer |
valueRange |  |  | Range |
valueRatio |  |  | Ratio |
valueSampledData |  |  | SampledData |
valueTime |  |  | time |
valueDateTime |  |  | dateTime |
valuePeriod |  |  | Period |
dataAbsentReason | SO C | 0..1 | CodeableConcept | Why the result is missing Binding: DataAbsentReason (extensible): Codes specifying why the result (Observation.value[x]) is missing.
Obligations | Actor
SHALL:populate-if-known | AU Core Responder
SHALL:no-error | AU Core Requester
interpretation |  | 0..* | CodeableConcept | High, low, normal, etc. Binding: ObservationInterpretationCodes (extensible): Codes identifying interpretations of observations.
note |  | 0..* | Annotation | Comments about the observation
bodySite | SO C | 0..1 | CodeableConcept | Observed body part Binding: Body Site (extensible) au-core-obs-04: If a coded body site is provided, at least one coding shall be from SNOMED CT
Obligations | Actor
SHALL:populate-if-known | AU Core Responder
SHALL:no-error | AU Core Requester
method |  | 0..1 | CodeableConcept | How it was done Binding: ObservationMethods (example): Methods for simple observations.
specimen |  | 0..1 | Reference(Specimen) | Specimen used for this observation
device |  | 0..1 | Reference(Device | DeviceMetric) | (Measurement) Device
referenceRange | C | 0..* | BackboneElement | Provides guide for interpretation obs-3: Must have at least a low or a high or text
id |  | 0..1 | string | Unique id for inter-element referencing
extension |  | 0..* | Extension | Additional content defined by implementations
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized
low | C | 0..1 | SimpleQuantity | Low Range, if relevant
high | C | 0..1 | SimpleQuantity | High Range, if relevant
type |  | 0..1 | CodeableConcept | Reference range qualifier Binding: ObservationReferenceRangeMeaningCodes (preferred): Code for the meaning of a reference range.
appliesTo |  | 0..* | CodeableConcept | Reference range population Binding: ObservationReferenceRangeAppliesToCodes (example): Codes identifying the population the reference range applies to.
age |  | 0..1 | Range | Applicable age range, if relevant
text |  | 0..1 | string | Text based reference range in an observation
hasMember | SO Σ C | 0..* | Reference(AU Core Diagnostic Result Observation | AU Core Pathology Result Observation) | Individual observations in a group, study, or panel
Obligations | Actor
SHALL:populate-if-known | AU Core Responder
SHALL:no-error | AU Core Requester
derivedFrom | Σ | 0..* | Reference(DocumentReference | ImagingStudy | Media | QuestionnaireResponse | Observation | MolecularSequence) | Related measurements the observation is made from
component | SO Σ C | 0..* | BackboneElement | Component results au-core-obs-03: The component shall at least have a value or a data absent reason
Obligations | Actor
SHALL:populate-if-known | AU Core Responder
SHALL:no-error | AU Core Requester
id |  | 0..1 | string | Unique id for inter-element referencing
extension |  | 0..* | Extension | Additional content defined by implementations
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized
code | SO Σ | 1..1 | CodeableConcept | Type of component observation (code / type) Binding: LOINCCodes (example): Codes identifying names of simple observations.
Obligations | Actor
SHALL:populate-if-known | AU Core Responder
SHALL:no-error | AU Core Requester
value[x] | SO Σ C | 0..1 |  | Actual component result
Obligations | Actor
SHALL:populate-if-known | AU Core Responder
SHALL:no-error | AU Core Requester
valueQuantity |  |  | Quantity |
valueCodeableConcept |  |  | CodeableConcept |
valueString |  |  | string |
valueBoolean |  |  | boolean |
valueInteger |  |  | integer |
valueRange |  |  | Range |
valueRatio |  |  | Ratio |
valueSampledData |  |  | SampledData |
valueTime |  |  | time |
valueDateTime |  |  | dateTime |
valuePeriod |  |  | Period |
dataAbsentReason | SO C | 0..1 | CodeableConcept | Why the component result is missing Binding: DataAbsentReason (extensible): Codes specifying why the result (Observation.value[x]) is missing.
Obligations | Actor
SHALL:populate-if-known | AU Core Responder
SHALL:no-error | AU Core Requester
interpretation |  | 0..* | CodeableConcept | High, low, normal, etc. Binding: ObservationInterpretationCodes (extensible): Codes identifying interpretations of observations.
referenceRange |  | 0..* | See referenceRange (Observation) | Provides guide for interpretation of component result
Documentation for this format

#### Terminology Bindings

Path | Conformance | ValueSet | URI
Observation.language | preferred | CommonLanguages `http://hl7.org/fhir/ValueSet/languages` from the FHIR Standard
Additional Bindings | Purpose
AllLanguages | Max Binding
Observation.status | required | ObservationStatus `http://hl7.org/fhir/ValueSet/observation-status|4.0.1` from the FHIR Standard
Observation.category | preferred | DiagnosticServiceSectionCodes `http://hl7.org/fhir/ValueSet/diagnostic-service-sections` from the FHIR Standard
Observation.code | example | EvaluationProcedure `https://healthterminologies.gov.au/fhir/ValueSet/evaluation-procedure-1` from https://tx.ontoserver.csiro.au/fhir
Observation.dataAbsentReason | extensible | DataAbsentReason `http://hl7.org/fhir/ValueSet/data-absent-reason` from the FHIR Standard
Observation.interpretation | extensible | ObservationInterpretationCodes `http://hl7.org/fhir/ValueSet/observation-interpretation` from the FHIR Standard
Observation.bodySite | extensible | BodySite `https://healthterminologies.gov.au/fhir/ValueSet/body-site-1` from https://tx.ontoserver.csiro.au/fhir
Observation.method | example | ObservationMethods `http://hl7.org/fhir/ValueSet/observation-methods` from the FHIR Standard
Observation.referenceRange.type | preferred | ObservationReferenceRangeMeaningCodes `http://hl7.org/fhir/ValueSet/referencerange-meaning` from the FHIR Standard
Observation.referenceRange.appliesTo | example | ObservationReferenceRangeAppliesToCodes `http://hl7.org/fhir/ValueSet/referencerange-appliesto` from the FHIR Standard
Observation.component.code | example | LOINCCodes (a valid code from LOINC) `http://hl7.org/fhir/ValueSet/observation-codes` from the FHIR Standard
Observation.component.dataAbsentReason | extensible | DataAbsentReason `http://hl7.org/fhir/ValueSet/data-absent-reason` from the FHIR Standard
Observation.component.interpretation | extensible | ObservationInterpretationCodes `http://hl7.org/fhir/ValueSet/observation-interpretation` from the FHIR Standard

#### Constraints

Id | Grade | Path(s) | Details | Requirements
au-core-obs-01 | error | Observation | If there is no component or hasMember element then at least value or data absent reason shall be present : (component.empty() and hasMember.empty()) implies (dataAbsentReason.exists() or value.exists()) |
au-core-obs-02 | error | Observation.effective[x] | Date shall be at least to day or, if not available, the Data Absent Reason extension shall be present : (($this is dateTime implies $this.toString().length() >= 10) and extension('http://hl7.org/fhir/StructureDefinition/data-absent-reason').value.exists().not()) xor ($this is dateTime implies ($this.hasValue().not() and extension('http://hl7.org/fhir/StructureDefinition/data-absent-reason').value.exists())) |
au-core-obs-03 | error | Observation.component | The component shall at least have a value or a data absent reason : value.exists() or dataAbsentReason.exists() |
au-core-obs-04 | error | Observation.bodySite | If a coded body site is provided, at least one coding shall be from SNOMED CT : coding.exists() implies coding.where(system='http://snomed.info/sct').exists() |
dom-2 | error | Observation | If the resource is contained in another resource, it SHALL NOT contain nested Resources : contained.contained.empty() |
dom-3 | error | Observation | If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource : contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().as(canonical) | %resource.descendants().as(uri) | %resource.descendants().as(url))) or descendants().where(reference = '#').exists() or descendants().where(as(canonical) = '#').exists() or descendants().where(as(canonical) = '#').exists()).not()).trace('unmatched', id).empty() |
dom-4 | error | Observation | If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated : contained.meta.versionId.empty() and contained.meta.lastUpdated.empty() |
dom-5 | error | Observation | If a resource is contained in another resource, it SHALL NOT have a security label : contained.meta.security.empty() |
dom-6 | best practice | Observation | A resource should have narrative for robust management : text.`div`.exists() |
ele-1 | error | **ALL** elements | All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count()) |
ext-1 | error | **ALL** extensions | Must have either extensions or value[x], not both : extension.exists() != value.exists() |
inv-obs-0 | error | Observation | A diagnostic result shall at least have value or data absent reason or a child observation with a value or data absent reason : value.exists() or dataAbsentReason.exists() or hasMember.exists() or component.value.exists() or component.dataAbsentReason.exists() |
inv-obs-1 | error | Observation | BodyStructure Reference extension shall only be present if the body site is not present : bodySite.exists() implies extension('http://hl7.org/fhir/StructureDefinition/bodySite').empty() |
obs-3 | error | Observation.referenceRange | Must have at least a low or a high or text : low.exists() or high.exists() or text.exists() |
obs-6 | error | Observation | dataAbsentReason SHALL only be present if Observation.value[x] is not present : dataAbsentReason.empty() or value.empty() |
obs-7 | error | Observation | If Observation.code is the same as an Observation.component.code then the value element associated with the code SHALL NOT be present : value.empty() or component.code.where(coding.intersect(%resource.code.coding).exists()).empty() |

This structure is derived from AUBaseDiagnosticResult

Summary

Mandatory: 3 elements
Must-Support: 14 elements

Structures

This structure refers to these other structures:

- AU Core Patient (http://hl7.org.au/fhir/core/StructureDefinition/au-core-patient)
- AU Core Practitioner (http://hl7.org.au/fhir/core/StructureDefinition/au-core-practitioner)
- AU Core PractitionerRole (http://hl7.org.au/fhir/core/StructureDefinition/au-core-practitionerrole)
- AU Core Organization (http://hl7.org.au/fhir/core/StructureDefinition/au-core-organization)
- AU Core RelatedPerson (http://hl7.org.au/fhir/core/StructureDefinition/au-core-relatedperson)
- AU Core Diagnostic Result Observation (http://hl7.org.au/fhir/core/StructureDefinition/au-core-diagnosticresult)
- AU Core Pathology Result Observation (http://hl7.org.au/fhir/core/StructureDefinition/au-core-diagnosticresult-path)

Maturity: 2

Other representations of profile: CSV, Excel, Schematron

### Notes:

Below is an overview of the mandatory and optional search parameters and combined search parameters. See the AU Core CapabilityStatements for a complete list of supported RESTful interactions for this IG.

FHIR search operations are described here and the syntax used to describe AU Core interactions is defined here.

Any search parameter defined in FHIR may be ‘allowed’ by the system unless explicitly marked as “SHALL NOT”. A few items are marked as MAY in this implementation guide to highlight their potential relevance.

Parameter(s) | Conformance | Type(s) | Requirements (when used alone or in combination)
--- | --- | --- | ---
patient+category | SHALL | `reference`+`token` |
patient+category+date | SHALL | `reference`+`token`+`date` |
patient+code | SHALL | `reference`+`token` |
patient+category+status | SHOULD | `reference`+`token`+`token` |
patient+code+date | SHOULD | `reference`+`token`+`date` |
patient | MAY | `reference` | The requester SHALL provide at least an id value and MAY provide both the Type and id values. The responder SHALL support both. The requester SHOULD support chained search patient.identifier using IHI, Medicare Number, and DVA Number identifiers as defined in the AU Core Patient profile. The responder SHOULD support chained search patient.identifier using IHI, Medicare Number, and DVA Number identifiers as defined in the AU Core Patient profile.
category | MAY | `token` | The requester SHALL provide at least a code value and MAY provide both the system and code values. The responder SHALL support both. The requester SHALL support search using the category code defined in this profile. The responder SHALL support search using the category code defined in this profile.
code | MAY | `token` | The requester SHALL provide at least a code value and MAY provide both the system and code values. The responder SHALL support both. The requester SHALL support search using the LOINC codes defined in this profile. The responder SHALL support search using the LOINC codes defined in this profile. The requester SHALL support `multipleOr`. The responder SHALL support `multipleOr`.
date | MAY | `date` | A requester SHALL provide a value precise to the second + time offset. A responder SHALL support a value precise to the second + time offset. The requester SHALL support these search comparators `gt`, `lt`, `ge`, `le`. The responder SHALL support these search comparators `gt`, `lt`, `ge`, `le`. The requester SHOULD support `multipleAnd`, and if `multipleAnd` is supported, SHALL support the search comparators `gt`, `lt`, `ge`, `le`. The responder SHOULD support `multipleAnd`, and if `multipleAnd` is supported, SHALL support the search comparators `gt`, `lt`, `ge`, `le`.
status | MAY | `token` | The requester SHALL provide at least a code value and MAY provide both the system and code values. The responder SHALL support both. The requester SHALL support `multipleOr`.The responder SHALL support `multipleOr`.

#### Mandatory Search Parameters:

The following search parameters and search parameter combinations SHALL be supported:

1. SHALL support searching using the combination of the `patient` and `category` search parameters:
   - SHOULD support chained searching of patient canonical identifier `patient.identifier` (e.g. `patient.identifier=[system|][code]`)

   `GET [base]/Observation?patient={Type/}[id]&category={system|}[code]`

   Example:

   1. GET [base]/Observation?patient=5678&category=http://terminology.hl7.org/CodeSystem/observation-category|survey

   Implementation Notes: Fetches a bundle of all Observation resources for the specified patient and a category code = `survey` (how to search by reference and how to search by token)

2. SHALL support searching using the combination of the `patient` and `code` search parameters:
   - SHOULD support chained searching of patient canonical identifier `patient.identifier` (e.g. `patient.identifier=[system|][code]`)
   - SHOULD support multipleOr search on `code` (e.g.`code={system|}[code],{system|}[code],...`)

   `GET [base]/Observation?patient={Type/}[id]&code={system|}[code]{,{system|}[code],...}`

   Example:

   1. GET [base]/Observation?patient=5678&code=http://snomed.info/sct|89240007,http://loinc.org|14683-7,http://loinc.org|85354-9

   Implementation Notes: Fetches a bundle of all Observation resources for the specified patient and observation code(s). The Observation `code` parameter searches `Observation.code` only. (how to search by reference and how to search by token)

3. SHALL support searching using the combination of the `patient` and `category` and `date` search parameters:
   - SHOULD support chained searching of patient canonical identifier `patient.identifier` (e.g. `patient.identifier=[system|][code]`)
   - SHALL support these `date` comparators: `gt,lt,ge,le`
   - SHOULD support multipleAnd search on `date` (e.g.`date=[date]&date=[date]]&...`), and if multipleAnd is supported, SHALL support the search comparators `gt,lt,ge,le`

   `GET [base]/Observation?patient={Type/}[id]&category={system|}[code]&date={gt|lt|ge|le}[date]{&date={gt|lt|ge|le}[date]&...}`

   Example:

   1. GET [base]/Observation?patient=5678&category=http://terminology.hl7.org/CodeSystem/observation-category|survey&date=ge2020-01-01T00:00:00Z

   Implementation Notes: Fetches a bundle of all Observation resources for the specified patient and date and category (how to search by reference and how to search by token and how to search by date)

#### Optional Search Parameters:

The following search parameters and search parameter combinations SHOULD be supported:

1. SHOULD support chained searching of patient canonical identifier `patient.identifier` (e.g. `patient.identifier=[system|][code]`)

   `GET [base]/Observation?patient.identifier=[system|][code]`

   Example:

   1. GET [base]/Observation?patient.identifier=http://ns.electronichealth.net.au/id/medicare-number|32788511952
   2. GET [base]/Observation?patient.identifier=http://ns.electronichealth.net.au/id/hi/ihi/1.0|8003608833357361

   Implementation Notes: Fetches a bundle of all Observation resources for the specified patient (how to search by reference and how to search by token)

2. SHOULD support searching using the combination of the `patient` and `category` and `status` search parameters:
   - SHOULD support chained searching of patient canonical identifier `patient.identifier` (e.g. `patient.identifier=[system|][code]`)
   - SHALL support multipleOr search on `status` (e.g.`status={system|}[code],{system|}[code],...`)

   `GET [base]/Observation?patient={Type/}[id]&category={system|}[code]&status={system|}[code]{,{system|}[code],...}`

   Example:

   1. GET [base]/Observation?patient=5678&category=http://terminology.hl7.org/CodeSystem/observation-category|survey&status=final

   Implementation Notes: Fetches a bundle of all Observation resources for the specified patient and category and status (how to search by reference and how to search by token)

3. SHOULD support searching using the combination of the `patient` and `code` and `date` search parameters:
   - SHOULD support chained searching of patient canonical identifier `patient.identifier` (e.g. `patient.identifier=[system|][code]`
   - SHOULD support multipleOr search on `code` (e.g.`code={system|}[code],{system|}[code],...`)
   - SHALL support these `date` comparators: `gt,lt,ge,le`
   - SHOULD support multipleAnd search on `date` (e.g.`date=[date]&date=[date]]&...`), and if multipleAnd is supported, SHALL support the search comparators `gt,lt,ge,le`

   `GET [base]/Observation?patient={Type/}[id]&code={system|}[code]{,{system|}[code],...}&date={gt|lt|ge|le}[date]{&date={gt|lt|ge|le}[date]&...}`

   Example:

   1. GET [base]/Observation?patient=5678&code=http://snomed.info/sct|89240007,http://loinc.org|14683-7,http://loinc.org|85354-9&date=ge2020-01-01T00:00:00Z
   2. GET [base]/Observation?patient.identifier=http://example.org/fhir/mrn|12345&code=http://snomed.info/sct|89240007,http://loinc.org|14683-7,http://loinc.org|85354-9&date=ge2020-01-01T00:00:00Z

   Implementation Notes: Fetches a bundle of all Observation resources for the specified patient and date and observation code(s). SHOULD support search by multiple codes. (how to search by reference and how to search by token and how to search by date)