Cancer Pathology Data Sharing
2.0.0 - STU 2 United States of America flag

This page is part of the Sharing eCC Data from Pathology Labs to EHR (v2.0.0: STU 2) based on FHIR (HL7® FHIR® Standard) R4. This is the current published version in its permanent home (it will always be available at this URL). For a full list of available versions, see the Directory of published versions

Resource Profile: US Pathology Observation

Official URL: http://hl7.org/fhir/us/cancer-reporting/StructureDefinition/us-pathology-observation Version: 2.0.0
Standards status: Trial-use Maturity Level: 2 Computable Name: USPathologyObservation

This Observation profile is inspired by both US Core Simple Observation and the IHE SDC/eCP on FHIR Observation Profile. It adds category to differentiate Section and Question Observations. Section(s) contain one or more hasMember relationships to Questions, will not have a value element, and have no derivedFrom relationships. Questions have a derivedFrom relationship with Section AND contain EITHER a value element OR one or more hasMember relationships.

Introduction

This US Pathology Observation profile is inspired by the IHE SDC/eCP on FHIR Observation Profile which maps the CAP protocol’s structured elements into FHIR Observations. The profile defines how to capture pathology data from structured cancer protocols in a standardized FHIR format.

Background

The IHE Structured Data Capture (SDC) standard, IHE SDC eCP on FHIR, uses a form-driven workflow to capture and encode data and then create FHIR Observations from the captured data. The College of American Pathologists (CAP) has developed and tested the IHE SDC IG for collection of data from electronic Cancer Protocols (eCPs) by means of Structured Data Capture templates with XML-based schema which enforces ordering, optionality and standardization.

CAP Protocol Structure

  • The CAP electronic Cancer Protocols (eCPs) templates utilize a structured format with several key components:

  • Sections: Represent major divisions within the protocol (e.g., “SPECIMEN,” “TUMOR”) that organize related content.
  • Child Items: Encapsulates questions, list fields, and sub-sections within a section.
  • Questions: Individual data elements which store captured responses which are derived from sections
  • Ordering: Indicated for each element through an order attribute (order = “27”) which explicitly defines the sequence of sections, questions, and responses.

Data Structure Rules

Category Slicing

The Observation resource is sliced based on the category element to distinguish between sections and questions:

  • category:section: When this slice is used (indicating the Observation represents a section), the code element must use a value from the “CAP eCP Section Codes” ValueSet (binding: required).

  • category:question: When this slice is used (indicating the Observation represents a question), the code element must use a value from the “CAP eCP Question Codes” ValueSet (binding: required).

This slicing approach enforces the appropriate terminology bindings based on whether the Observation represents a structural section or a specific question.

Hierarchical Structure

  • Sections: CAP protocol sections (e.g., “SPECIMEN,” “TUMOR”) are stored as Observations that act as a grouping container using hasMember, which references child Observations (i.e., questions within the section).
  • Parent-Child Relationships: If a question belongs to a section, the section Observation references its child Observations using hasMember whereas the child references the parent through derivedFrom.

Key Elements

  • category: Specifies whether this is a Section (has no value) or a Question (has a value)
    • Must use the appropriate slice (section or question) from ObservationCategoryCodes
  • code: Represents the CAP protocol section or question ID
    • For category:section, must come from the CAP eCP Section Codes ValueSet
    • For category:question, must come from the CAP eCP Question Codes ValueSet
  • value[x]: Stores responses for the question
  • derivedFrom: References parent Observations, allowing hierarchical relationships between related responses
  • hasMember: References child Observations, supporting nested data
  • component: Stores additional data fields related to a question such as “Other (Specify)”

Special Cases

  • Multiselect Questions: If the question is Multiselect, multiple Observations with the same Question Code should be created.
  • Follow-up Fields: If the question has a follow-up text or number entry field (e.g., “Other (Specify)”), the information from the textbox should be stored in the Observation.component.value, and the Observation.component.code should repeat the Observation.value as the sub-question.

Usages:

You can also check for usages in the FHIR IG Statistics

Formal Views of Profile Content

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

This structure is derived from USCoreSimpleObservationProfile

NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. Observation USCoreSimpleObservationProfile
... identifier S 1..* Identifier The SDC instanceGUID
... Slices for category Content/Rules for all slices
.... category:cap-form-category S 1..1 CodeableConcept (USCDI) Classification of type of observation
Binding: US Pathology Form Category Codes (required)
... code 1..1 CodeableConcept SDC question ID
.... value[x]:valueQuantity 0..1 Quantity (USCDI) Actual result
Binding: UnitsOfMeasureCaseSensitive (3.0.0) (required): This is the entire UCUM code set.
.... value[x]:valueCodeableConcept 0..1 CodeableConcept (USCDI) Actual result
Binding: CAP eCP Answer Codes (extensible)
... hasMember S 0..* Reference(US Pathology Observation) Child observation reference
... derivedFrom S 0..* Reference(US Pathology Observation) Parent observation reference
... component S 0..* BackboneElement Additional entry

doco Documentation for this format

Terminology Bindings (Differential)

Path Status Usage ValueSet Version Source
Observation.category:cap-form-category Base required US Pathology Form Category Codes 📦2.0.0 This IG
Observation.value[x]:valueQuantity Base required UnitsOfMeasureCaseSensitive 📍3.0.0 THO v6.5
Observation.value[x]:valueCodeableConcept Base extensible CAP eCP Answer Codes 📦2.0.0 This IG
NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. Observation C 0..* USCoreSimpleObservationProfile assessment observation
Constraints: obs-6, obs-7
... implicitRules ?!Σ 0..1 uri A set of rules under which this content was created
... modifierExtension ?! 0..* Extension Extensions that cannot be ignored
... identifier SΣ 1..* Identifier The SDC instanceGUID
... Slices for category S 1..* CodeableConcept (USCDI) Classification of type of observation
Slice: Unordered, Open by pattern:$this
Binding: ObservationCategoryCodes (preferred): Codes for high level observation categories.
.... category:us-core S 0..* CodeableConcept (USCDI) Classification of type of observation
Binding: US Core Simple Observation Category (required): Note that other codes are permitted, see Required Bindings When Slicing by Value Sets
.... category:cap-form-category S 1..1 CodeableConcept (USCDI) Classification of type of observation
Binding: US Pathology Form Category Codes (required)
... code SΣ 1..1 CodeableConcept SDC question ID
Binding: LOINCCodes (preferred)
... subject SΣ 1..1 Reference(US Core Patient Profile) (USCDI) Who and/or what the observation is about
... effective[x] SΣ 0..1 (USCDI) Clinically relevant time/time-period for observation
.... effectiveDateTime dateTime S
.... effectivePeriod Period
.... effectiveTiming Timing
.... effectiveInstant instant
... performer SΣ 0..* Reference(US Core Practitioner Profile | US Core Organization Profile | US Core Patient Profile | PractitionerRole | US Core CareTeam Profile | US Core RelatedPerson Profile) (USCDI) Who is responsible for the observation
... Slices for value[x] SΣC 0..1 (USCDI) Actual result
Slice: Unordered, Open by type:$this
.... valueQuantity Quantity S
.... valueCodeableConcept CodeableConcept S
.... valueString string S
.... valueBoolean boolean S
.... valueInteger integer
.... valueRange Range
.... valueRatio Ratio
.... valueSampledData SampledData
.... valueTime time
.... valueDateTime dateTime
.... valuePeriod Period
.... value[x]:valueQuantity SΣC 0..1 Quantity S (USCDI) Actual result
Binding: UnitsOfMeasureCaseSensitive (3.0.0) (required): This is the entire UCUM code set.
.... value[x]:valueCodeableConcept SΣC 0..1 CodeableConcept S (USCDI) Actual result
Binding: CAP eCP Answer Codes (extensible)
... hasMember SΣ 0..* Reference(US Pathology Observation) Child observation reference
... derivedFrom SΣ 0..* Reference(US Pathology Observation) Parent observation reference
... component SΣ 0..* BackboneElement Additional entry
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... code Σ 1..1 CodeableConcept Type of component observation (code / type)
Binding: LOINCCodes (example): Codes identifying names of simple observations.

doco Documentation for this format

Terminology Bindings

Path Status Usage ValueSet Version Source
Observation.status Base required ObservationStatus 📍4.0.1 FHIR Std.
Observation.category Base preferred Observation Category Codes 📦4.0.1 FHIR Std.
Observation.category:us-core Base required US Core Simple Observation Category 📦6.1.0 US Core v6.1
Observation.category:cap-form-category Base required US Pathology Form Category Codes 📦2.0.0 This IG
Observation.code Base preferred LOINC Codes 📦4.0.1 FHIR Std.
Observation.value[x]:valueQuantity Base required UnitsOfMeasureCaseSensitive 📍3.0.0 THO v6.5
Observation.value[x]:valueCodeableConcept Base extensible CAP eCP Answer Codes 📦2.0.0 This IG
Observation.component.​code Base example LOINC Codes 📦4.0.1 FHIR Std.

Constraints

Id Grade Path(s) Description Expression
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()
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()
NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. Observation C 0..* USCoreSimpleObservationProfile assessment observation
Constraints: obs-6, obs-7
... 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 BindingsPurpose
AllLanguages Max Binding
... text 0..1 Narrative Text summary of the resource, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
... contained 0..* Resource Contained, inline Resources
... extension 0..* Extension Additional content defined by implementations
... modifierExtension ?! 0..* Extension Extensions that cannot be ignored
... identifier SΣ 1..* Identifier The SDC instanceGUID
... 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 ?!SΣ 1..1 code (USCDI) registered | preliminary | final | amended +
Binding: ObservationStatus (required): Codes providing the status of an observation.
... Slices for category S 1..* CodeableConcept (USCDI) Classification of type of observation
Slice: Unordered, Open by pattern:$this
Binding: ObservationCategoryCodes (preferred): Codes for high level observation categories.
.... category:us-core S 0..* CodeableConcept (USCDI) Classification of type of observation
Binding: US Core Simple Observation Category (required): Note that other codes are permitted, see Required Bindings When Slicing by Value Sets
.... category:cap-form-category S 1..1 CodeableConcept (USCDI) Classification of type of observation
Binding: US Pathology Form Category Codes (required)
... code SΣ 1..1 CodeableConcept SDC question ID
Binding: LOINCCodes (preferred)
... subject SΣ 1..1 Reference(US Core Patient Profile) (USCDI) Who and/or what the observation is about
... focus Σ 0..* Reference(Resource) What the observation is about, when it is not about the subject of record
... encounter Σ 0..1 Reference(Encounter) Healthcare event during which this observation is made
... effective[x] SΣ 0..1 (USCDI) Clinically relevant time/time-period for observation
.... effectiveDateTime dateTime S
.... effectivePeriod Period
.... effectiveTiming Timing
.... effectiveInstant instant
... issued Σ 0..1 instant Date/Time this version was made available
... performer SΣ 0..* Reference(US Core Practitioner Profile | US Core Organization Profile | US Core Patient Profile | PractitionerRole | US Core CareTeam Profile | US Core RelatedPerson Profile) (USCDI) Who is responsible for the observation
... Slices for value[x] SΣC 0..1 (USCDI) Actual result
Slice: Unordered, Open by type:$this
.... valueQuantity Quantity S
.... valueCodeableConcept CodeableConcept S
.... valueString string S
.... valueBoolean boolean S
.... valueInteger integer
.... valueRange Range
.... valueRatio Ratio
.... valueSampledData SampledData
.... valueTime time
.... valueDateTime dateTime
.... valuePeriod Period
.... value[x]:valueQuantity SΣC 0..1 Quantity S (USCDI) Actual result
Binding: UnitsOfMeasureCaseSensitive (3.0.0) (required): This is the entire UCUM code set.
.... value[x]:valueCodeableConcept SΣC 0..1 CodeableConcept S (USCDI) Actual result
Binding: CAP eCP Answer Codes (extensible)
... dataAbsentReason C 0..1 CodeableConcept Why the result is missing
Binding: DataAbsentReason (extensible): Codes specifying why the result (Observation.value[x]) is missing.
... interpretation 0..* CodeableConcept High, low, normal, etc.
Binding: ObservationInterpretationCodes (extensible): Codes identifying interpretations of observations.
... note 0..* Annotation Comments about the observation
... bodySite 0..1 CodeableConcept Observed body part
Binding: SNOMEDCTBodyStructures (example): Codes describing anatomical locations. May include laterality.
... 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
Constraints: obs-3
.... 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 SΣ 0..* Reference(US Pathology Observation) Child observation reference
... derivedFrom SΣ 0..* Reference(US Pathology Observation) Parent observation reference
... component SΣ 0..* BackboneElement Additional entry
.... 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 Σ 1..1 CodeableConcept Type of component observation (code / type)
Binding: LOINCCodes (example): Codes identifying names of simple observations.
.... value[x] Σ 0..1 Actual component result
..... valueQuantity Quantity
..... valueCodeableConcept CodeableConcept
..... valueString string
..... valueBoolean boolean
..... valueInteger integer
..... valueRange Range
..... valueRatio Ratio
..... valueSampledData SampledData
..... valueTime time
..... valueDateTime dateTime
..... valuePeriod Period
.... dataAbsentReason C 0..1 CodeableConcept Why the component result is missing
Binding: DataAbsentReason (extensible): Codes specifying why the result (Observation.value[x]) is missing.
.... 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

doco Documentation for this format

Terminology Bindings

Path Status Usage ValueSet Version Source
Observation.language Base preferred Common Languages 📦4.0.1 FHIR Std.
Observation.status Base required ObservationStatus 📍4.0.1 FHIR Std.
Observation.category Base preferred Observation Category Codes 📦4.0.1 FHIR Std.
Observation.category:us-core Base required US Core Simple Observation Category 📦6.1.0 US Core v6.1
Observation.category:cap-form-category Base required US Pathology Form Category Codes 📦2.0.0 This IG
Observation.code Base preferred LOINC Codes 📦4.0.1 FHIR Std.
Observation.value[x]:valueQuantity Base required UnitsOfMeasureCaseSensitive 📍3.0.0 THO v6.5
Observation.value[x]:valueCodeableConcept Base extensible CAP eCP Answer Codes 📦2.0.0 This IG
Observation.dataAbsentReason Base extensible DataAbsentReason 📦4.0.1 FHIR Std.
Observation.interpretation Base extensible Observation Interpretation Codes 📦4.0.1 FHIR Std.
Observation.bodySite Base example SNOMED CT Body Structures 📦4.0.1 FHIR Std.
Observation.method Base example Observation Methods 📦4.0.1 FHIR Std.
Observation.referenceRange.​type Base preferred Observation Reference Range Meaning Codes 📦4.0.1 FHIR Std.
Observation.referenceRange.​appliesTo Base example Observation Reference Range Applies To Codes 📦4.0.1 FHIR Std.
Observation.component.​code Base example LOINC Codes 📦4.0.1 FHIR Std.
Observation.component.​dataAbsentReason Base extensible DataAbsentReason 📦4.0.1 FHIR Std.
Observation.component.​interpretation Base extensible Observation Interpretation Codes 📦4.0.1 FHIR Std.

Constraints

Id Grade Path(s) Description Expression
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()
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 USCoreSimpleObservationProfile

Summary

Mandatory: 2 elements
Must-Support: 5 elements

Structures

This structure refers to these other structures:

Slices

This structure defines the following Slices:

  • The element 1 is sliced based on the value of Observation.value[x]

Maturity: 2

Differential View

This structure is derived from USCoreSimpleObservationProfile

NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. Observation USCoreSimpleObservationProfile
... identifier S 1..* Identifier The SDC instanceGUID
... Slices for category Content/Rules for all slices
.... category:cap-form-category S 1..1 CodeableConcept (USCDI) Classification of type of observation
Binding: US Pathology Form Category Codes (required)
... code 1..1 CodeableConcept SDC question ID
.... value[x]:valueQuantity 0..1 Quantity (USCDI) Actual result
Binding: UnitsOfMeasureCaseSensitive (3.0.0) (required): This is the entire UCUM code set.
.... value[x]:valueCodeableConcept 0..1 CodeableConcept (USCDI) Actual result
Binding: CAP eCP Answer Codes (extensible)
... hasMember S 0..* Reference(US Pathology Observation) Child observation reference
... derivedFrom S 0..* Reference(US Pathology Observation) Parent observation reference
... component S 0..* BackboneElement Additional entry

doco Documentation for this format

Terminology Bindings (Differential)

Path Status Usage ValueSet Version Source
Observation.category:cap-form-category Base required US Pathology Form Category Codes 📦2.0.0 This IG
Observation.value[x]:valueQuantity Base required UnitsOfMeasureCaseSensitive 📍3.0.0 THO v6.5
Observation.value[x]:valueCodeableConcept Base extensible CAP eCP Answer Codes 📦2.0.0 This IG

Key Elements View

NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. Observation C 0..* USCoreSimpleObservationProfile assessment observation
Constraints: obs-6, obs-7
... implicitRules ?!Σ 0..1 uri A set of rules under which this content was created
... modifierExtension ?! 0..* Extension Extensions that cannot be ignored
... identifier SΣ 1..* Identifier The SDC instanceGUID
... Slices for category S 1..* CodeableConcept (USCDI) Classification of type of observation
Slice: Unordered, Open by pattern:$this
Binding: ObservationCategoryCodes (preferred): Codes for high level observation categories.
.... category:us-core S 0..* CodeableConcept (USCDI) Classification of type of observation
Binding: US Core Simple Observation Category (required): Note that other codes are permitted, see Required Bindings When Slicing by Value Sets
.... category:cap-form-category S 1..1 CodeableConcept (USCDI) Classification of type of observation
Binding: US Pathology Form Category Codes (required)
... code SΣ 1..1 CodeableConcept SDC question ID
Binding: LOINCCodes (preferred)
... subject SΣ 1..1 Reference(US Core Patient Profile) (USCDI) Who and/or what the observation is about
... effective[x] SΣ 0..1 (USCDI) Clinically relevant time/time-period for observation
.... effectiveDateTime dateTime S
.... effectivePeriod Period
.... effectiveTiming Timing
.... effectiveInstant instant
... performer SΣ 0..* Reference(US Core Practitioner Profile | US Core Organization Profile | US Core Patient Profile | PractitionerRole | US Core CareTeam Profile | US Core RelatedPerson Profile) (USCDI) Who is responsible for the observation
... Slices for value[x] SΣC 0..1 (USCDI) Actual result
Slice: Unordered, Open by type:$this
.... valueQuantity Quantity S
.... valueCodeableConcept CodeableConcept S
.... valueString string S
.... valueBoolean boolean S
.... valueInteger integer
.... valueRange Range
.... valueRatio Ratio
.... valueSampledData SampledData
.... valueTime time
.... valueDateTime dateTime
.... valuePeriod Period
.... value[x]:valueQuantity SΣC 0..1 Quantity S (USCDI) Actual result
Binding: UnitsOfMeasureCaseSensitive (3.0.0) (required): This is the entire UCUM code set.
.... value[x]:valueCodeableConcept SΣC 0..1 CodeableConcept S (USCDI) Actual result
Binding: CAP eCP Answer Codes (extensible)
... hasMember SΣ 0..* Reference(US Pathology Observation) Child observation reference
... derivedFrom SΣ 0..* Reference(US Pathology Observation) Parent observation reference
... component SΣ 0..* BackboneElement Additional entry
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... code Σ 1..1 CodeableConcept Type of component observation (code / type)
Binding: LOINCCodes (example): Codes identifying names of simple observations.

doco Documentation for this format

Terminology Bindings

Path Status Usage ValueSet Version Source
Observation.status Base required ObservationStatus 📍4.0.1 FHIR Std.
Observation.category Base preferred Observation Category Codes 📦4.0.1 FHIR Std.
Observation.category:us-core Base required US Core Simple Observation Category 📦6.1.0 US Core v6.1
Observation.category:cap-form-category Base required US Pathology Form Category Codes 📦2.0.0 This IG
Observation.code Base preferred LOINC Codes 📦4.0.1 FHIR Std.
Observation.value[x]:valueQuantity Base required UnitsOfMeasureCaseSensitive 📍3.0.0 THO v6.5
Observation.value[x]:valueCodeableConcept Base extensible CAP eCP Answer Codes 📦2.0.0 This IG
Observation.component.​code Base example LOINC Codes 📦4.0.1 FHIR Std.

Constraints

Id Grade Path(s) Description Expression
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()
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

NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. Observation C 0..* USCoreSimpleObservationProfile assessment observation
Constraints: obs-6, obs-7
... 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 BindingsPurpose
AllLanguages Max Binding
... text 0..1 Narrative Text summary of the resource, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
... contained 0..* Resource Contained, inline Resources
... extension 0..* Extension Additional content defined by implementations
... modifierExtension ?! 0..* Extension Extensions that cannot be ignored
... identifier SΣ 1..* Identifier The SDC instanceGUID
... 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 ?!SΣ 1..1 code (USCDI) registered | preliminary | final | amended +
Binding: ObservationStatus (required): Codes providing the status of an observation.
... Slices for category S 1..* CodeableConcept (USCDI) Classification of type of observation
Slice: Unordered, Open by pattern:$this
Binding: ObservationCategoryCodes (preferred): Codes for high level observation categories.
.... category:us-core S 0..* CodeableConcept (USCDI) Classification of type of observation
Binding: US Core Simple Observation Category (required): Note that other codes are permitted, see Required Bindings When Slicing by Value Sets
.... category:cap-form-category S 1..1 CodeableConcept (USCDI) Classification of type of observation
Binding: US Pathology Form Category Codes (required)
... code SΣ 1..1 CodeableConcept SDC question ID
Binding: LOINCCodes (preferred)
... subject SΣ 1..1 Reference(US Core Patient Profile) (USCDI) Who and/or what the observation is about
... focus Σ 0..* Reference(Resource) What the observation is about, when it is not about the subject of record
... encounter Σ 0..1 Reference(Encounter) Healthcare event during which this observation is made
... effective[x] SΣ 0..1 (USCDI) Clinically relevant time/time-period for observation
.... effectiveDateTime dateTime S
.... effectivePeriod Period
.... effectiveTiming Timing
.... effectiveInstant instant
... issued Σ 0..1 instant Date/Time this version was made available
... performer SΣ 0..* Reference(US Core Practitioner Profile | US Core Organization Profile | US Core Patient Profile | PractitionerRole | US Core CareTeam Profile | US Core RelatedPerson Profile) (USCDI) Who is responsible for the observation
... Slices for value[x] SΣC 0..1 (USCDI) Actual result
Slice: Unordered, Open by type:$this
.... valueQuantity Quantity S
.... valueCodeableConcept CodeableConcept S
.... valueString string S
.... valueBoolean boolean S
.... valueInteger integer
.... valueRange Range
.... valueRatio Ratio
.... valueSampledData SampledData
.... valueTime time
.... valueDateTime dateTime
.... valuePeriod Period
.... value[x]:valueQuantity SΣC 0..1 Quantity S (USCDI) Actual result
Binding: UnitsOfMeasureCaseSensitive (3.0.0) (required): This is the entire UCUM code set.
.... value[x]:valueCodeableConcept SΣC 0..1 CodeableConcept S (USCDI) Actual result
Binding: CAP eCP Answer Codes (extensible)
... dataAbsentReason C 0..1 CodeableConcept Why the result is missing
Binding: DataAbsentReason (extensible): Codes specifying why the result (Observation.value[x]) is missing.
... interpretation 0..* CodeableConcept High, low, normal, etc.
Binding: ObservationInterpretationCodes (extensible): Codes identifying interpretations of observations.
... note 0..* Annotation Comments about the observation
... bodySite 0..1 CodeableConcept Observed body part
Binding: SNOMEDCTBodyStructures (example): Codes describing anatomical locations. May include laterality.
... 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
Constraints: obs-3
.... 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 SΣ 0..* Reference(US Pathology Observation) Child observation reference
... derivedFrom SΣ 0..* Reference(US Pathology Observation) Parent observation reference
... component SΣ 0..* BackboneElement Additional entry
.... 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 Σ 1..1 CodeableConcept Type of component observation (code / type)
Binding: LOINCCodes (example): Codes identifying names of simple observations.
.... value[x] Σ 0..1 Actual component result
..... valueQuantity Quantity
..... valueCodeableConcept CodeableConcept
..... valueString string
..... valueBoolean boolean
..... valueInteger integer
..... valueRange Range
..... valueRatio Ratio
..... valueSampledData SampledData
..... valueTime time
..... valueDateTime dateTime
..... valuePeriod Period
.... dataAbsentReason C 0..1 CodeableConcept Why the component result is missing
Binding: DataAbsentReason (extensible): Codes specifying why the result (Observation.value[x]) is missing.
.... 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

doco Documentation for this format

Terminology Bindings

Path Status Usage ValueSet Version Source
Observation.language Base preferred Common Languages 📦4.0.1 FHIR Std.
Observation.status Base required ObservationStatus 📍4.0.1 FHIR Std.
Observation.category Base preferred Observation Category Codes 📦4.0.1 FHIR Std.
Observation.category:us-core Base required US Core Simple Observation Category 📦6.1.0 US Core v6.1
Observation.category:cap-form-category Base required US Pathology Form Category Codes 📦2.0.0 This IG
Observation.code Base preferred LOINC Codes 📦4.0.1 FHIR Std.
Observation.value[x]:valueQuantity Base required UnitsOfMeasureCaseSensitive 📍3.0.0 THO v6.5
Observation.value[x]:valueCodeableConcept Base extensible CAP eCP Answer Codes 📦2.0.0 This IG
Observation.dataAbsentReason Base extensible DataAbsentReason 📦4.0.1 FHIR Std.
Observation.interpretation Base extensible Observation Interpretation Codes 📦4.0.1 FHIR Std.
Observation.bodySite Base example SNOMED CT Body Structures 📦4.0.1 FHIR Std.
Observation.method Base example Observation Methods 📦4.0.1 FHIR Std.
Observation.referenceRange.​type Base preferred Observation Reference Range Meaning Codes 📦4.0.1 FHIR Std.
Observation.referenceRange.​appliesTo Base example Observation Reference Range Applies To Codes 📦4.0.1 FHIR Std.
Observation.component.​code Base example LOINC Codes 📦4.0.1 FHIR Std.
Observation.component.​dataAbsentReason Base extensible DataAbsentReason 📦4.0.1 FHIR Std.
Observation.component.​interpretation Base extensible Observation Interpretation Codes 📦4.0.1 FHIR Std.

Constraints

Id Grade Path(s) Description Expression
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()
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 USCoreSimpleObservationProfile

Summary

Mandatory: 2 elements
Must-Support: 5 elements

Structures

This structure refers to these other structures:

Slices

This structure defines the following Slices:

  • The element 1 is sliced based on the value of Observation.value[x]

Maturity: 2

 

Other representations of profile: CSV, Excel, Schematron