Introduction

This US Pathology Observation profile is based on 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 Checklist (eCC) 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 eCC 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 eCC 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 eCC Section Codes ValueSet
  • For category:question, must come from the CAP eCC 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.

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

Name	Flags	Card.	Type	Description & Constraints
Observation	C	0..*	USCoreSimpleObservationProfile	assessment observation 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
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
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
identifier	SΣ	1..*	Identifier	The SDC instanceGUID ele-1: All FHIR elements must have a @value or children
status	?!SΣ	1..1	code	(USCDI) 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
Slices for category	S	1..*	CodeableConcept	(USCDI) Classification of type of observation Slice: Unordered, Open by pattern:$this Binding: ObservationCategoryCodes (preferred): Codes for high level observation categories. ele-1: All FHIR elements must have a @value or children
category:us-core	S	0..*	CodeableConcept	(USCDI) Classification of type of observation Binding: US Core Simple Observation Category (required): Note that other codes are permitted, see Required Bindings When Slicing by Value Sets ele-1: All FHIR elements must have a @value or children
category:cap-form-category	S	1..1	CodeableConcept	(USCDI) Classification of type of observation Binding: US Pathology Form Category Codes (required) ele-1: All FHIR elements must have a @value or children
code	SΣ	1..1	CodeableConcept	SDC question ID Binding: LOINCCodes (preferred) ele-1: All FHIR elements must have a @value or children
subject	SΣ	1..1	Reference(US Core Patient Profile)	(USCDI) Who and/or what the observation is about ele-1: All FHIR elements must have a @value or children
effective[x]	SΣ	0..1		(USCDI) Clinically relevant time/time-period for observation ele-1: All FHIR elements must have a @value or children
effectiveDateTime			dateTime
performer	SΣ	0..*	Reference(US Core Practitioner Profile | US Core Organization Profile | US Core Patient Profile | PractitionerRole | US Core CareTeam Profile | US Core RelatedPerson Profile)	(USCDI) Who is responsible for the observation ele-1: All FHIR elements must have a @value or children
Slices for value[x]	SΣC	0..1		(USCDI) Actual result Slice: Unordered, Open by type:$this ele-1: All FHIR elements must have a @value or children
valueQuantity			Quantity
valueCodeableConcept			CodeableConcept
valueString			string
valueBoolean			boolean
value[x]:valueQuantity	SΣC	0..1	Quantity	(USCDI) Actual result Binding: UnitsOfMeasureCaseSensitive (3.0.0) (required): This is the entire UCUM code set. ele-1: All FHIR elements must have a @value or children
value[x]:valueCodeableConcept	SΣC	0..1	CodeableConcept	(USCDI) Actual result Binding: CAP eCC Answer Codes (extensible) ele-1: All FHIR elements must have a @value or children
hasMember	SΣ	0..*	Reference(US Pathology Observation)	Child observation reference ele-1: All FHIR elements must have a @value or children
derivedFrom	SΣ	0..*	Reference(US Pathology Observation)	Parent observation reference ele-1: All FHIR elements must have a @value or children
component	SΣ	0..*	BackboneElement	Additional entry ele-1: All FHIR elements must have a @value or children
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	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
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	ObservationCategoryCodes http://hl7.org/fhir/ValueSet/observation-category from the FHIR Standard
Observation.category:us-core	required	USCoreSimpleObservationCategory http://hl7.org/fhir/us/core/ValueSet/us-core-simple-observation-category
Observation.category:cap-form-category	required	USPathologyFormCategoryCodes (a valid code from US Pathology Code System) http://hl7.org/fhir/us/cancer-reporting/ValueSet/us-pathology-form-category-codes from this IG
Observation.code	preferred	LOINCCodes (a valid code from LOINC) http://hl7.org/fhir/ValueSet/observation-codes from the FHIR Standard
Observation.value[x]:valueQuantity	required	UnitsOfMeasureCaseSensitive (a valid code from UCUM) http://terminology.hl7.org/ValueSet/v3-UnitsOfMeasureCaseSensitive|3.0.0
Observation.value[x]:valueCodeableConcept	extensible	CAPeCCAnswerCodes http://hl7.org/fhir/us/cancer-reporting/ValueSet/cap-ecc-answer-codes from this IG
Observation.component.code	example	LOINCCodes (a valid code from LOINC) http://hl7.org/fhir/ValueSet/observation-codes from the FHIR Standard

Constraints

Id	Grade	Path(s)	Details	Requirements
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()

This structure is derived from USCoreSimpleObservationProfile

Name	Flags	Card.	Type	Description & Constraints
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
Slices for value[x]		0..1	Quantity, CodeableConcept, string, boolean, integer, Range, Ratio, SampledData, time, dateTime, Period	(USCDI) Actual result Slice: Unordered, Open by type:$this
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 eCC 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
Documentation for this format

Terminology Bindings (Differential)

Path	Conformance	ValueSet	URI
Observation.category:cap-form-category	required	USPathologyFormCategoryCodes (a valid code from US Pathology Code System) http://hl7.org/fhir/us/cancer-reporting/ValueSet/us-pathology-form-category-codes from this IG
Observation.value[x]:valueQuantity	required	UnitsOfMeasureCaseSensitive (a valid code from UCUM) http://terminology.hl7.org/ValueSet/v3-UnitsOfMeasureCaseSensitive|3.0.0
Observation.value[x]:valueCodeableConcept	extensible	CAPeCCAnswerCodes http://hl7.org/fhir/us/cancer-reporting/ValueSet/cap-ecc-answer-codes from this IG

Name	Flags	Card.	Type	Description & Constraints
Observation	C	0..*	USCoreSimpleObservationProfile	assessment observation 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
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
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 eCC 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 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	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
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	ObservationCategoryCodes http://hl7.org/fhir/ValueSet/observation-category from the FHIR Standard
Observation.category:us-core	required	USCoreSimpleObservationCategory http://hl7.org/fhir/us/core/ValueSet/us-core-simple-observation-category
Observation.category:cap-form-category	required	USPathologyFormCategoryCodes (a valid code from US Pathology Code System) http://hl7.org/fhir/us/cancer-reporting/ValueSet/us-pathology-form-category-codes from this IG
Observation.code	preferred	LOINCCodes (a valid code from LOINC) http://hl7.org/fhir/ValueSet/observation-codes from the FHIR Standard
Observation.value[x]:valueQuantity	required	UnitsOfMeasureCaseSensitive (a valid code from UCUM) http://terminology.hl7.org/ValueSet/v3-UnitsOfMeasureCaseSensitive|3.0.0
Observation.value[x]:valueCodeableConcept	extensible	CAPeCCAnswerCodes http://hl7.org/fhir/us/cancer-reporting/ValueSet/cap-ecc-answer-codes from this IG
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	example	SNOMEDCTBodyStructures http://hl7.org/fhir/ValueSet/body-site from the FHIR Standard
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
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()

Key Elements View

Name	Flags	Card.	Type	Description & Constraints
Observation	C	0..*	USCoreSimpleObservationProfile	assessment observation 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
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
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
identifier	SΣ	1..*	Identifier	The SDC instanceGUID ele-1: All FHIR elements must have a @value or children
status	?!SΣ	1..1	code	(USCDI) 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
Slices for category	S	1..*	CodeableConcept	(USCDI) Classification of type of observation Slice: Unordered, Open by pattern:$this Binding: ObservationCategoryCodes (preferred): Codes for high level observation categories. ele-1: All FHIR elements must have a @value or children
category:us-core	S	0..*	CodeableConcept	(USCDI) Classification of type of observation Binding: US Core Simple Observation Category (required): Note that other codes are permitted, see Required Bindings When Slicing by Value Sets ele-1: All FHIR elements must have a @value or children
category:cap-form-category	S	1..1	CodeableConcept	(USCDI) Classification of type of observation Binding: US Pathology Form Category Codes (required) ele-1: All FHIR elements must have a @value or children
code	SΣ	1..1	CodeableConcept	SDC question ID Binding: LOINCCodes (preferred) ele-1: All FHIR elements must have a @value or children
subject	SΣ	1..1	Reference(US Core Patient Profile)	(USCDI) Who and/or what the observation is about ele-1: All FHIR elements must have a @value or children
effective[x]	SΣ	0..1		(USCDI) Clinically relevant time/time-period for observation ele-1: All FHIR elements must have a @value or children
effectiveDateTime			dateTime
performer	SΣ	0..*	Reference(US Core Practitioner Profile | US Core Organization Profile | US Core Patient Profile | PractitionerRole | US Core CareTeam Profile | US Core RelatedPerson Profile)	(USCDI) Who is responsible for the observation ele-1: All FHIR elements must have a @value or children
Slices for value[x]	SΣC	0..1		(USCDI) Actual result Slice: Unordered, Open by type:$this ele-1: All FHIR elements must have a @value or children
valueQuantity			Quantity
valueCodeableConcept			CodeableConcept
valueString			string
valueBoolean			boolean
value[x]:valueQuantity	SΣC	0..1	Quantity	(USCDI) Actual result Binding: UnitsOfMeasureCaseSensitive (3.0.0) (required): This is the entire UCUM code set. ele-1: All FHIR elements must have a @value or children
value[x]:valueCodeableConcept	SΣC	0..1	CodeableConcept	(USCDI) Actual result Binding: CAP eCC Answer Codes (extensible) ele-1: All FHIR elements must have a @value or children
hasMember	SΣ	0..*	Reference(US Pathology Observation)	Child observation reference ele-1: All FHIR elements must have a @value or children
derivedFrom	SΣ	0..*	Reference(US Pathology Observation)	Parent observation reference ele-1: All FHIR elements must have a @value or children
component	SΣ	0..*	BackboneElement	Additional entry ele-1: All FHIR elements must have a @value or children
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	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
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	ObservationCategoryCodes http://hl7.org/fhir/ValueSet/observation-category from the FHIR Standard
Observation.category:us-core	required	USCoreSimpleObservationCategory http://hl7.org/fhir/us/core/ValueSet/us-core-simple-observation-category
Observation.category:cap-form-category	required	USPathologyFormCategoryCodes (a valid code from US Pathology Code System) http://hl7.org/fhir/us/cancer-reporting/ValueSet/us-pathology-form-category-codes from this IG
Observation.code	preferred	LOINCCodes (a valid code from LOINC) http://hl7.org/fhir/ValueSet/observation-codes from the FHIR Standard
Observation.value[x]:valueQuantity	required	UnitsOfMeasureCaseSensitive (a valid code from UCUM) http://terminology.hl7.org/ValueSet/v3-UnitsOfMeasureCaseSensitive|3.0.0
Observation.value[x]:valueCodeableConcept	extensible	CAPeCCAnswerCodes http://hl7.org/fhir/us/cancer-reporting/ValueSet/cap-ecc-answer-codes from this IG
Observation.component.code	example	LOINCCodes (a valid code from LOINC) http://hl7.org/fhir/ValueSet/observation-codes from the FHIR Standard

Constraints

Id	Grade	Path(s)	Details	Requirements
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()

Differential View

This structure is derived from USCoreSimpleObservationProfile

Name	Flags	Card.	Type	Description & Constraints
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
Slices for value[x]		0..1	Quantity, CodeableConcept, string, boolean, integer, Range, Ratio, SampledData, time, dateTime, Period	(USCDI) Actual result Slice: Unordered, Open by type:$this
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 eCC 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
Documentation for this format

Terminology Bindings (Differential)

Path	Conformance	ValueSet	URI
Observation.category:cap-form-category	required	USPathologyFormCategoryCodes (a valid code from US Pathology Code System) http://hl7.org/fhir/us/cancer-reporting/ValueSet/us-pathology-form-category-codes from this IG
Observation.value[x]:valueQuantity	required	UnitsOfMeasureCaseSensitive (a valid code from UCUM) http://terminology.hl7.org/ValueSet/v3-UnitsOfMeasureCaseSensitive|3.0.0
Observation.value[x]:valueCodeableConcept	extensible	CAPeCCAnswerCodes http://hl7.org/fhir/us/cancer-reporting/ValueSet/cap-ecc-answer-codes from this IG

Snapshot View

Name	Flags	Card.	Type	Description & Constraints
Observation	C	0..*	USCoreSimpleObservationProfile	assessment observation 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
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
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 eCC 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 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	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
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	ObservationCategoryCodes http://hl7.org/fhir/ValueSet/observation-category from the FHIR Standard
Observation.category:us-core	required	USCoreSimpleObservationCategory http://hl7.org/fhir/us/core/ValueSet/us-core-simple-observation-category
Observation.category:cap-form-category	required	USPathologyFormCategoryCodes (a valid code from US Pathology Code System) http://hl7.org/fhir/us/cancer-reporting/ValueSet/us-pathology-form-category-codes from this IG
Observation.code	preferred	LOINCCodes (a valid code from LOINC) http://hl7.org/fhir/ValueSet/observation-codes from the FHIR Standard
Observation.value[x]:valueQuantity	required	UnitsOfMeasureCaseSensitive (a valid code from UCUM) http://terminology.hl7.org/ValueSet/v3-UnitsOfMeasureCaseSensitive|3.0.0
Observation.value[x]:valueCodeableConcept	extensible	CAPeCCAnswerCodes http://hl7.org/fhir/us/cancer-reporting/ValueSet/cap-ecc-answer-codes from this IG
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	example	SNOMEDCTBodyStructures http://hl7.org/fhir/ValueSet/body-site from the FHIR Standard
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
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:

• US Pathology Observation (http://hl7.org/fhir/us/cancer-reporting/StructureDefinition/us-pathology-observation)

Slices

This structure defines the following Slices:

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