Allergy - Intolerance Observation - Consolidated CDA (C-CDA) v3.0.0

Consolidated CDA (C-CDA), published by Health Level Seven. This guide is not an authorized publication; it is the continuous build for version 3.0.0 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7/CDA-ccda/ and changes regularly. See the Directory of published versions

Logical Model: Allergy - Intolerance Observation

Official URL: http://hl7.org/cda/us/ccda/StructureDefinition/AllergyIntoleranceObservation				Version: 3.0.0
Draft as of 2024-05-07				Computable Name: AllergyIntoleranceObservation
Other Identifiers: urn:ietf:rfc:3986#Uniform Resource Identifier (URI)#urn:hl7ii:2.16.840.1.113883.10.20.22.4.7:2014-06-09

This template reflects a discrete observation about a patient’s allergy or intolerance. Because it is a discrete observation, it will have a statusCode of “completed”. The effectiveTime, also referred to as the “biologically relevant time” is the time at which the observation holds for the patient. For a provider seeing a patient in the clinic today, observing a history of penicillin allergy that developed five years ago, the effectiveTime is five years ago.

The effectiveTime of the Allergy - Intolerance Observation is the definitive indication of whether or not the underlying allergy/intolerance is resolved. If known to be resolved, then an effectiveTime/high would be present. If the date of resolution is not known, then effectiveTime/high will be present with a nullFlavor of “UNK”.

The agent responsible for an allergy or adverse reaction is not always a manufactured material (for example, food allergies), nor is it necessarily consumed. The following constraints reflect limitations in the base CDA R2 specification, and should be used to represent any type of responsible agent, i.e., use playingEntity classCode = “MMAT” for all agents, manufactured or not.

Usage:

Use this Logical Model: Allergy Concern Act, Health Concern Act and Risk Concern Act

Formal Views of Template Content

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

Key Elements Table
Differential Table
Snapshot Table
Statistics/References
All

This structure is derived from SubstanceOrDeviceAllergyIntoleranceObservation

Name	Card.	Type	Description & Constraints
Observation		SubstanceOrDeviceAllergyIntoleranceObservation	XML Namespace: urn:hl7-org:v3 Elements defined in Ancestors: @nullFlavor, realmCode, typeId, templateId, @classCode, @moodCode, @negationInd, id, code, derivationExpr, text, statusCode, effectiveTime, priorityCode, repeatNumber, languageCode, value, interpretationCode, methodCode, targetSiteCode, subject, specimen, performer, author, informant, participant, entryRelationship, reference, precondition, sdtcPrecondition2, referenceRange, sdtcInFulfillmentOf1, templateId, templateId, classCode, moodCode, id, code, text, statusCode, effectiveTime, value, author, participant, participant, entryRelationship, entryRelationship, entryRelationship, entryRelationship, entryRelationship Instances of this type are validated by templateId Logical Container: ClinicalDocument (CDA Class)
templateId	2..*	II
templateId:allergy	1..1	II
@root	1..1	oid, uuid, ruid	Required Pattern: 2.16.840.1.113883.10.20.22.4.7
@extension	1..1	st	Required Pattern: 2014-06-09
@negationInd	0..1	bl	Use negationInd="true" to indicate that the allergy was not observed.
effectiveTime	1..1	IVL_TS	If the allergy/intolerance is known to be resolved, but the date of resolution is not known, then the high element SHALL be present, and the nullFlavor attribute SHALL be set to 'UNK'.
participant:consumable	0..*	Participant2	participant
participantRole
playingEntity
code	1..1	CE	(USCDI) Substance Binding: Common substances for allergy and intolerance documentation including refutations (preferred)
Documentation for this format

Terminology Bindings (Differential)

Path	Conformance	ValueSet	URI
Observation.participant:consumable.participantRole.playingEntity.code	preferred	CommonSubstancesForAllergyAndIntoleranceDocumentationIncludingRefutations `http://cts.nlm.nih.gov/fhir/ValueSet/2.16.840.1.113762.1.4.1186.8` from https://vsac.nlm.nih.gov

Name	Flags	Card.	Type	Description & Constraints
Observation	C	1..1	SubstanceOrDeviceAllergyIntoleranceObservation	XML Namespace: urn:hl7-org:v3 Elements defined in Ancestors: @nullFlavor, realmCode, typeId, templateId, @classCode, @moodCode, @negationInd, id, code, derivationExpr, text, statusCode, effectiveTime, priorityCode, repeatNumber, languageCode, value, interpretationCode, methodCode, targetSiteCode, subject, specimen, performer, author, informant, participant, entryRelationship, reference, precondition, sdtcPrecondition2, referenceRange, sdtcInFulfillmentOf1, templateId, templateId, classCode, moodCode, id, code, text, statusCode, effectiveTime, value, author, participant, participant, entryRelationship, entryRelationship, entryRelationship, entryRelationship, entryRelationship Base for all types and resources Instances of this type are validated by templateId Logical Container: ClinicalDocument (CDA Class) should-text-ref-value: SHOULD contain text/reference/@value should-author: SHOULD contain author should-not-severity: Allergy SHOULD NOT include severity. Severity belongs at reaction level, while Criticality is used at the allergy level.
Slices for templateId		2..*	II	Slice: Unordered, Open by value:root, value:extension
templateId:substance-device-allergy-intolerance-obs		1..1	II
@root		1..1	oid, uuid, ruid	Required Pattern: 2.16.840.1.113883.10.20.24.3.90
@extension		1..1	st	Required Pattern: 2014-06-09
templateId:allergy		1..1	II
@root		1..1	oid, uuid, ruid	Required Pattern: 2.16.840.1.113883.10.20.22.4.7
@extension		1..1	st	Required Pattern: 2014-06-09
@classCode		1..1	cs	Binding: CDAActClassObservation (required) Fixed Value: OBS
@moodCode		1..1	cs	Binding: XActMoodDocumentObservation (2.0.0) (required) Fixed Value: EVN
@negationInd		0..1	bl	Use negationInd="true" to indicate that the allergy was not observed.
id		1..*	II
code		1..1	CD	Binding: ObservationType (example)
@code		1..1	cs	Required Pattern: ASSERTION
@codeSystem		1..1	oid, uuid, ruid	Required Pattern: 2.16.840.1.113883.5.4
statusCode		1..1	CS	Binding: ActStatus (required)
@code		1..1	cs	Fixed Value: completed
effectiveTime		1..1	IVL_TS	If the allergy/intolerance is known to be resolved, but the date of resolution is not known, then the high element SHALL be present, and the nullFlavor attribute SHALL be set to 'UNK'.
low		1..1	IVXB_TS
value		1..1	CD
@code		1..1	cs	Binding: Allergy and Intolerance Type (required)
Slices for participant		0..*	Participant2	Slice: Unordered, Open by value:typeCode
participant:consumable		0..*	Participant2	participant
@typeCode		1..1	cs	Binding: CDAParticipationType (required) Fixed Value: CSM
participantRole		1..1	ParticipantRole
@classCode		1..1	cs	Binding: CDARoleClassRoot (required) Fixed Value: MANU
playingEntity		1..1	PlayingEntity
@classCode		1..1	cs	Binding: EntityClassRoot (required) Fixed Value: MMAT
code		1..1	CE	(USCDI) Substance Binding: Common substances for allergy and intolerance documentation including refutations (preferred)
Slices for entryRelationship		0..*	EntryRelationship	Slice: Unordered, Open by profile:observation
entryRelationship:status		0..1	EntryRelationship	entryRelationship
@typeCode		1..1	cs	Binding: x_ActRelationshipEntryRelationship (required) Fixed Value: SUBJ
@inversionInd		1..1	bl	Fixed Value: true
observation	C	1..1	AllergyStatusObservation	Base for all types and resources should-text-ref-value: SHOULD contain text/reference/@value
entryRelationship:reaction		0..*	EntryRelationship	entryRelationship
@typeCode		1..1	cs	Binding: x_ActRelationshipEntryRelationship (required) Fixed Value: MFST
@inversionInd		1..1	bl	Fixed Value: true
observation	C	1..1	ReactionObservation	Base for all types and resources should-text-ref-value: SHOULD contain text/reference/@value should-effectiveTime: SHOULD contain effectiveTime
entryRelationship:severity		0..1	EntryRelationship	entryRelationship
@typeCode		1..1	cs	Binding: x_ActRelationshipEntryRelationship (required) Fixed Value: SUBJ
@inversionInd		1..1	bl	Fixed Value: true
observation	C	1..1	SeverityObservation	Base for all types and resources should-text-ref-value: SHOULD contain text/reference/@value
entryRelationship:criticality		0..1	EntryRelationship	entryRelationship
@typeCode		1..1	cs	Binding: x_ActRelationshipEntryRelationship (required) Fixed Value: SUBJ
@inversionInd		1..1	bl	Fixed Value: true
observation	C	1..1	CriticalityObservation	Base for all types and resources should-text-ref-value: SHOULD contain text/reference/@value
Documentation for this format

Terminology Bindings

Path	Conformance	ValueSet / Code	URI
Observation.classCode	required	Fixed Value: OBS `http://hl7.org/cda/stds/core/ValueSet/CDAActClassObservation`
Observation.moodCode	required	Fixed Value: EVN `http://terminology.hl7.org/ValueSet/v3-xActMoodDocumentObservation\|2.0.0`
Observation.code	example	ObservationType `http://terminology.hl7.org/ValueSet/v3-ObservationType`
Observation.statusCode	required	ActStatus `http://terminology.hl7.org/ValueSet/v3-ActStatus`
Observation.value.code	required	AllergyAndIntoleranceType `http://cts.nlm.nih.gov/fhir/ValueSet/2.16.840.1.113883.3.88.12.3221.6.2` from https://vsac.nlm.nih.gov
Observation.participant:consumable.typeCode	required	Fixed Value: CSM `http://hl7.org/cda/stds/core/ValueSet/CDAParticipationType`
Observation.participant:consumable.participantRole.classCode	required	Fixed Value: MANU `http://hl7.org/cda/stds/core/ValueSet/CDARoleClassRoot`
Observation.participant:consumable.participantRole.playingEntity.classCode	required	Fixed Value: MMAT `http://terminology.hl7.org/ValueSet/v3-EntityClassRoot`
Observation.participant:consumable.participantRole.playingEntity.code	preferred	CommonSubstancesForAllergyAndIntoleranceDocumentationIncludingRefutations `http://cts.nlm.nih.gov/fhir/ValueSet/2.16.840.1.113762.1.4.1186.8` from https://vsac.nlm.nih.gov
Observation.entryRelationship:status.typeCode	required	Fixed Value: SUBJ `http://terminology.hl7.org/ValueSet/v3-xActRelationshipEntryRelationship`
Observation.entryRelationship:reaction.typeCode	required	Fixed Value: MFST `http://terminology.hl7.org/ValueSet/v3-xActRelationshipEntryRelationship`
Observation.entryRelationship:severity.typeCode	required	Fixed Value: SUBJ `http://terminology.hl7.org/ValueSet/v3-xActRelationshipEntryRelationship`
Observation.entryRelationship:criticality.typeCode	required	Fixed Value: SUBJ `http://terminology.hl7.org/ValueSet/v3-xActRelationshipEntryRelationship`

Constraints

Id	Grade	Path(s)	Details	Requirements
should-author	warning	Observation	SHOULD contain author : author.exists()
should-effectiveTime	warning	Observation.entryRelationship:reaction.observation	SHOULD contain effectiveTime : effectiveTime.exists()
should-not-severity	warning	Observation	Allergy SHOULD NOT include severity. Severity belongs at reaction level, while Criticality is used at the allergy level. : entryRelationship.observation.where(code.code = 'SEV' and code.codeSystem = '2.16.840.1.113883.5.4').empty()
should-text-ref-value	warning	Observation, Observation.entryRelationship:status.observation, Observation.entryRelationship:reaction.observation, Observation.entryRelationship:severity.observation, Observation.entryRelationship:criticality.observation	SHOULD contain text/reference/@value : text.reference.value.exists()

Name	Flags	Card.	Type	Description & Constraints
Observation	C	1..1	SubstanceOrDeviceAllergyIntoleranceObservation	XML Namespace: urn:hl7-org:v3 Elements defined in Ancestors: @nullFlavor, realmCode, typeId, templateId, @classCode, @moodCode, @negationInd, id, code, derivationExpr, text, statusCode, effectiveTime, priorityCode, repeatNumber, languageCode, value, interpretationCode, methodCode, targetSiteCode, subject, specimen, performer, author, informant, participant, entryRelationship, reference, precondition, sdtcPrecondition2, referenceRange, sdtcInFulfillmentOf1, templateId, templateId, classCode, moodCode, id, code, text, statusCode, effectiveTime, value, author, participant, participant, entryRelationship, entryRelationship, entryRelationship, entryRelationship, entryRelationship Base for all types and resources Instances of this type are validated by templateId Logical Container: ClinicalDocument (CDA Class) should-text-ref-value: SHOULD contain text/reference/@value should-author: SHOULD contain author should-not-severity: Allergy SHOULD NOT include severity. Severity belongs at reaction level, while Criticality is used at the allergy level.
@nullFlavor		0..1	cs	Binding: CDANullFlavor (required)
realmCode		0..*	CS
typeId		0..1	II
@nullFlavor		0..1	cs	Binding: CDANullFlavor (required)
@assigningAuthorityName		0..1	st
@displayable		0..1	bl
@root		1..1	oid, uuid, ruid	Fixed Value: 2.16.840.1.113883.1.3
@extension		1..1	st
Slices for templateId		2..*	II	Slice: Unordered, Open by value:root, value:extension
templateId:substance-device-allergy-intolerance-obs		1..1	II
@nullFlavor		0..1	cs	Binding: CDANullFlavor (required)
@assigningAuthorityName		0..1	st
@displayable		0..1	bl
@root		1..1	oid, uuid, ruid	Required Pattern: 2.16.840.1.113883.10.20.24.3.90
@extension		1..1	st	Required Pattern: 2014-06-09
templateId:allergy		1..1	II
@nullFlavor		0..1	cs	Binding: CDANullFlavor (required)
@assigningAuthorityName		0..1	st
@displayable		0..1	bl
@root		1..1	oid, uuid, ruid	Required Pattern: 2.16.840.1.113883.10.20.22.4.7
@extension		1..1	st	Required Pattern: 2014-06-09
@classCode		1..1	cs	Binding: CDAActClassObservation (required) Fixed Value: OBS
@moodCode		1..1	cs	Binding: XActMoodDocumentObservation (2.0.0) (required) Fixed Value: EVN
@negationInd		0..1	bl	Use negationInd="true" to indicate that the allergy was not observed.
id		1..*	II
code		1..1	CD	Binding: ObservationType (example)
@nullFlavor		0..1	cs	Binding: CDANullFlavor (required)
@code		1..1	cs	Required Pattern: ASSERTION
@codeSystem		1..1	oid, uuid, ruid	Required Pattern: 2.16.840.1.113883.5.4
@codeSystemName		0..1	st
@codeSystemVersion		0..1	st
@displayName		0..1	st
@sdtcValueSet		0..1	oid	XML Namespace: urn:hl7-org:sdtc XML: valueSet (urn:hl7-org:sdtc)
@sdtcValueSetVersion		0..1	st	XML Namespace: urn:hl7-org:sdtc XML: valueSetVersion (urn:hl7-org:sdtc)
originalText		0..1	ED
qualifier		0..*	CR
translation		0..*	CD
derivationExpr		0..1	ST
text		0..1	ED	SHOULD reference the portion of section narrative text corresponding to this entry
@nullFlavor		0..1	cs	Binding: CDANullFlavor (required)
@compression		0..1	cs	Binding: CDACompressionAlgorithm (required)
@integrityCheck		0..1	bin
@integrityCheckAlgorithm		0..1	cs	Binding: IntegrityCheckAlgorithm (2.0.0) (required)
@language		0..1	cs
@mediaType		0..1	cs	Binding: MediaType (example)
@representation		0..1	cs	Binding: CDABinaryDataEncoding (required)
xmlText		0..1	st	Allows for mixed text content. If @representation='B64', this SHALL be a base64binary string.
reference	C	0..1	TEL	value-starts-octothorpe: If reference/@value is present, it SHALL begin with a '#' and SHALL point to its corresponding narrative
thumbnail		0..1	ED
statusCode		1..1	CS	Binding: ActStatus (required)
@nullFlavor		0..1	cs	Binding: CDANullFlavor (required)
@code		1..1	cs	Fixed Value: completed
@sdtcValueSet		0..1	oid	XML Namespace: urn:hl7-org:sdtc XML: valueSet (urn:hl7-org:sdtc)
@sdtcValueSetVersion		0..1	st	XML Namespace: urn:hl7-org:sdtc XML: valueSetVersion (urn:hl7-org:sdtc)
effectiveTime		1..1	IVL_TS	If the allergy/intolerance is known to be resolved, but the date of resolution is not known, then the high element SHALL be present, and the nullFlavor attribute SHALL be set to 'UNK'.
@nullFlavor		0..1	cs	Binding: CDANullFlavor (required)
@value		0..1	ts	Date Format: YYYYMMDDHHMMSS.UUUU[+\|-ZZzz]
@operator		0..1	cs	Binding: CDASetOperator (required)
low		1..1	IVXB_TS
center		0..1	TS
width		0..1	PQ
high		0..1	IVXB_TS
priorityCode		0..1	CE	Binding: ActPriority (example)
repeatNumber		0..1	IVL_INT
languageCode		0..1	CS	Binding: AllLanguages (required)
value		1..1	CD
@code		1..1	cs	Binding: Allergy and Intolerance Type (required)
@codeSystem		0..1	oid, uuid, ruid
@codeSystemName		0..1	st
@codeSystemVersion		0..1	st
@displayName		0..1	st
@sdtcValueSet		0..1	oid	XML Namespace: urn:hl7-org:sdtc XML: valueSet (urn:hl7-org:sdtc)
@sdtcValueSetVersion		0..1	st	XML Namespace: urn:hl7-org:sdtc XML: valueSetVersion (urn:hl7-org:sdtc)
originalText		0..1	ED
qualifier		0..*	CR
translation		0..*	CD
interpretationCode		0..*	CE	Binding: CDAObservationInterpretation (required)
methodCode		0..*	CE	Binding: ObservationMethod (example)
targetSiteCode		0..*	CD
subject		0..1	Subject
specimen		0..*	Specimen
performer		0..*	Performer2
author		0..*	AuthorParticipation	Base for all types and resources
informant		0..*	Informant
Slices for participant		0..*	Participant2	Slice: Unordered, Open by value:typeCode
participant:consumable		0..*	Participant2	participant
@nullFlavor		0..1	cs	Binding: CDANullFlavor (required)
realmCode		0..*	CS
typeId		0..1	II
@nullFlavor		0..1	cs	Binding: CDANullFlavor (required)
@assigningAuthorityName		0..1	st
@displayable		0..1	bl
@root		1..1	oid, uuid, ruid	Fixed Value: 2.16.840.1.113883.1.3
@extension		1..1	st
templateId		0..*	II
@typeCode		1..1	cs	Binding: CDAParticipationType (required) Fixed Value: CSM
@contextControlCode		0..1	cs	Binding: CDAContextControl (required) Fixed Value: OP
sdtcFunctionCode		0..1	CE	XML Namespace: urn:hl7-org:sdtc XML: functionCode (urn:hl7-org:sdtc)
time		0..1	IVL_TS
awarenessCode		0..1	CE
participantRole		1..1	ParticipantRole
@nullFlavor		0..1	cs	Binding: CDANullFlavor (required)
realmCode		0..*	CS
typeId		0..1	II
@nullFlavor		0..1	cs	Binding: CDANullFlavor (required)
@assigningAuthorityName		0..1	st
@displayable		0..1	bl
@root		1..1	oid, uuid, ruid	Fixed Value: 2.16.840.1.113883.1.3
@extension		1..1	st
templateId		0..*	II
@classCode		1..1	cs	Binding: CDARoleClassRoot (required) Fixed Value: MANU
id		0..*	II
sdtcIdentifiedBy		0..*	IdentifiedBy	XML Namespace: urn:hl7-org:sdtc XML: identifiedBy (urn:hl7-org:sdtc)
code		0..1	CE	Binding: CDARoleCode (example)
addr		0..*	AD
telecom		0..*	TEL
playingDevice		0..1	Device
playingEntity		1..1	PlayingEntity
@nullFlavor		0..1	cs	Binding: CDANullFlavor (required)
realmCode		0..*	CS
typeId		0..1	II
@nullFlavor		0..1	cs	Binding: CDANullFlavor (required)
@assigningAuthorityName		0..1	st
@displayable		0..1	bl
@root		1..1	oid, uuid, ruid	Fixed Value: 2.16.840.1.113883.1.3
@extension		1..1	st
templateId		0..*	II
@classCode		1..1	cs	Binding: EntityClassRoot (required) Fixed Value: MMAT
@determinerCode		0..1	cs	Binding: EntityDeterminer (required) Fixed Value: INSTANCE
code		1..1	CE	(USCDI) Substance Binding: Common substances for allergy and intolerance documentation including refutations (preferred)
quantity		0..*	PQ
name		0..*	PN
sdtcBirthTime		0..1	TS	XML Namespace: urn:hl7-org:sdtc XML: birthTime (urn:hl7-org:sdtc)
desc		0..1	ED
scopingEntity		0..1	Entity
Slices for entryRelationship		0..*	EntryRelationship	Slice: Unordered, Open by profile:observation
entryRelationship:status		0..1	EntryRelationship	entryRelationship
@nullFlavor		0..1	cs	Binding: CDANullFlavor (required)
realmCode		0..*	CS
typeId		0..1	II
@nullFlavor		0..1	cs	Binding: CDANullFlavor (required)
@assigningAuthorityName		0..1	st
@displayable		0..1	bl
@root		1..1	oid, uuid, ruid	Fixed Value: 2.16.840.1.113883.1.3
@extension		1..1	st
templateId		0..*	II
@typeCode		1..1	cs	Binding: x_ActRelationshipEntryRelationship (required) Fixed Value: SUBJ
@inversionInd		1..1	bl	Fixed Value: true
@contextConductionInd		0..1	bl
@negationInd		0..1	bl
sequenceNumber		0..1	INT
seperatableInd		0..1	BL
act		0..1	Act
encounter		0..1	Encounter
observation	C	1..1	AllergyStatusObservation	Base for all types and resources should-text-ref-value: SHOULD contain text/reference/@value
observationMedia		0..1	ObservationMedia
organizer		0..1	Organizer
procedure		0..1	Procedure
regionOfInterest		0..1	RegionOfInterest
substanceAdministration		0..1	SubstanceAdministration
supply		0..1	Supply
entryRelationship:reaction		0..*	EntryRelationship	entryRelationship
@nullFlavor		0..1	cs	Binding: CDANullFlavor (required)
realmCode		0..*	CS
typeId		0..1	II
@nullFlavor		0..1	cs	Binding: CDANullFlavor (required)
@assigningAuthorityName		0..1	st
@displayable		0..1	bl
@root		1..1	oid, uuid, ruid	Fixed Value: 2.16.840.1.113883.1.3
@extension		1..1	st
templateId		0..*	II
@typeCode		1..1	cs	Binding: x_ActRelationshipEntryRelationship (required) Fixed Value: MFST
@inversionInd		1..1	bl	Fixed Value: true
@contextConductionInd		0..1	bl
@negationInd		0..1	bl
sequenceNumber		0..1	INT
seperatableInd		0..1	BL
act		0..1	Act
encounter		0..1	Encounter
observation	C	1..1	ReactionObservation	Base for all types and resources should-text-ref-value: SHOULD contain text/reference/@value should-effectiveTime: SHOULD contain effectiveTime
observationMedia		0..1	ObservationMedia
organizer		0..1	Organizer
procedure		0..1	Procedure
regionOfInterest		0..1	RegionOfInterest
substanceAdministration		0..1	SubstanceAdministration
supply		0..1	Supply
entryRelationship:severity		0..1	EntryRelationship	entryRelationship
@nullFlavor		0..1	cs	Binding: CDANullFlavor (required)
realmCode		0..*	CS
typeId		0..1	II
@nullFlavor		0..1	cs	Binding: CDANullFlavor (required)
@assigningAuthorityName		0..1	st
@displayable		0..1	bl
@root		1..1	oid, uuid, ruid	Fixed Value: 2.16.840.1.113883.1.3
@extension		1..1	st
templateId		0..*	II
@typeCode		1..1	cs	Binding: x_ActRelationshipEntryRelationship (required) Fixed Value: SUBJ
@inversionInd		1..1	bl	Fixed Value: true
@contextConductionInd		0..1	bl
@negationInd		0..1	bl
sequenceNumber		0..1	INT
seperatableInd		0..1	BL
act		0..1	Act
encounter		0..1	Encounter
observation	C	1..1	SeverityObservation	Base for all types and resources should-text-ref-value: SHOULD contain text/reference/@value
observationMedia		0..1	ObservationMedia
organizer		0..1	Organizer
procedure		0..1	Procedure
regionOfInterest		0..1	RegionOfInterest
substanceAdministration		0..1	SubstanceAdministration
supply		0..1	Supply
entryRelationship:criticality		0..1	EntryRelationship	entryRelationship
@nullFlavor		0..1	cs	Binding: CDANullFlavor (required)
realmCode		0..*	CS
typeId		0..1	II
@nullFlavor		0..1	cs	Binding: CDANullFlavor (required)
@assigningAuthorityName		0..1	st
@displayable		0..1	bl
@root		1..1	oid, uuid, ruid	Fixed Value: 2.16.840.1.113883.1.3
@extension		1..1	st
templateId		0..*	II
@typeCode		1..1	cs	Binding: x_ActRelationshipEntryRelationship (required) Fixed Value: SUBJ
@inversionInd		1..1	bl	Fixed Value: true
@contextConductionInd		0..1	bl
@negationInd		0..1	bl
sequenceNumber		0..1	INT
seperatableInd		0..1	BL
act		0..1	Act
encounter		0..1	Encounter
observation	C	1..1	CriticalityObservation	Base for all types and resources should-text-ref-value: SHOULD contain text/reference/@value
observationMedia		0..1	ObservationMedia
organizer		0..1	Organizer
procedure		0..1	Procedure
regionOfInterest		0..1	RegionOfInterest
substanceAdministration		0..1	SubstanceAdministration
supply		0..1	Supply
reference		0..*	Reference
precondition		0..*	Precondition
sdtcPrecondition2		0..*	Precondition2	XML Namespace: urn:hl7-org:sdtc XML: precondition2 (urn:hl7-org:sdtc)
referenceRange		0..*	InfrastructureRoot
@nullFlavor		0..1	cs	Binding: CDANullFlavor (required)
realmCode		0..*	CS
typeId		0..1	II
@nullFlavor		0..1	cs	Binding: CDANullFlavor (required)
@assigningAuthorityName		0..1	st
@displayable		0..1	bl
@root		1..1	oid, uuid, ruid	Fixed Value: 2.16.840.1.113883.1.3
@extension		1..1	st
templateId		0..*	II
@typeCode		0..1	cs	Binding: CDAActRelationshipType (required) Fixed Value: REFV
observationRange		1..1	ObservationRange
sdtcInFulfillmentOf1		0..*	InFulfillmentOf1	XML Namespace: urn:hl7-org:sdtc XML: inFulfillmentOf1 (urn:hl7-org:sdtc)
Documentation for this format

Terminology Bindings

Path	Conformance	ValueSet / Code	URI
Observation.nullFlavor	required	CDANullFlavor `http://hl7.org/cda/stds/core/ValueSet/CDANullFlavor`
Observation.typeId.nullFlavor	required	CDANullFlavor `http://hl7.org/cda/stds/core/ValueSet/CDANullFlavor`
Observation.templateId:substance-device-allergy-intolerance-obs.nullFlavor	required	CDANullFlavor `http://hl7.org/cda/stds/core/ValueSet/CDANullFlavor`
Observation.templateId:allergy.nullFlavor	required	CDANullFlavor `http://hl7.org/cda/stds/core/ValueSet/CDANullFlavor`
Observation.classCode	required	Fixed Value: OBS `http://hl7.org/cda/stds/core/ValueSet/CDAActClassObservation`
Observation.moodCode	required	Fixed Value: EVN `http://terminology.hl7.org/ValueSet/v3-xActMoodDocumentObservation\|2.0.0`
Observation.code	example	ObservationType `http://terminology.hl7.org/ValueSet/v3-ObservationType`
Observation.code.nullFlavor	required	CDANullFlavor `http://hl7.org/cda/stds/core/ValueSet/CDANullFlavor`
Observation.text.nullFlavor	required	CDANullFlavor `http://hl7.org/cda/stds/core/ValueSet/CDANullFlavor`
Observation.text.compression	required	CDACompressionAlgorithm `http://hl7.org/cda/stds/core/ValueSet/CDACompressionAlgorithm`
Observation.text.integrityCheckAlgorithm	required	IntegrityCheckAlgorithm `http://terminology.hl7.org/ValueSet/v3-IntegrityCheckAlgorithm\|2.0.0`
Observation.text.mediaType	example	MediaType `http://terminology.hl7.org/ValueSet/v3-MediaType`
Observation.text.representation	required	BinaryDataEncoding `http://hl7.org/cda/stds/core/ValueSet/BinaryDataEncoding`
Observation.statusCode	required	ActStatus `http://terminology.hl7.org/ValueSet/v3-ActStatus`
Observation.statusCode.nullFlavor	required	CDANullFlavor `http://hl7.org/cda/stds/core/ValueSet/CDANullFlavor`
Observation.effectiveTime.nullFlavor	required	CDANullFlavor `http://hl7.org/cda/stds/core/ValueSet/CDANullFlavor`
Observation.effectiveTime.operator	required	CDASetOperator `http://hl7.org/cda/stds/core/ValueSet/CDASetOperator`
Observation.priorityCode	example	ActPriority `http://terminology.hl7.org/ValueSet/v3-ActPriority`
Observation.languageCode	required	AllLanguages `http://hl7.org/fhir/ValueSet/all-languages` from the FHIR Standard
Observation.value.code	required	AllergyAndIntoleranceType `http://cts.nlm.nih.gov/fhir/ValueSet/2.16.840.1.113883.3.88.12.3221.6.2` from https://vsac.nlm.nih.gov
Observation.interpretationCode	required	CDAObservationInterpretation `http://hl7.org/cda/stds/core/ValueSet/CDAObservationInterpretation`
Observation.methodCode	example	ObservationMethod `http://terminology.hl7.org/ValueSet/v3-ObservationMethod`
Observation.participant:consumable.nullFlavor	required	CDANullFlavor `http://hl7.org/cda/stds/core/ValueSet/CDANullFlavor`
Observation.participant:consumable.typeId.nullFlavor	required	CDANullFlavor `http://hl7.org/cda/stds/core/ValueSet/CDANullFlavor`
Observation.participant:consumable.typeCode	required	Fixed Value: CSM `http://hl7.org/cda/stds/core/ValueSet/CDAParticipationType`
Observation.participant:consumable.contextControlCode	required	Fixed Value: OP `http://hl7.org/cda/stds/core/ValueSet/CDAContextControl`
Observation.participant:consumable.participantRole.nullFlavor	required	CDANullFlavor `http://hl7.org/cda/stds/core/ValueSet/CDANullFlavor`
Observation.participant:consumable.participantRole.typeId.nullFlavor	required	CDANullFlavor `http://hl7.org/cda/stds/core/ValueSet/CDANullFlavor`
Observation.participant:consumable.participantRole.classCode	required	Fixed Value: MANU `http://hl7.org/cda/stds/core/ValueSet/CDARoleClassRoot`
Observation.participant:consumable.participantRole.code	example	CDARoleCode `http://hl7.org/cda/stds/core/ValueSet/CDARoleCode`
Observation.participant:consumable.participantRole.playingEntity.nullFlavor	required	CDANullFlavor `http://hl7.org/cda/stds/core/ValueSet/CDANullFlavor`
Observation.participant:consumable.participantRole.playingEntity.typeId.nullFlavor	required	CDANullFlavor `http://hl7.org/cda/stds/core/ValueSet/CDANullFlavor`
Observation.participant:consumable.participantRole.playingEntity.classCode	required	Fixed Value: MMAT `http://terminology.hl7.org/ValueSet/v3-EntityClassRoot`
Observation.participant:consumable.participantRole.playingEntity.determinerCode	required	Fixed Value: INSTANCE `http://terminology.hl7.org/ValueSet/v3-EntityDeterminer`
Observation.participant:consumable.participantRole.playingEntity.code	preferred	CommonSubstancesForAllergyAndIntoleranceDocumentationIncludingRefutations `http://cts.nlm.nih.gov/fhir/ValueSet/2.16.840.1.113762.1.4.1186.8` from https://vsac.nlm.nih.gov
Observation.entryRelationship:status.nullFlavor	required	CDANullFlavor `http://hl7.org/cda/stds/core/ValueSet/CDANullFlavor`
Observation.entryRelationship:status.typeId.nullFlavor	required	CDANullFlavor `http://hl7.org/cda/stds/core/ValueSet/CDANullFlavor`
Observation.entryRelationship:status.typeCode	required	Fixed Value: SUBJ `http://terminology.hl7.org/ValueSet/v3-xActRelationshipEntryRelationship`
Observation.entryRelationship:reaction.nullFlavor	required	CDANullFlavor `http://hl7.org/cda/stds/core/ValueSet/CDANullFlavor`
Observation.entryRelationship:reaction.typeId.nullFlavor	required	CDANullFlavor `http://hl7.org/cda/stds/core/ValueSet/CDANullFlavor`
Observation.entryRelationship:reaction.typeCode	required	Fixed Value: MFST `http://terminology.hl7.org/ValueSet/v3-xActRelationshipEntryRelationship`
Observation.entryRelationship:severity.nullFlavor	required	CDANullFlavor `http://hl7.org/cda/stds/core/ValueSet/CDANullFlavor`
Observation.entryRelationship:severity.typeId.nullFlavor	required	CDANullFlavor `http://hl7.org/cda/stds/core/ValueSet/CDANullFlavor`
Observation.entryRelationship:severity.typeCode	required	Fixed Value: SUBJ `http://terminology.hl7.org/ValueSet/v3-xActRelationshipEntryRelationship`
Observation.entryRelationship:criticality.nullFlavor	required	CDANullFlavor `http://hl7.org/cda/stds/core/ValueSet/CDANullFlavor`
Observation.entryRelationship:criticality.typeId.nullFlavor	required	CDANullFlavor `http://hl7.org/cda/stds/core/ValueSet/CDANullFlavor`
Observation.entryRelationship:criticality.typeCode	required	Fixed Value: SUBJ `http://terminology.hl7.org/ValueSet/v3-xActRelationshipEntryRelationship`
Observation.referenceRange.nullFlavor	required	CDANullFlavor `http://hl7.org/cda/stds/core/ValueSet/CDANullFlavor`
Observation.referenceRange.typeId.nullFlavor	required	CDANullFlavor `http://hl7.org/cda/stds/core/ValueSet/CDANullFlavor`
Observation.referenceRange.typeCode	required	Fixed Value: REFV `http://hl7.org/cda/stds/core/ValueSet/CDAActRelationshipType`

Constraints

Id	Grade	Path(s)	Details	Requirements
should-author	warning	Observation	SHOULD contain author : author.exists()
should-effectiveTime	warning	Observation.entryRelationship:reaction.observation	SHOULD contain effectiveTime : effectiveTime.exists()
should-not-severity	warning	Observation	Allergy SHOULD NOT include severity. Severity belongs at reaction level, while Criticality is used at the allergy level. : entryRelationship.observation.where(code.code = 'SEV' and code.codeSystem = '2.16.840.1.113883.5.4').empty()
should-text-ref-value	warning	Observation, Observation.entryRelationship:status.observation, Observation.entryRelationship:reaction.observation, Observation.entryRelationship:severity.observation, Observation.entryRelationship:criticality.observation	SHOULD contain text/reference/@value : text.reference.value.exists()
value-starts-octothorpe	error	Observation.text.reference	If reference/@value is present, it SHALL begin with a '#' and SHALL point to its corresponding narrative : value.exists() implies value.startsWith('#')

This structure is derived from SubstanceOrDeviceAllergyIntoleranceObservation

Summary

Mandatory: 3 elements

Differential View

This structure is derived from SubstanceOrDeviceAllergyIntoleranceObservation

Name	Card.	Type	Description & Constraints
Observation		SubstanceOrDeviceAllergyIntoleranceObservation	XML Namespace: urn:hl7-org:v3 Elements defined in Ancestors: @nullFlavor, realmCode, typeId, templateId, @classCode, @moodCode, @negationInd, id, code, derivationExpr, text, statusCode, effectiveTime, priorityCode, repeatNumber, languageCode, value, interpretationCode, methodCode, targetSiteCode, subject, specimen, performer, author, informant, participant, entryRelationship, reference, precondition, sdtcPrecondition2, referenceRange, sdtcInFulfillmentOf1, templateId, templateId, classCode, moodCode, id, code, text, statusCode, effectiveTime, value, author, participant, participant, entryRelationship, entryRelationship, entryRelationship, entryRelationship, entryRelationship Instances of this type are validated by templateId Logical Container: ClinicalDocument (CDA Class)
templateId	2..*	II
templateId:allergy	1..1	II
@root	1..1	oid, uuid, ruid	Required Pattern: 2.16.840.1.113883.10.20.22.4.7
@extension	1..1	st	Required Pattern: 2014-06-09
@negationInd	0..1	bl	Use negationInd="true" to indicate that the allergy was not observed.
effectiveTime	1..1	IVL_TS	If the allergy/intolerance is known to be resolved, but the date of resolution is not known, then the high element SHALL be present, and the nullFlavor attribute SHALL be set to 'UNK'.
participant:consumable	0..*	Participant2	participant
participantRole
playingEntity
code	1..1	CE	(USCDI) Substance Binding: Common substances for allergy and intolerance documentation including refutations (preferred)
Documentation for this format

Terminology Bindings (Differential)

Path	Conformance	ValueSet	URI
Observation.participant:consumable.participantRole.playingEntity.code	preferred	CommonSubstancesForAllergyAndIntoleranceDocumentationIncludingRefutations `http://cts.nlm.nih.gov/fhir/ValueSet/2.16.840.1.113762.1.4.1186.8` from https://vsac.nlm.nih.gov

Key Elements View

Name	Flags	Card.	Type	Description & Constraints
Observation	C	1..1	SubstanceOrDeviceAllergyIntoleranceObservation	XML Namespace: urn:hl7-org:v3 Elements defined in Ancestors: @nullFlavor, realmCode, typeId, templateId, @classCode, @moodCode, @negationInd, id, code, derivationExpr, text, statusCode, effectiveTime, priorityCode, repeatNumber, languageCode, value, interpretationCode, methodCode, targetSiteCode, subject, specimen, performer, author, informant, participant, entryRelationship, reference, precondition, sdtcPrecondition2, referenceRange, sdtcInFulfillmentOf1, templateId, templateId, classCode, moodCode, id, code, text, statusCode, effectiveTime, value, author, participant, participant, entryRelationship, entryRelationship, entryRelationship, entryRelationship, entryRelationship Base for all types and resources Instances of this type are validated by templateId Logical Container: ClinicalDocument (CDA Class) should-text-ref-value: SHOULD contain text/reference/@value should-author: SHOULD contain author should-not-severity: Allergy SHOULD NOT include severity. Severity belongs at reaction level, while Criticality is used at the allergy level.
Slices for templateId		2..*	II	Slice: Unordered, Open by value:root, value:extension
templateId:substance-device-allergy-intolerance-obs		1..1	II
@root		1..1	oid, uuid, ruid	Required Pattern: 2.16.840.1.113883.10.20.24.3.90
@extension		1..1	st	Required Pattern: 2014-06-09
templateId:allergy		1..1	II
@root		1..1	oid, uuid, ruid	Required Pattern: 2.16.840.1.113883.10.20.22.4.7
@extension		1..1	st	Required Pattern: 2014-06-09
@classCode		1..1	cs	Binding: CDAActClassObservation (required) Fixed Value: OBS
@moodCode		1..1	cs	Binding: XActMoodDocumentObservation (2.0.0) (required) Fixed Value: EVN
@negationInd		0..1	bl	Use negationInd="true" to indicate that the allergy was not observed.
id		1..*	II
code		1..1	CD	Binding: ObservationType (example)
@code		1..1	cs	Required Pattern: ASSERTION
@codeSystem		1..1	oid, uuid, ruid	Required Pattern: 2.16.840.1.113883.5.4
statusCode		1..1	CS	Binding: ActStatus (required)
@code		1..1	cs	Fixed Value: completed
effectiveTime		1..1	IVL_TS	If the allergy/intolerance is known to be resolved, but the date of resolution is not known, then the high element SHALL be present, and the nullFlavor attribute SHALL be set to 'UNK'.
low		1..1	IVXB_TS
value		1..1	CD
@code		1..1	cs	Binding: Allergy and Intolerance Type (required)
Slices for participant		0..*	Participant2	Slice: Unordered, Open by value:typeCode
participant:consumable		0..*	Participant2	participant
@typeCode		1..1	cs	Binding: CDAParticipationType (required) Fixed Value: CSM
participantRole		1..1	ParticipantRole
@classCode		1..1	cs	Binding: CDARoleClassRoot (required) Fixed Value: MANU
playingEntity		1..1	PlayingEntity
@classCode		1..1	cs	Binding: EntityClassRoot (required) Fixed Value: MMAT
code		1..1	CE	(USCDI) Substance Binding: Common substances for allergy and intolerance documentation including refutations (preferred)
Slices for entryRelationship		0..*	EntryRelationship	Slice: Unordered, Open by profile:observation
entryRelationship:status		0..1	EntryRelationship	entryRelationship
@typeCode		1..1	cs	Binding: x_ActRelationshipEntryRelationship (required) Fixed Value: SUBJ
@inversionInd		1..1	bl	Fixed Value: true
observation	C	1..1	AllergyStatusObservation	Base for all types and resources should-text-ref-value: SHOULD contain text/reference/@value
entryRelationship:reaction		0..*	EntryRelationship	entryRelationship
@typeCode		1..1	cs	Binding: x_ActRelationshipEntryRelationship (required) Fixed Value: MFST
@inversionInd		1..1	bl	Fixed Value: true
observation	C	1..1	ReactionObservation	Base for all types and resources should-text-ref-value: SHOULD contain text/reference/@value should-effectiveTime: SHOULD contain effectiveTime
entryRelationship:severity		0..1	EntryRelationship	entryRelationship
@typeCode		1..1	cs	Binding: x_ActRelationshipEntryRelationship (required) Fixed Value: SUBJ
@inversionInd		1..1	bl	Fixed Value: true
observation	C	1..1	SeverityObservation	Base for all types and resources should-text-ref-value: SHOULD contain text/reference/@value
entryRelationship:criticality		0..1	EntryRelationship	entryRelationship
@typeCode		1..1	cs	Binding: x_ActRelationshipEntryRelationship (required) Fixed Value: SUBJ
@inversionInd		1..1	bl	Fixed Value: true
observation	C	1..1	CriticalityObservation	Base for all types and resources should-text-ref-value: SHOULD contain text/reference/@value
Documentation for this format

Terminology Bindings

Path	Conformance	ValueSet / Code	URI
Observation.classCode	required	Fixed Value: OBS `http://hl7.org/cda/stds/core/ValueSet/CDAActClassObservation`
Observation.moodCode	required	Fixed Value: EVN `http://terminology.hl7.org/ValueSet/v3-xActMoodDocumentObservation\|2.0.0`
Observation.code	example	ObservationType `http://terminology.hl7.org/ValueSet/v3-ObservationType`
Observation.statusCode	required	ActStatus `http://terminology.hl7.org/ValueSet/v3-ActStatus`
Observation.value.code	required	AllergyAndIntoleranceType `http://cts.nlm.nih.gov/fhir/ValueSet/2.16.840.1.113883.3.88.12.3221.6.2` from https://vsac.nlm.nih.gov
Observation.participant:consumable.typeCode	required	Fixed Value: CSM `http://hl7.org/cda/stds/core/ValueSet/CDAParticipationType`
Observation.participant:consumable.participantRole.classCode	required	Fixed Value: MANU `http://hl7.org/cda/stds/core/ValueSet/CDARoleClassRoot`
Observation.participant:consumable.participantRole.playingEntity.classCode	required	Fixed Value: MMAT `http://terminology.hl7.org/ValueSet/v3-EntityClassRoot`
Observation.participant:consumable.participantRole.playingEntity.code	preferred	CommonSubstancesForAllergyAndIntoleranceDocumentationIncludingRefutations `http://cts.nlm.nih.gov/fhir/ValueSet/2.16.840.1.113762.1.4.1186.8` from https://vsac.nlm.nih.gov
Observation.entryRelationship:status.typeCode	required	Fixed Value: SUBJ `http://terminology.hl7.org/ValueSet/v3-xActRelationshipEntryRelationship`
Observation.entryRelationship:reaction.typeCode	required	Fixed Value: MFST `http://terminology.hl7.org/ValueSet/v3-xActRelationshipEntryRelationship`
Observation.entryRelationship:severity.typeCode	required	Fixed Value: SUBJ `http://terminology.hl7.org/ValueSet/v3-xActRelationshipEntryRelationship`
Observation.entryRelationship:criticality.typeCode	required	Fixed Value: SUBJ `http://terminology.hl7.org/ValueSet/v3-xActRelationshipEntryRelationship`

Constraints

Id	Grade	Path(s)	Details	Requirements
should-author	warning	Observation	SHOULD contain author : author.exists()
should-effectiveTime	warning	Observation.entryRelationship:reaction.observation	SHOULD contain effectiveTime : effectiveTime.exists()
should-not-severity	warning	Observation	Allergy SHOULD NOT include severity. Severity belongs at reaction level, while Criticality is used at the allergy level. : entryRelationship.observation.where(code.code = 'SEV' and code.codeSystem = '2.16.840.1.113883.5.4').empty()
should-text-ref-value	warning	Observation, Observation.entryRelationship:status.observation, Observation.entryRelationship:reaction.observation, Observation.entryRelationship:severity.observation, Observation.entryRelationship:criticality.observation	SHOULD contain text/reference/@value : text.reference.value.exists()

Snapshot View

Name	Flags	Card.	Type	Description & Constraints
Observation	C	1..1	SubstanceOrDeviceAllergyIntoleranceObservation	XML Namespace: urn:hl7-org:v3 Elements defined in Ancestors: @nullFlavor, realmCode, typeId, templateId, @classCode, @moodCode, @negationInd, id, code, derivationExpr, text, statusCode, effectiveTime, priorityCode, repeatNumber, languageCode, value, interpretationCode, methodCode, targetSiteCode, subject, specimen, performer, author, informant, participant, entryRelationship, reference, precondition, sdtcPrecondition2, referenceRange, sdtcInFulfillmentOf1, templateId, templateId, classCode, moodCode, id, code, text, statusCode, effectiveTime, value, author, participant, participant, entryRelationship, entryRelationship, entryRelationship, entryRelationship, entryRelationship Base for all types and resources Instances of this type are validated by templateId Logical Container: ClinicalDocument (CDA Class) should-text-ref-value: SHOULD contain text/reference/@value should-author: SHOULD contain author should-not-severity: Allergy SHOULD NOT include severity. Severity belongs at reaction level, while Criticality is used at the allergy level.
@nullFlavor		0..1	cs	Binding: CDANullFlavor (required)
realmCode		0..*	CS
typeId		0..1	II
@nullFlavor		0..1	cs	Binding: CDANullFlavor (required)
@assigningAuthorityName		0..1	st
@displayable		0..1	bl
@root		1..1	oid, uuid, ruid	Fixed Value: 2.16.840.1.113883.1.3
@extension		1..1	st
Slices for templateId		2..*	II	Slice: Unordered, Open by value:root, value:extension
templateId:substance-device-allergy-intolerance-obs		1..1	II
@nullFlavor		0..1	cs	Binding: CDANullFlavor (required)
@assigningAuthorityName		0..1	st
@displayable		0..1	bl
@root		1..1	oid, uuid, ruid	Required Pattern: 2.16.840.1.113883.10.20.24.3.90
@extension		1..1	st	Required Pattern: 2014-06-09
templateId:allergy		1..1	II
@nullFlavor		0..1	cs	Binding: CDANullFlavor (required)
@assigningAuthorityName		0..1	st
@displayable		0..1	bl
@root		1..1	oid, uuid, ruid	Required Pattern: 2.16.840.1.113883.10.20.22.4.7
@extension		1..1	st	Required Pattern: 2014-06-09
@classCode		1..1	cs	Binding: CDAActClassObservation (required) Fixed Value: OBS
@moodCode		1..1	cs	Binding: XActMoodDocumentObservation (2.0.0) (required) Fixed Value: EVN
@negationInd		0..1	bl	Use negationInd="true" to indicate that the allergy was not observed.
id		1..*	II
code		1..1	CD	Binding: ObservationType (example)
@nullFlavor		0..1	cs	Binding: CDANullFlavor (required)
@code		1..1	cs	Required Pattern: ASSERTION
@codeSystem		1..1	oid, uuid, ruid	Required Pattern: 2.16.840.1.113883.5.4
@codeSystemName		0..1	st
@codeSystemVersion		0..1	st
@displayName		0..1	st
@sdtcValueSet		0..1	oid	XML Namespace: urn:hl7-org:sdtc XML: valueSet (urn:hl7-org:sdtc)
@sdtcValueSetVersion		0..1	st	XML Namespace: urn:hl7-org:sdtc XML: valueSetVersion (urn:hl7-org:sdtc)
originalText		0..1	ED
qualifier		0..*	CR
translation		0..*	CD
derivationExpr		0..1	ST
text		0..1	ED	SHOULD reference the portion of section narrative text corresponding to this entry
@nullFlavor		0..1	cs	Binding: CDANullFlavor (required)
@compression		0..1	cs	Binding: CDACompressionAlgorithm (required)
@integrityCheck		0..1	bin
@integrityCheckAlgorithm		0..1	cs	Binding: IntegrityCheckAlgorithm (2.0.0) (required)
@language		0..1	cs
@mediaType		0..1	cs	Binding: MediaType (example)
@representation		0..1	cs	Binding: CDABinaryDataEncoding (required)
xmlText		0..1	st	Allows for mixed text content. If @representation='B64', this SHALL be a base64binary string.
reference	C	0..1	TEL	value-starts-octothorpe: If reference/@value is present, it SHALL begin with a '#' and SHALL point to its corresponding narrative
thumbnail		0..1	ED
statusCode		1..1	CS	Binding: ActStatus (required)
@nullFlavor		0..1	cs	Binding: CDANullFlavor (required)
@code		1..1	cs	Fixed Value: completed
@sdtcValueSet		0..1	oid	XML Namespace: urn:hl7-org:sdtc XML: valueSet (urn:hl7-org:sdtc)
@sdtcValueSetVersion		0..1	st	XML Namespace: urn:hl7-org:sdtc XML: valueSetVersion (urn:hl7-org:sdtc)
effectiveTime		1..1	IVL_TS	If the allergy/intolerance is known to be resolved, but the date of resolution is not known, then the high element SHALL be present, and the nullFlavor attribute SHALL be set to 'UNK'.
@nullFlavor		0..1	cs	Binding: CDANullFlavor (required)
@value		0..1	ts	Date Format: YYYYMMDDHHMMSS.UUUU[+\|-ZZzz]
@operator		0..1	cs	Binding: CDASetOperator (required)
low		1..1	IVXB_TS
center		0..1	TS
width		0..1	PQ
high		0..1	IVXB_TS
priorityCode		0..1	CE	Binding: ActPriority (example)
repeatNumber		0..1	IVL_INT
languageCode		0..1	CS	Binding: AllLanguages (required)
value		1..1	CD
@code		1..1	cs	Binding: Allergy and Intolerance Type (required)
@codeSystem		0..1	oid, uuid, ruid
@codeSystemName		0..1	st
@codeSystemVersion		0..1	st
@displayName		0..1	st
@sdtcValueSet		0..1	oid	XML Namespace: urn:hl7-org:sdtc XML: valueSet (urn:hl7-org:sdtc)
@sdtcValueSetVersion		0..1	st	XML Namespace: urn:hl7-org:sdtc XML: valueSetVersion (urn:hl7-org:sdtc)
originalText		0..1	ED
qualifier		0..*	CR
translation		0..*	CD
interpretationCode		0..*	CE	Binding: CDAObservationInterpretation (required)
methodCode		0..*	CE	Binding: ObservationMethod (example)
targetSiteCode		0..*	CD
subject		0..1	Subject
specimen		0..*	Specimen
performer		0..*	Performer2
author		0..*	AuthorParticipation	Base for all types and resources
informant		0..*	Informant
Slices for participant		0..*	Participant2	Slice: Unordered, Open by value:typeCode
participant:consumable		0..*	Participant2	participant
@nullFlavor		0..1	cs	Binding: CDANullFlavor (required)
realmCode		0..*	CS
typeId		0..1	II
@nullFlavor		0..1	cs	Binding: CDANullFlavor (required)
@assigningAuthorityName		0..1	st
@displayable		0..1	bl
@root		1..1	oid, uuid, ruid	Fixed Value: 2.16.840.1.113883.1.3
@extension		1..1	st
templateId		0..*	II
@typeCode		1..1	cs	Binding: CDAParticipationType (required) Fixed Value: CSM
@contextControlCode		0..1	cs	Binding: CDAContextControl (required) Fixed Value: OP
sdtcFunctionCode		0..1	CE	XML Namespace: urn:hl7-org:sdtc XML: functionCode (urn:hl7-org:sdtc)
time		0..1	IVL_TS
awarenessCode		0..1	CE
participantRole		1..1	ParticipantRole
@nullFlavor		0..1	cs	Binding: CDANullFlavor (required)
realmCode		0..*	CS
typeId		0..1	II
@nullFlavor		0..1	cs	Binding: CDANullFlavor (required)
@assigningAuthorityName		0..1	st
@displayable		0..1	bl
@root		1..1	oid, uuid, ruid	Fixed Value: 2.16.840.1.113883.1.3
@extension		1..1	st
templateId		0..*	II
@classCode		1..1	cs	Binding: CDARoleClassRoot (required) Fixed Value: MANU
id		0..*	II
sdtcIdentifiedBy		0..*	IdentifiedBy	XML Namespace: urn:hl7-org:sdtc XML: identifiedBy (urn:hl7-org:sdtc)
code		0..1	CE	Binding: CDARoleCode (example)
addr		0..*	AD
telecom		0..*	TEL
playingDevice		0..1	Device
playingEntity		1..1	PlayingEntity
@nullFlavor		0..1	cs	Binding: CDANullFlavor (required)
realmCode		0..*	CS
typeId		0..1	II
@nullFlavor		0..1	cs	Binding: CDANullFlavor (required)
@assigningAuthorityName		0..1	st
@displayable		0..1	bl
@root		1..1	oid, uuid, ruid	Fixed Value: 2.16.840.1.113883.1.3
@extension		1..1	st
templateId		0..*	II
@classCode		1..1	cs	Binding: EntityClassRoot (required) Fixed Value: MMAT
@determinerCode		0..1	cs	Binding: EntityDeterminer (required) Fixed Value: INSTANCE
code		1..1	CE	(USCDI) Substance Binding: Common substances for allergy and intolerance documentation including refutations (preferred)
quantity		0..*	PQ
name		0..*	PN
sdtcBirthTime		0..1	TS	XML Namespace: urn:hl7-org:sdtc XML: birthTime (urn:hl7-org:sdtc)
desc		0..1	ED
scopingEntity		0..1	Entity
Slices for entryRelationship		0..*	EntryRelationship	Slice: Unordered, Open by profile:observation
entryRelationship:status		0..1	EntryRelationship	entryRelationship
@nullFlavor		0..1	cs	Binding: CDANullFlavor (required)
realmCode		0..*	CS
typeId		0..1	II
@nullFlavor		0..1	cs	Binding: CDANullFlavor (required)
@assigningAuthorityName		0..1	st
@displayable		0..1	bl
@root		1..1	oid, uuid, ruid	Fixed Value: 2.16.840.1.113883.1.3
@extension		1..1	st
templateId		0..*	II
@typeCode		1..1	cs	Binding: x_ActRelationshipEntryRelationship (required) Fixed Value: SUBJ
@inversionInd		1..1	bl	Fixed Value: true
@contextConductionInd		0..1	bl
@negationInd		0..1	bl
sequenceNumber		0..1	INT
seperatableInd		0..1	BL
act		0..1	Act
encounter		0..1	Encounter
observation	C	1..1	AllergyStatusObservation	Base for all types and resources should-text-ref-value: SHOULD contain text/reference/@value
observationMedia		0..1	ObservationMedia
organizer		0..1	Organizer
procedure		0..1	Procedure
regionOfInterest		0..1	RegionOfInterest
substanceAdministration		0..1	SubstanceAdministration
supply		0..1	Supply
entryRelationship:reaction		0..*	EntryRelationship	entryRelationship
@nullFlavor		0..1	cs	Binding: CDANullFlavor (required)
realmCode		0..*	CS
typeId		0..1	II
@nullFlavor		0..1	cs	Binding: CDANullFlavor (required)
@assigningAuthorityName		0..1	st
@displayable		0..1	bl
@root		1..1	oid, uuid, ruid	Fixed Value: 2.16.840.1.113883.1.3
@extension		1..1	st
templateId		0..*	II
@typeCode		1..1	cs	Binding: x_ActRelationshipEntryRelationship (required) Fixed Value: MFST
@inversionInd		1..1	bl	Fixed Value: true
@contextConductionInd		0..1	bl
@negationInd		0..1	bl
sequenceNumber		0..1	INT
seperatableInd		0..1	BL
act		0..1	Act
encounter		0..1	Encounter
observation	C	1..1	ReactionObservation	Base for all types and resources should-text-ref-value: SHOULD contain text/reference/@value should-effectiveTime: SHOULD contain effectiveTime
observationMedia		0..1	ObservationMedia
organizer		0..1	Organizer
procedure		0..1	Procedure
regionOfInterest		0..1	RegionOfInterest
substanceAdministration		0..1	SubstanceAdministration
supply		0..1	Supply
entryRelationship:severity		0..1	EntryRelationship	entryRelationship
@nullFlavor		0..1	cs	Binding: CDANullFlavor (required)
realmCode		0..*	CS
typeId		0..1	II
@nullFlavor		0..1	cs	Binding: CDANullFlavor (required)
@assigningAuthorityName		0..1	st
@displayable		0..1	bl
@root		1..1	oid, uuid, ruid	Fixed Value: 2.16.840.1.113883.1.3
@extension		1..1	st
templateId		0..*	II
@typeCode		1..1	cs	Binding: x_ActRelationshipEntryRelationship (required) Fixed Value: SUBJ
@inversionInd		1..1	bl	Fixed Value: true
@contextConductionInd		0..1	bl
@negationInd		0..1	bl
sequenceNumber		0..1	INT
seperatableInd		0..1	BL
act		0..1	Act
encounter		0..1	Encounter
observation	C	1..1	SeverityObservation	Base for all types and resources should-text-ref-value: SHOULD contain text/reference/@value
observationMedia		0..1	ObservationMedia
organizer		0..1	Organizer
procedure		0..1	Procedure
regionOfInterest		0..1	RegionOfInterest
substanceAdministration		0..1	SubstanceAdministration
supply		0..1	Supply
entryRelationship:criticality		0..1	EntryRelationship	entryRelationship
@nullFlavor		0..1	cs	Binding: CDANullFlavor (required)
realmCode		0..*	CS
typeId		0..1	II
@nullFlavor		0..1	cs	Binding: CDANullFlavor (required)
@assigningAuthorityName		0..1	st
@displayable		0..1	bl
@root		1..1	oid, uuid, ruid	Fixed Value: 2.16.840.1.113883.1.3
@extension		1..1	st
templateId		0..*	II
@typeCode		1..1	cs	Binding: x_ActRelationshipEntryRelationship (required) Fixed Value: SUBJ
@inversionInd		1..1	bl	Fixed Value: true
@contextConductionInd		0..1	bl
@negationInd		0..1	bl
sequenceNumber		0..1	INT
seperatableInd		0..1	BL
act		0..1	Act
encounter		0..1	Encounter
observation	C	1..1	CriticalityObservation	Base for all types and resources should-text-ref-value: SHOULD contain text/reference/@value
observationMedia		0..1	ObservationMedia
organizer		0..1	Organizer
procedure		0..1	Procedure
regionOfInterest		0..1	RegionOfInterest
substanceAdministration		0..1	SubstanceAdministration
supply		0..1	Supply
reference		0..*	Reference
precondition		0..*	Precondition
sdtcPrecondition2		0..*	Precondition2	XML Namespace: urn:hl7-org:sdtc XML: precondition2 (urn:hl7-org:sdtc)
referenceRange		0..*	InfrastructureRoot
@nullFlavor		0..1	cs	Binding: CDANullFlavor (required)
realmCode		0..*	CS
typeId		0..1	II
@nullFlavor		0..1	cs	Binding: CDANullFlavor (required)
@assigningAuthorityName		0..1	st
@displayable		0..1	bl
@root		1..1	oid, uuid, ruid	Fixed Value: 2.16.840.1.113883.1.3
@extension		1..1	st
templateId		0..*	II
@typeCode		0..1	cs	Binding: CDAActRelationshipType (required) Fixed Value: REFV
observationRange		1..1	ObservationRange
sdtcInFulfillmentOf1		0..*	InFulfillmentOf1	XML Namespace: urn:hl7-org:sdtc XML: inFulfillmentOf1 (urn:hl7-org:sdtc)
Documentation for this format

Terminology Bindings

Path	Conformance	ValueSet / Code	URI
Observation.nullFlavor	required	CDANullFlavor `http://hl7.org/cda/stds/core/ValueSet/CDANullFlavor`
Observation.typeId.nullFlavor	required	CDANullFlavor `http://hl7.org/cda/stds/core/ValueSet/CDANullFlavor`
Observation.templateId:substance-device-allergy-intolerance-obs.nullFlavor	required	CDANullFlavor `http://hl7.org/cda/stds/core/ValueSet/CDANullFlavor`
Observation.templateId:allergy.nullFlavor	required	CDANullFlavor `http://hl7.org/cda/stds/core/ValueSet/CDANullFlavor`
Observation.classCode	required	Fixed Value: OBS `http://hl7.org/cda/stds/core/ValueSet/CDAActClassObservation`
Observation.moodCode	required	Fixed Value: EVN `http://terminology.hl7.org/ValueSet/v3-xActMoodDocumentObservation\|2.0.0`
Observation.code	example	ObservationType `http://terminology.hl7.org/ValueSet/v3-ObservationType`
Observation.code.nullFlavor	required	CDANullFlavor `http://hl7.org/cda/stds/core/ValueSet/CDANullFlavor`
Observation.text.nullFlavor	required	CDANullFlavor `http://hl7.org/cda/stds/core/ValueSet/CDANullFlavor`
Observation.text.compression	required	CDACompressionAlgorithm `http://hl7.org/cda/stds/core/ValueSet/CDACompressionAlgorithm`
Observation.text.integrityCheckAlgorithm	required	IntegrityCheckAlgorithm `http://terminology.hl7.org/ValueSet/v3-IntegrityCheckAlgorithm\|2.0.0`
Observation.text.mediaType	example	MediaType `http://terminology.hl7.org/ValueSet/v3-MediaType`
Observation.text.representation	required	BinaryDataEncoding `http://hl7.org/cda/stds/core/ValueSet/BinaryDataEncoding`
Observation.statusCode	required	ActStatus `http://terminology.hl7.org/ValueSet/v3-ActStatus`
Observation.statusCode.nullFlavor	required	CDANullFlavor `http://hl7.org/cda/stds/core/ValueSet/CDANullFlavor`
Observation.effectiveTime.nullFlavor	required	CDANullFlavor `http://hl7.org/cda/stds/core/ValueSet/CDANullFlavor`
Observation.effectiveTime.operator	required	CDASetOperator `http://hl7.org/cda/stds/core/ValueSet/CDASetOperator`
Observation.priorityCode	example	ActPriority `http://terminology.hl7.org/ValueSet/v3-ActPriority`
Observation.languageCode	required	AllLanguages `http://hl7.org/fhir/ValueSet/all-languages` from the FHIR Standard
Observation.value.code	required	AllergyAndIntoleranceType `http://cts.nlm.nih.gov/fhir/ValueSet/2.16.840.1.113883.3.88.12.3221.6.2` from https://vsac.nlm.nih.gov
Observation.interpretationCode	required	CDAObservationInterpretation `http://hl7.org/cda/stds/core/ValueSet/CDAObservationInterpretation`
Observation.methodCode	example	ObservationMethod `http://terminology.hl7.org/ValueSet/v3-ObservationMethod`
Observation.participant:consumable.nullFlavor	required	CDANullFlavor `http://hl7.org/cda/stds/core/ValueSet/CDANullFlavor`
Observation.participant:consumable.typeId.nullFlavor	required	CDANullFlavor `http://hl7.org/cda/stds/core/ValueSet/CDANullFlavor`
Observation.participant:consumable.typeCode	required	Fixed Value: CSM `http://hl7.org/cda/stds/core/ValueSet/CDAParticipationType`
Observation.participant:consumable.contextControlCode	required	Fixed Value: OP `http://hl7.org/cda/stds/core/ValueSet/CDAContextControl`
Observation.participant:consumable.participantRole.nullFlavor	required	CDANullFlavor `http://hl7.org/cda/stds/core/ValueSet/CDANullFlavor`
Observation.participant:consumable.participantRole.typeId.nullFlavor	required	CDANullFlavor `http://hl7.org/cda/stds/core/ValueSet/CDANullFlavor`
Observation.participant:consumable.participantRole.classCode	required	Fixed Value: MANU `http://hl7.org/cda/stds/core/ValueSet/CDARoleClassRoot`
Observation.participant:consumable.participantRole.code	example	CDARoleCode `http://hl7.org/cda/stds/core/ValueSet/CDARoleCode`
Observation.participant:consumable.participantRole.playingEntity.nullFlavor	required	CDANullFlavor `http://hl7.org/cda/stds/core/ValueSet/CDANullFlavor`
Observation.participant:consumable.participantRole.playingEntity.typeId.nullFlavor	required	CDANullFlavor `http://hl7.org/cda/stds/core/ValueSet/CDANullFlavor`
Observation.participant:consumable.participantRole.playingEntity.classCode	required	Fixed Value: MMAT `http://terminology.hl7.org/ValueSet/v3-EntityClassRoot`
Observation.participant:consumable.participantRole.playingEntity.determinerCode	required	Fixed Value: INSTANCE `http://terminology.hl7.org/ValueSet/v3-EntityDeterminer`
Observation.participant:consumable.participantRole.playingEntity.code	preferred	CommonSubstancesForAllergyAndIntoleranceDocumentationIncludingRefutations `http://cts.nlm.nih.gov/fhir/ValueSet/2.16.840.1.113762.1.4.1186.8` from https://vsac.nlm.nih.gov
Observation.entryRelationship:status.nullFlavor	required	CDANullFlavor `http://hl7.org/cda/stds/core/ValueSet/CDANullFlavor`
Observation.entryRelationship:status.typeId.nullFlavor	required	CDANullFlavor `http://hl7.org/cda/stds/core/ValueSet/CDANullFlavor`
Observation.entryRelationship:status.typeCode	required	Fixed Value: SUBJ `http://terminology.hl7.org/ValueSet/v3-xActRelationshipEntryRelationship`
Observation.entryRelationship:reaction.nullFlavor	required	CDANullFlavor `http://hl7.org/cda/stds/core/ValueSet/CDANullFlavor`
Observation.entryRelationship:reaction.typeId.nullFlavor	required	CDANullFlavor `http://hl7.org/cda/stds/core/ValueSet/CDANullFlavor`
Observation.entryRelationship:reaction.typeCode	required	Fixed Value: MFST `http://terminology.hl7.org/ValueSet/v3-xActRelationshipEntryRelationship`
Observation.entryRelationship:severity.nullFlavor	required	CDANullFlavor `http://hl7.org/cda/stds/core/ValueSet/CDANullFlavor`
Observation.entryRelationship:severity.typeId.nullFlavor	required	CDANullFlavor `http://hl7.org/cda/stds/core/ValueSet/CDANullFlavor`
Observation.entryRelationship:severity.typeCode	required	Fixed Value: SUBJ `http://terminology.hl7.org/ValueSet/v3-xActRelationshipEntryRelationship`
Observation.entryRelationship:criticality.nullFlavor	required	CDANullFlavor `http://hl7.org/cda/stds/core/ValueSet/CDANullFlavor`
Observation.entryRelationship:criticality.typeId.nullFlavor	required	CDANullFlavor `http://hl7.org/cda/stds/core/ValueSet/CDANullFlavor`
Observation.entryRelationship:criticality.typeCode	required	Fixed Value: SUBJ `http://terminology.hl7.org/ValueSet/v3-xActRelationshipEntryRelationship`
Observation.referenceRange.nullFlavor	required	CDANullFlavor `http://hl7.org/cda/stds/core/ValueSet/CDANullFlavor`
Observation.referenceRange.typeId.nullFlavor	required	CDANullFlavor `http://hl7.org/cda/stds/core/ValueSet/CDANullFlavor`
Observation.referenceRange.typeCode	required	Fixed Value: REFV `http://hl7.org/cda/stds/core/ValueSet/CDAActRelationshipType`

Constraints

Id	Grade	Path(s)	Details	Requirements
should-author	warning	Observation	SHOULD contain author : author.exists()
should-effectiveTime	warning	Observation.entryRelationship:reaction.observation	SHOULD contain effectiveTime : effectiveTime.exists()
should-not-severity	warning	Observation	Allergy SHOULD NOT include severity. Severity belongs at reaction level, while Criticality is used at the allergy level. : entryRelationship.observation.where(code.code = 'SEV' and code.codeSystem = '2.16.840.1.113883.5.4').empty()
should-text-ref-value	warning	Observation, Observation.entryRelationship:status.observation, Observation.entryRelationship:reaction.observation, Observation.entryRelationship:severity.observation, Observation.entryRelationship:criticality.observation	SHOULD contain text/reference/@value : text.reference.value.exists()
value-starts-octothorpe	error	Observation.text.reference	If reference/@value is present, it SHALL begin with a '#' and SHALL point to its corresponding narrative : value.exists() implies value.startsWith('#')

This structure is derived from SubstanceOrDeviceAllergyIntoleranceObservation

Summary

Mandatory: 3 elements

Other representations of profile: CSV, Excel