This page is part of the CCDA: Consolidated CDA Release (v3.0.0: CCDA 3.0) generated with FHIR (HL7® FHIR® Standard) v5.0.0. The current version which supersedes this version is 4.0.0. For a full list of available versions, see the Directory of published versions
| Official URL: http://hl7.org/cda/us/ccda/StructureDefinition/SubstanceOrDeviceAllergyIntoleranceObservation | Version: 3.0.0 | |||
| Draft as of 2024-05-18 | Computable Name: SubstanceOrDeviceAllergyIntoleranceObservation | |||
| Other Identifiers: urn:ietf:rfc:3986#Uniform Resource Identifier (URI)#urn:hl7ii:2.16.840.1.113883.10.20.24.3.90:2014-06-09 | ||||
This template reflects a discrete observation about a patient’s allergy or intolerance to a substance or device. Because it is a discrete observation, it will have a statusCode of “completed”. The effectiveTime, also referred to as the ‘clinically 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 Substance or Device 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”.
Usage:
Description of Template, Differentials, Snapshots and how the different presentations work.
This structure is derived from Observation
| Name | Flags | Card. | Type | Description & Constraints  | 
|---|---|---|---|---|
|   Observation | C | 1..1 | Observation | 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 Base for all types and resources Instance 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 | 1..* | 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 | |
|    @classCode | 1..1 | cs | Fixed Value: OBS | |
|    @moodCode | 1..1 | cs | Fixed Value: EVN | |
|    id | 1..* | II | ||
|    code | 1..1 | CD | ||
|     @code | 1..1 | cs | Required Pattern: ASSERTION | |
|     @codeSystem | 1..1 | oid, uuid, ruid | Required Pattern: 2.16.840.1.113883.5.4 | |
|    text | 0..1 | ED | SHOULD reference the portion of section narrative text corresponding to this entry | |
|     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 | 
|    statusCode | 1..1 | CS | ||
|     @code | 1..1 | cs | Fixed Value: completed | |
|    effectiveTime | 1..1 | IVL_TS | The effectiveTime/low (a.k.a. "onset date") asserts when the allergy/intolerance became clinically active. The effectiveTime/high (a.k.a. "resolution date") asserts when the allergy/intolerance became clinically resolved. 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 | ||
|     high | 0..1 | IVXB_TS | ||
|    value | 1..1 | CD | ||
|     @nullFlavor | 0..0 | |||
|     @code | 1..1 | cs | Binding: Allergy and Intolerance Type  (required) | |
|    author | 0..* | AuthorParticipation | Base for all types and resources | |
|    Slices for participant | 0..* | Participant2 | Slice: Unordered, Open by value:typeCode | |
|     participant:consumable | 0..* | Participant2 | participant | |
|      @typeCode | 1..1 | cs | Fixed Value: CSM | |
|      participantRole | 1..1 | ParticipantRole | ||
|       @classCode | 1..1 | cs | Fixed Value: MANU | |
|       playingEntity | 1..1 | PlayingEntity | ||
|        @classCode | 1..1 | cs | Fixed Value: MMAT | |
|        code | 1..1 | CE | Binding: Substance Reactant for Intolerance  (preferred) | |
|    Slices for entryRelationship | 0..* | EntryRelationship | Slice: Unordered, Open by profile:observation | |
|     entryRelationship:status | 0..1 | EntryRelationship | entryRelationship | |
|      @typeCode | 1..1 | cs | Fixed Value: SUBJ | |
|      @inversionInd | 1..1 | bl | Fixed Value: true | |
|      observation | 1..1 | AllergyStatusObservation | Base for all types and resources | |
|     entryRelationship:reaction | 0..* | EntryRelationship | entryRelationship | |
|      @typeCode | 1..1 | cs | Fixed Value: MFST | |
|      @inversionInd | 1..1 | bl | Fixed Value: true | |
|      observation | 1..1 | ReactionObservation | Base for all types and resources | |
|     entryRelationship:severity | 0..1 | EntryRelationship | entryRelationship | |
|      @typeCode | 1..1 | cs | Fixed Value: SUBJ | |
|      @inversionInd | 1..1 | bl | Fixed Value: true | |
|      observation | 1..1 | SeverityObservation | Base for all types and resources | |
|     entryRelationship:criticality | 0..1 | EntryRelationship | entryRelationship | |
|      @typeCode | 1..1 | cs | Fixed Value: SUBJ | |
|      @inversionInd | 1..1 | bl | Fixed Value: true | |
|      observation | 1..1 | CriticalityObservation | Base for all types and resources | |
|  Documentation for this format | ||||
| Path | Conformance | ValueSet | URI | 
| Observation.value.code | required | AllergyAndIntoleranceType  http://cts.nlm.nih.gov/fhir/ValueSet/2.16.840.1.113883.3.88.12.3221.6.2 | |
| Observation.participant:consumable.participantRole.playingEntity.code | preferred | SubstanceReactantForIntolerance  http://cts.nlm.nih.gov/fhir/ValueSet/2.16.840.1.113762.1.4.1010.1 | 
| Id | Grade | Path(s) | Details | Requirements | 
| should-author | warning | Observation | SHOULD contain author : author.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 | 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('#') | 
| Name | Flags | Card. | Type | Description & Constraints  | 
|---|---|---|---|---|
|   Observation | C | 1..1 | Observation | 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 Base for all types and resources Instance 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 | 1..* | 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 | |
|    @classCode | 1..1 | cs | Binding: CDAActClassObservation (required) Fixed Value: OBS | |
|    @moodCode | 1..1 | cs | Binding: XActMoodDocumentObservation (2.0.0) (required) Fixed Value: EVN | |
|    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 | |
|    text | 0..1 | ED | SHOULD reference the portion of section narrative text corresponding to this entry | |
|     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 | 
|    statusCode | 1..1 | CS | Binding: ActStatus (required) | |
|     @code | 1..1 | cs | Fixed Value: completed | |
|    effectiveTime | 1..1 | IVL_TS | The effectiveTime/low (a.k.a. "onset date") asserts when the allergy/intolerance became clinically active. The effectiveTime/high (a.k.a. "resolution date") asserts when the allergy/intolerance became clinically resolved. 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 | ||
|     high | 0..1 | IVXB_TS | ||
|    value | 1..1 | CD | ||
|     @code | 1..1 | cs | Binding: Allergy and Intolerance Type  (required) | |
|    author | 0..* | AuthorParticipation | Base for all types and resources | |
|    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 | Binding: Substance Reactant for Intolerance  (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 | ||||
| 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 | |
| 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 | SubstanceReactantForIntolerance  http://cts.nlm.nih.gov/fhir/ValueSet/2.16.840.1.113762.1.4.1010.1 | |
| 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 | 
| 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 | SHOULD contain text/reference/@value : text.reference.value.exists() | |
| should-text-ref-value | warning | 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('#') | 
| 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.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-languagesfrom 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 | |
| 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 | SubstanceReactantForIntolerance  http://cts.nlm.nih.gov/fhir/ValueSet/2.16.840.1.113762.1.4.1010.1 | |
| 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 | 
| 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 | SHOULD contain text/reference/@value : text.reference.value.exists() | |
| should-text-ref-value | warning | 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 Observation
Summary
Mandatory: 13 elements(12 nested mandatory elements)
 Fixed: 14 elements
 Prohibited: 1 element
Structures
This structure refers to these other structures:
Slices
This structure defines the following Slices:
Differential View
This structure is derived from Observation
| Name | Flags | Card. | Type | Description & Constraints  | 
|---|---|---|---|---|
|   Observation | C | 1..1 | Observation | 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 Base for all types and resources Instance 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 | 1..* | 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 | |
|    @classCode | 1..1 | cs | Fixed Value: OBS | |
|    @moodCode | 1..1 | cs | Fixed Value: EVN | |
|    id | 1..* | II | ||
|    code | 1..1 | CD | ||
|     @code | 1..1 | cs | Required Pattern: ASSERTION | |
|     @codeSystem | 1..1 | oid, uuid, ruid | Required Pattern: 2.16.840.1.113883.5.4 | |
|    text | 0..1 | ED | SHOULD reference the portion of section narrative text corresponding to this entry | |
|     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 | 
|    statusCode | 1..1 | CS | ||
|     @code | 1..1 | cs | Fixed Value: completed | |
|    effectiveTime | 1..1 | IVL_TS | The effectiveTime/low (a.k.a. "onset date") asserts when the allergy/intolerance became clinically active. The effectiveTime/high (a.k.a. "resolution date") asserts when the allergy/intolerance became clinically resolved. 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 | ||
|     high | 0..1 | IVXB_TS | ||
|    value | 1..1 | CD | ||
|     @nullFlavor | 0..0 | |||
|     @code | 1..1 | cs | Binding: Allergy and Intolerance Type  (required) | |
|    author | 0..* | AuthorParticipation | Base for all types and resources | |
|    Slices for participant | 0..* | Participant2 | Slice: Unordered, Open by value:typeCode | |
|     participant:consumable | 0..* | Participant2 | participant | |
|      @typeCode | 1..1 | cs | Fixed Value: CSM | |
|      participantRole | 1..1 | ParticipantRole | ||
|       @classCode | 1..1 | cs | Fixed Value: MANU | |
|       playingEntity | 1..1 | PlayingEntity | ||
|        @classCode | 1..1 | cs | Fixed Value: MMAT | |
|        code | 1..1 | CE | Binding: Substance Reactant for Intolerance  (preferred) | |
|    Slices for entryRelationship | 0..* | EntryRelationship | Slice: Unordered, Open by profile:observation | |
|     entryRelationship:status | 0..1 | EntryRelationship | entryRelationship | |
|      @typeCode | 1..1 | cs | Fixed Value: SUBJ | |
|      @inversionInd | 1..1 | bl | Fixed Value: true | |
|      observation | 1..1 | AllergyStatusObservation | Base for all types and resources | |
|     entryRelationship:reaction | 0..* | EntryRelationship | entryRelationship | |
|      @typeCode | 1..1 | cs | Fixed Value: MFST | |
|      @inversionInd | 1..1 | bl | Fixed Value: true | |
|      observation | 1..1 | ReactionObservation | Base for all types and resources | |
|     entryRelationship:severity | 0..1 | EntryRelationship | entryRelationship | |
|      @typeCode | 1..1 | cs | Fixed Value: SUBJ | |
|      @inversionInd | 1..1 | bl | Fixed Value: true | |
|      observation | 1..1 | SeverityObservation | Base for all types and resources | |
|     entryRelationship:criticality | 0..1 | EntryRelationship | entryRelationship | |
|      @typeCode | 1..1 | cs | Fixed Value: SUBJ | |
|      @inversionInd | 1..1 | bl | Fixed Value: true | |
|      observation | 1..1 | CriticalityObservation | Base for all types and resources | |
|  Documentation for this format | ||||
| Path | Conformance | ValueSet | URI | 
| Observation.value.code | required | AllergyAndIntoleranceType  http://cts.nlm.nih.gov/fhir/ValueSet/2.16.840.1.113883.3.88.12.3221.6.2 | |
| Observation.participant:consumable.participantRole.playingEntity.code | preferred | SubstanceReactantForIntolerance  http://cts.nlm.nih.gov/fhir/ValueSet/2.16.840.1.113762.1.4.1010.1 | 
| Id | Grade | Path(s) | Details | Requirements | 
| should-author | warning | Observation | SHOULD contain author : author.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 | 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('#') | 
Key Elements View
| Name | Flags | Card. | Type | Description & Constraints  | 
|---|---|---|---|---|
|   Observation | C | 1..1 | Observation | 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 Base for all types and resources Instance 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 | 1..* | 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 | |
|    @classCode | 1..1 | cs | Binding: CDAActClassObservation (required) Fixed Value: OBS | |
|    @moodCode | 1..1 | cs | Binding: XActMoodDocumentObservation (2.0.0) (required) Fixed Value: EVN | |
|    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 | |
|    text | 0..1 | ED | SHOULD reference the portion of section narrative text corresponding to this entry | |
|     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 | 
|    statusCode | 1..1 | CS | Binding: ActStatus (required) | |
|     @code | 1..1 | cs | Fixed Value: completed | |
|    effectiveTime | 1..1 | IVL_TS | The effectiveTime/low (a.k.a. "onset date") asserts when the allergy/intolerance became clinically active. The effectiveTime/high (a.k.a. "resolution date") asserts when the allergy/intolerance became clinically resolved. 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 | ||
|     high | 0..1 | IVXB_TS | ||
|    value | 1..1 | CD | ||
|     @code | 1..1 | cs | Binding: Allergy and Intolerance Type  (required) | |
|    author | 0..* | AuthorParticipation | Base for all types and resources | |
|    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 | Binding: Substance Reactant for Intolerance  (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 | ||||
| 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 | |
| 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 | SubstanceReactantForIntolerance  http://cts.nlm.nih.gov/fhir/ValueSet/2.16.840.1.113762.1.4.1010.1 | |
| 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 | 
| 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 | SHOULD contain text/reference/@value : text.reference.value.exists() | |
| should-text-ref-value | warning | 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('#') | 
Snapshot View
| 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.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-languagesfrom 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 | |
| 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 | SubstanceReactantForIntolerance  http://cts.nlm.nih.gov/fhir/ValueSet/2.16.840.1.113762.1.4.1010.1 | |
| 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 | 
| 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 | SHOULD contain text/reference/@value : text.reference.value.exists() | |
| should-text-ref-value | warning | 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 Observation
Summary
Mandatory: 13 elements(12 nested mandatory elements)
 Fixed: 14 elements
 Prohibited: 1 element
Structures
This structure refers to these other structures:
Slices
This structure defines the following Slices: