Consolidated CDA (C-CDA)
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Consolidated CDA (C-CDA), published by Health Level Seven. This guide is not an authorized publication; it is the continuous build for version 4.0.0-ballot 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: SubstanceOrDeviceAllergyIntoleranceObservation - Detailed Descriptions

Draft as of 2024-12-19

Definitions for the SubstanceOrDeviceAllergyIntoleranceObservation logical model.

Guidance on how to interpret the contents of this table can be found here

0. Observation
Logical ContainerClinicalDocument (CDA Class)
ValidationInstance of this type are validated by templateId
XML FormatIn the XML format, this property has the namespace urn:hl7-org:v3.
Invariantsshould-text-ref-value: SHOULD contain text/reference/@value (text.reference.value.exists())
should-author: SHOULD contain author (author.exists())
should-not-severity: 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())
2. Observation.templateId
Control1..?
SlicingThis element introduces a set of slices on Observation.templateId. The slices areUnordered and Open, and can be differentiated using the following discriminators:
  • value @ root
  • value @ extension
  • 4. Observation.templateId:substance-device-allergy-intolerance-obs
    Slice Namesubstance-device-allergy-intolerance-obs
    Control1..1
    6. Observation.templateId:substance-device-allergy-intolerance-obs.root
    Control1..?
    Pattern Value2.16.840.1.113883.10.20.24.3.90
    8. Observation.templateId:substance-device-allergy-intolerance-obs.extension
    Control1..?
    Pattern Value2014-06-09
    10. Observation.classCode
    Comments

    SHALL contain exactly one [1..1] @classCode="OBS" Observation (CodeSystem: HL7ActClass urn:oid:2.16.840.1.113883.5.6 STATIC) (CONF:1098-16303).

    Fixed ValueOBS
    12. Observation.moodCode
    Comments

    SHALL contain exactly one [1..1] @moodCode="EVN" Event (CodeSystem: HL7ActMood urn:oid:2.16.840.1.113883.5.1001 STATIC) (CONF:1098-16304).

    Fixed ValueEVN
    14. Observation.id
    Comments

    SHALL contain at least one [1..*] id (CONF:1098-16307).

    Control1..?
    16. Observation.code
    Comments

    SHALL contain exactly one [1..1] code (CONF:1098-16345).

    18. Observation.code.code
    Comments

    This code SHALL contain exactly one [1..1] @code="ASSERTION" Assertion (CONF:1098-16346).

    Control1..?
    Pattern ValueASSERTION
    20. Observation.code.codeSystem
    Comments

    This code SHALL contain exactly one [1..1] @codeSystem="2.16.840.1.113883.5.4" (CodeSystem: HL7ActCode urn:oid:2.16.840.1.113883.5.4) (CONF:1098-32171).

    Control1..?
    Pattern Value2.16.840.1.113883.5.4
    22. Observation.text
    ShortSHOULD reference the portion of section narrative text corresponding to this entry
    24. Observation.text.reference
    Invariantsvalue-starts-octothorpe: If reference/@value is present, it SHALL begin with a '#' and SHALL point to its corresponding narrative (value.exists() implies value.startsWith('#'))
    26. Observation.statusCode
    Comments

    SHALL contain exactly one [1..1] statusCode (CONF:1098-16308).

    Control1..?
    28. Observation.statusCode.code
    Comments

    This statusCode SHALL contain exactly one [1..1] @code="completed" Completed (CodeSystem: HL7ActStatus urn:oid:2.16.840.1.113883.5.14) (CONF:1098-26354).

    Control1..?
    Fixed Valuecompleted
    30. Observation.effectiveTime
    ShortThe 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'.
    Comments

    SHALL contain exactly one [1..1] effectiveTime (CONF:1098-16309).

    Control1..?
    32. Observation.effectiveTime.low
    Comments

    This effectiveTime SHALL contain exactly one [1..1] low (CONF:1098-31536).

    Control1..?
    34. Observation.effectiveTime.high
    Comments

    This effectiveTime MAY contain zero or one [0..1] high (CONF:1098-31537).

    36. Observation.value
    Comments

    SHALL contain exactly one [1..1] value with @xsi:type="CD" (CONF:1098-16312).

    Control1..1
    Typehttp://hl7.org/cda/stds/core/StructureDefinition/CD, http://hl7.org/cda/stds/core/StructureDefinition/EIVL-TS, http://hl7.org/cda/stds/core/StructureDefinition/CO, http://hl7.org/cda/stds/core/StructureDefinition/TEL, http://hl7.org/cda/stds/core/StructureDefinition/EN, http://hl7.org/cda/stds/core/StructureDefinition/BL, http://hl7.org/cda/stds/core/StructureDefinition/AD, http://hl7.org/cda/stds/core/StructureDefinition/PIVL-TS, http://hl7.org/cda/stds/core/StructureDefinition/RTO-PQ-PQ, http://hl7.org/cda/stds/core/StructureDefinition/SXPR-TS, http://hl7.org/cda/stds/core/StructureDefinition/ED, http://hl7.org/cda/stds/core/StructureDefinition/TS, http://hl7.org/cda/stds/core/StructureDefinition/II, http://hl7.org/cda/stds/core/StructureDefinition/ST, http://hl7.org/cda/stds/core/StructureDefinition/PQ, http://hl7.org/cda/stds/core/StructureDefinition/IVL-PQ, http://hl7.org/cda/stds/core/StructureDefinition/CE, http://hl7.org/cda/stds/core/StructureDefinition/MO, http://hl7.org/cda/stds/core/StructureDefinition/IVL-TS, http://hl7.org/cda/stds/core/StructureDefinition/ANY, http://hl7.org/cda/stds/core/StructureDefinition/INT, http://hl7.org/cda/stds/core/StructureDefinition/REAL, http://hl7.org/cda/stds/core/StructureDefinition/CV, http://hl7.org/cda/stds/core/StructureDefinition/SC
    38. Observation.value.nullFlavor
    Control0..0
    40. Observation.value.code
    Control1..?
    BindingThe codes SHALL be taken from Allergy and Intolerance Type .
    (required to http://cts.nlm.nih.gov/fhir/ValueSet/2.16.840.1.113883.3.88.12.3221.6.2)
    42. Observation.author
    Comments

    SHOULD contain zero or more [0..*] Author Participation (identifier: urn:oid:2.16.840.1.113883.10.20.22.4.119) (CONF:1098-31144).

    Typehttp://hl7.org/cda/stds/core/StructureDefinition/Author(Author Participation)
    44. Observation.participant
    Comments

    SHOULD contain zero or more [0..*] participant (CONF:1098-16318) such that it

    SlicingThis element introduces a set of slices on Observation.participant. The slices areUnordered and Open, and can be differentiated using the following discriminators:
    • value @ typeCode
    • 46. Observation.participant:consumable
      Slice Nameconsumable
      Shortparticipant
      Control0..*
      48. Observation.participant:consumable.typeCode
      Comments

      SHALL contain exactly one [1..1] @typeCode="CSM" Consumable (CodeSystem: HL7ParticipationType urn:oid:2.16.840.1.113883.5.90 STATIC) (CONF:1098-16319).

      Fixed ValueCSM
      50. Observation.participant:consumable.participantRole
      Comments

      SHALL contain exactly one [1..1] participantRole (CONF:1098-16320).

      52. Observation.participant:consumable.participantRole.classCode
      Comments

      This participantRole SHALL contain exactly one [1..1] @classCode="MANU" Manufactured Product (CodeSystem: HL7RoleClass urn:oid:2.16.840.1.113883.5.110 STATIC) (CONF:1098-16321).

      Control1..?
      Fixed ValueMANU
      54. Observation.participant:consumable.participantRole.playingEntity
      Comments

      This participantRole SHALL contain exactly one [1..1] playingEntity (CONF:1098-16322).

      Control1..?
      56. Observation.participant:consumable.participantRole.playingEntity.classCode
      Comments

      This playingEntity SHALL contain exactly one [1..1] @classCode="MMAT" Manufactured Material (CodeSystem: HL7EntityClass urn:oid:2.16.840.1.113883.5.41 STATIC) (CONF:1098-16323).

      Control1..?
      Fixed ValueMMAT
      58. Observation.participant:consumable.participantRole.playingEntity.code
      Comments

      This playingEntity SHALL contain exactly one [1..1] code, which MAY be selected from ValueSet Substance Reactant for Intolerance urn:oid:2.16.840.1.113762.1.4.1010.1 DYNAMIC (CONF:1098-16324).

      Control1..?
      BindingThe codes SHOULD be taken from Substance Reactant for Intolerance .
      (preferred to http://cts.nlm.nih.gov/fhir/ValueSet/2.16.840.1.113762.1.4.1010.1)
      60. Observation.entryRelationship
      Comments

      SHOULD contain zero or one [0..1] entryRelationship (CONF:1098-32935) such that it

      SlicingThis element introduces a set of slices on Observation.entryRelationship. The slices areUnordered and Open, and can be differentiated using the following discriminators:
      • profile @ observation
      • 62. Observation.entryRelationship:status
        Slice Namestatus
        ShortentryRelationship
        Comments

        MAY contain zero or one [0..1] entryRelationship (CONF:1098-16333) such that it

        Control0..1
        64. Observation.entryRelationship:status.typeCode
        Comments

        SHALL contain exactly one [1..1] @typeCode="SUBJ" Has subject (CodeSystem: HL7ActRelationshipType urn:oid:2.16.840.1.113883.5.1002 STATIC) (CONF:1098-16335).

        Fixed ValueSUBJ
        66. Observation.entryRelationship:status.inversionInd
        Comments

        SHALL contain exactly one [1..1] @inversionInd="true" True (CONF:1098-16334).

        Control1..?
        Fixed Valuetrue
        68. Observation.entryRelationship:status.observation
        Comments

        SHALL contain exactly one [1..1] Allergy Status Observation (identifier: urn:hl7ii:2.16.840.1.113883.10.20.22.4.28:2019-06-20) (CONF:1098-16336).

        Control1..?
        Typehttp://hl7.org/cda/stds/core/StructureDefinition/Observation(Allergy Status Observation)
        70. Observation.entryRelationship:reaction
        Slice Namereaction
        ShortentryRelationship
        Comments

        SHOULD contain zero or more [0..*] entryRelationship (CONF:1098-16337) such that it

        Control0..*
        72. Observation.entryRelationship:reaction.typeCode
        Comments

        SHALL contain exactly one [1..1] @typeCode="MFST" Is Manifestation of (CodeSystem: HL7ActRelationshipType urn:oid:2.16.840.1.113883.5.1002 STATIC) (CONF:1098-16339).

        Fixed ValueMFST
        74. Observation.entryRelationship:reaction.inversionInd
        Comments

        SHALL contain exactly one [1..1] @inversionInd="true" True (CONF:1098-16338).

        Control1..?
        Fixed Valuetrue
        76. Observation.entryRelationship:reaction.observation
        Comments

        SHALL contain exactly one [1..1] Reaction Observation (identifier: urn:hl7ii:2.16.840.1.113883.10.20.22.4.9:2014-06-09) (CONF:1098-16340).

        Control1..?
        Typehttp://hl7.org/cda/stds/core/StructureDefinition/Observation(Reaction Observation)
        78. Observation.entryRelationship:severity
        Slice Nameseverity
        ShortentryRelationship
        Comments

        SHOULD NOT contain zero or one [0..1] entryRelationship (CONF:1098-16341) such that it

        Control0..1
        80. Observation.entryRelationship:severity.typeCode
        Comments

        SHALL contain exactly one [1..1] @typeCode="SUBJ" Has Subject (CodeSystem: HL7ActRelationshipType urn:oid:2.16.840.1.113883.5.1002 STATIC) (CONF:1098-16342).

        Fixed ValueSUBJ
        82. Observation.entryRelationship:severity.inversionInd
        Comments

        SHALL contain exactly one [1..1] @inversionInd="true" True (CONF:1098-16343).

        Control1..?
        Fixed Valuetrue
        84. Observation.entryRelationship:severity.observation
        Comments

        SHALL contain exactly one [1..1] Severity Observation (identifier: urn:hl7ii:2.16.840.1.113883.10.20.22.4.8:2014-06-09) (CONF:1098-16344).

        Control1..?
        Typehttp://hl7.org/cda/stds/core/StructureDefinition/Observation(Severity Observation)
        86. Observation.entryRelationship:criticality
        Slice Namecriticality
        ShortentryRelationship
        Control0..1
        88. Observation.entryRelationship:criticality.typeCode
        Comments

        SHALL contain exactly one [1..1] @typeCode="SUBJ" Has Subject (CodeSystem: HL7ActRelationshipType urn:oid:2.16.840.1.113883.5.1002) (CONF:1098-32936).

        Fixed ValueSUBJ
        90. Observation.entryRelationship:criticality.inversionInd
        Comments

        SHALL contain exactly one [1..1] @inversionInd="true" True (CONF:1098-32937).

        Control1..?
        Fixed Valuetrue
        92. Observation.entryRelationship:criticality.observation
        Comments

        SHALL contain exactly one [1..1] Criticality Observation (identifier: urn:oid:2.16.840.1.113883.10.20.22.4.145) (CONF:1098-32938).

        Control1..?
        Typehttp://hl7.org/cda/stds/core/StructureDefinition/Observation(Criticality Observation)