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: ImmunizationActivity - Detailed Descriptions

Draft as of 2024-12-19

Definitions for the ImmunizationActivity logical model.

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

0. SubstanceAdministration
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-doseQuantity: SHOULD contain doseQuantity (doseQuantity.exists())
dose-unit-or-admin-unit: If doseQuantity/@unit is present, then administrationUnitCode SHALL NOT be present. (doseQuantity.unit.exists() implies administrationUnitCode.empty())
should-performer: SHOULD contain performer (performer.exists())
should-author: SHOULD contain author (author.exists())
2. SubstanceAdministration.templateId
Control1..?
SlicingThis element introduces a set of slices on SubstanceAdministration.templateId. The slices areUnordered and Open, and can be differentiated using the following discriminators:
  • value @ root
  • value @ extension
  • 4. SubstanceAdministration.templateId:immunization-activity
    Slice Nameimmunization-activity
    Control1..1
    6. SubstanceAdministration.templateId:immunization-activity.root
    Control1..?
    Pattern Value2.16.840.1.113883.10.20.22.4.52
    8. SubstanceAdministration.templateId:immunization-activity.extension
    Control1..?
    Pattern Value2015-08-01
    10. SubstanceAdministration.classCode
    Comments

    SHALL contain exactly one [1..1] @classCode="SBADM" (CodeSystem: HL7ActClass urn:oid:2.16.840.1.113883.5.6 STATIC) (CONF:1198-8826).

    12. SubstanceAdministration.moodCode
    Comments

    SHALL contain exactly one [1..1] @moodCode, which SHALL be selected from ValueSet MoodCodeEvnInt urn:oid:2.16.840.1.113883.11.20.9.18 STATIC (CONF:1198-8827).

    BindingThe codes SHALL be taken from MoodCodeEvnInt .
    (required to http://cts.nlm.nih.gov/fhir/ValueSet/2.16.840.1.113883.11.20.9.18)
    14. SubstanceAdministration.id
    Comments

    SHALL contain at least one [1..*] id (CONF:1198-8829).

    Control1..?
    16. SubstanceAdministration.code
    ShortSubstanceAdministration.code is an optional field. Per HL7 Pharmacy Committee, "this is intended to further specify the nature of the substance administration act. To date the committee has made no use of this attribute". Because the type of substance administration is generally implicit in the routeCode, in the consumable participant, etc., the field is generally not used and there is no defined value set.
    Comments

    MAY contain zero or one [0..1] code (CONF:1198-8830).

    18. SubstanceAdministration.negationInd
    ShortUse negationInd="true" to indicate that the immunization was not given.
    Comments

    SHALL contain exactly one [1..1] @negationInd (CONF:1198-8985).

    Control1..?
    20. SubstanceAdministration.text
    ShortSHOULD reference the portion of section narrative text corresponding to this entry
    22. SubstanceAdministration.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('#'))
    24. SubstanceAdministration.statusCode
    Comments

    SHALL contain exactly one [1..1] statusCode (CONF:1198-8833).

    Control1..?
    26. SubstanceAdministration.statusCode.nullFlavor
    Control0..0
    28. SubstanceAdministration.statusCode.code
    Control1..?
    BindingThe codes SHALL be taken from ActStatus
    (required to http://terminology.hl7.org/ValueSet/v3-ActStatus)
    30. SubstanceAdministration.effectiveTime
    Comments

    SHALL contain exactly one [1..1] effectiveTime (CONF:1198-8834).

    Control1..1
    32. SubstanceAdministration.repeatNumber
    ShortIn "INT" (intent) mood, the repeatNumber defines the number of allowed administrations. For example, a repeatNumber of "3" means that the substance can be administered up to 3 times. In "EVN" (event) mood, the repeatNumber is the number of occurrences. For example, a repeatNumber of "3" in a substance administration event means that the current administration is the 3rd in a series.
    Invariantsvalue-only: Interval fields SHALL NOT be present ((low | high | width | center).empty())
    34. SubstanceAdministration.repeatNumber.value
    Shortvalue should be used instead of low/high
    36. SubstanceAdministration.routeCode
    Comments

    MAY contain zero or one [0..1] routeCode, which SHALL be selected from ValueSet SPL Drug Route of Administration Terminology urn:oid:2.16.840.1.113883.3.88.12.3221.8.7 DYNAMIC (CONF:1198-8839).

    BindingThe codes SHALL be taken from SPL Drug Route of Administration Terminology .
    (required to http://cts.nlm.nih.gov/fhir/ValueSet/2.16.840.1.113883.3.88.12.3221.8.7)
    Invariantsshould-translation: SHOULD contain translation (translation.exists())
    38. SubstanceAdministration.routeCode.translation
    Comments

    The routeCode, if present, SHOULD contain zero or more [0..*] translation, which SHOULD be selected from ValueSet Medication Route urn:oid:2.16.840.1.113762.1.4.1099.12 DYNAMIC (CONF:1198-32960).

    BindingThe codes SHOULD be taken from Medication Route .
    (preferred to http://cts.nlm.nih.gov/fhir/ValueSet/2.16.840.1.113762.1.4.1099.12)
    40. SubstanceAdministration.approachSiteCode
    Comments

    MAY contain zero or one [0..1] approachSiteCode, where the code SHALL be selected from ValueSet Body Site Value Set urn:oid:2.16.840.1.113883.3.88.12.3221.8.9 DYNAMIC (CONF:1198-8840).

    Control0..1
    BindingThe codes SHALL be taken from Body Site Value Set .
    (required to http://cts.nlm.nih.gov/fhir/ValueSet/2.16.840.1.113883.3.88.12.3221.8.9)
    42. SubstanceAdministration.doseQuantity
    Comments

    SHOULD contain zero or one [0..1] doseQuantity (CONF:1198-8841).

    Invariantsshould-unit: SHOULD contain @unit (nullFlavor.exists() or unit.exists())
    44. SubstanceAdministration.doseQuantity.unit
    ShortNOTE: The base CDA R2.0 standard requires @unit to be drawn from UCUM, and best practice is to use case sensitive UCUM units
    Comments

    The doseQuantity, if present, SHOULD contain zero or one [0..1] @unit, which SHOULD be selected from ValueSet UnitsOfMeasureCaseSensitive urn:oid:2.16.840.1.113883.1.11.12839 DYNAMIC (CONF:1198-8842).

    BindingThe codes SHOULD be taken from UnitsOfMeasureCaseSensitive
    (preferred to http://terminology.hl7.org/ValueSet/v3-UnitsOfMeasureCaseSensitive)
    46. SubstanceAdministration.administrationUnitCode
    Comments

    MAY contain zero or one [0..1] administrationUnitCode, which SHALL be selected from ValueSet AdministrationUnitDoseForm urn:oid:2.16.840.1.113762.1.4.1021.30 DYNAMIC (CONF:1198-8846).

    BindingThe codes SHALL be taken from AdministrationUnitDoseForm .
    (required to http://cts.nlm.nih.gov/fhir/ValueSet/2.16.840.1.113762.1.4.1021.30)
    48. SubstanceAdministration.consumable
    Comments

    SHALL contain exactly one [1..1] consumable (CONF:1198-8847).

    50. SubstanceAdministration.consumable.manufacturedProduct
    Comments

    This consumable SHALL contain exactly one [1..1] Immunization Medication Information (identifier: urn:hl7ii:2.16.840.1.113883.10.20.22.4.54:2014-06-09) (CONF:1198-15546).

    Typehttp://hl7.org/cda/stds/core/StructureDefinition/ManufacturedProduct(Immunization Medication Information)
    52. SubstanceAdministration.performer
    Comments

    SHOULD contain zero or one [0..1] performer (CONF:1198-8849).

    Control0..1
    54. SubstanceAdministration.author
    Comments

    SHOULD contain zero or more [0..*] Author Participation (identifier: urn:oid:2.16.840.1.113883.10.20.22.4.119) (CONF:1198-31151).

    Typehttp://hl7.org/cda/stds/core/StructureDefinition/Author(Author Participation)
    56. SubstanceAdministration.participant
    SlicingThis element introduces a set of slices on SubstanceAdministration.participant. The slices areUnordered and Open, and can be differentiated using the following discriminators:
    • value @ typeCode
    • 58. SubstanceAdministration.participant:drugVehicle
      Slice NamedrugVehicle
      Comments

      MAY contain zero or more [0..*] participant (CONF:1198-8850) such that it

      Control0..*
      60. SubstanceAdministration.participant:drugVehicle.typeCode
      Comments

      SHALL contain exactly one [1..1] @typeCode="CSM" (CodeSystem: HL7ParticipationType urn:oid:2.16.840.1.113883.5.90 STATIC) (CONF:1198-8851).

      Fixed ValueCSM
      62. SubstanceAdministration.participant:drugVehicle.participantRole
      Comments

      SHALL contain exactly one [1..1] Drug Vehicle (identifier: urn:oid:2.16.840.1.113883.10.20.22.4.24) (CONF:1198-15547).

      Typehttp://hl7.org/cda/stds/core/StructureDefinition/ParticipantRole(Drug Vehicle)
      64. SubstanceAdministration.entryRelationship
      SlicingThis element introduces a set of slices on SubstanceAdministration.entryRelationship. The slices areUnordered and Open, and can be differentiated using the following discriminators:
      • profile @ act
      • profile @ observation
      • profile @ supply
      • 66. SubstanceAdministration.entryRelationship:indication
        Slice Nameindication
        Comments

        MAY contain zero or more [0..*] entryRelationship (CONF:1198-8853) such that it

        Control0..*
        68. SubstanceAdministration.entryRelationship:indication.typeCode
        Comments

        SHALL contain exactly one [1..1] @typeCode="RSON" (CodeSystem: HL7ActRelationshipType urn:oid:2.16.840.1.113883.5.1002 STATIC) (CONF:1198-8854).

        Fixed ValueRSON
        70. SubstanceAdministration.entryRelationship:indication.observation
        Comments

        SHALL contain exactly one [1..1] Indication (identifier: urn:hl7ii:2.16.840.1.113883.10.20.22.4.19:2014-06-09) (CONF:1198-15537).

        Control1..?
        Typehttp://hl7.org/cda/stds/core/StructureDefinition/Observation(Indication)
        72. SubstanceAdministration.entryRelationship:indication.observation.code
        ShortIndication for Immunization
        74. SubstanceAdministration.entryRelationship:indication.observation.code.code
        Control1..?
        Pattern Value59785-6
        76. SubstanceAdministration.entryRelationship:indication.observation.code.codeSystem
        ShortLOINC
        Control1..?
        Pattern Value2.16.840.1.113883.6.1
        78. SubstanceAdministration.entryRelationship:instruction
        Slice Nameinstruction
        Comments

        MAY contain zero or one [0..1] entryRelationship (CONF:1198-8856) such that it

        Control0..1
        80. SubstanceAdministration.entryRelationship:instruction.typeCode
        Comments

        SHALL contain exactly one [1..1] @typeCode="SUBJ" (CodeSystem: HL7ActRelationshipType urn:oid:2.16.840.1.113883.5.1002 STATIC) (CONF:1198-8857).

        Fixed ValueSUBJ
        82. SubstanceAdministration.entryRelationship:instruction.inversionInd
        Comments

        SHALL contain exactly one [1..1] @inversionInd="true" True (CONF:1198-8858).

        Control1..?
        Fixed Valuetrue
        84. SubstanceAdministration.entryRelationship:instruction.observation
        Control1..?
        Typehttp://hl7.org/cda/stds/core/StructureDefinition/Observation(Instruction Observation)
        86. SubstanceAdministration.entryRelationship:medSupplyOrder
        Slice NamemedSupplyOrder
        Comments

        MAY contain zero or one [0..1] entryRelationship (CONF:1198-8860) such that it

        Control0..1
        88. SubstanceAdministration.entryRelationship:medSupplyOrder.typeCode
        Comments

        SHALL contain exactly one [1..1] @typeCode="REFR" (CodeSystem: HL7ActRelationshipType urn:oid:2.16.840.1.113883.5.1002 STATIC) (CONF:1198-8861).

        Fixed ValueREFR
        90. SubstanceAdministration.entryRelationship:medSupplyOrder.supply
        Comments

        SHALL contain exactly one [1..1] Medication Supply Order (identifier: urn:hl7ii:2.16.840.1.113883.10.20.22.4.17:2014-06-09) (CONF:1198-15539).

        Control1..?
        Typehttp://hl7.org/cda/stds/core/StructureDefinition/Supply(Medication Supply Order)
        92. SubstanceAdministration.entryRelationship:medDispense
        Slice NamemedDispense
        Comments

        MAY contain zero or one [0..1] entryRelationship (CONF:1198-8863) such that it

        Control0..1
        94. SubstanceAdministration.entryRelationship:medDispense.typeCode
        Comments

        SHALL contain exactly one [1..1] @typeCode="REFR" (CodeSystem: HL7ActRelationshipType urn:oid:2.16.840.1.113883.5.1002 STATIC) (CONF:1198-8864).

        Fixed ValueREFR
        96. SubstanceAdministration.entryRelationship:medDispense.supply
        Comments

        SHALL contain exactly one [1..1] Medication Dispense (identifier: urn:hl7ii:2.16.840.1.113883.10.20.22.4.18:2014-06-09) (CONF:1198-15540).

        Control1..?
        Typehttp://hl7.org/cda/stds/core/StructureDefinition/Supply(Medication Dispense)
        98. SubstanceAdministration.entryRelationship:reactionObs
        Slice NamereactionObs
        Comments

        MAY contain zero or one [0..1] entryRelationship (CONF:1198-8866) such that it

        Control0..1
        100. SubstanceAdministration.entryRelationship:reactionObs.typeCode
        Comments

        SHALL contain exactly one [1..1] @typeCode="CAUS" (CodeSystem: HL7ActRelationshipType urn:oid:2.16.840.1.113883.5.1002 STATIC) (CONF:1198-8867).

        Fixed ValueCAUS
        102. SubstanceAdministration.entryRelationship:reactionObs.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:1198-15541).

        Control1..?
        Typehttp://hl7.org/cda/stds/core/StructureDefinition/Observation(Reaction Observation)
        104. SubstanceAdministration.entryRelationship:immunizationNotGiven
        Slice NameimmunizationNotGiven
        Comments

        MAY contain zero or one [0..1] entryRelationship (CONF:1198-8988) such that it

        Control0..1
        106. SubstanceAdministration.entryRelationship:immunizationNotGiven.typeCode
        Comments

        SHALL contain exactly one [1..1] @typeCode="RSON" (CodeSystem: HL7ActRelationshipType urn:oid:2.16.840.1.113883.5.1002 STATIC) (CONF:1198-8989).

        Fixed ValueRSON
        108. SubstanceAdministration.entryRelationship:immunizationNotGiven.observation
        Comments

        SHALL contain exactly one [1..1] Immunization Not Given Reason (identifier: urn:oid:2.16.840.1.113883.10.20.22.4.53:2024-05-01) (CONF:1198-15542).

        Control1..?
        Typehttp://hl7.org/cda/stds/core/StructureDefinition/Observation(Immunization Not Given Reason)
        110. SubstanceAdministration.entryRelationship:substanceAdmin
        Slice NamesubstanceAdmin
        ShortThe following entryRelationship is used to indicate a given immunization's order in a series. The nested Substance Administered Act identifies an administration in the series. The entryRelationship/sequenceNumber shows the order of this particular administration in that series.
        Comments

        SHOULD contain zero or more [0..*] entryRelationship (CONF:1198-31510) such that it

        Control0..*
        112. SubstanceAdministration.entryRelationship:substanceAdmin.typeCode
        Comments

        SHALL contain exactly one [1..1] @typeCode="COMP" Component (CodeSystem: HL7ActRelationshipType urn:oid:2.16.840.1.113883.5.1002) (CONF:1198-31511).

        Fixed ValueCOMP
        114. SubstanceAdministration.entryRelationship:substanceAdmin.inversionInd
        Comments

        SHALL contain exactly one [1..1] @inversionInd="true" (CONF:1198-31512).

        Control1..?
        Fixed Valuetrue
        116. SubstanceAdministration.entryRelationship:substanceAdmin.sequenceNumber
        Comments

        MAY contain zero or one [0..1] sequenceNumber (CONF:1198-31513).

        118. SubstanceAdministration.entryRelationship:substanceAdmin.act
        Comments

        SHALL contain exactly one [1..1] Substance Administered Act (identifier: urn:oid:2.16.840.1.113883.10.20.22.4.118) (CONF:1198-31514).

        Control1..?
        Typehttp://hl7.org/cda/stds/core/StructureDefinition/Act(Substance Administered Act)
        120. SubstanceAdministration.precondition
        SlicingThis element introduces a set of slices on SubstanceAdministration.precondition. The slices areUnordered and Open, and can be differentiated using the following discriminators:
        • profile @ criterion
        • 122. SubstanceAdministration.precondition:substanceAdmin
          Slice NamesubstanceAdmin
          Comments

          MAY contain zero or more [0..*] precondition (CONF:1198-8869) such that it

          Control0..*
          124. SubstanceAdministration.precondition:substanceAdmin.typeCode
          Comments

          SHALL contain exactly one [1..1] @typeCode="PRCN" (CodeSystem: HL7ActRelationshipType urn:oid:2.16.840.1.113883.5.1002 STATIC) (CONF:1198-8870).

          Control1..?
          126. SubstanceAdministration.precondition:substanceAdmin.criterion
          Comments

          SHALL contain exactly one [1..1] Precondition for Substance Administration (identifier: urn:hl7ii:2.16.840.1.113883.10.20.22.4.25:2014-06-09) (CONF:1198-15548).

          Typehttp://hl7.org/cda/stds/core/StructureDefinition/Criterion(Precondition for Substance Administration)