2026 US Quality Core Implementation Guide
0.5.0 - release United States of America flag

This page is part of the US Quality Core (v0.5.0: Release) based on FHIR (HL7® FHIR® Standard) R4. This is the current published version. For a full list of available versions, see the Directory of published versions

Resource Profile: US Quality Core Immunization Not Done

Official URL: http://fhir.org/guides/onc/us-quality-core/StructureDefinition/us-quality-core-immunizationnotdone Version: 0.5.0
Active as of 2026-06-05 Computable Name: USQualityCoreImmunizationNotDone

Negation profile of Immunization for decision support/quality metrics. Defines the core set of elements and extensions for quality rule and measure authors.

USCDI+ Quality Element Support Expectations

Systems are expected to support this profile as part of implementing USCDI+ Quality V1 in FHIR and meeting the conformance requirements of this guide.

The following elements are specifically relevant to USCDI+ Quality V1 data classes and elements. Systems are expected to support these elements as applicable to their role in US Quality Core data exchange. See the Must Support section of this guide for more information. These elements are tagged as (USCDI+ Quality) in the formal profile views.

USCDI+ Quality Elements:

  • status: (USCDI+ Quality) (USCDI) completed | entered-in-error | not-done
  • occurrence[x]: (USCDI+ Quality) (USCDI) Vaccine administration date

Because this profile is derived from US Core, systems are also expected to support Must Support requirements and (USCDI) tagged elements inherited from US Core. The Formal Views section also provides the formal summary, definitions, terminology requirements, and mandatory element requirements.

Profile Specific Implementation Guidance

This profile represents an immunization event that intentionally did not occur for a medical, patient, or system reason. To represent immunization events that did occur, use the US Quality Core Immunization profile.

Additional informational guidance for authoring CQL using this profile is provided in the CQL Authoring Usage (Informational) section of this page.

Usages:

You can also check for usages in the FHIR IG Statistics

Formal Views of Profile Content

Description Differentials, Snapshots, and other representations.

NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. Immunization C 0..* USCoreImmunizationProfile(6.1.0) Immunization event information
Constraints: us-core-5, ind-1
... implicitRules ?!Σ 0..1 uri A set of rules under which this content was created
... modifierExtension ?! 0..* Extension Extensions that cannot be ignored
... status ?!SΣ 1..1 code (USCDI+ Quality) (USCDI) completed | entered-in-error | not-done
Binding: ImmunizationStatusCodes (required)
Fixed Value: not-done
... vaccineCode SΣC 1..1 CodeableConcept (USCDI) Vaccine Product Type (bind to CVX)
Binding: CVX Vaccines Administered Vaccine Set . (extensible)
.... Slices for extension Content/Rules for all slices
..... extension:notDoneValueSet C 0..1 canonical(ValueSet) What wasn't administered
URL: http://fhir.org/guides/onc/us-quality-core/StructureDefinition/us-quality-core-notDoneValueSet
... patient SΣ 1..1 Reference(US Quality Core Patient) (USCDI) Who was immunized
... occurrence[x] SΣ 1..1 (USCDI+ Quality) (USCDI) Vaccine administration date
.... occurrenceDateTime dateTime S
.... occurrenceString string
... recorded 1..1 dateTime When the immunization was first captured in the subject's record
... primarySource SΣ 0..1 boolean (USCDI) Indicates context the data was recorded in
... isSubpotent ?!Σ 0..1 boolean Dose potency

doco Documentation for this format

Terminology Bindings

Path Status Usage ValueSet Version Source
Immunization.status Base required Immunization Status Codes 📦4.0.1 FHIR Std.
Immunization.statusReason Base extensible USQualityCore Negation Reason Codes 📦0.5.0 This IG
Immunization.vaccineCode Base extensible CVX Vaccines Administered Vaccine Set . 📦20230715 VSAC v0.18

Constraints

Id Grade Path(s) Description Expression
dom-2 error Immunization If the resource is contained in another resource, it SHALL NOT contain nested Resources contained.contained.empty()
dom-3 error Immunization If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().as(canonical) | %resource.descendants().as(uri) | %resource.descendants().as(url))) or descendants().where(reference = '#').exists() or descendants().where(as(canonical) = '#').exists() or descendants().where(as(canonical) = '#').exists()).not()).trace('unmatched', id).empty()
dom-4 error Immunization If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated contained.meta.versionId.empty() and contained.meta.lastUpdated.empty()
dom-5 error Immunization If a resource is contained in another resource, it SHALL NOT have a security label contained.meta.security.empty()
dom-6 best practice Immunization A resource should have narrative for robust management text.`div`.exists()
ele-1 error **ALL** elements All FHIR elements must have a @value or children hasValue() or (children().count() > id.count())
ext-1 error **ALL** extensions Must have either extensions or value[x], not both extension.exists() != value.exists()
ind-1 error Immunization To indicate what immunization was not done, either at least one coding in the vaccineCode element or a notDoneValueSet extension shall be provided vaccineCode.extension('http://fhir.org/guides/onc/us-quality-core/StructureDefinition/us-quality-core-notDoneValueSet').exists() xor vaccineCode.coding.exists()
us-core-5 best practice Immunization SHOULD have a translation to the NDC value set vaccineCode.coding.where(system='http://hl7.org/fhir/sid/ndc').empty()

NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. Immunization C 0..* USCoreImmunizationProfile(6.1.0) Immunization event information
Constraints: ind-1
... status 1..1 code (USCDI+ Quality) (USCDI) completed | entered-in-error | not-done
Fixed Value: not-done
... statusReason 1..1 CodeableConcept (USCDI) Reason not done
Binding: USQualityCore Negation Reason Codes (extensible): The reason the service was not requested
... vaccineCode 1..1 CodeableConcept (USCDI) Vaccine Product Type (bind to CVX)
.... Slices for extension Content/Rules for all slices
..... extension:notDoneValueSet C 0..1 canonical(ValueSet) What wasn't administered
URL: http://fhir.org/guides/onc/us-quality-core/StructureDefinition/us-quality-core-notDoneValueSet
... occurrence[x] 1..1 dateTime, string (USCDI+ Quality) (USCDI) Vaccine administration date
... recorded 1..1 dateTime When the immunization was first captured in the subject's record

doco Documentation for this format

Terminology Bindings (Differential)

Path Status Usage ValueSet Version Source
Immunization.statusReason Base extensible USQualityCore Negation Reason Codes 📦0.5.0 This IG

Constraints

Id Grade Path(s) Description Expression
ind-1 error Immunization To indicate what immunization was not done, either at least one coding in the vaccineCode element or a notDoneValueSet extension shall be provided vaccineCode.extension('http://fhir.org/guides/onc/us-quality-core/StructureDefinition/us-quality-core-notDoneValueSet').exists() xor vaccineCode.coding.exists()
NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. Immunization C 0..* USCoreImmunizationProfile(6.1.0) Immunization event information
Constraints: us-core-5, ind-1
... id Σ 0..1 id Logical id of this artifact
... meta Σ 0..1 Meta Metadata about the resource
... implicitRules ?!Σ 0..1 uri A set of rules under which this content was created
... language 0..1 code Language of the resource content
Binding: CommonLanguages (preferred): A human language.
Additional BindingsPurpose
AllLanguages Max Binding
... text 0..1 Narrative Text summary of the resource, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
... contained 0..* Resource Contained, inline Resources
... extension 0..* Extension Additional content defined by implementations
... modifierExtension ?! 0..* Extension Extensions that cannot be ignored
... identifier 0..* Identifier Business identifier
... status ?!SΣ 1..1 code (USCDI+ Quality) (USCDI) completed | entered-in-error | not-done
Binding: ImmunizationStatusCodes (required)
Fixed Value: not-done
... statusReason S 1..1 CodeableConcept (USCDI) Reason not done
Binding: USQualityCore Negation Reason Codes (extensible): The reason the service was not requested
... vaccineCode SΣC 1..1 CodeableConcept (USCDI) Vaccine Product Type (bind to CVX)
Binding: CVX Vaccines Administered Vaccine Set . (extensible)
.... id 0..1 string Unique id for inter-element referencing
.... Slices for extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
..... extension:notDoneValueSet C 0..1 canonical(ValueSet) What wasn't administered
URL: http://fhir.org/guides/onc/us-quality-core/StructureDefinition/us-quality-core-notDoneValueSet
.... coding Σ 0..* Coding Code defined by a terminology system
.... text Σ 0..1 string Plain text representation of the concept
... patient SΣ 1..1 Reference(US Quality Core Patient) (USCDI) Who was immunized
... encounter 0..1 Reference(Encounter) Encounter immunization was part of
... occurrence[x] SΣ 1..1 (USCDI+ Quality) (USCDI) Vaccine administration date
.... occurrenceDateTime dateTime S
.... occurrenceString string
... recorded 1..1 dateTime When the immunization was first captured in the subject's record
... primarySource SΣ 0..1 boolean (USCDI) Indicates context the data was recorded in
... reportOrigin 0..1 CodeableConcept Indicates the source of a secondarily reported record
Binding: ImmunizationOriginCodes (example): The source of the data for a record which is not from a primary source.
... location 0..1 Reference(Location) Where immunization occurred
... manufacturer 0..1 Reference(Organization) Vaccine manufacturer
... lotNumber 0..1 string Vaccine lot number
... expirationDate 0..1 date Vaccine expiration date
... site 0..1 CodeableConcept Body site vaccine was administered
Binding: CodesForImmunizationSiteOfAdministration (example): The site at which the vaccine was administered.
... route 0..1 CodeableConcept How vaccine entered body
Binding: ImmunizationRouteCodes (example): The route by which the vaccine was administered.
... doseQuantity 0..1 SimpleQuantity Amount of vaccine administered
... performer Σ 0..* BackboneElement Who performed event
.... id 0..1 string Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... function Σ 0..1 CodeableConcept What type of performance was done
Binding: ImmunizationFunctionCodes (extensible): The role a practitioner or organization plays in the immunization event.
.... actor Σ 1..1 Reference(Practitioner | PractitionerRole | Organization) Individual or organization who was performing
... note Σ 0..* Annotation Additional immunization notes
... reasonCode 0..* CodeableConcept Why immunization occurred
Binding: ImmunizationReasonCodes (example): The reason why a vaccine was administered.
... reasonReference 0..* Reference(Condition | Observation | DiagnosticReport) Why immunization occurred
... isSubpotent ?!Σ 0..1 boolean Dose potency
... subpotentReason 0..* CodeableConcept Reason for being subpotent
Binding: ImmunizationSubpotentReason (example): The reason why a dose is considered to be subpotent.
... education C 0..* BackboneElement Educational material presented to patient
Constraints: imm-1
.... id 0..1 string Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... documentType 0..1 string Educational material document identifier
.... reference 0..1 uri Educational material reference pointer
.... publicationDate 0..1 dateTime Educational material publication date
.... presentationDate 0..1 dateTime Educational material presentation date
... programEligibility 0..* CodeableConcept Patient eligibility for a vaccination program
Binding: ImmunizationProgramEligibility (example): The patient's eligibility for a vaccation program.
... fundingSource 0..1 CodeableConcept Funding source for the vaccine
Binding: ImmunizationFundingSource (example): The source of funding used to purchase the vaccine administered.
... reaction 0..* BackboneElement Details of a reaction that follows immunization
.... id 0..1 string Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... date 0..1 dateTime When reaction started
.... detail 0..1 Reference(Observation) Additional information on reaction
.... reported 0..1 boolean Indicates self-reported reaction
... protocolApplied 0..* BackboneElement Protocol followed by the provider
.... id 0..1 string Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... series 0..1 string Name of vaccine series
.... authority 0..1 Reference(Organization) Who is responsible for publishing the recommendations
.... targetDisease 0..* CodeableConcept Vaccine preventatable disease being targetted
Binding: ImmunizationTargetDiseaseCodes (example): The vaccine preventable disease the dose is being administered for.
.... doseNumber[x] 1..1 Dose number within series
..... doseNumberPositiveInt positiveInt
..... doseNumberString string
.... seriesDoses[x] 0..1 Recommended number of doses for immunity
..... seriesDosesPositiveInt positiveInt
..... seriesDosesString string

doco Documentation for this format

Terminology Bindings

Path Status Usage ValueSet Version Source
Immunization.language Base preferred Common Languages 📦4.0.1 FHIR Std.
Immunization.status Base required Immunization Status Codes 📦4.0.1 FHIR Std.
Immunization.statusReason Base extensible USQualityCore Negation Reason Codes 📦0.5.0 This IG
Immunization.vaccineCode Base extensible CVX Vaccines Administered Vaccine Set . 📦20230715 VSAC v0.18
Immunization.reportOrigin Base example Immunization Origin Codes 📦4.0.1 FHIR Std.
Immunization.site Base example Codes for Immunization Site of Administration 📦4.0.1 FHIR Std.
Immunization.route Base example Immunization Route Codes 📦4.0.1 FHIR Std.
Immunization.performer.​function Base extensible Immunization Function Codes 📦4.0.1 FHIR Std.
Immunization.reasonCode Base example Immunization Reason Codes 📦4.0.1 FHIR Std.
Immunization.subpotentReason Base example Immunization Subpotent Reason 📦4.0.1 FHIR Std.
Immunization.programEligibility Base example Immunization Program Eligibility 📦4.0.1 FHIR Std.
Immunization.fundingSource Base example Immunization Funding Source 📦4.0.1 FHIR Std.
Immunization.protocolApplied.​targetDisease Base example Immunization Target Disease Codes 📦4.0.1 FHIR Std.

Constraints

Id Grade Path(s) Description Expression
dom-2 error Immunization If the resource is contained in another resource, it SHALL NOT contain nested Resources contained.contained.empty()
dom-3 error Immunization If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().as(canonical) | %resource.descendants().as(uri) | %resource.descendants().as(url))) or descendants().where(reference = '#').exists() or descendants().where(as(canonical) = '#').exists() or descendants().where(as(canonical) = '#').exists()).not()).trace('unmatched', id).empty()
dom-4 error Immunization If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated contained.meta.versionId.empty() and contained.meta.lastUpdated.empty()
dom-5 error Immunization If a resource is contained in another resource, it SHALL NOT have a security label contained.meta.security.empty()
dom-6 best practice Immunization A resource should have narrative for robust management text.`div`.exists()
ele-1 error **ALL** elements All FHIR elements must have a @value or children hasValue() or (children().count() > id.count())
ext-1 error **ALL** extensions Must have either extensions or value[x], not both extension.exists() != value.exists()
imm-1 error Immunization.education One of documentType or reference SHALL be present documentType.exists() or reference.exists()
ind-1 error Immunization To indicate what immunization was not done, either at least one coding in the vaccineCode element or a notDoneValueSet extension shall be provided vaccineCode.extension('http://fhir.org/guides/onc/us-quality-core/StructureDefinition/us-quality-core-notDoneValueSet').exists() xor vaccineCode.coding.exists()
us-core-5 best practice Immunization SHOULD have a translation to the NDC value set vaccineCode.coding.where(system='http://hl7.org/fhir/sid/ndc').empty()

Summary

Mandatory: 2 elements
Fixed: 1 element

Structures

This structure refers to these other structures:

Extensions

This structure refers to these extensions:

Key Elements View

NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. Immunization C 0..* USCoreImmunizationProfile(6.1.0) Immunization event information
Constraints: us-core-5, ind-1
... implicitRules ?!Σ 0..1 uri A set of rules under which this content was created
... modifierExtension ?! 0..* Extension Extensions that cannot be ignored
... status ?!SΣ 1..1 code (USCDI+ Quality) (USCDI) completed | entered-in-error | not-done
Binding: ImmunizationStatusCodes (required)
Fixed Value: not-done
... vaccineCode SΣC 1..1 CodeableConcept (USCDI) Vaccine Product Type (bind to CVX)
Binding: CVX Vaccines Administered Vaccine Set . (extensible)
.... Slices for extension Content/Rules for all slices
..... extension:notDoneValueSet C 0..1 canonical(ValueSet) What wasn't administered
URL: http://fhir.org/guides/onc/us-quality-core/StructureDefinition/us-quality-core-notDoneValueSet
... patient SΣ 1..1 Reference(US Quality Core Patient) (USCDI) Who was immunized
... occurrence[x] SΣ 1..1 (USCDI+ Quality) (USCDI) Vaccine administration date
.... occurrenceDateTime dateTime S
.... occurrenceString string
... recorded 1..1 dateTime When the immunization was first captured in the subject's record
... primarySource SΣ 0..1 boolean (USCDI) Indicates context the data was recorded in
... isSubpotent ?!Σ 0..1 boolean Dose potency

doco Documentation for this format

Terminology Bindings

Path Status Usage ValueSet Version Source
Immunization.status Base required Immunization Status Codes 📦4.0.1 FHIR Std.
Immunization.statusReason Base extensible USQualityCore Negation Reason Codes 📦0.5.0 This IG
Immunization.vaccineCode Base extensible CVX Vaccines Administered Vaccine Set . 📦20230715 VSAC v0.18

Constraints

Id Grade Path(s) Description Expression
dom-2 error Immunization If the resource is contained in another resource, it SHALL NOT contain nested Resources contained.contained.empty()
dom-3 error Immunization If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().as(canonical) | %resource.descendants().as(uri) | %resource.descendants().as(url))) or descendants().where(reference = '#').exists() or descendants().where(as(canonical) = '#').exists() or descendants().where(as(canonical) = '#').exists()).not()).trace('unmatched', id).empty()
dom-4 error Immunization If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated contained.meta.versionId.empty() and contained.meta.lastUpdated.empty()
dom-5 error Immunization If a resource is contained in another resource, it SHALL NOT have a security label contained.meta.security.empty()
dom-6 best practice Immunization A resource should have narrative for robust management text.`div`.exists()
ele-1 error **ALL** elements All FHIR elements must have a @value or children hasValue() or (children().count() > id.count())
ext-1 error **ALL** extensions Must have either extensions or value[x], not both extension.exists() != value.exists()
ind-1 error Immunization To indicate what immunization was not done, either at least one coding in the vaccineCode element or a notDoneValueSet extension shall be provided vaccineCode.extension('http://fhir.org/guides/onc/us-quality-core/StructureDefinition/us-quality-core-notDoneValueSet').exists() xor vaccineCode.coding.exists()
us-core-5 best practice Immunization SHOULD have a translation to the NDC value set vaccineCode.coding.where(system='http://hl7.org/fhir/sid/ndc').empty()

Differential View

NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. Immunization C 0..* USCoreImmunizationProfile(6.1.0) Immunization event information
Constraints: ind-1
... status 1..1 code (USCDI+ Quality) (USCDI) completed | entered-in-error | not-done
Fixed Value: not-done
... statusReason 1..1 CodeableConcept (USCDI) Reason not done
Binding: USQualityCore Negation Reason Codes (extensible): The reason the service was not requested
... vaccineCode 1..1 CodeableConcept (USCDI) Vaccine Product Type (bind to CVX)
.... Slices for extension Content/Rules for all slices
..... extension:notDoneValueSet C 0..1 canonical(ValueSet) What wasn't administered
URL: http://fhir.org/guides/onc/us-quality-core/StructureDefinition/us-quality-core-notDoneValueSet
... occurrence[x] 1..1 dateTime, string (USCDI+ Quality) (USCDI) Vaccine administration date
... recorded 1..1 dateTime When the immunization was first captured in the subject's record

doco Documentation for this format

Terminology Bindings (Differential)

Path Status Usage ValueSet Version Source
Immunization.statusReason Base extensible USQualityCore Negation Reason Codes 📦0.5.0 This IG

Constraints

Id Grade Path(s) Description Expression
ind-1 error Immunization To indicate what immunization was not done, either at least one coding in the vaccineCode element or a notDoneValueSet extension shall be provided vaccineCode.extension('http://fhir.org/guides/onc/us-quality-core/StructureDefinition/us-quality-core-notDoneValueSet').exists() xor vaccineCode.coding.exists()

Snapshot ViewView

NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. Immunization C 0..* USCoreImmunizationProfile(6.1.0) Immunization event information
Constraints: us-core-5, ind-1
... id Σ 0..1 id Logical id of this artifact
... meta Σ 0..1 Meta Metadata about the resource
... implicitRules ?!Σ 0..1 uri A set of rules under which this content was created
... language 0..1 code Language of the resource content
Binding: CommonLanguages (preferred): A human language.
Additional BindingsPurpose
AllLanguages Max Binding
... text 0..1 Narrative Text summary of the resource, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
... contained 0..* Resource Contained, inline Resources
... extension 0..* Extension Additional content defined by implementations
... modifierExtension ?! 0..* Extension Extensions that cannot be ignored
... identifier 0..* Identifier Business identifier
... status ?!SΣ 1..1 code (USCDI+ Quality) (USCDI) completed | entered-in-error | not-done
Binding: ImmunizationStatusCodes (required)
Fixed Value: not-done
... statusReason S 1..1 CodeableConcept (USCDI) Reason not done
Binding: USQualityCore Negation Reason Codes (extensible): The reason the service was not requested
... vaccineCode SΣC 1..1 CodeableConcept (USCDI) Vaccine Product Type (bind to CVX)
Binding: CVX Vaccines Administered Vaccine Set . (extensible)
.... id 0..1 string Unique id for inter-element referencing
.... Slices for extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
..... extension:notDoneValueSet C 0..1 canonical(ValueSet) What wasn't administered
URL: http://fhir.org/guides/onc/us-quality-core/StructureDefinition/us-quality-core-notDoneValueSet
.... coding Σ 0..* Coding Code defined by a terminology system
.... text Σ 0..1 string Plain text representation of the concept
... patient SΣ 1..1 Reference(US Quality Core Patient) (USCDI) Who was immunized
... encounter 0..1 Reference(Encounter) Encounter immunization was part of
... occurrence[x] SΣ 1..1 (USCDI+ Quality) (USCDI) Vaccine administration date
.... occurrenceDateTime dateTime S
.... occurrenceString string
... recorded 1..1 dateTime When the immunization was first captured in the subject's record
... primarySource SΣ 0..1 boolean (USCDI) Indicates context the data was recorded in
... reportOrigin 0..1 CodeableConcept Indicates the source of a secondarily reported record
Binding: ImmunizationOriginCodes (example): The source of the data for a record which is not from a primary source.
... location 0..1 Reference(Location) Where immunization occurred
... manufacturer 0..1 Reference(Organization) Vaccine manufacturer
... lotNumber 0..1 string Vaccine lot number
... expirationDate 0..1 date Vaccine expiration date
... site 0..1 CodeableConcept Body site vaccine was administered
Binding: CodesForImmunizationSiteOfAdministration (example): The site at which the vaccine was administered.
... route 0..1 CodeableConcept How vaccine entered body
Binding: ImmunizationRouteCodes (example): The route by which the vaccine was administered.
... doseQuantity 0..1 SimpleQuantity Amount of vaccine administered
... performer Σ 0..* BackboneElement Who performed event
.... id 0..1 string Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... function Σ 0..1 CodeableConcept What type of performance was done
Binding: ImmunizationFunctionCodes (extensible): The role a practitioner or organization plays in the immunization event.
.... actor Σ 1..1 Reference(Practitioner | PractitionerRole | Organization) Individual or organization who was performing
... note Σ 0..* Annotation Additional immunization notes
... reasonCode 0..* CodeableConcept Why immunization occurred
Binding: ImmunizationReasonCodes (example): The reason why a vaccine was administered.
... reasonReference 0..* Reference(Condition | Observation | DiagnosticReport) Why immunization occurred
... isSubpotent ?!Σ 0..1 boolean Dose potency
... subpotentReason 0..* CodeableConcept Reason for being subpotent
Binding: ImmunizationSubpotentReason (example): The reason why a dose is considered to be subpotent.
... education C 0..* BackboneElement Educational material presented to patient
Constraints: imm-1
.... id 0..1 string Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... documentType 0..1 string Educational material document identifier
.... reference 0..1 uri Educational material reference pointer
.... publicationDate 0..1 dateTime Educational material publication date
.... presentationDate 0..1 dateTime Educational material presentation date
... programEligibility 0..* CodeableConcept Patient eligibility for a vaccination program
Binding: ImmunizationProgramEligibility (example): The patient's eligibility for a vaccation program.
... fundingSource 0..1 CodeableConcept Funding source for the vaccine
Binding: ImmunizationFundingSource (example): The source of funding used to purchase the vaccine administered.
... reaction 0..* BackboneElement Details of a reaction that follows immunization
.... id 0..1 string Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... date 0..1 dateTime When reaction started
.... detail 0..1 Reference(Observation) Additional information on reaction
.... reported 0..1 boolean Indicates self-reported reaction
... protocolApplied 0..* BackboneElement Protocol followed by the provider
.... id 0..1 string Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... series 0..1 string Name of vaccine series
.... authority 0..1 Reference(Organization) Who is responsible for publishing the recommendations
.... targetDisease 0..* CodeableConcept Vaccine preventatable disease being targetted
Binding: ImmunizationTargetDiseaseCodes (example): The vaccine preventable disease the dose is being administered for.
.... doseNumber[x] 1..1 Dose number within series
..... doseNumberPositiveInt positiveInt
..... doseNumberString string
.... seriesDoses[x] 0..1 Recommended number of doses for immunity
..... seriesDosesPositiveInt positiveInt
..... seriesDosesString string

doco Documentation for this format

Terminology Bindings

Path Status Usage ValueSet Version Source
Immunization.language Base preferred Common Languages 📦4.0.1 FHIR Std.
Immunization.status Base required Immunization Status Codes 📦4.0.1 FHIR Std.
Immunization.statusReason Base extensible USQualityCore Negation Reason Codes 📦0.5.0 This IG
Immunization.vaccineCode Base extensible CVX Vaccines Administered Vaccine Set . 📦20230715 VSAC v0.18
Immunization.reportOrigin Base example Immunization Origin Codes 📦4.0.1 FHIR Std.
Immunization.site Base example Codes for Immunization Site of Administration 📦4.0.1 FHIR Std.
Immunization.route Base example Immunization Route Codes 📦4.0.1 FHIR Std.
Immunization.performer.​function Base extensible Immunization Function Codes 📦4.0.1 FHIR Std.
Immunization.reasonCode Base example Immunization Reason Codes 📦4.0.1 FHIR Std.
Immunization.subpotentReason Base example Immunization Subpotent Reason 📦4.0.1 FHIR Std.
Immunization.programEligibility Base example Immunization Program Eligibility 📦4.0.1 FHIR Std.
Immunization.fundingSource Base example Immunization Funding Source 📦4.0.1 FHIR Std.
Immunization.protocolApplied.​targetDisease Base example Immunization Target Disease Codes 📦4.0.1 FHIR Std.

Constraints

Id Grade Path(s) Description Expression
dom-2 error Immunization If the resource is contained in another resource, it SHALL NOT contain nested Resources contained.contained.empty()
dom-3 error Immunization If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().as(canonical) | %resource.descendants().as(uri) | %resource.descendants().as(url))) or descendants().where(reference = '#').exists() or descendants().where(as(canonical) = '#').exists() or descendants().where(as(canonical) = '#').exists()).not()).trace('unmatched', id).empty()
dom-4 error Immunization If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated contained.meta.versionId.empty() and contained.meta.lastUpdated.empty()
dom-5 error Immunization If a resource is contained in another resource, it SHALL NOT have a security label contained.meta.security.empty()
dom-6 best practice Immunization A resource should have narrative for robust management text.`div`.exists()
ele-1 error **ALL** elements All FHIR elements must have a @value or children hasValue() or (children().count() > id.count())
ext-1 error **ALL** extensions Must have either extensions or value[x], not both extension.exists() != value.exists()
imm-1 error Immunization.education One of documentType or reference SHALL be present documentType.exists() or reference.exists()
ind-1 error Immunization To indicate what immunization was not done, either at least one coding in the vaccineCode element or a notDoneValueSet extension shall be provided vaccineCode.extension('http://fhir.org/guides/onc/us-quality-core/StructureDefinition/us-quality-core-notDoneValueSet').exists() xor vaccineCode.coding.exists()
us-core-5 best practice Immunization SHOULD have a translation to the NDC value set vaccineCode.coding.where(system='http://hl7.org/fhir/sid/ndc').empty()

Summary

Mandatory: 2 elements
Fixed: 1 element

Structures

This structure refers to these other structures:

Extensions

This structure refers to these extensions:

 

Other representations of profile: CSV, Excel, Schematron

Notes:

CQL Authoring Usage (Informational)

The Immunization and ImmunizationNotDone profiles represent the positive and negative statements for an immunization event.

The following illustrative CQL shows an exclusion pattern for immunizations not performed:

define "Reason for No Polio Immunization":
  ["ImmunizationNotDone": "Inactivated Polio Vaccine (IPV)"] PolioVaccination
    where PolioVaccination.statusReason in "Medical Reason"
      or PolioVaccination.statusReason in "Patient Refusal"

For a more complete discussion of representation of negation within US Quality Core and quality improvement artifacts, see the Negation in US Quality Core topic.