US Quality Core Implementation Guide
1.0.0-ballot - STU 1 - ballot United States of America flag

US Quality Core Implementation Guide, published by HL7 International / Clinical Quality Information. This guide is not an authorized publication; it is the continuous build for version 1.0.0-ballot built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7/fhir-us-quality-core/ and changes regularly. See the Directory of published versions

Resource Profile: US Quality Core Immunization Not Done

Official URL: http://hl7.org/fhir/us/quality-core/StructureDefinition/us-quality-core-immunizationnotdone Version: 1.0.0-ballot
Standards status: Trial-use Maturity Level: 4 Computable Name: USQualityCoreImmunizationNotDone
Other Identifiers: OID:2.16.840.1.113883.4.642.40.78.42.22

Negation profile of Communication for decision support/quality metrics. Indicates that the communication was not performed for a reason.

The Immunization profile defines the conformance expectations for an Immunization event, regardless of whether it is a positive or negative statement. The ImmunizationDone and ImmunizationNotDone profiles represent the positive and negative statements for an immunization event.

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.

USCDI+ Quality Element Support Expectations

Systems are expected to support this profile as part of implementing USCDI+ Quality V2 in FHIR and meeting the conformance requirements of this guide.

The following elements are specifically relevant to USCDI+ Quality V2 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 flagged as (USCDI+ Quality) in the formal profile views.

USCDI+ Quality Elements:

Profile element Description USCDI+ Quality Data Element(s)
performer.actor Individual or organization who was performing Provenance: Author
recorded Documented date Immunization did not occur. Healthcare Information Attributes: Reason Not Performed
status not-done Healthcare Information Attributes: Reason Not Performed
statusReason Reason not done Healthcare Information Attributes: Reason Not Performed
vaccineCode Vaccine Product Type (bind to CVX) Healthcare Information Attributes: Reason Not Performed
vaccineCode.extension:codeOptions Url of a value set of candidate vaccines Healthcare Information Attributes: Reason Not Performed

Because this profile is derived directly or indirectly from US Core, systems are also expected to support the Must Support and Additional USCDI requirements specified by the US Core profile this profile inherits from. For more information about those requirements, refer to the US Core Immunization Profile. The Formal Views section also provides the formal summary, definitions, terminology requirements, and mandatory element requirements.

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..* USQualityCoreImmunization Immunization event information
Constraints: us-core-5, qim-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) not-done
Binding: ImmunizationStatusCodes (required)
Fixed Value: not-done
... vaccineCode SΣC 1..1 CodeableConcept (USCDI+ Quality) Vaccine Product Type (bind to CVX)
Binding: CVX Vaccines Administered Vaccine Set . (extensible)
.... Slices for extension Content/Rules for all slices
..... extension:codeOptions C 0..1 canonical(ValueSet) (USCDI+ Quality) Url of a value set of candidate vaccines
URL: http://hl7.org/fhir/StructureDefinition/codeOptions
... patient SΣ 1..1 Reference(US Quality Core Patient) Who was immunized
... encounter S 0..1 Reference(US Quality Core Encounter) Encounter the immunization was part of
... occurrence[x] SΣ 1..1 Vaccine administration date
.... occurrenceDateTime dateTime S
.... occurrenceString string
... recorded 0..1 dateTime (USCDI+ Quality) Documented date Immunization did not occur.
... primarySource SΣ 0..1 boolean (USCDI+ Quality) Indicates context the data was recorded in
... location S 0..1 Reference(US Quality Core Location) Where the vaccine was administered
... lotNumber S 0..1 string (USCDI+ Quality) Vaccine lot number
... performer SΣ 0..* BackboneElement Who performed event
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... actor SΣ 1..1 Reference(US Core Practitioner Profile S | US Core PractitionerRole Profile | US Core Organization Profile) (USCDI+ Quality) Individual or organization who was performing
... 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 US Quality Core Negation Reason Codes 📦1.0.0-ballot This IG
Immunization.vaccineCode Base extensible CVX Vaccines Administered Vaccine Set . ⏿20260428 tx.fhir.org

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()
qim-1 error Immunization To indicate what vaccine, either at least one coding in the vaccineCode element or a codeOptions extension shall be provided vaccineCode.extension('http://hl7.org/fhir/StructureDefinition/codeOptions').exists() xor vaccineCode.coding.exists()
us-core-5 best practice Immunization SHOULD have an additional coding to the NDC value set vaccineCode.coding.where(system='http://hl7.org/fhir/sid/cvx').exists() implies vaccineCode.coding.where(system='http://hl7.org/fhir/sid/ndc').exists()

NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. Immunization 0..* USQualityCoreImmunization Immunization event information
... status 1..1 code (USCDI+ Quality) not-done
Fixed Value: not-done
... statusReason 1..1 CodeableConcept (USCDI+ Quality) Reason not done
Binding: US Quality Core Negation Reason Codes (extensible): The reason the service was not requested
... vaccineCode
.... Slices for extension Content/Rules for all slices
..... extension:codeOptions 0..1 CodeOptions(5.3.0) (USCDI+ Quality) Url of a value set of candidate vaccines
... recorded 0..1 dateTime (USCDI+ Quality) Documented date Immunization did not occur.
... location 0..1 Reference(US Quality Core Location) Where the vaccine was administered

doco Documentation for this format

Terminology Bindings (Differential)

Path Status Usage ValueSet Version Source
Immunization.statusReason Base extensible US Quality Core Negation Reason Codes 📦1.0.0-ballot This IG
NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. Immunization C 0..* USQualityCoreImmunization Immunization event information
Constraints: us-core-5, qim-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) not-done
Binding: ImmunizationStatusCodes (required)
Fixed Value: not-done
... statusReason S 1..1 CodeableConcept (USCDI+ Quality) Reason not done
Binding: US Quality Core Negation Reason Codes (extensible): The reason the service was not requested
... vaccineCode SΣC 1..1 CodeableConcept (USCDI+ Quality) 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:codeOptions C 0..1 canonical(ValueSet) (USCDI+ Quality) Url of a value set of candidate vaccines
URL: http://hl7.org/fhir/StructureDefinition/codeOptions
.... 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) Who was immunized
... encounter S 0..1 Reference(US Quality Core Encounter) Encounter the immunization was part of
... occurrence[x] SΣ 1..1 Vaccine administration date
.... occurrenceDateTime dateTime S
.... occurrenceString string
... recorded 0..1 dateTime (USCDI+ Quality) Documented date Immunization did not occur.
... primarySource SΣ 0..1 boolean (USCDI+ Quality) 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 S 0..1 Reference(US Quality Core Location) Where the vaccine was administered
... manufacturer 0..1 Reference(Organization) Vaccine manufacturer
... lotNumber S 0..1 string (USCDI+ Quality) 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(4.0.1) Amount of vaccine administered
... performer SΣ 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 SΣ 1..1 Reference(US Core Practitioner Profile S | US Core PractitionerRole Profile | US Core Organization Profile) (USCDI+ Quality) 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 US Quality Core Negation Reason Codes 📦1.0.0-ballot This IG
Immunization.vaccineCode Base extensible CVX Vaccines Administered Vaccine Set . ⏿20260428 tx.fhir.org
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()
qim-1 error Immunization To indicate what vaccine, either at least one coding in the vaccineCode element or a codeOptions extension shall be provided vaccineCode.extension('http://hl7.org/fhir/StructureDefinition/codeOptions').exists() xor vaccineCode.coding.exists()
us-core-5 best practice Immunization SHOULD have an additional coding to the NDC value set vaccineCode.coding.where(system='http://hl7.org/fhir/sid/cvx').exists() implies vaccineCode.coding.where(system='http://hl7.org/fhir/sid/ndc').exists()

Summary

Mandatory: 1 element
Fixed: 1 element

Maturity: 4

Key Elements View

NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. Immunization C 0..* USQualityCoreImmunization Immunization event information
Constraints: us-core-5, qim-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) not-done
Binding: ImmunizationStatusCodes (required)
Fixed Value: not-done
... vaccineCode SΣC 1..1 CodeableConcept (USCDI+ Quality) Vaccine Product Type (bind to CVX)
Binding: CVX Vaccines Administered Vaccine Set . (extensible)
.... Slices for extension Content/Rules for all slices
..... extension:codeOptions C 0..1 canonical(ValueSet) (USCDI+ Quality) Url of a value set of candidate vaccines
URL: http://hl7.org/fhir/StructureDefinition/codeOptions
... patient SΣ 1..1 Reference(US Quality Core Patient) Who was immunized
... encounter S 0..1 Reference(US Quality Core Encounter) Encounter the immunization was part of
... occurrence[x] SΣ 1..1 Vaccine administration date
.... occurrenceDateTime dateTime S
.... occurrenceString string
... recorded 0..1 dateTime (USCDI+ Quality) Documented date Immunization did not occur.
... primarySource SΣ 0..1 boolean (USCDI+ Quality) Indicates context the data was recorded in
... location S 0..1 Reference(US Quality Core Location) Where the vaccine was administered
... lotNumber S 0..1 string (USCDI+ Quality) Vaccine lot number
... performer SΣ 0..* BackboneElement Who performed event
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... actor SΣ 1..1 Reference(US Core Practitioner Profile S | US Core PractitionerRole Profile | US Core Organization Profile) (USCDI+ Quality) Individual or organization who was performing
... 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 US Quality Core Negation Reason Codes 📦1.0.0-ballot This IG
Immunization.vaccineCode Base extensible CVX Vaccines Administered Vaccine Set . ⏿20260428 tx.fhir.org

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()
qim-1 error Immunization To indicate what vaccine, either at least one coding in the vaccineCode element or a codeOptions extension shall be provided vaccineCode.extension('http://hl7.org/fhir/StructureDefinition/codeOptions').exists() xor vaccineCode.coding.exists()
us-core-5 best practice Immunization SHOULD have an additional coding to the NDC value set vaccineCode.coding.where(system='http://hl7.org/fhir/sid/cvx').exists() implies vaccineCode.coding.where(system='http://hl7.org/fhir/sid/ndc').exists()

Differential View

NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. Immunization 0..* USQualityCoreImmunization Immunization event information
... status 1..1 code (USCDI+ Quality) not-done
Fixed Value: not-done
... statusReason 1..1 CodeableConcept (USCDI+ Quality) Reason not done
Binding: US Quality Core Negation Reason Codes (extensible): The reason the service was not requested
... vaccineCode
.... Slices for extension Content/Rules for all slices
..... extension:codeOptions 0..1 CodeOptions(5.3.0) (USCDI+ Quality) Url of a value set of candidate vaccines
... recorded 0..1 dateTime (USCDI+ Quality) Documented date Immunization did not occur.
... location 0..1 Reference(US Quality Core Location) Where the vaccine was administered

doco Documentation for this format

Terminology Bindings (Differential)

Path Status Usage ValueSet Version Source
Immunization.statusReason Base extensible US Quality Core Negation Reason Codes 📦1.0.0-ballot This IG

Snapshot ViewView

NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. Immunization C 0..* USQualityCoreImmunization Immunization event information
Constraints: us-core-5, qim-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) not-done
Binding: ImmunizationStatusCodes (required)
Fixed Value: not-done
... statusReason S 1..1 CodeableConcept (USCDI+ Quality) Reason not done
Binding: US Quality Core Negation Reason Codes (extensible): The reason the service was not requested
... vaccineCode SΣC 1..1 CodeableConcept (USCDI+ Quality) 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:codeOptions C 0..1 canonical(ValueSet) (USCDI+ Quality) Url of a value set of candidate vaccines
URL: http://hl7.org/fhir/StructureDefinition/codeOptions
.... 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) Who was immunized
... encounter S 0..1 Reference(US Quality Core Encounter) Encounter the immunization was part of
... occurrence[x] SΣ 1..1 Vaccine administration date
.... occurrenceDateTime dateTime S
.... occurrenceString string
... recorded 0..1 dateTime (USCDI+ Quality) Documented date Immunization did not occur.
... primarySource SΣ 0..1 boolean (USCDI+ Quality) 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 S 0..1 Reference(US Quality Core Location) Where the vaccine was administered
... manufacturer 0..1 Reference(Organization) Vaccine manufacturer
... lotNumber S 0..1 string (USCDI+ Quality) 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(4.0.1) Amount of vaccine administered
... performer SΣ 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 SΣ 1..1 Reference(US Core Practitioner Profile S | US Core PractitionerRole Profile | US Core Organization Profile) (USCDI+ Quality) 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 US Quality Core Negation Reason Codes 📦1.0.0-ballot This IG
Immunization.vaccineCode Base extensible CVX Vaccines Administered Vaccine Set . ⏿20260428 tx.fhir.org
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()
qim-1 error Immunization To indicate what vaccine, either at least one coding in the vaccineCode element or a codeOptions extension shall be provided vaccineCode.extension('http://hl7.org/fhir/StructureDefinition/codeOptions').exists() xor vaccineCode.coding.exists()
us-core-5 best practice Immunization SHOULD have an additional coding to the NDC value set vaccineCode.coding.where(system='http://hl7.org/fhir/sid/cvx').exists() implies vaccineCode.coding.where(system='http://hl7.org/fhir/sid/ndc').exists()

Summary

Mandatory: 1 element
Fixed: 1 element

Maturity: 4

 

Other representations of profile: CSV, Excel, Schematron

Notes:

Element Conformance Indicators by Profile Layer

Badges identify the profile layer where each conformance indicator is first introduced. Indicators introduced in an earlier layer remain applicable in later derived profiles.

Element conformance indicators organized by the profile layer where they are first introduced
Profile element FHIR US Core US Quality Core
status Mandatory Must Support USCDI+ Quality
statusReason Must Support Mandatory USCDI+ Quality
vaccineCode Mandatory Must Support USCDI+ Quality
vaccineCode.extension:codeOptions USCDI+ Quality
patient Mandatory Must Support
encounter Must Support
occurrence[x] Mandatory Must Support USCDI+ Quality
recorded USCDI+ Quality
primarySource Must Support USCDI+ Quality
location Must Support USCDI+ Quality
lotNumber Must Support USCDI+ Quality
performer Must Support
performer.actor Mandatory Must Support USCDI+ Quality
protocolApplied.doseNumber[x] Mandatory

Cardinality note: “Mandatory” means the element has a minimum cardinality greater than zero. For nested elements, the cardinality indicator applies when the containing element is present.

Mandatory US Quality Core Server Search Parameters

The searches below are the focused set identified by US Quality Core as needed to retrieve USCDI+ Quality data for quality measurement and reporting. See the US Core FHIR RESTful Search API Requirements for detailed information on requirements by search parameter type.

Because this profile derives directly or indirectly from US Core, servers SHALL also support all mandatory searches described in the US Core Server CapabilityStatement requirements for Immunization. When possible, this guide reuses mandatory searches from US Core and notes them with the EXISTING US CORE REQUIREMENT flag. While US Quality Core may restate US Core requirements to highlight searches directly relevant to USCDI+ Quality data access, US Core requirements not restated here remain applicable.

See the US Quality Core Server CapabilityStatement for complete requirements for the underlying Immunization resource and Search Requirement Selection for how this focused set was selected.

Servers supporting this profile SHALL support the following search parameters and search parameter combinations:

  1. SHALL support searching for all Immunization resources for a patient using the patient search parameter. EXISTING US CORE REQUIREMENT

    GET [base]/Immunization?patient={Patient/}[id]

    Example:

    GET [base]/Immunization?patient=Patient/example

    Implementation Notes: Fetches a bundle of US Quality Core Immunization Not Done resources matching the specified search criteria. See how to search by reference.

    Rationale for inclusion: Supports patient-scoped retrieval of Immunization resources for USCDI+ Quality workflows.

  2. SHALL support searching for all Immunization resources for a patient using the combination of the patient and status search parameters.

    • Including optional support for OR search on status (e.g.status=[status],[status],...).

    GET [base]/Immunization?patient={Patient/}[id]&status=[status]

    Example:

    GET [base]/Immunization?patient=Patient/example&status=not-done

    Implementation Notes: Fetches a bundle of US Quality Core Immunization Not Done resources matching the specified search criteria. See how to search by reference and how to search by token.

    Rationale for inclusion: Supports patient-scoped retrieval of Immunization resources filtered by status; status is used to indicate negation.