US Core Implementation Guide (Release 1.0.1)

This page is part of the US Core (v1.0.1: STU1) based on FHIR R3. The current version which supercedes this version is 5.0.1. For a full list of available versions, see the Directory of published versions

D.4.1.4 StructureDefinition: - Detailed Descriptions

Definitions for the StructureDefinition-us-core-immunization Profile.

Immunization
Definition

The US Core Immunization Profile is based upon the core FHIR Immunization Resource and created to meet the 2015 Edition Common Clinical Data Set 'Immunizations' requirements.

Control0..*
InvariantsDefined on this element
dom-1: If the resource is contained in another resource, it SHALL NOT contain any narrative (: contained.text.empty())
dom-2: If the resource is contained in another resource, it SHALL NOT contain nested Resources (: contained.contained.empty())
dom-3: If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource (: contained.where(('#'+id in %resource.descendants().reference).not()).empty())
dom-4: 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())
imm-1: If immunization was not administered (notGiven=true) then there SHALL be no reaction nor explanation.reason present (: (notGiven = true).not() or (reaction.empty() and explanation.reason.empty()))
imm-2: If immunization was administered (notGiven=false) then explanation.reasonNotGiven SHALL be absent. (: (notGiven = true) or explanation.reasonNotGiven.empty())
Immunization.id
Definition

The logical id of the resource, as used in the URL for the resource. Once assigned, this value never changes.

Control0..1
Typeid
Comments

The only time that a resource does not have an id is when it is being submitted to the server using a create operation.

Immunization.meta
Definition

The metadata about the resource. This is content that is maintained by the infrastructure. Changes to the content may not always be associated with version changes to the resource.

Control0..1
TypeMeta
Immunization.implicitRules
Definition

A reference to a set of rules that were followed when the resource was constructed, and which must be understood when processing the content.

Control0..1
Typeuri
Is Modifiertrue
Comments

Asserting this rule set restricts the content to be only understood by a limited set of trading partners. This inherently limits the usefulness of the data in the long term. However, the existing health eco-system is highly fractured, and not yet ready to define, collect, and exchange data in a generally computable sense. Wherever possible, implementers and/or specification writers should avoid using this element.

This element is labelled as a modifier because the implicit rules may provide additional knowledge about the resource that modifies it's meaning or interpretation.

Immunization.language
Definition

The base language in which the resource is written.

Control0..1
BindingA human language.
The codes SHALL be taken from Common Languages; other codes may be used where these codes are not suitable
Typecode
Comments

Language is provided to support indexing and accessibility (typically, services such as text to speech use the language tag). The html language tag in the narrative applies to the narrative. The language tag on the resource may be used to specify the language of other presentations generated from the data in the resource Not all the content has to be in the base language. The Resource.language should not be assumed to apply to the narrative automatically. If a language is specified, it should it also be specified on the div element in the html (see rules in HTML5 for information about the relationship between xml:lang and the html lang attribute).

Immunization.text
Definition

A human-readable narrative that contains a summary of the resource, and may be used to represent the content of the resource to a human. The narrative need not encode all the structured data, but is required to contain sufficient detail to make it "clinically safe" for a human to just read the narrative. Resource definitions may define what content should be represented in the narrative to ensure clinical safety.

Control0..1 This element is affected by the following invariants: dom-1
TypeNarrative
Alternate Namesnarrative, html, xhtml, display
Comments

Contained resources do not have narrative. Resources that are not contained SHOULD have a narrative. In some cases, a resource may only have text with little or no additional discrete data (as long as all minOccurs=1 elements are satisfied). This may be necessary for data from legacy systems where information is captured as a "text blob" or where text is additionally entered raw or narrated and encoded in formation is added later.

Immunization.contained
Definition

These resources do not have an independent existence apart from the resource that contains them - they cannot be identified independently, and nor can they have their own independent transaction scope.

Control0..*
TypeResource
Alternate Namesinline resources, anonymous resources, contained resources
Comments

This should never be done when the content can be identified properly, as once identification is lost, it is extremely difficult (and context dependent) to restore it again.

Immunization.extension
Definition

May be used to represent additional information that is not part of the basic definition of the resource. In order to make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer is allowed to define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

Control0..*
TypeExtension
Alternate Namesextensions, user content
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Immunization.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the resource, and that modifies the understanding of the element that contains it. Usually modifier elements provide negation or qualification. In order to make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer is allowed to define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Control0..*
TypeExtension
Is Modifiertrue
Alternate Namesextensions, user content
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Immunization.identifier
Definition

A unique identifier assigned to this immunization record.

NoteThis is a business identifer, not a resource identifier (see discussion)
Control0..*
TypeIdentifier
Immunization.status
Definition

Indicates the current status of the vaccination event.

Control1..1
BindingConstrained list of immunizaiotn status
The codes SHALL be taken from Immunization Status Codes
Typecode
Is Modifiertrue
Must Supporttrue
Comments

Will generally be set to show that the immunization has been completed.

This element is labeled as a modifier because the status contains codes that mark the resource as not currently valid.

Immunization.notGiven
Definition

Indicates if the vaccination was or was not given.

Control1..1
Typeboolean
Is Modifiertrue
Must Supporttrue
Comments

This element is labeled as a modifier because it indicates that an immunization didn't happen.

Immunization.vaccineCode
Definition

Vaccine that was administered or was to be administered.

Control1..1
BindingThe CVX (vaccine administered) code system
The codes SHALL be taken from Vaccine Administered Value Set (CVX); other codes may be used where these codes are not suitable
TypeCodeableConcept
Must Supporttrue
InvariantsDefined on this element
us-core-1: SHOULD have a translation to the NDC value set (: coding.where(system='http://hl7.org/fhir/sid/ndc').empty())
Immunization.patient
Definition

The patient who either received or did not receive the immunization.

Control1..1
TypeReference(US Core Patient Profile)
Must Supporttrue
Alternate NamesPatient
Immunization.encounter
Definition

The visit or admission or other contact between patient and health care provider the immunization was performed as part of.

Control0..1
TypeReference(Encounter)
Immunization.date
Definition

Date vaccine administered or was to be administered.

Control1..1
TypedateTime
Must Supporttrue
Comments

When immunizations are given a specific date and time should always be known. When immunizations are patient reported, a specific date might not be known.  Although partial dates are allowed, an adult patient might not be able to recall the year a childhood immunization was given.

Immunization.primarySource
Definition

An indication that the content of the record is based on information from the person who administered the vaccine. This reflects the context under which the data was originally recorded.

Control1..1
Typeboolean
Must Supporttrue
Comments

Reflects the “reliability” of the content.

Immunization.reportOrigin
Definition

The source of the data when the report of the immunization event is not based on information from the person who administered the vaccine.

Control0..1
BindingThe source of the data for a record which is not from a primary source.
For example codes, see Immunization Origin Codes
TypeCodeableConcept
Comments

Should not be populated if primarySource = True, will not be required even if primarySource = False.

Immunization.location
Definition

The service delivery location where the vaccine administration occurred.

Control0..1
TypeReference(Location)
Immunization.manufacturer
Definition

Name of vaccine manufacturer.

Control0..1
TypeReference(Organization)
Immunization.lotNumber
Definition

Lot number of the vaccine product.

Control0..1
Typestring
Immunization.expirationDate
Definition

Date vaccine batch expires.

Control0..1
Typedate
Immunization.site
Definition

Body site where vaccine was administered.

Control0..1
BindingThe site at which the vaccine was administered
For example codes, see Codes for Immunization Site of Administration
TypeCodeableConcept
Immunization.route
Definition

The path by which the vaccine product is taken into the body.

Control0..1
BindingThe route by which the vaccine was administered
For example codes, see Immunization Route Codes
TypeCodeableConcept
Immunization.doseQuantity
Definition

The quantity of vaccine product that was administered.

Control0..1
TypeQuantity(SimpleQuantity)
Immunization.practitioner
Definition

Indicates who or what performed the event.

Control0..*
TypeBackboneElement
InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() | (children().count() > id.count()))
Immunization.practitioner.id
Definition

unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

Control0..1
Typestring
Immunization.practitioner.extension
Definition

May be used to represent additional information that is not part of the basic definition of the element. In order to make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer is allowed to define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

Control0..*
TypeExtension
Alternate Namesextensions, user content
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Immunization.practitioner.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element, and that modifies the understanding of the element that contains it. Usually modifier elements provide negation or qualification. In order to make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer is allowed to define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Control0..*
TypeExtension
Is Modifiertrue
Alternate Namesextensions, user content, modifiers
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Immunization.practitioner.role
Definition

Describes the type of performance (e.g. ordering provider, administering provider, etc.).

Control0..1
BindingThe role a practitioner plays in the immunization event
The codes SHALL be taken from Immunization Role Codes; other codes may be used where these codes are not suitable
TypeCodeableConcept
Immunization.practitioner.actor
Definition

The device, practitioner, etc. who performed the action.

Control1..1
TypeReference(Practitioner)
Immunization.note
Definition

Extra information about the immunization that is not conveyed by the other attributes.

Control0..*
TypeAnnotation
Immunization.explanation
Definition

Reasons why a vaccine was or was not administered.

Control0..1
TypeBackboneElement
InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() | (children().count() > id.count()))
Immunization.explanation.id
Definition

unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

Control0..1
Typestring
Immunization.explanation.extension
Definition

May be used to represent additional information that is not part of the basic definition of the element. In order to make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer is allowed to define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

Control0..*
TypeExtension
Alternate Namesextensions, user content
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Immunization.explanation.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element, and that modifies the understanding of the element that contains it. Usually modifier elements provide negation or qualification. In order to make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer is allowed to define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Control0..*
TypeExtension
Is Modifiertrue
Alternate Namesextensions, user content, modifiers
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Immunization.explanation.reason
Definition

Reasons why a vaccine was administered.

Control0..*
BindingThe reason why a vaccine was administered
For example codes, see Immunization Reason Codes
TypeCodeableConcept
Immunization.explanation.reasonNotGiven
Definition

Reason why a vaccine was not administered.

Control0..*
BindingThe reason why a vaccine was not administered
For example codes, see Immunization Reasons for Not Immunizing Codes
TypeCodeableConcept
Immunization.reaction
Definition

Categorical data indicating that an adverse event is associated in time to an immunization.

Control0..*
TypeBackboneElement
Comments

A reaction may be an indication of an allergy or intolerance and, if this is determined to be the case, it should be recorded as a new AllergyIntolerance resource instance as most systems will not query against past Immunization.reaction elements.

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() | (children().count() > id.count()))
Immunization.reaction.id
Definition

unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

Control0..1
Typestring
Immunization.reaction.extension
Definition

May be used to represent additional information that is not part of the basic definition of the element. In order to make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer is allowed to define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

Control0..*
TypeExtension
Alternate Namesextensions, user content
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Immunization.reaction.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element, and that modifies the understanding of the element that contains it. Usually modifier elements provide negation or qualification. In order to make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer is allowed to define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Control0..*
TypeExtension
Is Modifiertrue
Alternate Namesextensions, user content, modifiers
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Immunization.reaction.date
Definition

Date of reaction to the immunization.

Control0..1
TypedateTime
Immunization.reaction.detail
Definition

Details of the reaction.

Control0..1
TypeReference(Observation)
Immunization.reaction.reported
Definition

Self-reported indicator.

Control0..1
Typeboolean
Immunization.vaccinationProtocol
Definition

Contains information about the protocol(s) under which the vaccine was administered.

Control0..*
TypeBackboneElement
InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() | (children().count() > id.count()))
Immunization.vaccinationProtocol.id
Definition

unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

Control0..1
Typestring
Immunization.vaccinationProtocol.extension
Definition

May be used to represent additional information that is not part of the basic definition of the element. In order to make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer is allowed to define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

Control0..*
TypeExtension
Alternate Namesextensions, user content
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Immunization.vaccinationProtocol.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element, and that modifies the understanding of the element that contains it. Usually modifier elements provide negation or qualification. In order to make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer is allowed to define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Control0..*
TypeExtension
Is Modifiertrue
Alternate Namesextensions, user content, modifiers
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Immunization.vaccinationProtocol.doseSequence
Definition

Nominal position in a series.

Control0..1
TypepositiveInt
Immunization.vaccinationProtocol.description
Definition

Contains the description about the protocol under which the vaccine was administered.

Control0..1
Typestring
Immunization.vaccinationProtocol.authority
Definition

Indicates the authority who published the protocol. E.g. ACIP.

Control0..1
TypeReference(Organization)
Immunization.vaccinationProtocol.series
Definition

One possible path to achieve presumed immunity against a disease - within the context of an authority.

Control0..1
Typestring
Immunization.vaccinationProtocol.seriesDoses
Definition

The recommended number of doses to achieve immunity.

Control0..1
TypepositiveInt
Immunization.vaccinationProtocol.targetDisease
Definition

The targeted disease.

Control1..*
BindingThe disease target of the vaccination protocol
For example codes, see Vaccination Protocol Dose Target Codes
TypeCodeableConcept
Immunization.vaccinationProtocol.doseStatus
Definition

Indicates if the immunization event should "count" against the protocol.

Control1..1
BindingThe status of the vaccination protocol (i.e. should this count)
For example codes, see Vaccination Protocol Dose Status codes
TypeCodeableConcept
Comments

May need to differentiate between status declarations by a provider vs. a CDS engine.

Immunization.vaccinationProtocol.doseStatusReason
Definition

Provides an explanation as to why an immunization event should or should not count against the protocol.

Control0..1
BindingThe reason for the determining if a vaccination should count or why vaccination should not count.
For example codes, see Vaccination Protocol Dose Status Reason codes
TypeCodeableConcept