HL7 FHIR® US Core Implementation Guide STU 3

This page is part of the US Core (v2.1.0: STU3 Ballot 1) based on FHIR R4. The current version which supercedes this version is 5.0.1. For a full list of available versions, see the Directory of published versions

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

1. 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-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 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: 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: If a resource is contained in another resource, it SHALL NOT have a security label (: contained.meta.security.empty())
dom-6: A resource should have narrative for robust management (: text.div.exists())
2. 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.

3. Immunization.meta
Definition

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

Control0..1
TypeMeta
4. 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. Often, this is a reference to an implementation guide that defines the special rules along with other profiles etc.

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. Often, when used, the URL is a reference to an implementation guide that defines these special rules as part of it's narrative along with other profiles, value sets, etc.

5. Immunization.language
Definition

The base language in which the resource is written.

Control0..1
BindingA human language.
The codes SHOULD be taken from CommonLanguages
Max Binding: AllLanguages
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).

6. Immunization.text
Definition

A human-readable narrative that contains a summary of the resource and can 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
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 information is added later.

7. 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. Contained resources may have profiles and tags In their meta elements, but SHALL NOT have security labels.

8. Immunization.extension
Definition

May be used to represent additional information that is not part of the basic definition of the resource. 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 can 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.

9. 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 and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. 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.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

Control0..*
TypeExtension
Is Modifiertrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

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.

10. Immunization.identifier
Definition

A unique identifier assigned to this immunization record.

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

Indicates the current status of the immunization event.

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

Will generally be set to show that the immunization has been completed or not done. This element is labeled as a modifier because the status contains codes that mark the resource as not currently valid.

12. Immunization.statusReason
Definition

Indicates the reason the immunization event was not performed.

Control0..1
BindingFor example codes, see ImmunizationStatusReasonCodes
TypeCodeableConcept
Must Supporttrue
Comments

This is generally only used for the status of "not-done". The reason for performing the immunization event is captured in reasonCode, not here.

13. 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 US Core Vaccine Administered Value Set (CVX); other codes may be used where these codes are not suitable
Max Binding: US Core Vaccine Administered Value Set (CVX)
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())
14. Immunization.patient
Definition

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

Control1..1
TypeReference(USCorePatientProfile)
Must Supporttrue
Alternate NamesPatient
15. 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)
16. Immunization.occurrence[x]
Definition

Date vaccine administered or was to be administered.

Control1..1
TypeChoice of: dateTime, string
[x] NoteSee Choice of Data Types for further information about how to use [x]
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. An exact date is always preferable, but the use of the String data type is acceptable when an exact date is not known. A small number of vaccines (e.g. live oral typhoid vaccine) are given as a series of patient self-administered dose over a span of time. In cases like this, often, only the first dose (typically a provider supervised dose) is recorded with the occurrence indicating the date/time of the first dose.

17. Immunization.recorded
Definition

The date the occurrence of the immunization was first captured in the record - potentially significantly after the occurrence of the event.

Control0..1
TypedateTime
18. 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.

19. 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 ImmunizationOriginCodes
TypeCodeableConcept
Comments

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

20. Immunization.location
Definition

The service delivery location where the vaccine administration occurred.

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

Name of vaccine manufacturer.

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

Lot number of the vaccine product.

Control0..1
Typestring
23. Immunization.expirationDate
Definition

Date vaccine batch expires.

Control0..1
Typedate
24. Immunization.site
Definition

Body site where vaccine was administered.

Control0..1
BindingThe site at which the vaccine was administered.
For example codes, see CodesForImmunizationSiteOfAdministration
TypeCodeableConcept
25. 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 ImmunizationRouteCodes
TypeCodeableConcept
26. Immunization.doseQuantity
Definition

The quantity of vaccine product that was administered.

Control0..1
TypeQuantity(SimpleQuantity)
27. Immunization.performer
Definition

Indicates who performed the immunization event.

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

May be used to represent additional information that is not part of the basic definition of the element. 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 can 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.

30. Immunization.performer.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 in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. 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 can 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.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

Control0..*
TypeExtension
Is Modifiertrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

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.

31. Immunization.performer.function
Definition

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

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

The practitioner or organization who performed the action.

Control1..1
TypeReference(Practitioner | PractitionerRole | Organization)
Comments

When the individual practitioner who performed the action is known, it is best to send.

33. Immunization.note
Definition

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

Control0..*
TypeAnnotation
34. Immunization.reasonCode
Definition

Reasons why the vaccine was administered.

Control0..*
BindingThe reason why a vaccine was administered.
For example codes, see ImmunizationReasonCodes
TypeCodeableConcept
35. Immunization.reasonReference
Definition

Condition, Observation or DiagnosticReport that supports why the immunization was administered.

Control0..*
TypeReference(Condition | Observation | DiagnosticReport)
36. Immunization.isSubpotent
Definition

Indication if a dose is considered to be subpotent. By default, a dose should be considered to be potent.

Control0..1
Typeboolean
Is Modifiertrue
Comments

Typically, the recognition of the dose being sub-potent is retrospective, after the administration (ex. notification of a manufacturer recall after administration). However, in the case of a partial administration (the patient moves unexpectedly and only some of the dose is actually administered), subpotency may be recognized immediately, but it is still important to record the event.

Meaning if MissingBy default, a dose should be considered to be potent.
37. Immunization.subpotentReason
Definition

Reason why a dose is considered to be subpotent.

Control0..*
BindingThe reason why a dose is considered to be subpotent.
For example codes, see ImmunizationSubpotentReason
TypeCodeableConcept
38. Immunization.education
Definition

Educational material presented to the patient (or guardian) at the time of vaccine administration.

Control0..*
TypeBackboneElement
InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
imm-1: One of documentType or reference SHALL be present (: documentType.exists() or reference.exists())
39. Immunization.education.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
40. Immunization.education.extension
Definition

May be used to represent additional information that is not part of the basic definition of the element. 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 can 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.

41. Immunization.education.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 in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. 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 can 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.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

Control0..*
TypeExtension
Is Modifiertrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

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.

42. Immunization.education.documentType
Definition

Identifier of the material presented to the patient.

Control0..1
Typestring
43. Immunization.education.reference
Definition

Reference pointer to the educational material given to the patient if the information was on line.

Control0..1
Typeuri
44. Immunization.education.publicationDate
Definition

Date the educational material was published.

Control0..1
TypedateTime
45. Immunization.education.presentationDate
Definition

Date the educational material was given to the patient.

Control0..1
TypedateTime
46. Immunization.programEligibility
Definition

Indicates a patient's eligibility for a funding program.

Control0..*
BindingThe patient's eligibility for a vaccation program.
For example codes, see ImmunizationProgramEligibility
TypeCodeableConcept
47. Immunization.fundingSource
Definition

Indicates the source of the vaccine actually administered. This may be different than the patient eligibility (e.g. the patient may be eligible for a publically purchased vaccine but due to inventory issues, vaccine purchased with private funds was actually administered).

Control0..1
BindingThe source of funding used to purchase the vaccine administered.
For example codes, see ImmunizationFundingSource
TypeCodeableConcept
48. 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() or (children().count() > id.count()))
49. 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
50. Immunization.reaction.extension
Definition

May be used to represent additional information that is not part of the basic definition of the element. 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 can 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.

51. 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 in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. 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 can 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.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

Control0..*
TypeExtension
Is Modifiertrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

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.

52. Immunization.reaction.date
Definition

Date of reaction to the immunization.

Control0..1
TypedateTime
53. Immunization.reaction.detail
Definition

Details of the reaction.

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

Self-reported indicator.

Control0..1
Typeboolean
55. Immunization.protocolApplied
Definition

The protocol (set of recommendations) being followed by the provider who administered the dose.

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

May be used to represent additional information that is not part of the basic definition of the element. 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 can 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.

58. Immunization.protocolApplied.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 in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. 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 can 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.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

Control0..*
TypeExtension
Is Modifiertrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

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.

59. Immunization.protocolApplied.series
Definition

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

Control0..1
Typestring
60. Immunization.protocolApplied.authority
Definition

Indicates the authority who published the protocol (e.g. ACIP) that is being followed.

Control0..1
TypeReference(Organization)
61. Immunization.protocolApplied.targetDisease
Definition

The vaccine preventable disease the dose is being administered against.

Control0..*
BindingThe vaccine preventable disease the dose is being administered for.
For example codes, see ImmunizationTargetDiseaseCodes
TypeCodeableConcept
62. Immunization.protocolApplied.doseNumber[x]
Definition

Nominal position in a series.

Control1..1
TypeChoice of: positiveInt, string
[x] NoteSee Choice of Data Types for further information about how to use [x]
Comments

The use of an integer is preferred if known. A string should only be used in cases where an integer is not available (such as when documenting a recurring booster dose).

63. Immunization.protocolApplied.seriesDoses[x]
Definition

The recommended number of doses to achieve immunity.

Control0..1
TypeChoice of: positiveInt, string
[x] NoteSee Choice of Data Types for further information about how to use [x]
Comments

The use of an integer is preferred if known. A string should only be used in cases where an integer is not available (such as when documenting a recurring booster dose).