US Core Implementation Guide
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US Core Implementation Guide, published by HL7 International / Cross-Group Projects. This guide is not an authorized publication; it is the continuous build for version 8.0.0 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7/US-Core/ and changes regularly. See the Directory of published versions

Resource Profile: US Core Immunization Profile

Official URL: http://hl7.org/fhir/us/core/StructureDefinition/us-core-immunization Version: 8.0.0
Standards status: Trial-use Computable Name: USCoreImmunizationProfile
Other Identifiers: OID:2.16.840.1.113883.4.642.40.2.42.31

Copyright/Legal: Used by permission of HL7 International, all rights reserved Creative Commons License

The US Core Immunization Profile inherits from the FHIR Immunization resource; refer to it for scope and usage definitions. This profile sets minimum expectations for the Immunization resource to record, search, and fetch immunization history associated with a patient. It specifies which core elements, extensions, vocabularies, and value sets SHALL be present and constrains how the elements are used. Providing the floor for standards development for specific use cases promotes interoperability and adoption.

Example Usage Scenarios:

The following are example usage scenarios for the US Core-Core Immunization profile:

  • Query for immunizations belonging to a Patient
  • Record or update immunizations belonging to a Patient

Mandatory and Must Support Data Elements

The following data elements must always be present (Mandatory definition) or must be supported if the data is present in the sending system (Must Support definition). They are presented below in a simple human-readable explanation. Profile specific guidance and examples are provided as well. The Formal Views below provides the formal summary, definitions, and terminology requirements.

Each Immunization Must Have:

  1. a status
  2. a vaccine code that identifies the kind of vaccine administered*
  3. a patient
  4. a date the vaccine was administered

Each Immunization Must Support:

  1. a statusReason if the vaccine wasn't given
  2. a flag to indicate whether the vaccine was reported by someone other than the person who administered the vaccine.
  3. the encounter the immunization was part of
  4. where the vaccine was administered
  5. vaccine lot number*
  6. a performer*

*see guidance below

Profile Specific Implementation Guidance:

  • Use the status code: not-done to represent that an immunization was not given.
  • Based upon the ONC U.S. Core Data for Interoperability (USCDI) requirements, CVX vaccine codes1 are required, and the NDC vaccine codes SHOULD be supported as a translation.
    • The preferred code system identifiers are http://hl7.org/fhir/sid/cvx for CVX and http://hl7.org/fhir/sid/ndc for NDC vaccine codes. Note that the vaccineCode binding link in the formal definition and the CDC links below use the associated OID as the code system identifiers.
    • Be aware that there is a 10-digit (with dashes) NDC format displayed on drug packaging and an 11-digit (no dashes) NDC format for billing and prescribing (for example, "49281-121-65" and "49281012165"). Normalization may be required to avoid validation errors and warnings.
    • The CDC provides the CDC National Drug Code (NDC) Directory – Vaccine NDC Linker Table to assist implementers. The example Immunization-imm-1 illustrates using the CVX and 11-digit NDC codes based on this table.
    • *Although there is no guarantee that vaccine lot numbers are globally unique, they effectively are when combined with the vaccine code. NDC codes are defined by manufacturer, and CVX codes, which are much less granular, are often limited to a single product made by a single manufacturer. Implementers MAY communicate the Immunization.manufacturer as well to ensure global uniqueness to lot numbers.
  • *The profile element Immunization.performer.actor communicates the individual level provenance author data corresponding to the U.S. Core Data for Interoperability (USCDI) Provenance Author Data Elements.

Usage:

Changes since version 7.0.0:

  • The data elements list has changed
  • Formal Views of Profile Content

    Description of Profiles, Differentials, Snapshots and how the different presentations work.

    NameFlagsCard.TypeDescription & Constraintsdoco
    .. Immunization C 0..* Immunization Immunization event information
    dom-2: If the resource is contained in another resource, it SHALL NOT contain nested Resources
    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
    dom-4: If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated
    dom-5: If a resource is contained in another resource, it SHALL NOT have a security label
    dom-6: A resource should have narrative for robust management
    us-core-5: SHOULD have a translation to the NDC value set
    ... implicitRules ?!Σ 0..1 uri A set of rules under which this content was created
    ele-1: All FHIR elements must have a @value or children
    ... modifierExtension ?! 0..* Extension Extensions that cannot be ignored
    ele-1: All FHIR elements must have a @value or children
    ext-1: Must have either extensions or value[x], not both
    ... status ?!SΣ 1..1 code completed | entered-in-error | not-done
    Binding: ImmunizationStatusCodes (required)
    ele-1: All FHIR elements must have a @value or children
    ... statusReason S 0..1 CodeableConcept Reason not done
    Binding: ImmunizationStatusReasonCodes (example)
    ele-1: All FHIR elements must have a @value or children
    ... vaccineCode SΣC 1..1 CodeableConcept Vaccine Product Type (bind to CVX)
    Binding: CVX Vaccines Administered Vaccine Set . (extensible)
    ele-1: All FHIR elements must have a @value or children
    ... patient SΣ 1..1 Reference(US Core Patient Profile) Who was immunized
    ele-1: All FHIR elements must have a @value or children
    ... encounter S 0..1 Reference(US Core Encounter Profile) Encounter the immunization was part of
    ele-1: All FHIR elements must have a @value or children
    ... occurrence[x] SΣ 1..1 Vaccine administration date
    ele-1: All FHIR elements must have a @value or children
    .... occurrenceDateTime dateTime
    ... primarySource SΣ 0..1 boolean Indicates context the data was recorded in
    ele-1: All FHIR elements must have a @value or children
    ... location S 0..1 Reference(US Core Location Profile) Where the vaccine was administered
    ele-1: All FHIR elements must have a @value or children
    ... lotNumber S 0..1 string Vaccine lot number
    ele-1: All FHIR elements must have a @value or children
    ... performer SΣ 0..* BackboneElement Who performed event
    ele-1: All FHIR elements must have a @value or children
    .... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
    ele-1: All FHIR elements must have a @value or children
    ext-1: Must have either extensions or value[x], not both
    .... actor SΣ 1..1 Reference(US Core Practitioner Profile) Individual or organization who was performing
    ele-1: All FHIR elements must have a @value or children
    ... isSubpotent ?!Σ 0..1 boolean Dose potency
    ele-1: All FHIR elements must have a @value or children

    doco Documentation for this format

    Terminology Bindings

    PathConformanceValueSetURI
    Immunization.statusrequiredImmunizationStatusCodes
    http://hl7.org/fhir/ValueSet/immunization-status
    from the FHIR Standard
    Immunization.statusReasonexampleImmunizationStatusReasonCodes
    http://hl7.org/fhir/ValueSet/immunization-status-reason
    from the FHIR Standard
    Immunization.vaccineCodeextensibleCVXVaccinesAdministeredVaccineSet .
    http://cts.nlm.nih.gov/fhir/ValueSet/2.16.840.1.113762.1.4.1010.6

    Constraints

    IdGradePath(s)DetailsRequirements
    us-core-5best practiceImmunizationSHOULD have a translation 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()

     

    Other representations of profile: CSV, Excel, Schematron

    Notes:


    Quick Start


    Below is an overview of the required Server RESTful FHIR interactions for this profile - for example, search and read operations - when supporting the US Core interactions to access this profile's information (Profile Support + Interaction Support). Note that systems that support only US Core Profiles (Profile Only Support) are not required to support these interactions. See the US Core Server CapabilityStatement for a complete list of supported RESTful interactions for this IG.

    • See the Scopes Format section for a description of the SMART scopes syntax.
    • See the Search Syntax section for a description of the US Core search syntax.
    • See the General Requirements section for additional rules and expectations when a Server requires status parameters.
    • See the General Guidance section for additional guidance on searching for multiple patients.

    US Core Scopes

    Servers providing access to immunization data SHALL support these US Core SMART Scopes:

    Mandatory Search Parameters:

    The following search parameters and search parameter combinations SHALL be supported:

    1. SHALL support searching for all immunizations for a patient using the patient search parameter:

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

      Example:

      1. GET [base]/Immunization?patient=1137192

      Implementation Notes: Fetches a bundle of all Immunization resources for the specified patient (how to search by reference)

    Optional Search Parameters:

    The following search parameter combinations SHOULD be supported:

    1. SHOULD support searching using the combination of the patient and date search parameters:
      • including support for these date comparators: gt,lt,ge,le
      • including optional support for AND search on date (e.g.date=[date]&date=[date]]&...)

      GET [base]/Immunization?patient={Type/}[id]&date={gt|lt|ge|le}[date]{&date={gt|lt|ge|le}[date]&...}

      Example:

      1. GET [base]/Immunization?patient=1137192&date=ge2019-01-14T00:00:00Z

      Implementation Notes: Fetches a bundle of all Immunization resources for the specified patient and date (how to search by date and how to search by reference)

    2. SHOULD support searching using the combination of the patient and status search parameters:

      GET [base]/Immunization?patient={Type/}[id]&status={system|}[code]

      Example:

      1. GET [base]/Immunization?patient=1137192&status=completed

      Implementation Notes: Fetches a bundle of all Immunization resources for the specified patient and status (how to search by reference and how to search by date)


    1 Although the CVX code system contains some concepts that are procedures, medications, or substances rather than immunizations, the value set defined in VSAC has removed those and retained only the vaccine codes (see the exclusion definition in VSAC for more detail)