R6 Ballot (2nd Draft)

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Public Health icon Work GroupMaturity Level: 5 Trial UseSecurity Category: Patient Compartments: Patient, Practitioner

Detailed Descriptions for the elements in the Immunization resource.

Immunization
Element Id Immunization
Definition

Describes the event of a patient being administered a vaccine or a record of an immunization as reported by a patient, a clinician or another party.

Short Display Immunization event information
Cardinality 0..*
Type DomainResource
Summary false
Immunization.identifier
Element Id Immunization.identifier
Definition

A unique identifier assigned to this immunization record.

Short Display Business identifier
Note This is a business identifier, not a resource identifier (see discussion)
Cardinality 0..*
Type Identifier
Summary false
Immunization.basedOn
Element Id Immunization.basedOn
Definition

A plan, order or recommendation fulfilled in whole or in part by this immunization.

Short Display Authority that the immunization event is based on
Cardinality 0..*
Type Reference(CarePlan | MedicationRequest | ServiceRequest | ImmunizationRecommendation)
Summary true
Comments

Allows tracing of an authorization for the Immunization.

Immunization.status
Element Id Immunization.status
Definition

Indicates the current status of the immunization event.

Short Display completed | entered-in-error | not-done
Cardinality 1..1
Terminology Binding Immunization Status Codes (Required)
Type code
Is Modifier true (Reason: This element is labeled as a modifier because it is a status element that contains statuses entered-in-error and not-done which means that the resource should not be treated as valid)
Summary true
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.

Immunization.statusReason
Element Id Immunization.statusReason
Definition

Indicates the reason the immunization event was not performed.

Short Display Reason for current status
Cardinality 0..1
Terminology Binding Immunization Status Reason Codes (Example)
Type CodeableConcept
Summary false
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.

Immunization.vaccineCode
Element Id Immunization.vaccineCode
Definition

Vaccine that was administered or was to be administered.

Short Display Vaccine administered
Cardinality 1..1
Terminology Binding Vaccine Administered Value Set (Example)
Type CodeableConcept
Summary true
Comments

The code for the administered vaccine may be reported at various levels of granularity from a very generic code for a general type of vaccine (e.g. the SNOMED or CVX code for the flu vaccine) to a very discrete code for a specific product including the form and packaging (e.g. an NDC code). Because vaccineCode uses the CodeableConcept data type, multiple codes at different levels of granularity may be reported for a single immunization event provided that all codes are appropriate for the same vaccine. For example, both NDC and CVX codes may be provided for a given immunization event by repeating the coding element within vaccineCode.

Immunization.administeredProduct
Element Id Immunization.administeredProduct
Definition

An indication of which product was administered to the patient. This is typically a more detailed representation of the concept conveyed by the vaccineCode data element. If a Medication resource is referenced, it may be to a stand-alone resource or a contained resource within the Immunization resource.

Short Display Product that was administered
Cardinality 0..1
Type CodeableReference(Medication)
Summary false
Immunization.manufacturer
Element Id Immunization.manufacturer
Definition

Name of vaccine manufacturer.

Short Display Vaccine manufacturer
Cardinality 0..1
Type CodeableReference(Organization)
Summary false
Immunization.lotNumber
Element Id Immunization.lotNumber
Definition

Lot number of the vaccine product.

Short Display Vaccine lot number
Cardinality 0..1
Type string
Summary false
Immunization.expirationDate
Element Id Immunization.expirationDate
Definition

Date vaccine batch expires.

Short Display Vaccine expiration date
Cardinality 0..1
Type date
Summary false
Immunization.patient
Element Id Immunization.patient
Definition

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

Short Display Who was immunized
Cardinality 1..1
Type Reference(Patient)
Summary true
Immunization.encounter
Element Id Immunization.encounter
Definition

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

Short Display Encounter immunization was part of
Cardinality 0..1
Type Reference(Encounter)
Summary false
Immunization.supportingInformation
Element Id Immunization.supportingInformation
Definition

Additional information that is relevant to the immunization (e.g. for a vaccine recipient who is pregnant, the gestational age of the fetus). The reason why a vaccine was given (e.g. occupation, underlying medical condition) should be conveyed in Immunization.reason, not as supporting information. The reason why a vaccine was not given (e.g. contraindication) should be conveyed in Immunization.statusReason, not as supporting information.

Short Display Additional information in support of the immunization
Cardinality 0..*
Type Reference(Any)
Summary false
Immunization.occurrence[x]
Element Id Immunization.occurrence[x]
Definition

Date vaccine administered or was to be administered.

Short Display Vaccine administration date
Cardinality 1..1
Type dateTime|string
[x] Note See Choice of Datatypes for further information about how to use [x]
Summary true
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.

Immunization.primarySource
Element Id Immunization.primarySource
Definition

Indicates whether the data contained in the resource was captured by the individual/organization which was responsible for the administration of the vaccine rather than as 'secondary reported' data documented by a third party. A value of 'true' means this data originated with the individual/organization which was responsible for the administration of the vaccine.

Short Display Indicates context the data was captured in
Cardinality 0..1
Type boolean
Summary true
Comments

Reflects the “reliability” of the content.

Immunization.informationSource
Element Id Immunization.informationSource
Definition

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

Short Display Indicates the source of a reported record
Cardinality 0..1
Terminology Binding Immunization Origin Codes (Example)
Type CodeableReference(Patient | Practitioner | PractitionerRole | RelatedPerson | Organization)
Summary false
Comments

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

Immunization.location
Element Id Immunization.location
Definition

The service delivery location where the vaccine administration occurred.

Short Display The service delivery location
Cardinality 0..1
Type Reference(Location)
Summary false
Immunization.site
Element Id Immunization.site
Definition

Body site where vaccine was administered.

Short Display Body site vaccine was administered
Cardinality 0..1
Terminology Binding Codes for Immunization Site of Administration (Example)
Type CodeableConcept
Summary false
Immunization.route
Element Id Immunization.route
Definition

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

Short Display How vaccine entered body
Cardinality 0..1
Terminology Binding Immunization Route Codes (Example)
Type CodeableConcept
Summary false
Immunization.doseQuantity
Element Id Immunization.doseQuantity
Definition

The quantity of vaccine product that was administered.

Short Display Amount of vaccine administered
Cardinality 0..1
Type SimpleQuantity
Summary false
Immunization.performer
Element Id Immunization.performer
Definition

Indicates who performed the immunization event.

Short Display Who performed event
Cardinality 0..*
Summary true
Immunization.performer.function
Element Id Immunization.performer.function
Definition

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

Short Display What type of performance was done
Cardinality 0..1
Terminology Binding Immunization Function Codes (Extensible)
Type CodeableConcept
Summary true
Immunization.performer.actor
Element Id Immunization.performer.actor
Definition

The practitioner or organization who performed the action.

Short Display Individual or organization who was performing
Cardinality 1..1
Type Reference(Practitioner | PractitionerRole | Organization | Patient | RelatedPerson)
Summary true
Comments

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

Immunization.note
Element Id Immunization.note
Definition

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

Short Display Additional immunization notes
Cardinality 0..*
Type Annotation
Summary true
Immunization.reason
Element Id Immunization.reason
Definition

Describes why the immunization occurred in coded or textual form, or Indicates another resource (Condition, Observation or DiagnosticReport) whose existence justifies this immunization.

Short Display Why immunization occurred
Cardinality 0..*
Terminology Binding Immunization Reason Codes (Example)
Type CodeableReference(Condition | Observation | DiagnosticReport)
Summary false
Immunization.isSubpotent
Element Id Immunization.isSubpotent
Definition

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

Short Display Dose potency
Cardinality 0..1
Type boolean
Is Modifier true (Reason: This element is labeled as a modifier because an immunization event with a subpotent vaccine doesn't protect the patient the same way as a potent dose.)
Meaning if Missing By default, a dose should be considered to be potent.
Summary true
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.

Immunization.subpotentReason
Element Id Immunization.subpotentReason
Definition

Reason why a dose is considered to be subpotent.

Short Display Reason for being subpotent
Cardinality 0..*
Terminology Binding Immunization Subpotent Reason (Example)
Type CodeableConcept
Summary false
Immunization.programEligibility
Element Id Immunization.programEligibility
Definition

Indicates a patient's eligibility for a funding program.

Short Display Patient eligibility for a specific vaccination program
Cardinality 0..*
Summary false
Immunization.programEligibility.program
Element Id Immunization.programEligibility.program
Definition

Indicates which program the patient had their eligility evaluated for.

Short Display The program that eligibility is declared for
Cardinality 1..1
Terminology Binding Vaccine Funding Programs (Example)
Type CodeableConcept
Summary false
Immunization.programEligibility.programStatus
Element Id Immunization.programEligibility.programStatus
Definition

Indicates the patient's eligility status for for a specific payment program.

Short Display The patient's eligibility status for the program
Cardinality 1..1
Terminology Binding Immunization Program Eligibility (Example)
Type CodeableConcept
Summary false
Immunization.fundingSource
Element Id 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).

Short Display Funding source for the vaccine
Cardinality 0..1
Terminology Binding Immunization Funding Source (Example)
Type CodeableConcept
Summary false
Immunization.reaction
Element Id Immunization.reaction
Definition

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

Short Display Details of a reaction that follows immunization
Cardinality 0..*
Summary false
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.

Immunization.reaction.date
Element Id Immunization.reaction.date
Definition

Date of reaction to the immunization.

Short Display When reaction started
Cardinality 0..1
Type dateTime
Summary false
Immunization.reaction.manifestation
Element Id Immunization.reaction.manifestation
Definition

Details of the reaction.

Short Display Additional information on reaction
Cardinality 0..1
Type CodeableReference(Observation)
Summary false
Immunization.reaction.reported
Element Id Immunization.reaction.reported
Definition

Self-reported indicator.

Short Display Indicates self-reported reaction
Cardinality 0..1
Type boolean
Summary false
Immunization.protocolApplied
Element Id Immunization.protocolApplied
Definition

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

Short Display Protocol followed by the provider
Cardinality 0..*
Summary false
Immunization.protocolApplied.series
Element Id Immunization.protocolApplied.series
Definition

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

Short Display Name of vaccine series
Cardinality 0..1
Type string
Summary false
Immunization.protocolApplied.authority
Element Id Immunization.protocolApplied.authority
Definition

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

Short Display Who is responsible for publishing the recommendations
Cardinality 0..1
Type Reference(Organization)
Summary false
Immunization.protocolApplied.targetDisease
Element Id Immunization.protocolApplied.targetDisease
Definition

The vaccine preventable disease the dose is being administered against.

Short Display Vaccine preventatable disease being targeted
Cardinality 0..*
Terminology Binding Immunization Target Disease Codes (Example)
Type CodeableConcept
Summary false
Immunization.protocolApplied.doseNumber
Element Id Immunization.protocolApplied.doseNumber
Definition

Nominal position in a series as intended by the practitioner administering the dose.

Short Display Dose number within series
Cardinality 0..1
Type string
Summary false
Comments

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

Immunization.protocolApplied.seriesDoses
Element Id Immunization.protocolApplied.seriesDoses
Definition

The recommended number of doses to achieve immunity as intended by the practitioner administering the dose.

Short Display Recommended number of doses for immunity
Cardinality 0..1
Type string
Summary false
Comments

The use of an integer is preferred if known.