Introduction

This profile is used to represent de-identified Immunization information. The de-identification process has to remove all data elements not explicitly identified as “SUPPORTED” in the profile.

The HHS De-identification Guidance is to be followed to ensure appropriate level of de-identification is performed.

According to the HHS guidance, dates should not have a precision of more than the year. This means month and day cannot be included. This includes Immunization.occurenceDateTime.

In FHIR Resources, text elements and reference.display elements which provide human readable information to the providers may be generated using programs and tools from the data present within the resource. For e.g a Immunization resource text element may contain information such as the Immunization date, patient information. This type of information will enable identification of the individuals. In order to avoid inadvertent revealing of PII/PHI, text elements cannot be included in the De-identified FHIR resource and the submission will be rejected when text elements are present by the validation process.

Ids and References

The original Immunization resource id should not be included in the De-identified Immunization instance. Instead a new id should be created and provided as part of the FHIR resource. The Data Submitter should be capable of using the generated id to relink the data to the original Immunization. All resource references to the Immunization submitted as part of the UDS+ report should refer to newly generated id.

Resource references cannot contain text element as it may contain PHI/PII. The text element for following references are not allowed

• patient

Date Truncation

The Data Submitter has to truncate the following dates to only have a precision of year

• occurence[x]
• recorded

• Differential Table
• Key Elements Table
• Snapshot Table
• Statistics/References
• All

This structure is derived from Immunization

Name	Flags	Card.	Type	Description & Constraints
Immunization		0..*	Immunization	De-Identified UDS Plus Immunization
id	S	0..1	id	The de-identified Immunization identifier created by the health center to send data to UDS+ Data Receiver
text		0..0
contained		0..0
status	S	1..1	code	completed | entered-in-error | not-done
statusReason	S	0..1	CodeableConcept	Reason not done
vaccineCode	S	1..1	CodeableConcept	Vaccine product administered
patient	S	1..1	Reference(De-Identified UDS Plus Patient)	Who was immunized
occurrence[x]	S	1..1	dateTime	Vaccine administration date
recorded	S	0..1	dateTime	When the immunization was first captured in the subject's record
primarySource	S	1..1	boolean	Indicates context the data was recorded in
Documentation for this format

Name	Flags	Card.	Type	Description & Constraints
Immunization		0..*	Immunization	De-Identified UDS Plus Immunization
id	SΣ	0..1	id	The de-identified Immunization identifier created by the health center to send data to UDS+ Data Receiver
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	completed | entered-in-error | not-done Binding: ImmunizationStatusCodes (required): A set of codes indicating the current status of an Immunization.
statusReason	S	0..1	CodeableConcept	Reason not done Binding: ImmunizationStatusReasonCodes (example): The reason why a vaccine was not administered.
vaccineCode	SΣ	1..1	CodeableConcept	Vaccine product administered Binding: VaccineAdministeredValueSet (example): The code for vaccine product administered.
patient	SΣ	1..1	Reference(De-Identified UDS Plus Patient)	Who was immunized
occurrence[x]	SΣ	1..1	dateTime	Vaccine administration date
recorded	S	0..1	dateTime	When the immunization was first captured in the subject's record
primarySource	SΣ	1..1	boolean	Indicates context the data was recorded in
isSubpotent	?!Σ	0..1	boolean	Dose potency
Documentation for this format

Terminology Bindings

Path	Conformance	ValueSet
Immunization.status	required	ImmunizationStatusCodes
Immunization.statusReason	example	ImmunizationStatusReasonCodes
Immunization.vaccineCode	example	VaccineAdministeredValueSet

Constraints

Id	Grade	Path(s)	Details	Requirements
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()

Name	Flags	Card.	Type	Description & Constraints
Immunization		0..*	Immunization	De-Identified UDS Plus Immunization
id	SΣ	0..1	id	The de-identified Immunization identifier created by the health center to send data to UDS+ Data Receiver
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 Bindings Purpose AllLanguages Max Binding
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	completed | entered-in-error | not-done Binding: ImmunizationStatusCodes (required): A set of codes indicating the current status of an Immunization.
statusReason	S	0..1	CodeableConcept	Reason not done Binding: ImmunizationStatusReasonCodes (example): The reason why a vaccine was not administered.
vaccineCode	SΣ	1..1	CodeableConcept	Vaccine product administered Binding: VaccineAdministeredValueSet (example): The code for vaccine product administered.
patient	SΣ	1..1	Reference(De-Identified UDS Plus Patient)	Who was immunized
encounter		0..1	Reference(Encounter)	Encounter immunization was part of
occurrence[x]	SΣ	1..1	dateTime	Vaccine administration date
recorded	S	0..1	dateTime	When the immunization was first captured in the subject's record
primarySource	SΣ	1..1	boolean	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		0..1	Reference(Location)	Where immunization occurred
manufacturer		0..1	Reference(Organization)	Vaccine manufacturer
lotNumber		0..1	string	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	Amount of vaccine administered
performer	Σ	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	Σ	1..1	Reference(Practitioner | PractitionerRole | Organization)	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
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
Documentation for this format

Terminology Bindings

Path	Conformance	ValueSet
Immunization.language	preferred	CommonLanguages Additional Bindings Purpose AllLanguages Max Binding
Immunization.status	required	ImmunizationStatusCodes
Immunization.statusReason	example	ImmunizationStatusReasonCodes
Immunization.vaccineCode	example	VaccineAdministeredValueSet
Immunization.reportOrigin	example	ImmunizationOriginCodes
Immunization.site	example	CodesForImmunizationSiteOfAdministration
Immunization.route	example	ImmunizationRouteCodes
Immunization.performer.function	extensible	ImmunizationFunctionCodes
Immunization.reasonCode	example	ImmunizationReasonCodes
Immunization.subpotentReason	example	ImmunizationSubpotentReason
Immunization.programEligibility	example	ImmunizationProgramEligibility
Immunization.fundingSource	example	ImmunizationFundingSource
Immunization.protocolApplied.targetDisease	example	ImmunizationTargetDiseaseCodes

Constraints

Id	Grade	Path(s)	Details	Requirements
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()

Differential View

This structure is derived from Immunization

Name	Flags	Card.	Type	Description & Constraints
Immunization		0..*	Immunization	De-Identified UDS Plus Immunization
id	S	0..1	id	The de-identified Immunization identifier created by the health center to send data to UDS+ Data Receiver
text		0..0
contained		0..0
status	S	1..1	code	completed | entered-in-error | not-done
statusReason	S	0..1	CodeableConcept	Reason not done
vaccineCode	S	1..1	CodeableConcept	Vaccine product administered
patient	S	1..1	Reference(De-Identified UDS Plus Patient)	Who was immunized
occurrence[x]	S	1..1	dateTime	Vaccine administration date
recorded	S	0..1	dateTime	When the immunization was first captured in the subject's record
primarySource	S	1..1	boolean	Indicates context the data was recorded in
Documentation for this format

Key Elements View

Name	Flags	Card.	Type	Description & Constraints
Immunization		0..*	Immunization	De-Identified UDS Plus Immunization
id	SΣ	0..1	id	The de-identified Immunization identifier created by the health center to send data to UDS+ Data Receiver
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	completed | entered-in-error | not-done Binding: ImmunizationStatusCodes (required): A set of codes indicating the current status of an Immunization.
statusReason	S	0..1	CodeableConcept	Reason not done Binding: ImmunizationStatusReasonCodes (example): The reason why a vaccine was not administered.
vaccineCode	SΣ	1..1	CodeableConcept	Vaccine product administered Binding: VaccineAdministeredValueSet (example): The code for vaccine product administered.
patient	SΣ	1..1	Reference(De-Identified UDS Plus Patient)	Who was immunized
occurrence[x]	SΣ	1..1	dateTime	Vaccine administration date
recorded	S	0..1	dateTime	When the immunization was first captured in the subject's record
primarySource	SΣ	1..1	boolean	Indicates context the data was recorded in
isSubpotent	?!Σ	0..1	boolean	Dose potency
Documentation for this format

Terminology Bindings

Path	Conformance	ValueSet
Immunization.status	required	ImmunizationStatusCodes
Immunization.statusReason	example	ImmunizationStatusReasonCodes
Immunization.vaccineCode	example	VaccineAdministeredValueSet

Constraints

Id	Grade	Path(s)	Details	Requirements
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()

Snapshot View

Name	Flags	Card.	Type	Description & Constraints
Immunization		0..*	Immunization	De-Identified UDS Plus Immunization
id	SΣ	0..1	id	The de-identified Immunization identifier created by the health center to send data to UDS+ Data Receiver
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 Bindings Purpose AllLanguages Max Binding
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	completed | entered-in-error | not-done Binding: ImmunizationStatusCodes (required): A set of codes indicating the current status of an Immunization.
statusReason	S	0..1	CodeableConcept	Reason not done Binding: ImmunizationStatusReasonCodes (example): The reason why a vaccine was not administered.
vaccineCode	SΣ	1..1	CodeableConcept	Vaccine product administered Binding: VaccineAdministeredValueSet (example): The code for vaccine product administered.
patient	SΣ	1..1	Reference(De-Identified UDS Plus Patient)	Who was immunized
encounter		0..1	Reference(Encounter)	Encounter immunization was part of
occurrence[x]	SΣ	1..1	dateTime	Vaccine administration date
recorded	S	0..1	dateTime	When the immunization was first captured in the subject's record
primarySource	SΣ	1..1	boolean	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		0..1	Reference(Location)	Where immunization occurred
manufacturer		0..1	Reference(Organization)	Vaccine manufacturer
lotNumber		0..1	string	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	Amount of vaccine administered
performer	Σ	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	Σ	1..1	Reference(Practitioner | PractitionerRole | Organization)	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
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
Documentation for this format

Terminology Bindings

Path	Conformance	ValueSet
Immunization.language	preferred	CommonLanguages Additional Bindings Purpose AllLanguages Max Binding
Immunization.status	required	ImmunizationStatusCodes
Immunization.statusReason	example	ImmunizationStatusReasonCodes
Immunization.vaccineCode	example	VaccineAdministeredValueSet
Immunization.reportOrigin	example	ImmunizationOriginCodes
Immunization.site	example	CodesForImmunizationSiteOfAdministration
Immunization.route	example	ImmunizationRouteCodes
Immunization.performer.function	extensible	ImmunizationFunctionCodes
Immunization.reasonCode	example	ImmunizationReasonCodes
Immunization.subpotentReason	example	ImmunizationSubpotentReason
Immunization.programEligibility	example	ImmunizationProgramEligibility
Immunization.fundingSource	example	ImmunizationFundingSource
Immunization.protocolApplied.targetDisease	example	ImmunizationTargetDiseaseCodes

Constraints

Id	Grade	Path(s)	Details	Requirements
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()

This structure is derived from Immunization

Summary

Mandatory: 5 elements
Must-Support: 8 elements
Prohibited: 2 elements

Structures

This structure refers to these other structures:

• De-Identified UDS Plus Patient (http://fhir.org/guides/hrsa/uds-plus/StructureDefinition/de-identified-uds-plus-patient)

Maturity: 2