Introduction

This profile is used to represent de-identified AllergyIntolerance 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 AllergyIntolerance.recorded and onset elements.

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 AllergyIntolerance resource text element may contain information such as the AllergyIntolerance dates, 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 AllergyIntolerance resource id should not be included in the De-identified AllergyIntolerance 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 AllergyIntolerance. All resource references to the AllergyIntolerance 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

• onset
• recordedDate

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

This structure is derived from AllergyIntolerance

Name	Flags	Card.	Type	Description & Constraints
AllergyIntolerance		0..*	AllergyIntolerance	De-Identified UDS Plus AllergyIntolerance
id	S	0..1	id	The de-identified AllergyIntolerance identifier created by the health center to send data to UDS+ Data Receiver
text		0..0
contained		0..0
clinicalStatus	S	0..1	CodeableConcept	active | inactive | resolved
verificationStatus	S	0..1	CodeableConcept	unconfirmed | confirmed | refuted | entered-in-error
type	S	0..1	code	allergy | intolerance - Underlying mechanism (if known)
category	S	0..*	code	food | medication | environment | biologic
criticality	S	0..1	code	low | high | unable-to-assess
code	S	1..1	CodeableConcept	Code that identifies the allergy or intolerance Binding: Common substances for allergy and intolerance documentation including refutations (extensible): The set of codes indicating the allergy or intolerance
patient	S	1..1	Reference(De-Identified UDS Plus Patient)	Who the sensitivity is for
display		0..0
encounter
display		0..0
onset[x]	SC	0..1		When allergy or intolerance was identified uds-plus-all-1: All dateTime data elements should be truncated to a year only for de-identified resources.
onsetDateTime			dateTime
onsetAge			Age
recordedDate	SC	0..1	dateTime	Date first version of the resource instance was recorded uds-plus-all-2: All dateTime data elements should be truncated to a year only for de-identified resources.
recorder
display		0..0
asserter
display		0..0
lastOccurrence	C	0..1	dateTime	Date(/time) of last known occurrence of a reaction uds-plus-all-3: All dateTime data elements should be truncated to a year only for de-identified resources.
note		0..0
reaction	S	0..*	BackboneElement	Adverse Reaction Events linked to exposure to substance
manifestation	S	1..*	CodeableConcept	Clinical symptoms/signs associated with the Event
onset	C	0..1	dateTime	Date(/time) when manifestations showed uds-plus-all-4: All dateTime data elements should be truncated to a year only for de-identified resources.
severity	S	0..1	code	mild | moderate | severe (of event as a whole)
note		0..0
Documentation for this format

Terminology Bindings (Differential)

Path	Conformance	ValueSet	URI
AllergyIntolerance.code	extensible	CommonSubstancesForAllergyAndIntoleranceDocumentationIncludingRefutations http://cts.nlm.nih.gov/fhir/ValueSet/2.16.840.1.113762.1.4.1186.8 from https://vsac.nlm.nih.gov

Constraints

Id	Grade	Path(s)	Details	Requirements
uds-plus-all-1	error	AllergyIntolerance.onset[x]	All dateTime data elements should be truncated to a year only for de-identified resources. : $this is DateTime implies $this.toString().length() = 4
uds-plus-all-2	error	AllergyIntolerance.recordedDate	All dateTime data elements should be truncated to a year only for de-identified resources. : $this is DateTime implies $this.toString().length() = 4
uds-plus-all-3	error	AllergyIntolerance.lastOccurrence	All dateTime data elements should be truncated to a year only for de-identified resources. : $this is DateTime implies $this.toString().length() = 4
uds-plus-all-4	error	AllergyIntolerance.reaction.onset	All dateTime data elements should be truncated to a year only for de-identified resources. : $this is DateTime implies $this.toString().length() = 4

Name	Flags	Card.	Type	Description & Constraints
AllergyIntolerance	C	0..*	AllergyIntolerance	De-Identified UDS Plus AllergyIntolerance ait-1: AllergyIntolerance.clinicalStatus SHALL be present if verificationStatus is not entered-in-error. ait-2: AllergyIntolerance.clinicalStatus SHALL NOT be present if verification Status is entered-in-error
id	SΣ	0..1	id	The de-identified AllergyIntolerance 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
clinicalStatus	?!SΣC	0..1	CodeableConcept	active | inactive | resolved Binding: AllergyIntoleranceClinicalStatusCodes (required): The clinical status of the allergy or intolerance.
verificationStatus	?!SΣC	0..1	CodeableConcept	unconfirmed | confirmed | refuted | entered-in-error Binding: AllergyIntoleranceVerificationStatusCodes (required): Assertion about certainty associated with a propensity, or potential risk, of a reaction to the identified substance.
type	SΣ	0..1	code	allergy | intolerance - Underlying mechanism (if known) Binding: AllergyIntoleranceType (required): Identification of the underlying physiological mechanism for a Reaction Risk.
category	SΣ	0..*	code	food | medication | environment | biologic Binding: AllergyIntoleranceCategory (required): Category of an identified substance associated with allergies or intolerances.
criticality	SΣ	0..1	code	low | high | unable-to-assess Binding: AllergyIntoleranceCriticality (required): Estimate of the potential clinical harm, or seriousness, of a reaction to an identified substance.
code	SΣ	1..1	CodeableConcept	Code that identifies the allergy or intolerance Binding: Common substances for allergy and intolerance documentation including refutations (extensible): The set of codes indicating the allergy or intolerance
patient	SΣ	1..1	Reference(De-Identified UDS Plus Patient)	Who the sensitivity is for
onset[x]	SC	0..1		When allergy or intolerance was identified uds-plus-all-1: All dateTime data elements should be truncated to a year only for de-identified resources.
onsetDateTime			dateTime
onsetAge			Age
recordedDate	SC	0..1	dateTime	Date first version of the resource instance was recorded uds-plus-all-2: All dateTime data elements should be truncated to a year only for de-identified resources.
lastOccurrence	C	0..1	dateTime	Date(/time) of last known occurrence of a reaction uds-plus-all-3: All dateTime data elements should be truncated to a year only for de-identified resources.
reaction	S	0..*	BackboneElement	Adverse Reaction Events linked to exposure to substance
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
manifestation	S	1..*	CodeableConcept	Clinical symptoms/signs associated with the Event Binding: SNOMEDCTClinicalFindings (example): Clinical symptoms and/or signs that are observed or associated with an Adverse Reaction Event.
onset	C	0..1	dateTime	Date(/time) when manifestations showed uds-plus-all-4: All dateTime data elements should be truncated to a year only for de-identified resources.
severity	S	0..1	code	mild | moderate | severe (of event as a whole) Binding: AllergyIntoleranceSeverity (required): Clinical assessment of the severity of a reaction event as a whole, potentially considering multiple different manifestations.
Documentation for this format

Terminology Bindings

Path	Conformance	ValueSet	URI
AllergyIntolerance.clinicalStatus	required	AllergyIntoleranceClinicalStatusCodes http://hl7.org/fhir/ValueSet/allergyintolerance-clinical|4.0.1 from the FHIR Standard
AllergyIntolerance.verificationStatus	required	AllergyIntoleranceVerificationStatusCodes http://hl7.org/fhir/ValueSet/allergyintolerance-verification|4.0.1 from the FHIR Standard
AllergyIntolerance.type	required	AllergyIntoleranceType http://hl7.org/fhir/ValueSet/allergy-intolerance-type|4.0.1 from the FHIR Standard
AllergyIntolerance.category	required	AllergyIntoleranceCategory http://hl7.org/fhir/ValueSet/allergy-intolerance-category|4.0.1 from the FHIR Standard
AllergyIntolerance.criticality	required	AllergyIntoleranceCriticality http://hl7.org/fhir/ValueSet/allergy-intolerance-criticality|4.0.1 from the FHIR Standard
AllergyIntolerance.code	extensible	CommonSubstancesForAllergyAndIntoleranceDocumentationIncludingRefutations http://cts.nlm.nih.gov/fhir/ValueSet/2.16.840.1.113762.1.4.1186.8 from https://vsac.nlm.nih.gov
AllergyIntolerance.reaction.manifestation	example	SNOMEDCTClinicalFindings http://hl7.org/fhir/ValueSet/clinical-findings from the FHIR Standard
AllergyIntolerance.reaction.severity	required	AllergyIntoleranceSeverity http://hl7.org/fhir/ValueSet/reaction-event-severity|4.0.1 from the FHIR Standard

Constraints

Id	Grade	Path(s)	Details	Requirements
ait-1	error	AllergyIntolerance	AllergyIntolerance.clinicalStatus SHALL be present if verificationStatus is not entered-in-error. : verificationStatus.coding.where(system = 'http://terminology.hl7.org/CodeSystem/allergyintolerance-verification' and code = 'entered-in-error').exists() or clinicalStatus.exists()
ait-2	error	AllergyIntolerance	AllergyIntolerance.clinicalStatus SHALL NOT be present if verification Status is entered-in-error : verificationStatus.coding.where(system = 'http://terminology.hl7.org/CodeSystem/allergyintolerance-verification' and code = 'entered-in-error').empty() or clinicalStatus.empty()
dom-2	error	AllergyIntolerance	If the resource is contained in another resource, it SHALL NOT contain nested Resources : contained.contained.empty()
dom-3	error	AllergyIntolerance	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	AllergyIntolerance	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	AllergyIntolerance	If a resource is contained in another resource, it SHALL NOT have a security label : contained.meta.security.empty()
dom-6	best practice	AllergyIntolerance	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()
uds-plus-all-1	error	AllergyIntolerance.onset[x]	All dateTime data elements should be truncated to a year only for de-identified resources. : $this is DateTime implies $this.toString().length() = 4
uds-plus-all-2	error	AllergyIntolerance.recordedDate	All dateTime data elements should be truncated to a year only for de-identified resources. : $this is DateTime implies $this.toString().length() = 4
uds-plus-all-3	error	AllergyIntolerance.lastOccurrence	All dateTime data elements should be truncated to a year only for de-identified resources. : $this is DateTime implies $this.toString().length() = 4
uds-plus-all-4	error	AllergyIntolerance.reaction.onset	All dateTime data elements should be truncated to a year only for de-identified resources. : $this is DateTime implies $this.toString().length() = 4

Name	Flags	Card.	Type	Description & Constraints
AllergyIntolerance	C	0..*	AllergyIntolerance	De-Identified UDS Plus AllergyIntolerance ait-1: AllergyIntolerance.clinicalStatus SHALL be present if verificationStatus is not entered-in-error. ait-2: AllergyIntolerance.clinicalStatus SHALL NOT be present if verification Status is entered-in-error
id	SΣ	0..1	id	The de-identified AllergyIntolerance 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	Σ	0..*	Identifier	External ids for this item
clinicalStatus	?!SΣC	0..1	CodeableConcept	active | inactive | resolved Binding: AllergyIntoleranceClinicalStatusCodes (required): The clinical status of the allergy or intolerance.
verificationStatus	?!SΣC	0..1	CodeableConcept	unconfirmed | confirmed | refuted | entered-in-error Binding: AllergyIntoleranceVerificationStatusCodes (required): Assertion about certainty associated with a propensity, or potential risk, of a reaction to the identified substance.
type	SΣ	0..1	code	allergy | intolerance - Underlying mechanism (if known) Binding: AllergyIntoleranceType (required): Identification of the underlying physiological mechanism for a Reaction Risk.
category	SΣ	0..*	code	food | medication | environment | biologic Binding: AllergyIntoleranceCategory (required): Category of an identified substance associated with allergies or intolerances.
criticality	SΣ	0..1	code	low | high | unable-to-assess Binding: AllergyIntoleranceCriticality (required): Estimate of the potential clinical harm, or seriousness, of a reaction to an identified substance.
code	SΣ	1..1	CodeableConcept	Code that identifies the allergy or intolerance Binding: Common substances for allergy and intolerance documentation including refutations (extensible): The set of codes indicating the allergy or intolerance
patient	SΣ	1..1	Reference(De-Identified UDS Plus Patient)	Who the sensitivity is for
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
reference	ΣC	0..1	string	Literal reference, Relative, internal or absolute URL
type	Σ	0..1	uri	Type the reference refers to (e.g. "Patient") Binding: ResourceType (extensible): Aa resource (or, for logical models, the URI of the logical model).
identifier	Σ	0..1	Identifier	Logical reference, when literal reference is not known
encounter		0..1	Reference(Encounter)	Encounter when the allergy or intolerance was asserted
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
reference	ΣC	0..1	string	Literal reference, Relative, internal or absolute URL
type	Σ	0..1	uri	Type the reference refers to (e.g. "Patient") Binding: ResourceType (extensible): Aa resource (or, for logical models, the URI of the logical model).
identifier	Σ	0..1	Identifier	Logical reference, when literal reference is not known
onset[x]	SC	0..1		When allergy or intolerance was identified uds-plus-all-1: All dateTime data elements should be truncated to a year only for de-identified resources.
onsetDateTime			dateTime
onsetAge			Age
recordedDate	SC	0..1	dateTime	Date first version of the resource instance was recorded uds-plus-all-2: All dateTime data elements should be truncated to a year only for de-identified resources.
recorder		0..1	Reference(Practitioner | PractitionerRole | Patient | RelatedPerson)	Who recorded the sensitivity
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
reference	ΣC	0..1	string	Literal reference, Relative, internal or absolute URL
type	Σ	0..1	uri	Type the reference refers to (e.g. "Patient") Binding: ResourceType (extensible): Aa resource (or, for logical models, the URI of the logical model).
identifier	Σ	0..1	Identifier	Logical reference, when literal reference is not known
asserter	Σ	0..1	Reference(Patient | RelatedPerson | Practitioner | PractitionerRole)	Source of the information about the allergy
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
reference	ΣC	0..1	string	Literal reference, Relative, internal or absolute URL
type	Σ	0..1	uri	Type the reference refers to (e.g. "Patient") Binding: ResourceType (extensible): Aa resource (or, for logical models, the URI of the logical model).
identifier	Σ	0..1	Identifier	Logical reference, when literal reference is not known
lastOccurrence	C	0..1	dateTime	Date(/time) of last known occurrence of a reaction uds-plus-all-3: All dateTime data elements should be truncated to a year only for de-identified resources.
reaction	S	0..*	BackboneElement	Adverse Reaction Events linked to exposure to substance
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
substance		0..1	CodeableConcept	Specific substance or pharmaceutical product considered to be responsible for event Binding: SubstanceCode (example): Codes defining the type of the substance (including pharmaceutical products).
manifestation	S	1..*	CodeableConcept	Clinical symptoms/signs associated with the Event Binding: SNOMEDCTClinicalFindings (example): Clinical symptoms and/or signs that are observed or associated with an Adverse Reaction Event.
description		0..1	string	Description of the event as a whole
onset	C	0..1	dateTime	Date(/time) when manifestations showed uds-plus-all-4: All dateTime data elements should be truncated to a year only for de-identified resources.
severity	S	0..1	code	mild | moderate | severe (of event as a whole) Binding: AllergyIntoleranceSeverity (required): Clinical assessment of the severity of a reaction event as a whole, potentially considering multiple different manifestations.
exposureRoute		0..1	CodeableConcept	How the subject was exposed to the substance Binding: SNOMEDCTRouteCodes (example): A coded concept describing the route or physiological path of administration of a therapeutic agent into or onto the body of a subject.
Documentation for this format

Terminology Bindings

Path	Conformance	ValueSet	URI
AllergyIntolerance.language	preferred	CommonLanguages Additional Bindings Purpose AllLanguages Max Binding http://hl7.org/fhir/ValueSet/languages from the FHIR Standard
AllergyIntolerance.clinicalStatus	required	AllergyIntoleranceClinicalStatusCodes http://hl7.org/fhir/ValueSet/allergyintolerance-clinical|4.0.1 from the FHIR Standard
AllergyIntolerance.verificationStatus	required	AllergyIntoleranceVerificationStatusCodes http://hl7.org/fhir/ValueSet/allergyintolerance-verification|4.0.1 from the FHIR Standard
AllergyIntolerance.type	required	AllergyIntoleranceType http://hl7.org/fhir/ValueSet/allergy-intolerance-type|4.0.1 from the FHIR Standard
AllergyIntolerance.category	required	AllergyIntoleranceCategory http://hl7.org/fhir/ValueSet/allergy-intolerance-category|4.0.1 from the FHIR Standard
AllergyIntolerance.criticality	required	AllergyIntoleranceCriticality http://hl7.org/fhir/ValueSet/allergy-intolerance-criticality|4.0.1 from the FHIR Standard
AllergyIntolerance.code	extensible	CommonSubstancesForAllergyAndIntoleranceDocumentationIncludingRefutations http://cts.nlm.nih.gov/fhir/ValueSet/2.16.840.1.113762.1.4.1186.8 from https://vsac.nlm.nih.gov
AllergyIntolerance.patient.type	extensible	ResourceType http://hl7.org/fhir/ValueSet/resource-types from the FHIR Standard
AllergyIntolerance.encounter.type	extensible	ResourceType http://hl7.org/fhir/ValueSet/resource-types from the FHIR Standard
AllergyIntolerance.recorder.type	extensible	ResourceType http://hl7.org/fhir/ValueSet/resource-types from the FHIR Standard
AllergyIntolerance.asserter.type	extensible	ResourceType http://hl7.org/fhir/ValueSet/resource-types from the FHIR Standard
AllergyIntolerance.reaction.substance	example	SubstanceCode http://hl7.org/fhir/ValueSet/substance-code from the FHIR Standard
AllergyIntolerance.reaction.manifestation	example	SNOMEDCTClinicalFindings http://hl7.org/fhir/ValueSet/clinical-findings from the FHIR Standard
AllergyIntolerance.reaction.severity	required	AllergyIntoleranceSeverity http://hl7.org/fhir/ValueSet/reaction-event-severity|4.0.1 from the FHIR Standard
AllergyIntolerance.reaction.exposureRoute	example	SNOMEDCTRouteCodes http://hl7.org/fhir/ValueSet/route-codes from the FHIR Standard

Constraints

Id	Grade	Path(s)	Details	Requirements
ait-1	error	AllergyIntolerance	AllergyIntolerance.clinicalStatus SHALL be present if verificationStatus is not entered-in-error. : verificationStatus.coding.where(system = 'http://terminology.hl7.org/CodeSystem/allergyintolerance-verification' and code = 'entered-in-error').exists() or clinicalStatus.exists()
ait-2	error	AllergyIntolerance	AllergyIntolerance.clinicalStatus SHALL NOT be present if verification Status is entered-in-error : verificationStatus.coding.where(system = 'http://terminology.hl7.org/CodeSystem/allergyintolerance-verification' and code = 'entered-in-error').empty() or clinicalStatus.empty()
dom-2	error	AllergyIntolerance	If the resource is contained in another resource, it SHALL NOT contain nested Resources : contained.contained.empty()
dom-3	error	AllergyIntolerance	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	AllergyIntolerance	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	AllergyIntolerance	If a resource is contained in another resource, it SHALL NOT have a security label : contained.meta.security.empty()
dom-6	best practice	AllergyIntolerance	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()
uds-plus-all-1	error	AllergyIntolerance.onset[x]	All dateTime data elements should be truncated to a year only for de-identified resources. : $this is DateTime implies $this.toString().length() = 4
uds-plus-all-2	error	AllergyIntolerance.recordedDate	All dateTime data elements should be truncated to a year only for de-identified resources. : $this is DateTime implies $this.toString().length() = 4
uds-plus-all-3	error	AllergyIntolerance.lastOccurrence	All dateTime data elements should be truncated to a year only for de-identified resources. : $this is DateTime implies $this.toString().length() = 4
uds-plus-all-4	error	AllergyIntolerance.reaction.onset	All dateTime data elements should be truncated to a year only for de-identified resources. : $this is DateTime implies $this.toString().length() = 4

Differential View

This structure is derived from AllergyIntolerance

Name	Flags	Card.	Type	Description & Constraints
AllergyIntolerance		0..*	AllergyIntolerance	De-Identified UDS Plus AllergyIntolerance
id	S	0..1	id	The de-identified AllergyIntolerance identifier created by the health center to send data to UDS+ Data Receiver
text		0..0
contained		0..0
clinicalStatus	S	0..1	CodeableConcept	active | inactive | resolved
verificationStatus	S	0..1	CodeableConcept	unconfirmed | confirmed | refuted | entered-in-error
type	S	0..1	code	allergy | intolerance - Underlying mechanism (if known)
category	S	0..*	code	food | medication | environment | biologic
criticality	S	0..1	code	low | high | unable-to-assess
code	S	1..1	CodeableConcept	Code that identifies the allergy or intolerance Binding: Common substances for allergy and intolerance documentation including refutations (extensible): The set of codes indicating the allergy or intolerance
patient	S	1..1	Reference(De-Identified UDS Plus Patient)	Who the sensitivity is for
display		0..0
encounter
display		0..0
onset[x]	SC	0..1		When allergy or intolerance was identified uds-plus-all-1: All dateTime data elements should be truncated to a year only for de-identified resources.
onsetDateTime			dateTime
onsetAge			Age
recordedDate	SC	0..1	dateTime	Date first version of the resource instance was recorded uds-plus-all-2: All dateTime data elements should be truncated to a year only for de-identified resources.
recorder
display		0..0
asserter
display		0..0
lastOccurrence	C	0..1	dateTime	Date(/time) of last known occurrence of a reaction uds-plus-all-3: All dateTime data elements should be truncated to a year only for de-identified resources.
note		0..0
reaction	S	0..*	BackboneElement	Adverse Reaction Events linked to exposure to substance
manifestation	S	1..*	CodeableConcept	Clinical symptoms/signs associated with the Event
onset	C	0..1	dateTime	Date(/time) when manifestations showed uds-plus-all-4: All dateTime data elements should be truncated to a year only for de-identified resources.
severity	S	0..1	code	mild | moderate | severe (of event as a whole)
note		0..0
Documentation for this format

Terminology Bindings (Differential)

Path	Conformance	ValueSet	URI
AllergyIntolerance.code	extensible	CommonSubstancesForAllergyAndIntoleranceDocumentationIncludingRefutations http://cts.nlm.nih.gov/fhir/ValueSet/2.16.840.1.113762.1.4.1186.8 from https://vsac.nlm.nih.gov

Constraints

Id	Grade	Path(s)	Details	Requirements
uds-plus-all-1	error	AllergyIntolerance.onset[x]	All dateTime data elements should be truncated to a year only for de-identified resources. : $this is DateTime implies $this.toString().length() = 4
uds-plus-all-2	error	AllergyIntolerance.recordedDate	All dateTime data elements should be truncated to a year only for de-identified resources. : $this is DateTime implies $this.toString().length() = 4
uds-plus-all-3	error	AllergyIntolerance.lastOccurrence	All dateTime data elements should be truncated to a year only for de-identified resources. : $this is DateTime implies $this.toString().length() = 4
uds-plus-all-4	error	AllergyIntolerance.reaction.onset	All dateTime data elements should be truncated to a year only for de-identified resources. : $this is DateTime implies $this.toString().length() = 4

Key Elements View

Name	Flags	Card.	Type	Description & Constraints
AllergyIntolerance	C	0..*	AllergyIntolerance	De-Identified UDS Plus AllergyIntolerance ait-1: AllergyIntolerance.clinicalStatus SHALL be present if verificationStatus is not entered-in-error. ait-2: AllergyIntolerance.clinicalStatus SHALL NOT be present if verification Status is entered-in-error
id	SΣ	0..1	id	The de-identified AllergyIntolerance 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
clinicalStatus	?!SΣC	0..1	CodeableConcept	active | inactive | resolved Binding: AllergyIntoleranceClinicalStatusCodes (required): The clinical status of the allergy or intolerance.
verificationStatus	?!SΣC	0..1	CodeableConcept	unconfirmed | confirmed | refuted | entered-in-error Binding: AllergyIntoleranceVerificationStatusCodes (required): Assertion about certainty associated with a propensity, or potential risk, of a reaction to the identified substance.
type	SΣ	0..1	code	allergy | intolerance - Underlying mechanism (if known) Binding: AllergyIntoleranceType (required): Identification of the underlying physiological mechanism for a Reaction Risk.
category	SΣ	0..*	code	food | medication | environment | biologic Binding: AllergyIntoleranceCategory (required): Category of an identified substance associated with allergies or intolerances.
criticality	SΣ	0..1	code	low | high | unable-to-assess Binding: AllergyIntoleranceCriticality (required): Estimate of the potential clinical harm, or seriousness, of a reaction to an identified substance.
code	SΣ	1..1	CodeableConcept	Code that identifies the allergy or intolerance Binding: Common substances for allergy and intolerance documentation including refutations (extensible): The set of codes indicating the allergy or intolerance
patient	SΣ	1..1	Reference(De-Identified UDS Plus Patient)	Who the sensitivity is for
onset[x]	SC	0..1		When allergy or intolerance was identified uds-plus-all-1: All dateTime data elements should be truncated to a year only for de-identified resources.
onsetDateTime			dateTime
onsetAge			Age
recordedDate	SC	0..1	dateTime	Date first version of the resource instance was recorded uds-plus-all-2: All dateTime data elements should be truncated to a year only for de-identified resources.
lastOccurrence	C	0..1	dateTime	Date(/time) of last known occurrence of a reaction uds-plus-all-3: All dateTime data elements should be truncated to a year only for de-identified resources.
reaction	S	0..*	BackboneElement	Adverse Reaction Events linked to exposure to substance
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
manifestation	S	1..*	CodeableConcept	Clinical symptoms/signs associated with the Event Binding: SNOMEDCTClinicalFindings (example): Clinical symptoms and/or signs that are observed or associated with an Adverse Reaction Event.
onset	C	0..1	dateTime	Date(/time) when manifestations showed uds-plus-all-4: All dateTime data elements should be truncated to a year only for de-identified resources.
severity	S	0..1	code	mild | moderate | severe (of event as a whole) Binding: AllergyIntoleranceSeverity (required): Clinical assessment of the severity of a reaction event as a whole, potentially considering multiple different manifestations.
Documentation for this format

Terminology Bindings

Path	Conformance	ValueSet	URI
AllergyIntolerance.clinicalStatus	required	AllergyIntoleranceClinicalStatusCodes http://hl7.org/fhir/ValueSet/allergyintolerance-clinical|4.0.1 from the FHIR Standard
AllergyIntolerance.verificationStatus	required	AllergyIntoleranceVerificationStatusCodes http://hl7.org/fhir/ValueSet/allergyintolerance-verification|4.0.1 from the FHIR Standard
AllergyIntolerance.type	required	AllergyIntoleranceType http://hl7.org/fhir/ValueSet/allergy-intolerance-type|4.0.1 from the FHIR Standard
AllergyIntolerance.category	required	AllergyIntoleranceCategory http://hl7.org/fhir/ValueSet/allergy-intolerance-category|4.0.1 from the FHIR Standard
AllergyIntolerance.criticality	required	AllergyIntoleranceCriticality http://hl7.org/fhir/ValueSet/allergy-intolerance-criticality|4.0.1 from the FHIR Standard
AllergyIntolerance.code	extensible	CommonSubstancesForAllergyAndIntoleranceDocumentationIncludingRefutations http://cts.nlm.nih.gov/fhir/ValueSet/2.16.840.1.113762.1.4.1186.8 from https://vsac.nlm.nih.gov
AllergyIntolerance.reaction.manifestation	example	SNOMEDCTClinicalFindings http://hl7.org/fhir/ValueSet/clinical-findings from the FHIR Standard
AllergyIntolerance.reaction.severity	required	AllergyIntoleranceSeverity http://hl7.org/fhir/ValueSet/reaction-event-severity|4.0.1 from the FHIR Standard

Constraints

Id	Grade	Path(s)	Details	Requirements
ait-1	error	AllergyIntolerance	AllergyIntolerance.clinicalStatus SHALL be present if verificationStatus is not entered-in-error. : verificationStatus.coding.where(system = 'http://terminology.hl7.org/CodeSystem/allergyintolerance-verification' and code = 'entered-in-error').exists() or clinicalStatus.exists()
ait-2	error	AllergyIntolerance	AllergyIntolerance.clinicalStatus SHALL NOT be present if verification Status is entered-in-error : verificationStatus.coding.where(system = 'http://terminology.hl7.org/CodeSystem/allergyintolerance-verification' and code = 'entered-in-error').empty() or clinicalStatus.empty()
dom-2	error	AllergyIntolerance	If the resource is contained in another resource, it SHALL NOT contain nested Resources : contained.contained.empty()
dom-3	error	AllergyIntolerance	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	AllergyIntolerance	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	AllergyIntolerance	If a resource is contained in another resource, it SHALL NOT have a security label : contained.meta.security.empty()
dom-6	best practice	AllergyIntolerance	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()
uds-plus-all-1	error	AllergyIntolerance.onset[x]	All dateTime data elements should be truncated to a year only for de-identified resources. : $this is DateTime implies $this.toString().length() = 4
uds-plus-all-2	error	AllergyIntolerance.recordedDate	All dateTime data elements should be truncated to a year only for de-identified resources. : $this is DateTime implies $this.toString().length() = 4
uds-plus-all-3	error	AllergyIntolerance.lastOccurrence	All dateTime data elements should be truncated to a year only for de-identified resources. : $this is DateTime implies $this.toString().length() = 4
uds-plus-all-4	error	AllergyIntolerance.reaction.onset	All dateTime data elements should be truncated to a year only for de-identified resources. : $this is DateTime implies $this.toString().length() = 4

Snapshot View

Name	Flags	Card.	Type	Description & Constraints
AllergyIntolerance	C	0..*	AllergyIntolerance	De-Identified UDS Plus AllergyIntolerance ait-1: AllergyIntolerance.clinicalStatus SHALL be present if verificationStatus is not entered-in-error. ait-2: AllergyIntolerance.clinicalStatus SHALL NOT be present if verification Status is entered-in-error
id	SΣ	0..1	id	The de-identified AllergyIntolerance 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	Σ	0..*	Identifier	External ids for this item
clinicalStatus	?!SΣC	0..1	CodeableConcept	active | inactive | resolved Binding: AllergyIntoleranceClinicalStatusCodes (required): The clinical status of the allergy or intolerance.
verificationStatus	?!SΣC	0..1	CodeableConcept	unconfirmed | confirmed | refuted | entered-in-error Binding: AllergyIntoleranceVerificationStatusCodes (required): Assertion about certainty associated with a propensity, or potential risk, of a reaction to the identified substance.
type	SΣ	0..1	code	allergy | intolerance - Underlying mechanism (if known) Binding: AllergyIntoleranceType (required): Identification of the underlying physiological mechanism for a Reaction Risk.
category	SΣ	0..*	code	food | medication | environment | biologic Binding: AllergyIntoleranceCategory (required): Category of an identified substance associated with allergies or intolerances.
criticality	SΣ	0..1	code	low | high | unable-to-assess Binding: AllergyIntoleranceCriticality (required): Estimate of the potential clinical harm, or seriousness, of a reaction to an identified substance.
code	SΣ	1..1	CodeableConcept	Code that identifies the allergy or intolerance Binding: Common substances for allergy and intolerance documentation including refutations (extensible): The set of codes indicating the allergy or intolerance
patient	SΣ	1..1	Reference(De-Identified UDS Plus Patient)	Who the sensitivity is for
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
reference	ΣC	0..1	string	Literal reference, Relative, internal or absolute URL
type	Σ	0..1	uri	Type the reference refers to (e.g. "Patient") Binding: ResourceType (extensible): Aa resource (or, for logical models, the URI of the logical model).
identifier	Σ	0..1	Identifier	Logical reference, when literal reference is not known
encounter		0..1	Reference(Encounter)	Encounter when the allergy or intolerance was asserted
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
reference	ΣC	0..1	string	Literal reference, Relative, internal or absolute URL
type	Σ	0..1	uri	Type the reference refers to (e.g. "Patient") Binding: ResourceType (extensible): Aa resource (or, for logical models, the URI of the logical model).
identifier	Σ	0..1	Identifier	Logical reference, when literal reference is not known
onset[x]	SC	0..1		When allergy or intolerance was identified uds-plus-all-1: All dateTime data elements should be truncated to a year only for de-identified resources.
onsetDateTime			dateTime
onsetAge			Age
recordedDate	SC	0..1	dateTime	Date first version of the resource instance was recorded uds-plus-all-2: All dateTime data elements should be truncated to a year only for de-identified resources.
recorder		0..1	Reference(Practitioner | PractitionerRole | Patient | RelatedPerson)	Who recorded the sensitivity
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
reference	ΣC	0..1	string	Literal reference, Relative, internal or absolute URL
type	Σ	0..1	uri	Type the reference refers to (e.g. "Patient") Binding: ResourceType (extensible): Aa resource (or, for logical models, the URI of the logical model).
identifier	Σ	0..1	Identifier	Logical reference, when literal reference is not known
asserter	Σ	0..1	Reference(Patient | RelatedPerson | Practitioner | PractitionerRole)	Source of the information about the allergy
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
reference	ΣC	0..1	string	Literal reference, Relative, internal or absolute URL
type	Σ	0..1	uri	Type the reference refers to (e.g. "Patient") Binding: ResourceType (extensible): Aa resource (or, for logical models, the URI of the logical model).
identifier	Σ	0..1	Identifier	Logical reference, when literal reference is not known
lastOccurrence	C	0..1	dateTime	Date(/time) of last known occurrence of a reaction uds-plus-all-3: All dateTime data elements should be truncated to a year only for de-identified resources.
reaction	S	0..*	BackboneElement	Adverse Reaction Events linked to exposure to substance
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
substance		0..1	CodeableConcept	Specific substance or pharmaceutical product considered to be responsible for event Binding: SubstanceCode (example): Codes defining the type of the substance (including pharmaceutical products).
manifestation	S	1..*	CodeableConcept	Clinical symptoms/signs associated with the Event Binding: SNOMEDCTClinicalFindings (example): Clinical symptoms and/or signs that are observed or associated with an Adverse Reaction Event.
description		0..1	string	Description of the event as a whole
onset	C	0..1	dateTime	Date(/time) when manifestations showed uds-plus-all-4: All dateTime data elements should be truncated to a year only for de-identified resources.
severity	S	0..1	code	mild | moderate | severe (of event as a whole) Binding: AllergyIntoleranceSeverity (required): Clinical assessment of the severity of a reaction event as a whole, potentially considering multiple different manifestations.
exposureRoute		0..1	CodeableConcept	How the subject was exposed to the substance Binding: SNOMEDCTRouteCodes (example): A coded concept describing the route or physiological path of administration of a therapeutic agent into or onto the body of a subject.
Documentation for this format

Terminology Bindings

Path	Conformance	ValueSet	URI
AllergyIntolerance.language	preferred	CommonLanguages Additional Bindings Purpose AllLanguages Max Binding http://hl7.org/fhir/ValueSet/languages from the FHIR Standard
AllergyIntolerance.clinicalStatus	required	AllergyIntoleranceClinicalStatusCodes http://hl7.org/fhir/ValueSet/allergyintolerance-clinical|4.0.1 from the FHIR Standard
AllergyIntolerance.verificationStatus	required	AllergyIntoleranceVerificationStatusCodes http://hl7.org/fhir/ValueSet/allergyintolerance-verification|4.0.1 from the FHIR Standard
AllergyIntolerance.type	required	AllergyIntoleranceType http://hl7.org/fhir/ValueSet/allergy-intolerance-type|4.0.1 from the FHIR Standard
AllergyIntolerance.category	required	AllergyIntoleranceCategory http://hl7.org/fhir/ValueSet/allergy-intolerance-category|4.0.1 from the FHIR Standard
AllergyIntolerance.criticality	required	AllergyIntoleranceCriticality http://hl7.org/fhir/ValueSet/allergy-intolerance-criticality|4.0.1 from the FHIR Standard
AllergyIntolerance.code	extensible	CommonSubstancesForAllergyAndIntoleranceDocumentationIncludingRefutations http://cts.nlm.nih.gov/fhir/ValueSet/2.16.840.1.113762.1.4.1186.8 from https://vsac.nlm.nih.gov
AllergyIntolerance.patient.type	extensible	ResourceType http://hl7.org/fhir/ValueSet/resource-types from the FHIR Standard
AllergyIntolerance.encounter.type	extensible	ResourceType http://hl7.org/fhir/ValueSet/resource-types from the FHIR Standard
AllergyIntolerance.recorder.type	extensible	ResourceType http://hl7.org/fhir/ValueSet/resource-types from the FHIR Standard
AllergyIntolerance.asserter.type	extensible	ResourceType http://hl7.org/fhir/ValueSet/resource-types from the FHIR Standard
AllergyIntolerance.reaction.substance	example	SubstanceCode http://hl7.org/fhir/ValueSet/substance-code from the FHIR Standard
AllergyIntolerance.reaction.manifestation	example	SNOMEDCTClinicalFindings http://hl7.org/fhir/ValueSet/clinical-findings from the FHIR Standard
AllergyIntolerance.reaction.severity	required	AllergyIntoleranceSeverity http://hl7.org/fhir/ValueSet/reaction-event-severity|4.0.1 from the FHIR Standard
AllergyIntolerance.reaction.exposureRoute	example	SNOMEDCTRouteCodes http://hl7.org/fhir/ValueSet/route-codes from the FHIR Standard

Constraints

Id	Grade	Path(s)	Details	Requirements
ait-1	error	AllergyIntolerance	AllergyIntolerance.clinicalStatus SHALL be present if verificationStatus is not entered-in-error. : verificationStatus.coding.where(system = 'http://terminology.hl7.org/CodeSystem/allergyintolerance-verification' and code = 'entered-in-error').exists() or clinicalStatus.exists()
ait-2	error	AllergyIntolerance	AllergyIntolerance.clinicalStatus SHALL NOT be present if verification Status is entered-in-error : verificationStatus.coding.where(system = 'http://terminology.hl7.org/CodeSystem/allergyintolerance-verification' and code = 'entered-in-error').empty() or clinicalStatus.empty()
dom-2	error	AllergyIntolerance	If the resource is contained in another resource, it SHALL NOT contain nested Resources : contained.contained.empty()
dom-3	error	AllergyIntolerance	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	AllergyIntolerance	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	AllergyIntolerance	If a resource is contained in another resource, it SHALL NOT have a security label : contained.meta.security.empty()
dom-6	best practice	AllergyIntolerance	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()
uds-plus-all-1	error	AllergyIntolerance.onset[x]	All dateTime data elements should be truncated to a year only for de-identified resources. : $this is DateTime implies $this.toString().length() = 4
uds-plus-all-2	error	AllergyIntolerance.recordedDate	All dateTime data elements should be truncated to a year only for de-identified resources. : $this is DateTime implies $this.toString().length() = 4
uds-plus-all-3	error	AllergyIntolerance.lastOccurrence	All dateTime data elements should be truncated to a year only for de-identified resources. : $this is DateTime implies $this.toString().length() = 4
uds-plus-all-4	error	AllergyIntolerance.reaction.onset	All dateTime data elements should be truncated to a year only for de-identified resources. : $this is DateTime implies $this.toString().length() = 4

This structure is derived from AllergyIntolerance

Summary

Mandatory: 2 elements(1 nested mandatory element)
Must-Support: 13 elements
Prohibited: 8 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