This profile sets minimum expectations for the AllergyIntolerance resource to record, search, and fetch allergies/adverse reactions associated with a patient. It identifies the mandatory core elements, extensions, vocabularies and value sets which SHALL be present in the AllergyIntolerance resource when using this profile.

Example Usage Scenarios:

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

• Query for Allergies belonging to a Patient
• Record or update a Patient Allergy

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 Profile Definition below provides the formal summary, definitions, and terminology requirements.

Each AllergyIntolerance must have:

1. a status of the allergy*
2. a code which tells you what the patient is allergic to
3. a patient

*The clinicalStatus element has the following constraints: SHALL be present if verification status is not entered-in-error and SHALL NOT be present if verification Status is entered-in-error.

Each AllergyIntolerance must support:

1. a verification status
2. a reaction manifestation

Profile specific implementation guidance:

• No Known Allergies may be represented using the US Core-AllergyIntolerance profile with appropriate negation code in AllergyIntolerence.code and the appropriate verification status in AllergyIntolerance.verificationStatus.

  If a patient has not been asked about their allergies, this would be represented as:

  • AllergyIntolerance.code = “1631000175102” (Patient not asked (contextual qualifier) (qualifier value))

  • AllergyIntolerance.verificationStatus = “unconfirmed” or empty (in other words, then element omitted)

  If a patient has been asked, but has indicated they have no known allergies, this would be represented as:

  • AllergyIntolerance.code = “716186003” (No known allergy (situation))

  • AllergyIntolerance.verificationStatus = “confirmed”

Examples

• AllergyIntolerance-example

• Text Summary
• Differential Table
• Snapshot Table
• Snapshot Table (Must Support)
• All

This structure is derived from AllergyIntolerance

Name	Flags	Card.	Type	Description & Constraints
AllergyIntolerance		0..*	AllergyIntolerance	Allergy or Intolerance (generally: Risk of adverse reaction to a substance)
clinicalStatus	S	0..1	CodeableConcept	active | inactive | resolved Binding: AllergyIntoleranceClinicalStatusCodes (required)
verificationStatus	S	0..1	CodeableConcept	unconfirmed | confirmed | refuted | entered-in-error Binding: AllergyIntoleranceVerificationStatusCodes (required)
code	S	1..1	CodeableConcept	Code that identifies the allergy or intolerance Binding: Common substances for allergy and intolerance documentation including refutations (extensible)
patient	S	1..1	Reference(US Core Patient Profile)	Who the sensitivity is for
reaction	S	0..*	BackboneElement	Adverse Reaction Events linked to exposure to substance
manifestation	S	1..*	CodeableConcept	Clinical symptoms/signs associated with the Event Binding: SNOMEDCTClinicalFindings (extensible)
Documentation for this format

Name	Flags	Card.	Type	Description & Constraints
AllergyIntolerance	I	0..*	AllergyIntolerance	Allergy or Intolerance (generally: Risk of adverse reaction to a substance)
id	Σ	0..1	string	Logical id of this artifact
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) Max Binding: AllLanguages: A human language.
text		0..1	Narrative	Text summary of the resource, for human interpretation
contained		0..*	Resource	Contained, inline Resources
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	?!SΣI	0..1	CodeableConcept	active | inactive | resolved Binding: AllergyIntoleranceClinicalStatusCodes (required)
verificationStatus	?!SΣI	0..1	CodeableConcept	unconfirmed | confirmed | refuted | entered-in-error Binding: AllergyIntoleranceVerificationStatusCodes (required)
type	Σ	0..1	code	allergy | intolerance - Underlying mechanism (if known) Binding: AllergyIntoleranceType (required): Identification of the underlying physiological mechanism for a Reaction Risk.
category	Σ	0..*	code	food | medication | environment | biologic Binding: AllergyIntoleranceCategory (required): Category of an identified substance associated with allergies or intolerances.
criticality	Σ	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)
patient	SΣ	1..1	Reference(US Core Patient Profile)	Who the sensitivity is for
encounter		0..1	Reference(Encounter)	Encounter when the allergy or intolerance was asserted
onset[x]		0..1		When allergy or intolerance was identified
onsetDateTime			dateTime
onsetAge			Age
onsetPeriod			Period
onsetRange			Range
onsetString			string
recordedDate		0..1	dateTime	Date first version of the resource instance was recorded
recorder		0..1	Reference(Practitioner | PractitionerRole | Patient | RelatedPerson)	Who recorded the sensitivity
asserter	Σ	0..1	Reference(Patient | RelatedPerson | Practitioner | PractitionerRole)	Source of the information about the allergy
lastOccurrence		0..1	dateTime	Date(/time) of last known occurrence of a reaction
note		0..*	Annotation	Additional text not captured in other fields
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 (extensible)
description		0..1	string	Description of the event as a whole
onset		0..1	dateTime	Date(/time) when manifestations showed
severity		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.
note		0..*	Annotation	Text about event not captured in other fields
Documentation for this format

Name	Flags	Card.	Type	Description & Constraints
AllergyIntolerance	I	0..*	AllergyIntolerance	Allergy or Intolerance (generally: Risk of adverse reaction to a substance)
clinicalStatus	?!ΣI	0..1	CodeableConcept	active | inactive | resolved Binding: AllergyIntoleranceClinicalStatusCodes (required)
verificationStatus	?!ΣI	0..1	CodeableConcept	unconfirmed | confirmed | refuted | entered-in-error Binding: AllergyIntoleranceVerificationStatusCodes (required)
code	Σ	1..1	CodeableConcept	Code that identifies the allergy or intolerance Binding: Common substances for allergy and intolerance documentation including refutations (extensible)
patient	Σ	1..1	Reference(US Core Patient Profile)	Who the sensitivity is for
reaction		0..*	BackboneElement	Adverse Reaction Events linked to exposure to substance
manifestation		1..*	CodeableConcept	Clinical symptoms/signs associated with the Event Binding: SNOMEDCTClinicalFindings (extensible)
Documentation for this format

This structure is derived from AllergyIntolerance

Summary

Mandatory: 2 elements (1 nested mandatory element)
Must-Support: 6 elements

Structures

This structure refers to these other structures:

• http://hl7.org/fhir/us/core/StructureDefinition/us-core-patient

Differential View

This structure is derived from AllergyIntolerance

Name	Flags	Card.	Type	Description & Constraints
AllergyIntolerance		0..*	AllergyIntolerance	Allergy or Intolerance (generally: Risk of adverse reaction to a substance)
clinicalStatus	S	0..1	CodeableConcept	active | inactive | resolved Binding: AllergyIntoleranceClinicalStatusCodes (required)
verificationStatus	S	0..1	CodeableConcept	unconfirmed | confirmed | refuted | entered-in-error Binding: AllergyIntoleranceVerificationStatusCodes (required)
code	S	1..1	CodeableConcept	Code that identifies the allergy or intolerance Binding: Common substances for allergy and intolerance documentation including refutations (extensible)
patient	S	1..1	Reference(US Core Patient Profile)	Who the sensitivity is for
reaction	S	0..*	BackboneElement	Adverse Reaction Events linked to exposure to substance
manifestation	S	1..*	CodeableConcept	Clinical symptoms/signs associated with the Event Binding: SNOMEDCTClinicalFindings (extensible)
Documentation for this format

Snapshot View

Name	Flags	Card.	Type	Description & Constraints
AllergyIntolerance	I	0..*	AllergyIntolerance	Allergy or Intolerance (generally: Risk of adverse reaction to a substance)
id	Σ	0..1	string	Logical id of this artifact
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) Max Binding: AllLanguages: A human language.
text		0..1	Narrative	Text summary of the resource, for human interpretation
contained		0..*	Resource	Contained, inline Resources
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	?!SΣI	0..1	CodeableConcept	active | inactive | resolved Binding: AllergyIntoleranceClinicalStatusCodes (required)
verificationStatus	?!SΣI	0..1	CodeableConcept	unconfirmed | confirmed | refuted | entered-in-error Binding: AllergyIntoleranceVerificationStatusCodes (required)
type	Σ	0..1	code	allergy | intolerance - Underlying mechanism (if known) Binding: AllergyIntoleranceType (required): Identification of the underlying physiological mechanism for a Reaction Risk.
category	Σ	0..*	code	food | medication | environment | biologic Binding: AllergyIntoleranceCategory (required): Category of an identified substance associated with allergies or intolerances.
criticality	Σ	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)
patient	SΣ	1..1	Reference(US Core Patient Profile)	Who the sensitivity is for
encounter		0..1	Reference(Encounter)	Encounter when the allergy or intolerance was asserted
onset[x]		0..1		When allergy or intolerance was identified
onsetDateTime			dateTime
onsetAge			Age
onsetPeriod			Period
onsetRange			Range
onsetString			string
recordedDate		0..1	dateTime	Date first version of the resource instance was recorded
recorder		0..1	Reference(Practitioner | PractitionerRole | Patient | RelatedPerson)	Who recorded the sensitivity
asserter	Σ	0..1	Reference(Patient | RelatedPerson | Practitioner | PractitionerRole)	Source of the information about the allergy
lastOccurrence		0..1	dateTime	Date(/time) of last known occurrence of a reaction
note		0..*	Annotation	Additional text not captured in other fields
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 (extensible)
description		0..1	string	Description of the event as a whole
onset		0..1	dateTime	Date(/time) when manifestations showed
severity		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.
note		0..*	Annotation	Text about event not captured in other fields
Documentation for this format

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.

• The syntax used to describe the interactions is described here.
• See the General Guidance 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.

Mandatory Search Parameters:

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

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

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

   Example:

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

   Implementation Notes: Fetches a bundle of all AllergyIntolerance 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 clinical-status search parameters:

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

   Example:

   1. GET [base]/AllergyIntolerance?patient=[id]&clinical-status=http://terminology.hl7.org/CodeSystem/allergyintolerance-clinical|active

   Implementation Notes: Fetches a bundle of all AllergyIntolerance resources for the specified patient and status code. This will not return any "entered in error" resources because of the conditional presence of the clinicalStatus element. (how to search by reference and how to search by token)