StructureDefinition UKCore-AllergyIntolerance

Substances include, but are not limited to: a therapeutic substance administered correctly at an appropriate dosage for the individual; food; material derived from plants or animals; or venom from insect stings.

• dom-2: If the resource is contained in another resource, it SHALL NOT contain nested Resources
  contained.contained.empty()
• dom-4: 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-3: If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource
  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-6: A resource should have narrative for robust management
  text.`div`.exists()
• dom-5: If a resource is contained in another resource, it SHALL NOT have a security label
  contained.meta.security.empty()
• ait-1: 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: 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()

• rim: Entity. Role, or Act
• rim: Observation[classCode=OBS, moodCode=EVN]

The only time that a resource does not have an id is when it is being submitted to the server using a create operation.

• ele-1: All FHIR elements must have a @value or children
  hasValue() or (children().count() > id.count())

• rim: n/a
• rim: N/A

Asserting this rule set restricts the content to be only understood by a limited set of trading partners. This inherently limits the usefulness of the data in the long term. However, the existing health eco-system is highly fractured, and not yet ready to define, collect, and exchange data in a generally computable sense. Wherever possible, implementers and/or specification writers should avoid using this element. Often, when used, the URL is a reference to an implementation guide that defines these special rules as part of it's narrative along with other profiles, value sets, etc.

• ele-1: All FHIR elements must have a @value or children
  hasValue() or (children().count() > id.count())

• rim: n/a

Language is provided to support indexing and accessibility (typically, services such as text to speech use the language tag). The html language tag in the narrative applies to the narrative. The language tag on the resource may be used to specify the language of other presentations generated from the data in the resource. Not all the content has to be in the base language. The Resource.language should not be assumed to apply to the narrative automatically. If a language is specified, it should it also be specified on the div element in the html (see rules in HTML5 for information about the relationship between xml:lang and the html lang attribute).

• ele-1: All FHIR elements must have a @value or children
  hasValue() or (children().count() > id.count())

• rim: n/a

Contained resources do not have narrative. Resources that are not contained SHOULD have a narrative. In some cases, a resource may only have text with little or no additional discrete data (as long as all minOccurs=1 elements are satisfied). This may be necessary for data from legacy systems where information is captured as a "text blob" or where text is additionally entered raw or narrated and encoded information is added later.

• ele-1: All FHIR elements must have a @value or children
  hasValue() or (children().count() > id.count())

• rim: n/a
• rim: N/A
• rim: Act.text?

This should never be done when the content can be identified properly, as once identification is lost, it is extremely difficult (and context dependent) to restore it again. Contained resources may have profiles and tags In their meta elements, but SHALL NOT have security labels.

• rim: Entity. Role, or Act
• rim: N/A

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

• ele-1: All FHIR elements must have a @value or children
  hasValue() or (children().count() > id.count())
• ext-1: Must have either extensions or value[x], not both
  extension.exists() != value.exists()

• rim: n/a
• rim: N/A

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

• ele-1: All FHIR elements must have a @value or children
  hasValue() or (children().count() > id.count())
• ext-1: Must have either extensions or value[x], not both
  extension.exists() != value.exists()

• rim: n/a
• rim: N/A

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

• ele-1: All FHIR elements must have a @value or children
  hasValue() or (children().count() > id.count())
• ext-1: Must have either extensions or value[x], not both
  extension.exists() != value.exists()

• rim: n/a
• rim: N/A

Allows identification of the AllergyIntolerance as it is known by various participating systems and in a way that remains consistent across servers.

This is a business identifier, not a resource identifier (see discussion). It is best practice for the identifier to only appear on a single resource instance, however business practices may occasionally dictate that multiple resource instances with the same identifier can exist - possibly even with different resource types. For example, multiple Patient and a Person resource instance might share the same social insurance number.

• ele-1: All FHIR elements must have a @value or children
  hasValue() or (children().count() > id.count())

• rim: n/a
• v2: CX / EI (occasionally, more often EI maps to a resource id or a URL)
• rim: II - The Identifier class is a little looser than the v3 type II because it allows URIs as well as registered OIDs or GUIDs. Also maps to Role[classCode=IDENT]
• servd: Identifier
• w5: FiveWs.identifier
• v2: IAM-7
• rim: id

Refer to discussion if clincalStatus is missing data. The data type is CodeableConcept because clinicalStatus has some clinical judgment involved, such that there might need to be more specificity than the required FHIR value set allows. For example, a SNOMED coding might allow for additional specificity.

• ele-1: All FHIR elements must have a @value or children
  hasValue() or (children().count() > id.count())

• rim: n/a
• v2: CE/CNE/CWE
• rim: CD
• orim: fhir:CodeableConcept rdfs:subClassOf dt:CD
• w5: FiveWs.status
• rim: Observation ACT .inboundRelationship[typeCode=COMP].source[classCode=OBS, code="clinicalStatus", moodCode=EVN].value

• rim: n/a

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

• ele-1: All FHIR elements must have a @value or children
  hasValue() or (children().count() > id.count())
• ext-1: Must have either extensions or value[x], not both
  extension.exists() != value.exists()

• rim: n/a
• rim: N/A

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

• ele-1: All FHIR elements must have a @value or children
  hasValue() or (children().count() > id.count())
• ext-1: Must have either extensions or value[x], not both
  extension.exists() != value.exists()

• rim: n/a
• rim: N/A

Allows for alternative encodings within a code system, and translations to other code systems.

Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.

• ele-1: All FHIR elements must have a @value or children
  hasValue() or (children().count() > id.count())

• rim: n/a
• v2: CE/CNE/CWE subset one of the sets of component 1-3 or 4-6
• rim: CV
• orim: fhir:Coding rdfs:subClassOf dt:CDCoding
• v2: C*E.1-8, C*E.10-22
• rim: union(., ./translation)
• orim: fhir:CodeableConcept.coding rdfs:subPropertyOf dt:CD.coding

The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source.

Very often the text is the same as a displayName of one of the codings.

• ele-1: All FHIR elements must have a @value or children
  hasValue() or (children().count() > id.count())

• rim: n/a
• v2: C*E.9. But note many systems use C*E.2 for this
• rim: ./originalText[mediaType/code="text/plain"]/data
• orim: fhir:CodeableConcept.text rdfs:subPropertyOf dt:CD.originalText

The data type is CodeableConcept because verificationStatus has some clinical judgment involved, such that there might need to be more specificity than the required FHIR value set allows. For example, a SNOMED coding might allow for additional specificity.

• ele-1: All FHIR elements must have a @value or children
  hasValue() or (children().count() > id.count())

• rim: n/a
• v2: CE/CNE/CWE
• rim: CD
• orim: fhir:CodeableConcept rdfs:subClassOf dt:CD
• w5: FiveWs.status
• rim: Observation ACT .inboundRelationship[typeCode=COMP].source[classCode=OBS, code="verificationStatus", moodCode=EVN].value

Allergic (typically immune-mediated) reactions have been traditionally regarded as an indicator for potential escalation to significant future risk. Contemporary knowledge suggests that some reactions previously thought to be immune-mediated are, in fact, non-immune, but in some cases can still pose a life threatening risk. It is acknowledged that many clinicians might not be in a position to distinguish the mechanism of a particular reaction. Often the term "allergy" is used rather generically and may overlap with the use of "intolerance" - in practice the boundaries between these two concepts might not be well-defined or understood. This data element is included nevertheless, because many legacy systems have captured this attribute. Immunologic testing may provide supporting evidence for the basis of the reaction and the causative substance, but no tests are 100% sensitive or specific for sensitivity to a particular substance. If, as is commonly the case, it is unclear whether the reaction is due to an allergy or an intolerance, then the type element should be omitted from the resource.

• ele-1: All FHIR elements must have a @value or children
  hasValue() or (children().count() > id.count())

• rim: n/a
• w5: FiveWs.class
• v2: IAM-9
• rim: code

This data element has been included because it is currently being captured in some clinical systems. This data can be derived from the substance where coding systems are used, and is effectively redundant in that situation. When searching on category, consider the implications of AllergyIntolerance resources without a category. For example, when searching on category = medication, medication allergies that don't have a category valued will not be returned. Refer to search for more information on how to search category with a :missing modifier to get allergies that don't have a category. Additionally, category should be used with caution because category can be subjective based on the sender.

• ele-1: All FHIR elements must have a @value or children
  hasValue() or (children().count() > id.count())

• rim: n/a
• w5: FiveWs.class
• v2: AL1-2
• rim: value < IntoleranceValue (Agent)

The default criticality value for any propensity to an adverse reaction should be 'Low Risk', indicating at the very least a relative contraindication to deliberate or voluntary exposure to the substance. 'High Risk' is flagged if the clinician has identified a propensity for a more serious or potentially life-threatening reaction, such as anaphylaxis, and implies an absolute contraindication to deliberate or voluntary exposure to the substance. If this element is missing, the criticality is unknown (though it may be known elsewhere). Systems that capture a severity at the condition level are actually representing the concept of criticality whereas the severity documented at the reaction level is representing the true reaction severity. Existing systems that are capturing both condition criticality and reaction severity may use the term "severity" to represent both. Criticality is the worst it could be in the future (i.e. situation-agnostic) whereas severity is situation-dependent.

• ele-1: All FHIR elements must have a @value or children
  hasValue() or (children().count() > id.count())

• rim: n/a
• w5: FiveWs.grade
• v2: AL1-4
• rim: inboundRelationship[typeCode=SUBJ].source[classCode=OBS, moodCode=EVN, code=SEV, value <= SeverityObservation (Severity Level)]

It is strongly recommended that this element be populated using a terminology, where possible. For example, some terminologies used include RxNorm, SNOMED CT, DM+D, NDFRT, ICD-9, IDC-10, UNII, and ATC. Plain text should only be used if there is no appropriate terminology available. Additional details can be specified in the text.

When a substance or product code is specified for the 'code' element, the "default" semantic context is that this is a positive statement of an allergy or intolerance (depending on the value of the 'type' element, if present) condition to the specified substance/product. In the corresponding SNOMED CT allergy model, the specified substance/product is the target (destination) of the "Causative agent" relationship.

The 'substanceExposureRisk' extension is available as a structured and more flexible alternative to the 'code' element for making positive or negative allergy or intolerance statements. This extension provides the capability to make "no known allergy" (or "no risk of adverse reaction") statements regarding any coded substance/product (including cases when a pre-coordinated "no allergy to x" concept for that substance/product does not exist). If the 'substanceExposureRisk' extension is present, the AllergyIntolerance.code element SHALL be omitted.

• ele-1: All FHIR elements must have a @value or children
  hasValue() or (children().count() > id.count())

• rim: n/a
• v2: CE/CNE/CWE
• rim: CD
• orim: fhir:CodeableConcept rdfs:subClassOf dt:CD
• w5: FiveWs.what[x]
• v2: AL1-3 / IAM-3
• rim: substance/product: .participation[typeCode=CAGNT].role[classCode=ADMM].player[classCode=MAT, determinerCode=KIND, code <= ExposureAgentEntityType] negated/excluded substance/product: .participation[typeCode=CAGNT, negationInd=true].role[classCode=ADMM].player[classCode=MAT, determinerCode=KIND, code <= ExposureAgentEntityType] positive or negated/excluded condition/situation: Observation.code=ASSERTION; Observation.value

References SHALL be a reference to an actual FHIR resource, and SHALL be resolveable (allowing for access control, temporary unavailability, etc.). Resolution can be either by retrieval from the URL, or, where applicable by resource type, by treating an absolute reference as a canonical URL and looking it up in a local registry/repository.

• ele-1: All FHIR elements must have a @value or children
  hasValue() or (children().count() > id.count())
• ref-1: SHALL have a contained resource if a local reference is provided
  reference.startsWith('#').not() or (reference.substring(1).trace('url') in %rootResource.contained.id.trace('ids'))

• rim: n/a
• rim: The target of a resource reference is a RIM entry point (Act, Role, or Entity)
• w5: FiveWs.subject[x]
• v2: (PID-3)
• rim: .participation[typeCode=SBJ].role[classCode=PAT]
• w5: FiveWs.subject

References SHALL be a reference to an actual FHIR resource, and SHALL be resolveable (allowing for access control, temporary unavailability, etc.). Resolution can be either by retrieval from the URL, or, where applicable by resource type, by treating an absolute reference as a canonical URL and looking it up in a local registry/repository.

• ele-1: All FHIR elements must have a @value or children
  hasValue() or (children().count() > id.count())
• ref-1: SHALL have a contained resource if a local reference is provided
  reference.startsWith('#').not() or (reference.substring(1).trace('url') in %rootResource.contained.id.trace('ids'))

• rim: n/a
• rim: The target of a resource reference is a RIM entry point (Act, Role, or Entity)
• w5: FiveWs.context
• rim: .inboundRelationship[typeCode=COMP].source[classCode=ENC, moodCode=EVN]

• ele-1: All FHIR elements must have a @value or children
  hasValue() or (children().count() > id.count())

• rim: n/a
• w5: FiveWs.init
• rim: effectiveTime.low

• ele-1: All FHIR elements must have a @value or children
  hasValue() or (children().count() > id.count())

• rim: n/a
• w5: FiveWs.recorded
• v2: IAM-13
• rim: .participation[typeCode=AUT].time

References SHALL be a reference to an actual FHIR resource, and SHALL be resolveable (allowing for access control, temporary unavailability, etc.). Resolution can be either by retrieval from the URL, or, where applicable by resource type, by treating an absolute reference as a canonical URL and looking it up in a local registry/repository.

• ele-1: All FHIR elements must have a @value or children
  hasValue() or (children().count() > id.count())
• ref-1: SHALL have a contained resource if a local reference is provided
  reference.startsWith('#').not() or (reference.substring(1).trace('url') in %rootResource.contained.id.trace('ids'))

• rim: n/a
• rim: The target of a resource reference is a RIM entry point (Act, Role, or Entity)
• w5: FiveWs.author
• rim: .participation[typeCode=AUT].role

The recorder takes responsibility for the content, but can reference the source from where they got it.

• ele-1: All FHIR elements must have a @value or children
  hasValue() or (children().count() > id.count())
• ref-1: SHALL have a contained resource if a local reference is provided
  reference.startsWith('#').not() or (reference.substring(1).trace('url') in %rootResource.contained.id.trace('ids'))

• rim: n/a
• rim: The target of a resource reference is a RIM entry point (Act, Role, or Entity)
• w5: FiveWs.source
• v2: IAM-14 (if patient) / IAM-18 (if practitioner)
• rim: .participation[typeCode=INF].role

This date may be replicated by one of the Onset of Reaction dates. Where a textual representation of the date of last occurrence is required e.g. 'In Childhood, '10 years ago' the Comment element should be used.

• ele-1: All FHIR elements must have a @value or children
  hasValue() or (children().count() > id.count())

• rim: n/a
• rim: outBoundRelationship[typeCode=SUBJ].target[classCode=OBS, moodCode=EVN, code <= CommonClinicalObservationType, value <= ObservationValue (Reaction Type)].effectiveTime

For example: including reason for flagging a seriousness of 'High Risk'; and instructions related to future exposure or administration of the substance, such as administration within an Intensive Care Unit or under corticosteroid cover. The notes should be related to an allergy or intolerance as a condition in general and not related to any particular episode of it. For episode notes and descriptions, use AllergyIntolerance.event.description and AllergyIntolerance.event.notes.

• ele-1: All FHIR elements must have a @value or children
  hasValue() or (children().count() > id.count())

• rim: n/a
• v2: N/A
• rim: Act
• rim: subjectOf.observationEvent[code="annotation"].value

• ele-1: All FHIR elements must have a @value or children
  hasValue() or (children().count() > id.count())

• rim: n/a
• rim: outBoundRelationship[typeCode=SUBJ].target[classCode=OBS, moodCode=EVN, code <= CommonClinicalObservationType, value <= ObservationValue (Reaction Type)]

• rim: n/a

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

• ele-1: All FHIR elements must have a @value or children
  hasValue() or (children().count() > id.count())
• ext-1: Must have either extensions or value[x], not both
  extension.exists() != value.exists()

• rim: n/a
• rim: N/A

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

• ele-1: All FHIR elements must have a @value or children
  hasValue() or (children().count() > id.count())
• ext-1: Must have either extensions or value[x], not both
  extension.exists() != value.exists()

• rim: n/a
• rim: N/A

Coding of the specific substance (or pharmaceutical product) with a terminology capable of triggering decision support should be used wherever possible. The 'code' element allows for the use of a specific substance or pharmaceutical product, or a group or class of substances. In the case of an allergy or intolerance to a class of substances, (for example, "penicillins"), the 'reaction.substance' element could be used to code the specific substance that was identified as having caused the reaction (for example, "amoxycillin"). Duplication of the value in the 'code' and 'reaction.substance' elements is acceptable when a specific substance has been recorded in 'code'.

• ele-1: All FHIR elements must have a @value or children
  hasValue() or (children().count() > id.count())

• rim: n/a
• v2: CE/CNE/CWE
• rim: CD
• orim: fhir:CodeableConcept rdfs:subClassOf dt:CD
• rim: outBoundRelationship[typeCode=SAS].target[classCode=SBADM, code <= ExposureCode].participation[typeCode=CSM].role[classCode=ADMM].player[classCode=MAT, determinerCode=KIND, code <= ExposureAgentEntityType]

Manifestation can be expressed as a single word, phrase or brief description. For example: nausea, rash or no reaction. It is preferable that manifestation should be coded with a terminology, where possible. The values entered here may be used to display on an application screen as part of a list of adverse reactions, as recommended in the UK NHS CUI guidelines. Terminologies commonly used include, but are not limited to, SNOMED CT or ICD10.

• ele-1: All FHIR elements must have a @value or children
  hasValue() or (children().count() > id.count())

• rim: n/a
• v2: CE/CNE/CWE
• rim: CD
• orim: fhir:CodeableConcept rdfs:subClassOf dt:CD
• v2: AL1-5
• rim: code

Use the description to provide any details of a particular event of the occurred reaction such as circumstances, reaction specifics, what happened before/after. Information, related to the event, but not describing a particular care should be captured in the comment field. For example: at the age of four, the patient was given penicillin for strep throat and subsequently developed severe hives.

• ele-1: All FHIR elements must have a @value or children
  hasValue() or (children().count() > id.count())

• rim: n/a
• rim: text

• ele-1: All FHIR elements must have a @value or children
  hasValue() or (children().count() > id.count())

• rim: n/a
• v2: AL1-6
• rim: effectiveTime.low

It is acknowledged that this assessment is very subjective. There may be some specific practice domains where objective scales have been applied. Objective scales can be included in this model as extensions.

• ele-1: All FHIR elements must have a @value or children
  hasValue() or (children().count() > id.count())

• rim: n/a
• rim: inboundRelationship[typeCode=SUBJ].source[classCode=OBS, moodCode=EVN, code=SEV, value <= SeverityObservation (Severity Level)]

Coding of the route of exposure with a terminology should be used wherever possible.

• ele-1: All FHIR elements must have a @value or children
  hasValue() or (children().count() > id.count())

• rim: n/a
• v2: CE/CNE/CWE
• rim: CD
• orim: fhir:CodeableConcept rdfs:subClassOf dt:CD
• rim: outBoundRelationship[typeCode=SAS].target[classCode=SBADM, code <= ExposureCode].routeCode

Use this field to record information indirectly related to a particular event and not captured in the description. For example: Clinical records are no longer available, recorded based on information provided to the patient by her mother and her mother is deceased.

• ele-1: All FHIR elements must have a @value or children
  hasValue() or (children().count() > id.count())

• rim: n/a
• v2: N/A
• rim: Act
• rim: subjectOf.observationEvent[code="annotation"].value