Generated Narrative: StructureDefinition ProfileAllergyIntoleranceHCEU Name Flags Card. Type Description & Constraints<img src="[binary]" alt="doco" style="background-color: inherit"/> AllergyIntolerance 0..* AllergyIntolerance Allergy or Intolerance (generally: Risk of adverse reaction to a substance) <a style="font-style: italic; font-style: italic" href="StructureDefinition-ProfileAllergyIntoleranceHCEU-definitions.html#AllergyIntolerance.identifier" title="Business identifiers assigned to this condition by the performer or other systems which remain constant as the resource is updated and propagates from server to server. ☛ El sistema de codificación es un campo opcional y en esta caso esta definido por los catálogos de los sistemas de atención clínica donde se crean los registros clínicos; se recomienda que dicho manejo sea controlado por las fuentes de forma tal que se pueda identificar de forma univoca cada registro de condición clínica asociada al paciente">Slices for identifier S 1..* Identifier External ids for this item Slice: Unordered, Open by pattern:use identifier:HISdentifier 1..1 Identifier External ids for this item use 1..1 code usual | official | temp | secondary | old (If known) Fixed Value: usual type 0..0 system 1..1 uri The namespace for the identifier value Example HIS uri: http://hospitalSystemInformation.example.org/AllergyIntolerances/ <a href="StructureDefinition-ProfileAllergyIntoleranceHCEU-definitions.html#AllergyIntolerance.identifier:HISdentifier.value" title="The portion of the identifier typically relevant to the user and which is unique within the context of the system. A pesar de que se pueden asociar multiples identificadores canonicos al recurso, se recomienda tener un valor unico tipo GUID, OID o con llaves compuestas">value 1..1 string The value that is unique period 0..0 assigner 0..0 clinicalStatus 0..1 CodeableConcept active Binding: https://hl7.org/fhir/R4/valueset-allergyintolerance-code.html (required) coding 1..1 Coding Code defined by a terminology system system 1..1 uri Identity of the terminology system Fixed Value: https://hl7.org/fhir/R4/valueset-allergyintolerance-code.html code 1..1 code Symbol in syntax defined by the system verificationStatus 0..0 type 0..1 code allergy | intolerance - Underlying mechanism (if known) Example ej: allergy <a href="StructureDefinition-ProfileAllergyIntoleranceHCEU-definitions.html#AllergyIntolerance.code" title="Code for an allergy or intolerance statement (either a positive or a negated/excluded statement). This may be a code for a substance or pharmaceutical product that is considered to be responsible for the adverse reaction risk (e.g., "Latex"), an allergy or intolerance condition (e.g., "Latex allergy"), or a negated/excluded code for a specific substance or class (e.g., "No latex allergy") or a general or categorical negated statement (e.g., "No known allergy", "No known drug allergies"). Note: the substance for a specific reaction may be different from the substance identified as the cause of the risk, but it must be consistent with it. For instance, it may be a more specific substance (e.g. a brand medication) or a composite product that includes the identified substance. It must be clinically safe to only process the 'code' and ignore the 'reaction.substance'. If a receiving system is unable to confirm that AllergyIntolerance.reaction.substance falls within the semantic scope of AllergyIntolerance.code, then the receiving system should ignore AllergyIntolerance.reaction.substance. Se recomienda usar CUMS o ATC en los escenarios de medicamentos o sustancias en farmacos; y para el caso de alimentos revisar si el Invima tiene dichos códigos">code S 0..1 CodeableConcept Code that identifies the allergy or intolerance Example ej: {"coding":[{"system":"https://hl7.org/fhir/R4/valueset-allergyintolerance-code.html","code":"3692009","display":"Sodium sulfite"}]} patient 1..1 Reference(HCEU - Patient) Who the sensitivity is for encounter 0..1 Reference(HCEU - Intramural - Encounter) Encounter when the allergy or intolerance was asserted onset[x] 0..1 Period When allergy or intolerance was identified recordedDate 1..1 dateTime Date first version of the resource instance was recorded recorder 1..1 Reference(HCEU - Practitioner | HCEU - PractitionerRole) Who recorded the sensitivity asserter S 0..1 Reference(HCEU - Patient | HCEU - Related Person | HCEU - Practitioner | HCEU - PractitionerRole) Source of the information about the allergy lastOccurrence 0..0 note S 0..* Annotation Additional text not captured in other fields reaction 0..0 <img src="[binary]" alt="doco" style="background-color: inherit"/> Documentation for this format
Recurso que permite registrar información de la respuesta que tiene un paciente al ser expesto a una substancia
Allergy or Intolerance (generally: Risk of adverse reaction to a substance)
Risk of harmful or undesirable, physiological response which is unique to an individual and associated with exposure to a substance.
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.
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()
f:verificationStatus/f:coding/f:code/@value='entered-in-error' or exists(f:clinicalStatus)
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()
not(f:verificationStatus/f:coding/f:code/@value='entered-in-error') or not(exists(f:clinicalStatus))
If the resource is contained in another resource, it SHALL NOT contain nested Resources
not(parent::f:contained and f:contained)
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()
not(exists(for $id in f:contained/*/f:id/@value return $contained[not(parent::*/descendant::f:reference/@value=concat('#', $contained/*/id/@value) or descendant::f:reference[@value='#'])]))
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()
not(exists(f:contained/*/f:meta/f:versionId)) and not(exists(f:contained/*/f:meta/f:lastUpdated))
If a resource is contained in another resource, it SHALL NOT have a security label
When a resource has no narrative, only systems that fully understand the data can display the resource to a human safely. Including a human readable representation in the resource makes for a much more robust eco-system and cheaper handling of resources by intermediary systems. Some ecosystems restrict distribution of resources to only those systems that do fully understand the resources, and as a consequence implementers may believe that the narrative is superfluous. However experience shows that such eco-systems often open up to new participants over time.
A resource should have narrative for robust management
Observation[classCode=OBS, moodCode=EVN]
The logical id of the resource, as used in the URL for the resource. Once assigned, this value never changes.
The only time that a resource does not have an id is when it is being submitted to the server using a create operation.
The metadata about the resource. This is content that is maintained by the infrastructure. Changes to the content might not always be associated with version changes to the resource.
All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())
A set of rules under which this content was created
A reference to a set of rules that were followed when the resource was constructed, and which must be understood when processing the content. Often, this is a reference to an implementation guide that defines the special rules along with other profiles etc.
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.
This element is labeled as a modifier because the implicit rules may provide additional knowledge about the resource that modifies it's meaning or interpretation
The base language in which the resource is written.
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).
Text summary of the resource, for human interpretation
A human-readable narrative that contains a summary of the resource and can be used to represent the content of the resource to a human. The narrative need not encode all the structured data, but is required to contain sufficient detail to make it "clinically safe" for a human to just read the narrative. Resource definitions may define what content should be represented in the narrative to ensure clinical safety.
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.
These resources do not have an independent existence apart from the resource that contains them - they cannot be identified independently, and nor can they have their own independent transaction scope.
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.
Additional content defined by implementations
May be used to represent additional information that is not part of the basic definition of the resource. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.
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.
Must have either extensions or value[x], not both
exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])
May be used to represent additional information that is not part of the basic definition of the resource and that modifies the understanding of the element that contains it and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer is allowed to define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).
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](http://hl7.org/fhir/R4/extensibility.html#modifierExtension).
Modifier extensions are expected to modify the meaning or interpretation of the resource that contains them
Business identifiers assigned to this condition by the performer or other systems which remain constant as the resource is updated and propagates from server to server. ☛ El sistema de codificación es un campo opcional y en esta caso esta definido por los catálogos de los sistemas de atención clínica donde se crean los registros clínicos; se recomienda que dicho manejo sea controlado por las fuentes de forma tal que se pueda identificar de forma univoca cada registro de condición clínica asociada al paciente
This is a business identifier, not a resource identifier (see [discussion](http://hl7.org/fhir/R4/resource.html#identifiers)). 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.
Allows identification of the AllergyIntolerance as it is known by various participating systems and in a way that remains consistent across servers.
Identificador del registro en el HIS origen
Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.
Extensions are always sliced by (at least) url
May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.
usual | official | temp | secondary | old (If known)
Applications can assume that an identifier is permanent unless it explicitly says that it is temporary.
Allows the appropriate identifier for a particular context of use to be selected from among a set of identifiers.
This is labeled as "Is Modifier" because applications should not mistake a temporary id for a permanent one.
Identifies the purpose for this identifier, if known .
A coded type for the identifier that can be used to determine which identifier to use for a specific purpose.
This element deals only with general categories of identifiers. It SHOULD not be used for codes that correspond 1..1 with the Identifier.system. Some identifiers may fall into multiple categories due to common usage. Where the system is known, a type is unnecessary because the type is always part of the system definition. However systems often need to handle identifiers where the system is not known. There is not a 1:1 relationship between type and system, since many different systems have the same type.
Allows users to make use of identifiers when the identifier system is not known.
A coded type for an identifier that can be used to determine which identifier to use for a specific purpose.
Establishes the namespace for the value - that is, a URL that describes a set values that are unique.
Identifier.system is always case sensitive.
There are many sets of identifiers. To perform matching of two identifiers, we need to know what set we're dealing with. The system identifies a particular set of unique identifiers.
The portion of the identifier typically relevant to the user and which is unique within the context of the system. A pesar de que se pueden asociar multiples identificadores canonicos al recurso, se recomienda tener un valor unico tipo GUID, OID o con llaves compuestas
If the value is a full URI, then the system SHALL be urn:ietf:rfc:3986. The value's primary purpose is computational mapping. As a result, it may be normalized for comparison purposes (e.g. removing non-significant whitespace, dashes, etc.) A value formatted for human display can be conveyed using the [Rendered Value extension](http://hl7.org/fhir/R4/extension-rendered-value.html). Identifier.value is to be treated as case sensitive unless knowledge of the Identifier.system allows the processer to be confident that non-case-sensitive processing is safe.
II.extension or II.root if system indicates OID or GUID (Or Role.id.extension or root)
Time period when id is/was valid for use
Time period during which identifier is/was valid for use.
Role.effectiveTime or implied by context
Organization that issued id (may be just text)
Organization that issued/manages the identifier.
The Identifier.assigner may omit the .reference element and only contain a .display element reflecting the name or other textual information about the assigning organization.
II.assigningAuthorityName but note that this is an improper use by the definition of the field. Also Role.scoper
The clinical status of the allergy or intolerance. Este elemento solo permite registrar alergias activas por lo que el valor por defecto debe ser="active"
Refer to [discussion](http://hl7.org/fhir/R4/extensibility.html#Special-Case) 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.
This element is labeled as a modifier because the status contains the codes inactive and resolved that mark the AllergyIntolerance as no longer active.
Observation ACT .inboundRelationship[typeCode=COMP].source[classCode=OBS, code="clinicalStatus", moodCode=EVN].value
A reference to a code defined by a terminology system.
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.
Allows for alternative encodings within a code system, and translations to other code systems.
fhir:CodeableConcept.coding rdfs:subPropertyOf dt:CD.coding
The identification of the code system that defines the meaning of the symbol in the code.
The URI may be an OID (urn:oid:...) or a UUID (urn:uuid:...). OIDs and UUIDs SHALL be references to the HL7 OID registry. Otherwise, the URI should come from HL7's list of FHIR defined special URIs or it should reference to some definition that establishes the system clearly and unambiguously.
Need to be unambiguous about the source of the definition of the symbol.
fhir:Coding.system rdfs:subPropertyOf dt:CDCoding.codeSystem
The version of the code system which was used when choosing this code. Note that a well-maintained code system does not need the version reported, because the meaning of codes is consistent across versions. However this cannot consistently be assured, and when the meaning is not guaranteed to be consistent, the version SHOULD be exchanged.
Where the terminology does not clearly define what string should be used to identify code system versions, the recommendation is to use the date (expressed in FHIR date format) on which that version was officially published as the version date.
fhir:Coding.version rdfs:subPropertyOf dt:CDCoding.codeSystemVersion
A symbol in syntax defined by the system. The symbol may be a predefined code or an expression in a syntax defined by the coding system (e.g. post-coordination).
Need to refer to a particular code in the system.
fhir:Coding.code rdfs:subPropertyOf dt:CDCoding.code
A representation of the meaning of the code in the system, following the rules of the system.
Need to be able to carry a human-readable meaning of the code for readers that do not know the system.
C*E.2 - but note this is not well followed
fhir:Coding.display rdfs:subPropertyOf dt:CDCoding.displayName
If this coding was chosen directly by the user
Indicates that this coding was chosen by a user directly - e.g. off a pick list of available items (codes or displays).
Amongst a set of alternatives, a directly chosen code is the most appropriate starting point for new translations. There is some ambiguity about what exactly 'directly chosen' implies, and trading partner agreement may be needed to clarify the use of this element and its consequences more completely.
This has been identified as a clinical safety criterium - that this exact system/code pair was chosen explicitly, rather than inferred by the system based on some rules or language processing.
fhir:Coding.userSelected fhir:mapsTo dt:CDCoding.codingRationale. fhir:Coding.userSelected fhir:hasMap fhir:Coding.userSelected.map. fhir:Coding.userSelected.map a fhir:Map; fhir:target dt:CDCoding.codingRationale. fhir:Coding.userSelected\#true a [ fhir:source "true"; fhir:target dt:CDCoding.codingRationale\#O ]
Plain text representation of the concept
A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user.
Very often the text is the same as a displayName of one of the codings.
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.
C*E.9. But note many systems use C*E.2 for this
fhir:CodeableConcept.text rdfs:subPropertyOf dt:CD.originalText
unconfirmed | confirmed | refuted | entered-in-error
Assertion about certainty associated with the propensity, or potential risk, of a reaction to the identified substance (including pharmaceutical product).
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.
This element is labeled as a modifier because the status contains the codes refuted and entered-in-error that mark the AllergyIntolerance as not currently valid.
Assertion about certainty associated with a propensity, or potential risk, of a reaction to the identified substance.
Observation ACT .inboundRelationship[typeCode=COMP].source[classCode=OBS, code="verificationStatus", moodCode=EVN].value
allergy | intolerance - Underlying mechanism (if known)
Identification of the underlying physiological mechanism for the reaction risk.
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.
Identification of the underlying physiological mechanism for a Reaction Risk.
food | medication | environment | biologic
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](http://hl7.org/fhir/R4/search.html) 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.
Category of an identified substance associated with allergies or intolerances.
Estimate of the potential clinical harm, or seriousness, of the reaction to the identified substance.
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.
Estimate of the potential clinical harm, or seriousness, of a reaction to an identified substance.
inboundRelationship[typeCode=SUBJ].source[classCode=OBS, moodCode=EVN, code=SEV, value <= SeverityObservation (Severity Level)]
Code that identifies the allergy or intolerance
Code for an allergy or intolerance statement (either a positive or a negated/excluded statement). This may be a code for a substance or pharmaceutical product that is considered to be responsible for the adverse reaction risk (e.g., "Latex"), an allergy or intolerance condition (e.g., "Latex allergy"), or a negated/excluded code for a specific substance or class (e.g., "No latex allergy") or a general or categorical negated statement (e.g., "No known allergy", "No known drug allergies"). Note: the substance for a specific reaction may be different from the substance identified as the cause of the risk, but it must be consistent with it. For instance, it may be a more specific substance (e.g. a brand medication) or a composite product that includes the identified substance. It must be clinically safe to only process the 'code' and ignore the 'reaction.substance'. If a receiving system is unable to confirm that AllergyIntolerance.reaction.substance falls within the semantic scope of AllergyIntolerance.code, then the receiving system should ignore AllergyIntolerance.reaction.substance. Se recomienda usar CUMS o ATC en los escenarios de medicamentos o sustancias en farmacos; y para el caso de alimentos revisar si el Invima tiene dichos códigos
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.
Type of the substance/product, allergy or intolerance condition, or negation/exclusion codes for reporting no known allergies.
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
The patient who has the allergy or intolerance.
Encounter when the allergy or intolerance was asserted
The encounter when the allergy or intolerance was asserted.
.inboundRelationship[typeCode=COMP].source[classCode=ENC, moodCode=EVN]
When allergy or intolerance was identified
Estimated or actual date, date-time, or age when allergy or intolerance was identified. No se espera el elemento "end" ya que solo se registran las alergias o intolerancias activas
Date first version of the resource instance was recorded
The recordedDate represents when this particular AllergyIntolerance record was created in the system, which is often a system-generated date.
Individual who recorded the record and takes responsibility for its content.
Source of the information about the allergy
The source of the information about the allergy that is recorded.
The recorder takes responsibility for the content, but can reference the source from where they got it.
IAM-14 (if patient) / IAM-18 (if practitioner)
Date(/time) of last known occurrence of a reaction
Represents the date and/or time of the last known occurrence of a reaction event.
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.
outBoundRelationship[typeCode=SUBJ].target[classCode=OBS, moodCode=EVN, code <= CommonClinicalObservationType, value <= ObservationValue (Reaction Type)].effectiveTime
Additional text not captured in other fields
Additional narrative about the propensity for the Adverse Reaction, not captured in other fields.
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.
Adverse Reaction Events linked to exposure to substance
Details about each adverse reaction event linked to exposure to the identified substance.
outBoundRelationship[typeCode=SUBJ].target[classCode=OBS, moodCode=EVN, code <= CommonClinicalObservationType, value <= ObservationValue (Reaction Type)]
Extensions that cannot be ignored even if unrecognized
May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).
Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Specific substance or pharmaceutical product considered to be responsible for event
Identification of the specific substance (or pharmaceutical product) considered to be responsible for the Adverse Reaction event. Note: the substance for a specific reaction may be different from the substance identified as the cause of the risk, but it must be consistent with it. For instance, it may be a more specific substance (e.g. a brand medication) or a composite product that includes the identified substance. It must be clinically safe to only process the 'code' and ignore the 'reaction.substance'. If a receiving system is unable to confirm that AllergyIntolerance.reaction.substance falls within the semantic scope of AllergyIntolerance.code, then the receiving system should ignore AllergyIntolerance.reaction.substance.
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'.
Codes defining the type of the substance (including pharmaceutical products).
outBoundRelationship[typeCode=SAS].target[classCode=SBADM, code <= ExposureCode].participation[typeCode=CSM].role[classCode=ADMM].player[classCode=MAT, determinerCode=KIND, code <= ExposureAgentEntityType]
Clinical symptoms/signs associated with the Event
Clinical symptoms and/or signs that are observed or associated with the adverse reaction event.
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.
Clinical symptoms and/or signs that are observed or associated with an Adverse Reaction Event.
Text description about the reaction as a whole, including details of the manifestation if required.
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.
Record of the date and/or time of the onset of the Reaction.
mild | moderate | severe (of event as a whole)
Clinical assessment of the severity of the reaction event as a whole, potentially considering multiple different manifestations.
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.
Clinical assessment of the severity of a reaction event as a whole, potentially considering multiple different manifestations.
How the subject was exposed to the substance
Identification of the route by which the subject was exposed to the substance.
Coding of the route of exposure with a terminology should be used wherever possible.
A coded concept describing the route or physiological path of administration of a therapeutic agent into or onto the body of a subject.
outBoundRelationship[typeCode=SAS].target[classCode=SBADM, code <= ExposureCode].routeCode
Text about event not captured in other fields
Additional text about the adverse reaction event not captured in other fields.
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.