DSTU2

This page is part of the FHIR Specification (v0.0.82: (v1.0.2: DSTU 1). 2). The current version which supercedes this version is 5.0.0 . For a full list of available versions, see the Directory of published versions . Page versions: R5 R4B R4 R3 R2

4.2 4.1 Resource AllergyIntolerance - Content

Patient Care Work Group Maturity Level : 1 Compartments : Patient , Practitioner , RelatedPerson

Indicates the patient has a susceptibility Risk of harmful or undesirable, physiological response which is unique to an adverse reaction upon individual and associated with exposure to a specified substance.

4.2.1 4.1.1 Scope and Usage

Allergy/Intolerance resources are used A record of a clinical assessment of an allergy or intolerance; a propensity, or a potential risk to provide information about an individual, to have an adverse sensitivities reaction on future exposure to substances that lead the specified substance, or class of substance.

Where a propensity is identified, to physiologic changes record information or evidence about a reaction event that are clinically observable. An adverse sensitivity is defined as: characterized by any harmful or undesirable physiological response that is specific to the individual and triggered by exposure of an individual to the identified substance or class of substance.

A 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.

Note for Reviewers

Presently open issues for this resource:

  • This resource represents a condition of susceptibility to a substance, with a list of supporting events and/or symptoms, and has no direct relationship to an event reporting framework; this will be re-assessed when adverse event reporting resource(s) and/or profiles are added to FHIR (not expected to result happen prior to DSTU 2)
  • Other HL7 models and the openEHR archetype have "exposure date" but this is not found in undesirable physiologic any surveyed systems, so this is left as an extension (more appropriate for adverse event reporting)

4.1.2 Boundaries and Relationships

This resource is used to provide a single place within the health record to document a range of clinical statements about adverse reactions, including:

  • record a clinical assessment of the individual's propensity to a potential future reaction upon re-exposure
  • record cumulative information about the reaction to each exposure, including 'no reaction' if appropriate

Use to record information about the positive presence of the risk of an amount adverse reaction:

  • to support direct clinical care of an individual
  • as part of a substance managed adverse reaction or allergy/intolerance list
  • to support exchange of information about the propensity and events related to adverse reactions
  • to inform adverse reaction reporting
  • to assist computerized knowledge-based activities such as clinical decision support and alerts

Use to record information about adverse reactions to a broad range of substances, including: biological & blood products; incipients and excipients in medicinal preparations; foods; metal salts; and organic chemical compounds.

Adverse reactions may be:

  • an allergy (typically type I hypersensitivity, plus other "allergy-like" reactions, including pseudoallergy)
  • an intolerance (typically non-immune adverse reactions that would are not determined or perceived to be allergic or "allergy-like", and are to some degree idiosyncratic and/or individually specific [i.e. are not produce a reaction in that is expected to occur with most individuals. The substance or all patients given similar circumstances])

In clinical practice distinguishing between allergy and intolerance is difficult and may not be practical. Often the trigger of an immunologic response that produces term "allergy" is used rather generically and may overlap with "intolerance", and the observed physiologic changes, boundaries between these concepts may not be well-defined or in some instances nonimmunologic mechanisms understood. As noted above, the term "intolerance" should generally be applied to a propensity for adverse reactions which is either determined (to the extent that produce clinically identical physiologic changes. The immunologic response might is possible) or perceived to not be considered allergic or "allergy-like". If it is not possible to determine whether a particular propensity condition is an allergy or an intolerance, then the actual cause type element should be omitted from the resource. Identification of the reaction, but it type of reaction is exposure not a proxy for seriousness or risk of harm to the trigger substance that patient, which is clinically observable. better expressed in the documentation of the clinical manifestation and the assessment of criticality.

This definition excludes clinically identical episodes The sensitivity in the case of either an allergy or intolerance is unique to the individual, and is distinguished from those reactions that may be caused by physical agents, are a property of the circumstance, such as heat, cold, sunlight, or vibration, by exercise activity, toxicity of a food or by infectious agents. Those conditions caused by physical agents drug, overdose, drug-drug, drug-food, or infectious drug-disease interaction (which are reactions that would be captured on expected to occur for any individual given the problem list ( List / Condition Resources). same circumstances).

The allergy/intolerance list risk of an adverse reaction event or manifestation should not be recorded without identifying a proposed causative substance or class of substance. If there is uncertainty that a list specific substance is the cause, this uncertainty can be recorded using the 'status' data element. If there are multiple possible substances that may have caused a reaction/manifestation, each substance should be recorded using a separate instance of conditions this resource with the 'status' set to an initial state of 'unconfirmed' so that represent adverse reaction checking can be supported in clinical systems. If a propensity unique substance, agent or class is later proven not to this individual be the cause for a given reaction upon future exposure then the 'status' can be modified to a specified substance. 'refuted'.

Note that this specification draws a distinction between the patients condition/problem list and an allergy/intolerance list, even though allergies and intolerances are also conditions. This resource has been designed to allow recording of information about a specific substance (e.g., amoxicillin, oysters, or bee sting venom) or, alternatively, a class of substance (e.g., penicillins). If a class of substance is because recorded, then identification of the distinction is exact substance can be recorded on a long established per exposure basis.

The scope of this FHIR resource has deliberately focused on identifying a pragmatic data set that are used in most clinical workflow, even to patients. Asking an individual "if they have any problems" is not going systems or will be suitable for most common clinical scenarios; extensions can be used to invoke an account add additional detail if required. Examples of their past reactions clinical situations where the extension may be required include: a detailed allergist/immunologist assessment, for reporting to medications regulatory bodies or foods. Instead, they are asked if they "have use in a clinical trial.

The act of recording any allergies". An allergy/intolerance is also different adverse reaction in a health record involves the clinical assessment that a potential harm from exposure to hazard exists for an external substance individual if they are exposed to the same substance/agent/class in the future - that may be ordered by is, a provider relative contraindication - and, in the course absence of their care but additional information indicating a higher level of potential risk, the default 'criticality' value should be set to 'Low Risk'. If a clinician considers that it is not inherent safe for the individual to exposure be deliberately re-exposed to that substance the substance/agent again, for example, following a manifestation of a life-threatening anaphylaxis, then the general population. 'criticality' data element should be amended to 'High Risk'.

4.2.2 Background and Context

Most A formal adverse event report to regulatory bodies is a document that will contain a broad range of information in addition to the specific details about the adverse reaction. The report could utilize parts of this resource plus include additional data as required per jurisdiction.

An adverse reaction or allergy/intolerance list is a record of all identified propensities for an adverse reaction for the sensitivity individual upon future exposure to the substance or class, plus provides potential access to the evidence provided by details about each reaction event, such as manifestation.

Valuable first-level information that could be presented to the clinician when they need to assess propensity for future reactions are:

  • statements about previous clinical manifestations following exposure
  • source of the information/reporter
  • the 'criticality' flag

Second-level information can be found drawn from each exposure event and links to additional detailed information such as history, examination and diagnoses stored elsewhere in the set record, if it is available.

AllergyIntolerance and RiskAssessment

AllergyIntolerance describes a specific type of reactions risk - propensity to reaction to a substance while RiskAssessment that are associated with the resource, though these may describes general risks to a subject, not generally based on a reaction.

AllergyIntolerance and Immunization.reaction

Immunization.reaction may be an indication of an allergy or intolerance. If this is deemed to be present when the patient has not provided enough information. Adverse Reactions case, a separate AllergyIntolerance do record should be created to indicate it, as most systems will not have query against past Immunization.reaction.

Misuse

  • The allergy/intolerance list exists as a patient safety tool to be always associated with an AllergyIntolerance inform decision support around ordering of medications and nutrition and to guide clinical treatment. Other reactions triggered by physical stimuli -- light, heat, cold, pressure, vibration, which may appropriate when an single reaction has mimic allergic or intolerance reactions, should be recorded as Condition on the problem list, not provided enough evidence for a meaningful Allergy/Intolerance, using AllergyIntolerance.
  • Not to be used to record adverse events, including failures of clinical process, interventions or products. For example, abnormal use or mistakes/errors made in specific views maladministration of events rather than in an agent or substance, incorrect dosage, mislabelling, harm or injury caused by an intervention or procedure, overdose/poisoning, etc.
  • Not to be used as a general clinical record. proxy for an adverse event report. See above for how it may be used as one component of an adverse event report
  • Not to be used for recording alerts. Alerts are handled using Flag or - where event-specific, DetectedIssue
  • Not to be used for recording failed therapy

This resource is referenced by ClinicalImpression , ImmunizationRecommendation and NutritionOrder

4.2.3 4.1.3 Resource Content

Structure

Name Flags Card. Type Description & Constraints doco
.. AllergyIntolerance DomainResource Allergy or Intolerance (generally: Risk Of Adverse reaction to a substance)
... identifier Σ 0..* Identifier External ids for this item
... onset Σ 0..1 dateTime Date(/time) when manifestations showed
... recordedDate Σ 0..1 dateTime When recorded
... recorder Σ 0..1 Reference ( Practitioner | Patient ) Who recorded the sensitivity
... patient Σ 1..1 Reference ( Patient ) Who the sensitivity is for
... reporter Σ 0..1 Reference ( Patient | RelatedPerson | Practitioner ) Source of the information about the allergy
... substance Σ 1..1 CodeableConcept Substance, (or class) considered to be responsible for risk
AllergyIntolerance Substance and Negation Codes ( Example )
... status ?! Σ 0..1 code active | unconfirmed | confirmed | inactive | resolved | refuted | entered-in-error
AllergyIntoleranceStatus ( Required )
... criticality Σ 0..1 code CRITL | CRITH | CRITU
AllergyIntoleranceCriticality ( Required )
... type Σ 0..1 code allergy | intolerance - Underlying mechanism (if known)
AllergyIntoleranceType ( Required )
... category Σ 0..1 code food | medication | environment | other - Category of Substance
AllergyIntoleranceCategory ( Required )
... lastOccurence Σ 0..1 dateTime Date(/time) of last known occurrence of a reaction
... note 0..1 Annotation Additional text not captured in other fields
... reaction 0..* BackboneElement Adverse Reaction Events linked to exposure to substance
.... substance Σ 0..1 CodeableConcept Specific substance considered to be responsible for event
Substance Code ( Example )
.... certainty Σ 0..1 code unlikely | likely | confirmed - clinical certainty about the specific substance
AllergyIntoleranceCertainty ( Required )
.... manifestation Σ 1..* CodeableConcept Clinical symptoms/signs associated with the Event
SNOMED CT Clinical Findings ( Example )
.... description 0..1 string Description of the event as a whole
.... onset Σ 0..1 dateTime Date(/time) when manifestations showed
.... severity Σ 0..1 code mild | moderate | severe (of event as a whole)
AllergyIntoleranceSeverity ( Required )
.... exposureRoute Σ 0..1 CodeableConcept How the subject was exposed to the substance
SNOMED CT Route Codes ( Example )
.... note 0..1 Annotation Text about event not captured in other fields

doco Documentation for this format

UML Diagram

AllergyIntolerance ( Resource DomainResource ) This records identifiers associated with this allergy/intolerance concern that are defined by business processed and/ or processes and/or used to refer to it when a direct URL reference to the resource itself is not appropriate (e.g. in CDA documents, or in written / printed documentation) identifier : Identifier 0..* [0..*] Criticality Record of the date and/or time of the onset of the Allergy or Intolerance onset : dateTime [0..1] Date when the sensitivity was recorded criticality recordedDate : dateTime [0..1] Individual who recorded the record and takes responsibility for its conten recorder : Reference [0..1] « Practitioner | Patient » The patient who has the allergy or intolerance patient : Reference [1..1] « Patient » The source of the information about the allergy that is recorded reporter : Reference [0..1] « Patient | RelatedPerson | Practitioner » Identification of a substance, or a class of substances, that is considered to be responsible for the adverse reaction risk substance : CodeableConcept [1..1] « Type of the substance and Negation codes for reporting no known allergies. (Strength=Example) AllergyIntolerance Substance ... ?? » Assertion about certainty associated with the propensity, or potential risk, of a reaction to the identified Substance (this element modifies the meaning of other elements) status : code 0..1 << [0..1] « The Assertion about certainty associated with a propensity, or potential risk, of a reaction to the identified Substance. (Strength=Required) AllergyIntoleranceStatus ! » Estimate of the potential clinical harm, or seriousness, of the reaction to the identified Substance criticality : code [0..1] « Estimate of the potential clinical harm, or seriousness, of a reaction to an adverse sensitivity identified Substance. (Strength=Required) Criticality AllergyIntoleranceCriticality ! » Identification of the underlying physiological mechanism for the reaction risk type >> : code [0..1] « Identification of the underlying physiological mechanism for a Reaction Risk. (Strength=Required) AllergyIntoleranceType ! » Type Category of the sensitivity identified Substance sensitivityType category : code 1..1 << [0..1] « The Category of an identified Substance. (Strength=Required) AllergyIntoleranceCategory ! » Represents the date and/or time of the last known occurrence of a reaction event lastOccurence : dateTime [0..1] Additional narrative about the propensity for the Adverse Reaction, not captured in other fields note : Annotation [0..1] Reaction Identification of the specific substance considered to be responsible for the Adverse Reaction event. Note: the substance for a specific reaction may be different to the substance identified as the cause of the risk, but must be consistent with it. For instance, it may be a more specific substance (e.g. a brand medication) or a composite substance that includes the identified substance. It must be clinically safe to only process the AllergyIntolerance.substance and ignore the AllergyIntolerance.event.substance substance : CodeableConcept [0..1] « Codes defining the type of the substance. (Strength=Example) Substance Code ?? » Statement about the degree of clinical certainty that the specific substance was the cause of the manifestation in this reaction event certainty : code [0..1] « Statement about the degree of clinical certainty that a Specific Substance was the cause of the Manifestation in an reaction event. (Strength=Required) AllergyIntoleranceCertainty ! » Clinical symptoms and/or signs that are observed or associated with the adverse sensitivity reaction event SensitivityType manifestation >> : CodeableConcept [1..*] « Clinical symptoms and/or signs that are observed or associated with an Adverse Reaction Event. (Strength=Example) SNOMED CT Clinical Findings ?? » Date when Text description about the sensitivity was recorded reaction as a whole, including details of the manifestation if required recordedDate description : string [0..1] Record of the date and/or time of the onset of the Reaction onset : dateTime 0..1 [0..1] Status Clinical assessment of the sensitivity (this element modifies the meaning severity of other elements) the reaction event as a whole, potentially considering multiple different manifestations status severity : code 1..1 << [0..1] « The status Clinical assessment of the severity of a reaction event as a whole, potentially considering multiple different manifestations. (Strength=Required) AllergyIntoleranceSeverity ! » Identification of the route by which the subject was exposed to the substance exposureRoute : CodeableConcept [0..1] « A coded concept describing the route or physiological path of administration of a therapeutic agent into or onto the body of a subject. (Strength=Example) SNOMED CT Route ?? » Additional text about the adverse sensitivity reaction event not captured in other fields SensitivityStatus note >> : Annotation [0..1] The Details about each adverse reaction event linked to exposure to the identified Substance reaction [0..*]

XML Template 


<AllergyIntolerance xmlns="http://hl7.org/fhir"> doco
 <!-- from Resource: id, meta, implicitRules, and language -->
 <!-- from DomainResource: text, contained, extension, and modifierExtension -->
 <identifier><!-- 0..* Identifier External ids for this item --></identifier>
 <onset value="[dateTime]"/><!-- 0..1 Date(/time) when manifestations showed -->
 <recordedDate value="[dateTime]"/><!-- 0..1 When recorded -->
 <recorder><!-- 0..1 Reference(Practitioner|Patient) Who recorded the sensitivity --></recorder>
 <patient><!-- 1..1 Reference(Patient) Who the sensitivity is for --></patient>
 <reporter><!-- 0..1 Reference(Patient|RelatedPerson|Practitioner) Source of the information about the allergy --></reporter>
 <substance><!-- 1..1 CodeableConcept Substance, (or class) considered to be responsible for risk --></substance>
 <status value="[code]"/><!-- 0..1 active | unconfirmed | confirmed | inactive | resolved | refuted | entered-in-error -->
 <criticality value="[code]"/><!-- 0..1 CRITL | CRITH | CRITU -->
 <type value="[code]"/><!-- 0..1 allergy | intolerance - Underlying mechanism (if known) -->
 <category value="[code]"/><!-- 0..1 food | medication | environment | other - Category of Substance -->
 <lastOccurence value="[dateTime]"/><!-- 0..1 Date(/time) of last known occurrence of a reaction -->
 <note><!-- 0..1 Annotation Additional text not captured in other fields --></note>
 <reaction>  <!-- 0..* Adverse Reaction Events linked to exposure to substance -->
  <substance><!-- 0..1 CodeableConcept Specific substance considered to be responsible for event --></substance>
  <certainty value="[code]"/><!-- 0..1 unlikely | likely | confirmed - clinical certainty about the specific substance -->
  <manifestation><!-- 1..* CodeableConcept Clinical symptoms/signs associated with the Event --></manifestation>
  <description value="[string]"/><!-- 0..1 Description of the event as a whole -->
  <onset value="[dateTime]"/><!-- 0..1 Date(/time) when manifestations showed -->
  <severity value="[code]"/><!-- 0..1 mild | moderate | severe (of event as a whole) -->
  <exposureRoute><!-- 0..1 CodeableConcept How the subject was exposed to the substance --></exposureRoute>
  <note><!-- 0..1 Annotation Text about event not captured in other fields --></note>
 </reaction>
</AllergyIntolerance>

JSON Template 


{doco
  "resourceType" : "AllergyIntolerance",
  // from Resource: id, meta, implicitRules, and language
  // from DomainResource: text, contained, extension, and modifierExtension
  "identifier" : [{ Identifier }], // External ids for this item
  "onset" : "<dateTime>", // Date(/time) when manifestations showed
  "recordedDate" : "<dateTime>", // When recorded
  "recorder" : { Reference(Practitioner|Patient) }, // Who recorded the sensitivity
  "patient" : { Reference(Patient) }, // R!  Who the sensitivity is for
  "reporter" : { Reference(Patient|RelatedPerson|Practitioner) }, // Source of the information about the allergy
  "substance" : { CodeableConcept }, // R!  Substance, (or class) considered to be responsible for risk
  "status" : "<code>", // active | unconfirmed | confirmed | inactive | resolved | refuted | entered-in-error
  "criticality" : "<code>", // CRITL | CRITH | CRITU
  "type" : "<code>", // allergy | intolerance - Underlying mechanism (if known)
  "category" : "<code>", // food | medication | environment | other - Category of Substance
  "lastOccurence" : "<dateTime>", // Date(/time) of last known occurrence of a reaction
  "note" : { Annotation }, // Additional text not captured in other fields
  "reaction" : [{ // Adverse Reaction Events linked to exposure to substance
    "substance" : { CodeableConcept }, // Specific substance considered to be responsible for event
    "certainty" : "<code>", // unlikely | likely | confirmed - clinical certainty about the specific substance
    "manifestation" : [{ CodeableConcept }], // R!  Clinical symptoms/signs associated with the Event
    "description" : "<string>", // Description of the event as a whole
    "onset" : "<dateTime>", // Date(/time) when manifestations showed
    "severity" : "<code>", // mild | moderate | severe (of event as a whole)
    "exposureRoute" : { CodeableConcept }, // How the subject was exposed to the substance
    "note" : { Annotation } // Text about event not captured in other fields
  }]
}

Structure

Name Flags Card. Type Description & Constraints doco
.. AllergyIntolerance DomainResource Allergy or Intolerance (generally: Risk Of Adverse reaction to a substance)
... identifier Σ 0..* Identifier External ids for this item
... onset Σ 0..1 dateTime Date(/time) when manifestations showed
... recordedDate Σ 0..1 dateTime When recorded
... recorder Σ 0..1 Reference ( Practitioner | Patient ) Who recorded the sensitivity
... patient who has Σ 1..1 Reference ( Patient ) Who the sensitivity is for
... reporter Σ 0..1 Reference ( Patient | RelatedPerson | Practitioner ) Source of the information about the allergy or
. . . substance Σ 1..1 CodeableConcept Substance, (or class) considered to be responsible for risk
AllergyIntolerance Substance and Negation Codes ( Example )
... status ?! Σ 0..1 code active | unconfirmed | confirmed | inactive | resolved | refuted | entered-in-error
AllergyIntoleranceStatus ( Required )
... criticality Σ 0..1 code CRITL | CRITH | CRITU
AllergyIntoleranceCriticality ( Required )
... type Σ 0..1 code allergy | intolerance - Underlying mechanism (if known)
AllergyIntoleranceType ( Required )
... category Σ 0..1 code food | medication | environment | other - Category of Substance
AllergyIntoleranceCategory ( Required )
... lastOccurence Σ 0..1 dateTime Date(/time) of last known occurrence of a reaction
... note 0..1 Annotation Additional text not captured in other fields
... reaction 0..* BackboneElement Adverse Reaction Events linked to exposure to substance
.... substance Σ 0..1 CodeableConcept Specific substance considered to be responsible for event
Substance Code ( Example )
.... certainty Σ 0..1 code unlikely | likely | confirmed - clinical certainty about the specific substance
AllergyIntoleranceCertainty ( Required )
.... manifestation Σ 1..* CodeableConcept Clinical symptoms/signs associated with the Event
SNOMED CT Clinical Findings ( Example )
.... description 0..1 string Description of the event as a whole
.... onset Σ 0..1 dateTime Date(/time) when manifestations showed
.... severity Σ 0..1 code mild | moderate | severe (of event as a whole)
AllergyIntoleranceSeverity ( Required )
.... exposureRoute Σ 0..1 CodeableConcept How the subject was exposed to the substance
SNOMED CT Route Codes : Resource ( Example )
.... note 0..1 Annotation Text about event not captured in other fields

doco Documentation for this format

UML Diagram

AllergyIntolerance ( Patient DomainResource ) 1..1 This records identifiers associated with this allergy/intolerance concern that are defined by business processes and/or used to refer to it when a direct URL reference to the resource itself is not appropriate (e.g. in CDA documents, or in written / printed documentation) identifier : Identifier [0..*] Record of the date and/or time of the onset of the Allergy or Intolerance onset : dateTime [0..1] Date when the sensitivity was recorded recordedDate : dateTime [0..1] Indicates Individual who has responsibility for recorded the record and takes responsibility for its conten recorder : Resource Reference ( [0..1] « Practitioner | Patient ) 0..1 » The substance patient who has the allergy or intolerance patient : Reference [1..1] « Patient » The source of the information about the allergy that causes is recorded reporter : Reference [0..1] « Patient | RelatedPerson | Practitioner » Identification of a substance, or a class of substances, that is considered to be responsible for the sensitivity adverse reaction risk substance : Resource CodeableConcept ( [1..1] « Type of the substance and Negation codes for reporting no known allergies. (Strength=Example) AllergyIntolerance Substance ) 1..1 ... ?? » Reactions Assertion about certainty associated with the sensitivity propensity, or potential risk, of a reaction to the identified Substance (this element modifies the meaning of other elements) status : code [0..1] « Assertion about certainty associated with a propensity, or potential risk, of a reaction to the identified Substance. (Strength=Required) AllergyIntoleranceStatus ! » Estimate of the potential clinical harm, or seriousness, of the reaction to the identified Substance criticality : Resource code ( AdverseReaction [0..1] « Estimate of the potential clinical harm, or seriousness, of a reaction to an identified Substance. (Strength=Required) AllergyIntoleranceCriticality ! » Identification of the underlying physiological mechanism for the reaction risk type ) 0..* : code [0..1] « Identification of the underlying physiological mechanism for a Reaction Risk. (Strength=Required) AllergyIntoleranceType ! » Observations Category of the identified Substance category : code [0..1] « Category of an identified Substance. (Strength=Required) AllergyIntoleranceCategory ! » Represents the date and/or time of the last known occurrence of a reaction event lastOccurence : dateTime [0..1] Additional narrative about the propensity for the Adverse Reaction, not captured in other fields note : Annotation [0..1] Reaction Identification of the specific substance considered to be responsible for the Adverse Reaction event. Note: the substance for a specific reaction may be different to the substance identified as the cause of the risk, but must be consistent with it. For instance, it may be a more specific substance (e.g. a brand medication) or a composite substance that confirm includes the identified substance. It must be clinically safe to only process the AllergyIntolerance.substance and ignore the AllergyIntolerance.event.substance substance : CodeableConcept [0..1] « Codes defining the type of the substance. (Strength=Example) Substance Code ?? » Statement about the degree of clinical certainty that the specific substance was the cause of the manifestation in this reaction event certainty : code [0..1] « Statement about the degree of clinical certainty that a Specific Substance was the cause of the Manifestation in an reaction event. (Strength=Required) AllergyIntoleranceCertainty ! » Clinical symptoms and/or signs that are observed or refute associated with the sensitivity adverse reaction event sensitivityTest manifestation : Resource CodeableConcept ( Observation [1..*] « Clinical symptoms and/or signs that are observed or associated with an Adverse Reaction Event. (Strength=Example) SNOMED CT Clinical Findings ) 0..* ?? » This resource is referenced Text description about the reaction as a whole, including details of the manifestation if required description : string [0..1] Record of the date and/or time of the onset of the Reaction onset : dateTime [0..1] Clinical assessment of the severity of the reaction event as a whole, potentially considering multiple different manifestations severity : code [0..1] « Clinical assessment of the severity of a reaction event as a whole, potentially considering multiple different manifestations. (Strength=Required) AllergyIntoleranceSeverity ! » Identification of the route by ImmunizationRecommendation which the subject was exposed to the substance exposureRoute and Procedure : CodeableConcept [0..1] « A coded concept describing the route or physiological path of administration of a therapeutic agent into or onto the body of a subject. (Strength=Example) SNOMED CT Route ?? » Additional text about the adverse reaction event not captured in other fields note : Annotation < <!-- from --> <</identifier> < < < < <</subject> <</recorder> <</substance> <</reaction> < Observations that confirm or refute</sensitivityTest> [0..1] Details about each adverse reaction event linked to exposure to the identified Substance reaction [0..*]

XML Template 


<AllergyIntolerance xmlns="http://hl7.org/fhir"> doco
 <!-- from Resource: id, meta, implicitRules, and language -->
 <!-- from DomainResource: text, contained, extension, and modifierExtension -->
 <identifier><!-- 0..* Identifier External ids for this item --></identifier>
 <onset value="[dateTime]"/><!-- 0..1 Date(/time) when manifestations showed -->
 <recordedDate value="[dateTime]"/><!-- 0..1 When recorded -->
 <recorder><!-- 0..1 Reference(Practitioner|Patient) Who recorded the sensitivity --></recorder>
 <patient><!-- 1..1 Reference(Patient) Who the sensitivity is for --></patient>
 <reporter><!-- 0..1 Reference(Patient|RelatedPerson|Practitioner) Source of the information about the allergy --></reporter>
 <substance><!-- 1..1 CodeableConcept Substance, (or class) considered to be responsible for risk --></substance>
 <status value="[code]"/><!-- 0..1 active | unconfirmed | confirmed | inactive | resolved | refuted | entered-in-error -->
 <criticality value="[code]"/><!-- 0..1 CRITL | CRITH | CRITU -->
 <type value="[code]"/><!-- 0..1 allergy | intolerance - Underlying mechanism (if known) -->
 <category value="[code]"/><!-- 0..1 food | medication | environment | other - Category of Substance -->
 <lastOccurence value="[dateTime]"/><!-- 0..1 Date(/time) of last known occurrence of a reaction -->
 <note><!-- 0..1 Annotation Additional text not captured in other fields --></note>
 <reaction>  <!-- 0..* Adverse Reaction Events linked to exposure to substance -->
  <substance><!-- 0..1 CodeableConcept Specific substance considered to be responsible for event --></substance>
  <certainty value="[code]"/><!-- 0..1 unlikely | likely | confirmed - clinical certainty about the specific substance -->
  <manifestation><!-- 1..* CodeableConcept Clinical symptoms/signs associated with the Event --></manifestation>
  <description value="[string]"/><!-- 0..1 Description of the event as a whole -->
  <onset value="[dateTime]"/><!-- 0..1 Date(/time) when manifestations showed -->
  <severity value="[code]"/><!-- 0..1 mild | moderate | severe (of event as a whole) -->
  <exposureRoute><!-- 0..1 CodeableConcept How the subject was exposed to the substance --></exposureRoute>
  <note><!-- 0..1 Annotation Text about event not captured in other fields --></note>
 </reaction>

</AllergyIntolerance>

JSON Template 


{doco
  "resourceType" : "AllergyIntolerance",
  // from Resource: id, meta, implicitRules, and language
  // from DomainResource: text, contained, extension, and modifierExtension
  "identifier" : [{ Identifier }], // External ids for this item
  "onset" : "<dateTime>", // Date(/time) when manifestations showed
  "recordedDate" : "<dateTime>", // When recorded
  "recorder" : { Reference(Practitioner|Patient) }, // Who recorded the sensitivity
  "patient" : { Reference(Patient) }, // R!  Who the sensitivity is for
  "reporter" : { Reference(Patient|RelatedPerson|Practitioner) }, // Source of the information about the allergy
  "substance" : { CodeableConcept }, // R!  Substance, (or class) considered to be responsible for risk
  "status" : "<code>", // active | unconfirmed | confirmed | inactive | resolved | refuted | entered-in-error
  "criticality" : "<code>", // CRITL | CRITH | CRITU
  "type" : "<code>", // allergy | intolerance - Underlying mechanism (if known)
  "category" : "<code>", // food | medication | environment | other - Category of Substance
  "lastOccurence" : "<dateTime>", // Date(/time) of last known occurrence of a reaction
  "note" : { Annotation }, // Additional text not captured in other fields
  "reaction" : [{ // Adverse Reaction Events linked to exposure to substance
    "substance" : { CodeableConcept }, // Specific substance considered to be responsible for event
    "certainty" : "<code>", // unlikely | likely | confirmed - clinical certainty about the specific substance
    "manifestation" : [{ CodeableConcept }], // R!  Clinical symptoms/signs associated with the Event
    "description" : "<string>", // Description of the event as a whole
    "onset" : "<dateTime>", // Date(/time) when manifestations showed
    "severity" : "<code>", // mild | moderate | severe (of event as a whole)
    "exposureRoute" : { CodeableConcept }, // How the subject was exposed to the substance
    "note" : { Annotation } // Text about event not captured in other fields
  }]
}

 

Alternate definitions: Schema / Schematron , Resource Profile ( XML , JSON ), Questionnaire

4.2.3.1 4.1.3.1 Terminology Bindings

AllergyIntolerance.sensitivityType AllergyIntolerance.status
Path Definition Type Reference
AllergyIntolerance.substance Type of the substance and Negation codes for reporting no known allergies. Example AllergyIntolerance Substance and Negation Codes
AllergyIntolerance.status Assertion about certainty associated with a propensity, or potential risk, of a reaction to the identified Substance. Required AllergyIntoleranceStatus
AllergyIntolerance.criticality The criticality Estimate of the potential clinical harm, or seriousness, of a reaction to an adverse sensitivity identified Substance. Fixed Required http://hl7.org/fhir/criticality AllergyIntoleranceCriticality
AllergyIntolerance.type Identification of the underlying physiological mechanism for a Reaction Risk. Required AllergyIntoleranceType
AllergyIntolerance.category The Category of an identified Substance. Required AllergyIntoleranceCategory
AllergyIntolerance.reaction.substance Codes defining the type of the substance. Example Substance Code
AllergyIntolerance.reaction.certainty Statement about the degree of clinical certainty that a Specific Substance was the cause of the Manifestation in an adverse sensitivity reaction event. Fixed Required http://hl7.org/fhir/sensitivitytype AllergyIntoleranceCertainty
AllergyIntolerance.reaction.manifestation Clinical symptoms and/or signs that are observed or associated with an Adverse Reaction Event. Example SNOMED CT Clinical Findings
AllergyIntolerance.reaction.severity The status Clinical assessment of the adverse sensitivity severity of a reaction event as a whole, potentially considering multiple different manifestations. Fixed Required http://hl7.org/fhir/sensitivitystatus AllergyIntoleranceSeverity
AllergyIntolerance.reaction.exposureRoute A coded concept describing the route or physiological path of administration of a therapeutic agent into or onto the body of a subject. Example SNOMED CT Route Codes

4.2.4 4.1.3.2 Notes: Criticality vs Severity Negated Allergies and Intolerances

Criticality It is defined as "The potential seriousness of important to differentiate between affirmatively stating that a future reaction." This represents patient has no known allergies versus either not including allergies in the record (for example an episodic document where the allergies are not considered relevant to the document); or asserting that allergies were not reviewed and are unknown.

Allergies with the status "entered-in-error" are considered to be inactive allergies.

Allergies with the status "refuted" must be displayed to indicate that a reaction to a substance has been ruled out with the high level of clinical judgment certainty (e.g. additional testing, rechallenging).

Prior to adding a new allergy/intolerance, a list of existing negated and refuted reactions should be reviewed and reconciled.

Allergies Not Reviewed, Not Asked

When a sending system does not have any information about allergies being reviewed or the worst case scenario for a future reaction. It would statement is about Allergies not being asked yet, then the List resource should be based on used to indicate the severity of past reactions, List.emptyReason.code="notasked".

Allergies Reviewed, None Identified

Systems should use the dose and route List.emptyReason when a statement is about the full scope of exposure that produced past reactions, and the life-threatening list (i.e. the patient has no known allergies or organ system threatening potential intolerances of any type), while it will use negated AllergyIntolerance instances when the reaction type. Criticality record is an attribute more fine-grained (e.g. no drug allergies, no food allergies, no nut allergies, etc.)

However, it's possible to include negation statements that apply at the level of the allergic condition, not whole list and it's also possible to have separate lists for things like medication allergies vs. food allergies, where that's appropriate to the reaction(s). High criticality does not equate architecture. Also note that care should be used when adding new AllergyIntolerances to a future severe reaction, but rather list to ensure that any negation statements that are voided by the potential for addition of a severe and life-threatening reaction. Most reaction types new record are dose dependent, including anaphylaxis. Therefore, although they have removed from the list. E.g. If the list contains a sensitivity "no known food allergies" record and you add an "intolerance to grape flavor" record, then be sure you remove the "no known food allergies" record.

No Known Allergies, using the List resource 


  <List xmlns="http://hl7.org/fhir" xmlns:xsi="http://www.w3.org/2001/XMLSchema-instance" xsi:schemaLocation="http://hl7.org/fhir ..\..\schema\list.xsd">
 <id value="example-empty-allergy"/>
  <text>
    <status value="generated"/>
    <div xmlns="http://www.w3.org/1999/xhtml">
      <p> The patient is not aware of any allergies.</p>
    </div>
  </text>
<code>
    <coding>
      <system value="http://loinc.org"/>
      <code value="52472-8"/>
      <display value="Allergies and Adverse Drug Reactions"/>
    </coding>
    <text value="Current Allergy List"/>
  </code>
  <source>
    <reference value="Patient/example"/>
  </source>
  <status value="current"/>
  <date value="2012-11-26T07:30:23+11:00"/>
  <mode value="snapshot"/>
  <emptyReason>
    <coding>
      <system value="http://hl7.org/fhir/special-values"/>
      <code value="nil-known"/>
      <display value="Nil Known"/>
    </coding>
    <text value="The patient is not aware of any allergies."/>
  </emptyReason>
</List>

No Known Food Allergies and Medication Allergy List 


  <?xml version="1.0" encoding="UTF-8"?>
<List xmlns="http://hl7.org/fhir" xmlns:xsi="http://www.w3.org/2001/XMLSchema-instance" xsi:schemaLocation="http://hl7.org/fhir ..\..\schema\list.xsd">
  <id value="current-allergies"/>
  <text>
    <status value="generated"/>
    <div xmlns="http://www.w3.org/1999/xhtml">
      <p>Patient Peter Chalmers, DOB = Dec 25, 1974, MRN = 12345 (Acme Healthcare) has the following allergies</p>
      <ul>
        <li>No known food allergies</li>
        <li>Allergenic extract, penicillin (high)</li>
      </ul>
    </div>
  </text>
  <code>
    <coding>
      <system value="http://loinc.org"/>
      <code value="52472-8"/>
      <display value="Allergies and Adverse Drug Reactions"/>
    </coding>
    <text value="Current Allergy List"/>
  </code>
  <source>
    <reference value="Patient/example"/>
  </source>
  <status value="current"/>
  <date value="2015-07-14T23:10:23+11:00"/>
  <mode value="snapshot"/>
  <entry>
    <item> 
      <reference value="AllergyIntolerance/nofoodallergies"/>
    </item>
  </entry>
  <entry>
    <item> 
      <reference value="AllergyIntolerance/penicillin"/>
    </item>
  </entry>  
</List>

If new allergy is discovered, the negated allergy record must be updated with the "refuted" status - to ensure that systems referring to this record are aware that this is no longer true.

DSTU Note: There are two ways of high criticality, exposure reporting "No Known Allergies" in the current specification: using the CodeableConcept, as described above, or using the List resource with emptyReason. During the trial use period for this DSTU, it is not recommended to a small dose use the List resource for "No Known Allergies" reporting purposes.

Feedback is sought here .

4.1.3.3 Use of AllergyIntolerance.criticality

Systems that only support one notion will have to determine whether what they're capturing is criticality or severity and map to the substance appropriate place. Criticality refers to which they are sensitive might the likelihood the allergy/intolerance could result in only a mild reaction. significant harm. Severity refers to the degree of manifestation of the reaction symptom. Moderate breathing difficulty would have high criticality while a severe rash would have low criticality. Severity is also dependent specific to a particular reaction occurrence.

For systems that only track generic reaction characteristics rather than a specific reaction will provide guidance to use the "reaction" structure and simply provide no date.

4.1.3.4 References

4.2.5 4.1.4 Search Parameters

Search parameters for this resource. The standard common parameters also apply. See Searching for more information about searching in REST, messaging, and services.

Name Type Description Paths
_id category token The logical resource id associated with the resource (must be supported by all servers) food | medication | environment | other - Category of Substance AllergyIntolerance.category
_language criticality token The language of the resource CRITL | CRITH | CRITU AllergyIntolerance.criticality
date date Recorded date/time. When recorded AllergyIntolerance.recordedDate
recorder identifier token External ids for this item AllergyIntolerance.identifier
last-date date Date(/time) of last known occurrence of a reaction AllergyIntolerance.lastOccurence
manifestation token Clinical symptoms/signs associated with the Event AllergyIntolerance.reaction.manifestation
onset date Date(/time) when manifestations showed AllergyIntolerance.reaction.onset
patient reference Who recorded the sensitivity is for AllergyIntolerance.recorder AllergyIntolerance.patient
( Patient , Practitioner )
status recorder token reference The status of Who recorded the sensitivity AllergyIntolerance.status AllergyIntolerance.recorder
( Patient , Practitioner )
subject reporter reference The subject that Source of the sensitivity is information about the allergy AllergyIntolerance.subject AllergyIntolerance.reporter
( Patient , Practitioner , RelatedPerson )
substance route reference token The name or code of How the substance that produces subject was exposed to the sensitivity substance AllergyIntolerance.substance ( Substance AllergyIntolerance.reaction.exposureRoute
severity token ) mild | moderate | severe (of event as a whole) AllergyIntolerance.reaction.severity
type status token The active | unconfirmed | confirmed | inactive | resolved | refuted | entered-in-error AllergyIntolerance.status
substance token Substance, (or class) considered to be responsible for risk AllergyIntolerance.substance, AllergyIntolerance.reaction.substance
type of sensitivity AllergyIntolerance.sensitivityType token allergy | intolerance - Underlying mechanism (if known) AllergyIntolerance.type
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