ARCHETYPE Adverse reaction event summary (openEHR-EHR-CLUSTER.adverse_reaction_event_summary.v0)

ARCHETYPE IDopenEHR-EHR-CLUSTER.adverse_reaction_event_summary.v0
ConceptAdverse reaction event summary
DescriptionSummary information about a specific adverse reaction event.
UseUse to record summary information about a specific adverse reaction event.
MisuseNot to be used to record adverse events, including failures of clinical process, interventions or products. For example: abnormal use or mistakes/errors made in maladministration of an agent or substance; incorrect dosage; mislabelling; harm or injury caused by an intervention or procedure; overdose/poisoning etc. Use a specific archetype for this purpose.
PurposeTo record summary information about a specific adverse reaction event.
ReferencesDerived from: Adverse reaction risk, Published archetype [Internet]. openEHR Foundation, openEHR Clinical Knowledge Manager [cited: 2021-10-04]. Available from: https://ckm.openehr.org/ckm/archetypes/1013.1.1713
Copyright© openEHR Foundation
AuthorsAuthor name: Silje Ljosland Bakke
Organisation: Helse Vest IKT AS
Email: silje.ljosland.bakke@helse-vest-ikt.no
Date originally authored: 2021-09-17
Other Details LanguageAuthor name: Silje Ljosland Bakke
Organisation: Helse Vest IKT AS
Email: silje.ljosland.bakke@helse-vest-ikt.no
Date originally authored: 2021-09-17
OtherDetails Language Independent{licence=This work is licensed under the Creative Commons Attribution-ShareAlike 4.0 International License. To view a copy of this license, visit http://creativecommons.org/licenses/by-sa/4.0/., custodian_organisation=openEHR Foundation, references=Derived from: Adverse reaction risk, Published archetype [Internet]. openEHR Foundation, openEHR Clinical Knowledge Manager [cited: 2021-10-04]. Available from: https://ckm.openehr.org/ckm/archetypes/1013.1.1713, original_namespace=org.openehr, original_publisher=openEHR Foundation, custodian_namespace=org.openehr, MD5-CAM-1.0.1=185BBADF62CC16CC0A7FEE4D2465192E, build_uid=d0fcbc91-ca53-4f4c-82a8-40703e6e5f77, revision=0.0.1-alpha}
Keywords
Lifecyclein_development
UIDc7268388-7669-4c78-8b5c-d394226e3f98
Language useden
Citeable Identifier1013.1.5795
Revision Number0.0.1-alpha
AllArchetype [runtimeNameConstraintForConceptName=null, archetypeConceptBinding=null, archetypeConceptDescription=Summary information about a specific adverse reaction event., archetypeConceptComment=null, otherContributors=, originalLanguage=en, translators=Norwegian Bokmål: Silje Ljosland Bakke, Helse Vest IKT AS, silje.ljosland.bakke@helse-vest-ikt.no
, subjectOfData=unconstrained, archetypeTranslationTree=null, topLevelToAshis={ism_transition=[], relationships=[], target=[], items=[ResourceSimplifiedHierarchyItem [path=/items[at0001], code=at0001, itemType=ELEMENT, level=1, text=Specific substance, description=Identification of the substance considered to be responsible for the specific adverse reaction event., comment=For example: 'Amoxycillin'. Only an individual substance is a valid entry in 'Specific substance'. A substance may be a compound of simpler substances, for example a medicinal product. If the value in 'Substance' recorded in the parent archetype is an individual substance and not a substance class, then it may be duplicated in this data element, or this element may be redundant. It is strongly recommended that 'Specific substance' be coded with a terminology., uncommonOntologyItems=null, occurencesFormal=0..1, occurencesText=Optional, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=DV_TEXT, bindings=null, values=, extendedValues=null], ResourceSimplifiedHierarchyItem [path=/items[at0002], code=at0002, itemType=ELEMENT, level=1, text=Certainty, description=Statement about the degree of clinical certainty that the identified 'Specific substance' was the cause of the 'Manifestation' in this reaction event., comment=null, uncommonOntologyItems=null, occurencesFormal=0..1, occurencesText=Optional, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=DV_CODED_TEXT, bindings=null, values=
  • Suspected [A low level of clinical certainty that the reaction was caused by the identified 'Specific substance'.]
  • Likely [A reasonable level of clinical certainty that the reaction was caused by the identified 'Specific substance'.]
  • Confirmed [A high level of clinical certainty that the reaction was due to the identified 'Substance', which may include clinical evidence by testing or re-challenge.]
, extendedValues=null], ResourceSimplifiedHierarchyItem [path=/items[at0006], code=at0006, itemType=ELEMENT, level=1, text=Manifestation, description=Clinical symptoms and/or signs that are observed or associated with the adverse reaction., comment=Manifestation can be expressed as a single word, phrase or brief description. For example: nausea, rash. 'No reaction'may be appropriate where a previous reaction has been noted but the reaction did not re-occur after further exposure. 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., uncommonOntologyItems=null, occurencesFormal=0..*, occurencesText=Optional, repeating, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=DV_TEXT, bindings=null, values=, extendedValues=null], ResourceSimplifiedHierarchyItem [path=/items[at0007], code=at0007, itemType=ELEMENT, level=1, text=Reaction description, description=Narrative description about the adverse reaction as a whole, including details of the manifestation if required., comment=null, uncommonOntologyItems=null, occurencesFormal=0..1, occurencesText=Optional, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=DV_TEXT, bindings=null, values=, extendedValues=null], ResourceSimplifiedHierarchyItem [path=/items[at0008], code=at0008, itemType=ELEMENT, level=1, text=Onset of reaction, description=Record of the date and/or time of the onset of the reaction., comment=null, uncommonOntologyItems=null, occurencesFormal=0..1, occurencesText=Optional, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=DV_DATE_TIME, bindings=null, values=, extendedValues=null], ResourceSimplifiedHierarchyItem [path=/items[at0009], code=at0009, itemType=ELEMENT, level=1, text=Duration of reaction, description=The total amount of time that the manifestation of the adverse reaction persisted., comment=null, uncommonOntologyItems=null, occurencesFormal=0..1, occurencesText=Optional, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=DV_DURATION, bindings=null, values=, extendedValues=null], ResourceSimplifiedHierarchyItem [path=/items[at0010], code=at0010, itemType=ELEMENT, level=1, text=Severity of reaction, description=Clinical assessment of the severity of the reaction event as a whole, potentially considering multiple different manifestations., comment=It is acknowledged that this assessment is very subjective. There may be some some specific practice domains where objective scales have been applied. Objective scales can be included in this model using the 'Reaction details' Cluster., uncommonOntologyItems=null, occurencesFormal=0..1, occurencesText=Optional, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=CHOICE, bindings=null, values=Choice of:
  •  Coded Text
    • Mild [Causes mild physiological effects.]
    • Moderate [Causes moderate physiological effects.]
    • Severe [Causes severe physiological effects.]
  •  Text
, extendedValues=null], ResourceSimplifiedHierarchyItem [path=/items[at0014], code=at0014, itemType=SLOT, level=1, text=Reaction details, description=Additional details about the adverse reaction, including anatomical location and Common Toxicity Criteria, can be provided by inclusion of specific archetypes in this SLOT., comment=May include structured detail about symptoms; the anatomical location of the manifestation; grading, classification or formal severity assessments such as Common Terminology Criteria for Adverse Events; or the Multimedia CLUSTER archetype. [Note: FHIR - These would be extensions as specified in a profile.], uncommonOntologyItems=null, occurencesFormal=0..*, occurencesText=Optional, repeating, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=CLUSTER, bindings=null, values=Include:
openEHR-EHR-CLUSTER.anatomical_location.v1 and specialisations or
openEHR-EHR-CLUSTER.media_file.v1 and specialisations or
openEHR-EHR-CLUSTER.anatomical_location_relative.v2 and specialisations or
openEHR-EHR-CLUSTER.symptom_sign.v1 and specialisations, extendedValues=null], ResourceSimplifiedHierarchyItem [path=/items[at0015], code=at0015, itemType=ELEMENT, level=1, text=Initial exposure, description=Record of the date and/or time of the first exposure to the Substance for this Reaction Event., comment=Exposure can be more complicated by more than one exposure events leading to a reaction. Further details about the nature of the exposure can be provided by use of additional archetypes in the 'Exposure details' SLOT or as text in the 'Exposure description'., uncommonOntologyItems=null, occurencesFormal=0..1, occurencesText=Optional, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=DV_DATE_TIME, bindings=null, values=, extendedValues=null], ResourceSimplifiedHierarchyItem [path=/items[at0016], code=at0016, itemType=ELEMENT, level=1, text=Duration of exposure, description=The total amount of time the individual was exposed to the identified 'Specific substance'., comment=null, uncommonOntologyItems=null, occurencesFormal=0..1, occurencesText=Optional, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=DV_DURATION, bindings=null, values=, extendedValues=null], ResourceSimplifiedHierarchyItem [path=/items[at0017], code=at0017, itemType=ELEMENT, level=1, text=Route of exposure, description=Identification of the route by which the subject was exposed to the identified 'Specific substance'., comment=Coding of the Route of Exposure with a terminology should be used wherever possible., uncommonOntologyItems=null, occurencesFormal=0..1, occurencesText=Optional, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=DV_TEXT, bindings=null, values=, extendedValues=null], ResourceSimplifiedHierarchyItem [path=/items[at0018], code=at0018, itemType=ELEMENT, level=1, text=Exposure description, description=Narrative description about exposure to the identified 'Specific substance'., comment=null, uncommonOntologyItems=null, occurencesFormal=0..1, occurencesText=Optional, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=DV_TEXT, bindings=null, values=, extendedValues=null], ResourceSimplifiedHierarchyItem [path=/items[at0019], code=at0019, itemType=SLOT, level=1, text=Exposure details, description=Additional details about exposure to the 'Specific substance', especially in situations where there may have been multiple or cumulative exposures can be provided by inclusion of specific archetypes in this SLOT., comment=null, uncommonOntologyItems=null, occurencesFormal=0..*, occurencesText=Optional, repeating, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=CLUSTER, bindings=null, values=Include:
openEHR-EHR-CLUSTER.citation.v1 and specialisations or
openEHR-EHR-CLUSTER.citation.v0 and specialisations, extendedValues=null], ResourceSimplifiedHierarchyItem [path=/items[at0020], code=at0020, itemType=ELEMENT, level=1, text=Clinical management description, description=Narrative description about the clinical management provided., comment=null, uncommonOntologyItems=null, occurencesFormal=0..1, occurencesText=Optional, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=DV_TEXT, bindings=null, values=, extendedValues=null], ResourceSimplifiedHierarchyItem [path=/items[at0021], code=at0021, itemType=SLOT, level=1, text=Clinical management details, description=Additional structured details about clinical management for this reaction event can be provided by inclusion of specific archetypes in this SLOT., comment=null, uncommonOntologyItems=null, occurencesFormal=0..*, occurencesText=Optional, repeating, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=CLUSTER, bindings=null, values=Include:
All not explicitly excluded archetypes, extendedValues=null], ResourceSimplifiedHierarchyItem [path=/items[at0022], code=at0022, itemType=SLOT, level=1, text=Reporting details, description=Additional structured details required for reporting to regulatory bodies can be provided by inclusion of specific archetypes in this SLOT., comment=null, uncommonOntologyItems=null, occurencesFormal=0..*, occurencesText=Optional, repeating, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=CLUSTER, bindings=null, values=Include:
All not explicitly excluded archetypes, extendedValues=null], ResourceSimplifiedHierarchyItem [path=/items[at0023], code=at0023, itemType=SLOT, level=1, text=Information source, description=Details about the provenance of the information can be provided by inclusion of specific archetypes in this SLOT., comment=This SLOT is intended to provide details about the source of information for this particular 'Reaction event'. Details about the source of information for the entire 'Adverse reaction risk' should be recorded using the 'Information Provider' reference model attribute., uncommonOntologyItems=null, occurencesFormal=0..*, occurencesText=Optional, repeating, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=CLUSTER, bindings=null, values=Include:
All not explicitly excluded archetypes, extendedValues=null], ResourceSimplifiedHierarchyItem [path=/items[at0025], code=at0025, itemType=ELEMENT, level=1, text=Supporting clinical record information, description=Link to further information about the presentation and findings that exist elsewhere in the health record, including allergy test reports., comment=For example, presenting symptoms, examination findings, diagnosis etc. [Note: FHIR,DAM: Maps to Sensitivity Test.], uncommonOntologyItems=null, occurencesFormal=0..*, occurencesText=Optional, repeating, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=DV_EHR_URI, bindings=null, values=, extendedValues=null], ResourceSimplifiedHierarchyItem [path=/items[at0024], code=at0024, itemType=ELEMENT, level=1, text=Comment, description=Additional narrative about the adverse reaction event not captured in other fields., comment=null, uncommonOntologyItems=null, occurencesFormal=0..1, occurencesText=Optional, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=DV_TEXT, bindings=null, values=, extendedValues=null]], protocol=[], identities=[], state=[], events=[], content=[], source=[], capabilities=[], other_participations=[], details=[], context=[], activities=[], contacts=[], data=[], credentials=[], provider=[], description=[]}, topLevelItems={items=ResourceSimplifiedHierarchyItem [path=ROOT_/, code=at0000, itemType=CLUSTER, level=0, text=null, description=null, comment=null, uncommonOntologyItems=null, occurencesFormal=1..1, occurencesText=Mandatory, cardinalityFormal=1..*, cardinalityText=, subCardinalityFormal=null, subCardinalityText=null, dataType=CLUSTER, bindings=null, values=null, extendedValues=null]}, addHierarchyItemsTo=items, currentHierarchyItemsForAdding=[ResourceSimplifiedHierarchyItem [path=/items[at0001], code=at0001, itemType=ELEMENT, level=1, text=Specific substance, description=Identification of the substance considered to be responsible for the specific adverse reaction event., comment=For example: 'Amoxycillin'. Only an individual substance is a valid entry in 'Specific substance'. A substance may be a compound of simpler substances, for example a medicinal product. If the value in 'Substance' recorded in the parent archetype is an individual substance and not a substance class, then it may be duplicated in this data element, or this element may be redundant. It is strongly recommended that 'Specific substance' be coded with a terminology., uncommonOntologyItems=null, occurencesFormal=0..1, occurencesText=Optional, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=DV_TEXT, bindings=null, values=, extendedValues=null], ResourceSimplifiedHierarchyItem [path=/items[at0002], code=at0002, itemType=ELEMENT, level=1, text=Certainty, description=Statement about the degree of clinical certainty that the identified 'Specific substance' was the cause of the 'Manifestation' in this reaction event., comment=null, uncommonOntologyItems=null, occurencesFormal=0..1, occurencesText=Optional, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=DV_CODED_TEXT, bindings=null, values=
  • Suspected [A low level of clinical certainty that the reaction was caused by the identified 'Specific substance'.]
  • Likely [A reasonable level of clinical certainty that the reaction was caused by the identified 'Specific substance'.]
  • Confirmed [A high level of clinical certainty that the reaction was due to the identified 'Substance', which may include clinical evidence by testing or re-challenge.]
, extendedValues=null], ResourceSimplifiedHierarchyItem [path=/items[at0006], code=at0006, itemType=ELEMENT, level=1, text=Manifestation, description=Clinical symptoms and/or signs that are observed or associated with the adverse reaction., comment=Manifestation can be expressed as a single word, phrase or brief description. For example: nausea, rash. 'No reaction'may be appropriate where a previous reaction has been noted but the reaction did not re-occur after further exposure. 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., uncommonOntologyItems=null, occurencesFormal=0..*, occurencesText=Optional, repeating, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=DV_TEXT, bindings=null, values=, extendedValues=null], ResourceSimplifiedHierarchyItem [path=/items[at0007], code=at0007, itemType=ELEMENT, level=1, text=Reaction description, description=Narrative description about the adverse reaction as a whole, including details of the manifestation if required., comment=null, uncommonOntologyItems=null, occurencesFormal=0..1, occurencesText=Optional, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=DV_TEXT, bindings=null, values=, extendedValues=null], ResourceSimplifiedHierarchyItem [path=/items[at0008], code=at0008, itemType=ELEMENT, level=1, text=Onset of reaction, description=Record of the date and/or time of the onset of the reaction., comment=null, uncommonOntologyItems=null, occurencesFormal=0..1, occurencesText=Optional, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=DV_DATE_TIME, bindings=null, values=, extendedValues=null], ResourceSimplifiedHierarchyItem [path=/items[at0009], code=at0009, itemType=ELEMENT, level=1, text=Duration of reaction, description=The total amount of time that the manifestation of the adverse reaction persisted., comment=null, uncommonOntologyItems=null, occurencesFormal=0..1, occurencesText=Optional, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=DV_DURATION, bindings=null, values=, extendedValues=null], ResourceSimplifiedHierarchyItem [path=/items[at0010], code=at0010, itemType=ELEMENT, level=1, text=Severity of reaction, description=Clinical assessment of the severity of the reaction event as a whole, potentially considering multiple different manifestations., comment=It is acknowledged that this assessment is very subjective. There may be some some specific practice domains where objective scales have been applied. Objective scales can be included in this model using the 'Reaction details' Cluster., uncommonOntologyItems=null, occurencesFormal=0..1, occurencesText=Optional, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=CHOICE, bindings=null, values=Choice of:
  •  Coded Text
    • Mild [Causes mild physiological effects.]
    • Moderate [Causes moderate physiological effects.]
    • Severe [Causes severe physiological effects.]
  •  Text
, extendedValues=null], ResourceSimplifiedHierarchyItem [path=/items[at0014], code=at0014, itemType=SLOT, level=1, text=Reaction details, description=Additional details about the adverse reaction, including anatomical location and Common Toxicity Criteria, can be provided by inclusion of specific archetypes in this SLOT., comment=May include structured detail about symptoms; the anatomical location of the manifestation; grading, classification or formal severity assessments such as Common Terminology Criteria for Adverse Events; or the Multimedia CLUSTER archetype. [Note: FHIR - These would be extensions as specified in a profile.], uncommonOntologyItems=null, occurencesFormal=0..*, occurencesText=Optional, repeating, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=CLUSTER, bindings=null, values=Include:
openEHR-EHR-CLUSTER.anatomical_location.v1 and specialisations or
openEHR-EHR-CLUSTER.media_file.v1 and specialisations or
openEHR-EHR-CLUSTER.anatomical_location_relative.v2 and specialisations or
openEHR-EHR-CLUSTER.symptom_sign.v1 and specialisations, extendedValues=null], ResourceSimplifiedHierarchyItem [path=/items[at0015], code=at0015, itemType=ELEMENT, level=1, text=Initial exposure, description=Record of the date and/or time of the first exposure to the Substance for this Reaction Event., comment=Exposure can be more complicated by more than one exposure events leading to a reaction. Further details about the nature of the exposure can be provided by use of additional archetypes in the 'Exposure details' SLOT or as text in the 'Exposure description'., uncommonOntologyItems=null, occurencesFormal=0..1, occurencesText=Optional, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=DV_DATE_TIME, bindings=null, values=, extendedValues=null], ResourceSimplifiedHierarchyItem [path=/items[at0016], code=at0016, itemType=ELEMENT, level=1, text=Duration of exposure, description=The total amount of time the individual was exposed to the identified 'Specific substance'., comment=null, uncommonOntologyItems=null, occurencesFormal=0..1, occurencesText=Optional, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=DV_DURATION, bindings=null, values=, extendedValues=null], ResourceSimplifiedHierarchyItem [path=/items[at0017], code=at0017, itemType=ELEMENT, level=1, text=Route of exposure, description=Identification of the route by which the subject was exposed to the identified 'Specific substance'., comment=Coding of the Route of Exposure with a terminology should be used wherever possible., uncommonOntologyItems=null, occurencesFormal=0..1, occurencesText=Optional, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=DV_TEXT, bindings=null, values=, extendedValues=null], ResourceSimplifiedHierarchyItem [path=/items[at0018], code=at0018, itemType=ELEMENT, level=1, text=Exposure description, description=Narrative description about exposure to the identified 'Specific substance'., comment=null, uncommonOntologyItems=null, occurencesFormal=0..1, occurencesText=Optional, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=DV_TEXT, bindings=null, values=, extendedValues=null], ResourceSimplifiedHierarchyItem [path=/items[at0019], code=at0019, itemType=SLOT, level=1, text=Exposure details, description=Additional details about exposure to the 'Specific substance', especially in situations where there may have been multiple or cumulative exposures can be provided by inclusion of specific archetypes in this SLOT., comment=null, uncommonOntologyItems=null, occurencesFormal=0..*, occurencesText=Optional, repeating, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=CLUSTER, bindings=null, values=Include:
openEHR-EHR-CLUSTER.citation.v1 and specialisations or
openEHR-EHR-CLUSTER.citation.v0 and specialisations, extendedValues=null], ResourceSimplifiedHierarchyItem [path=/items[at0020], code=at0020, itemType=ELEMENT, level=1, text=Clinical management description, description=Narrative description about the clinical management provided., comment=null, uncommonOntologyItems=null, occurencesFormal=0..1, occurencesText=Optional, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=DV_TEXT, bindings=null, values=, extendedValues=null], ResourceSimplifiedHierarchyItem [path=/items[at0021], code=at0021, itemType=SLOT, level=1, text=Clinical management details, description=Additional structured details about clinical management for this reaction event can be provided by inclusion of specific archetypes in this SLOT., comment=null, uncommonOntologyItems=null, occurencesFormal=0..*, occurencesText=Optional, repeating, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=CLUSTER, bindings=null, values=Include:
All not explicitly excluded archetypes, extendedValues=null], ResourceSimplifiedHierarchyItem [path=/items[at0022], code=at0022, itemType=SLOT, level=1, text=Reporting details, description=Additional structured details required for reporting to regulatory bodies can be provided by inclusion of specific archetypes in this SLOT., comment=null, uncommonOntologyItems=null, occurencesFormal=0..*, occurencesText=Optional, repeating, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=CLUSTER, bindings=null, values=Include:
All not explicitly excluded archetypes, extendedValues=null], ResourceSimplifiedHierarchyItem [path=/items[at0023], code=at0023, itemType=SLOT, level=1, text=Information source, description=Details about the provenance of the information can be provided by inclusion of specific archetypes in this SLOT., comment=This SLOT is intended to provide details about the source of information for this particular 'Reaction event'. Details about the source of information for the entire 'Adverse reaction risk' should be recorded using the 'Information Provider' reference model attribute., uncommonOntologyItems=null, occurencesFormal=0..*, occurencesText=Optional, repeating, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=CLUSTER, bindings=null, values=Include:
All not explicitly excluded archetypes, extendedValues=null], ResourceSimplifiedHierarchyItem [path=/items[at0025], code=at0025, itemType=ELEMENT, level=1, text=Supporting clinical record information, description=Link to further information about the presentation and findings that exist elsewhere in the health record, including allergy test reports., comment=For example, presenting symptoms, examination findings, diagnosis etc. [Note: FHIR,DAM: Maps to Sensitivity Test.], uncommonOntologyItems=null, occurencesFormal=0..*, occurencesText=Optional, repeating, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=DV_EHR_URI, bindings=null, values=, extendedValues=null], ResourceSimplifiedHierarchyItem [path=/items[at0024], code=at0024, itemType=ELEMENT, level=1, text=Comment, description=Additional narrative about the adverse reaction event not captured in other fields., comment=null, uncommonOntologyItems=null, occurencesFormal=0..1, occurencesText=Optional, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=DV_TEXT, bindings=null, values=, extendedValues=null]], minIndents={}, termBindingRetrievalErrorMessage=null]