HL7 FHIR Implementation Guide: Profiles for ICSR Transfusion and Vaccination Adverse Event Detection and Reporting
0.1.0 - STU 1 Ballot
HL7 FHIR Implementation Guide: Profiles for ICSR Transfusion and Vaccination Adverse Event Detection and Reporting
0.1.0 - STU 1 Ballot
This page is part of the Profiles for ICSR Transfusion and Vaccination Adverse Event Detection and Reporting (v0.1.0: STU 1 Ballot 1) based on FHIR R4. The current version which supercedes this version is 1.0.0. For a full list of available versions, see the Directory of published versions 
@prefix fhir: <http://hl7.org/fhir/> .
@prefix loinc: <http://loinc.org/rdf#> .
@prefix owl: <http://www.w3.org/2002/07/owl#> .
@prefix rdfs: <http://www.w3.org/2000/01/rdf-schema#> .
@prefix xsd: <http://www.w3.org/2001/XMLSchema#> .
# - resource -------------------------------------------------------------------
a fhir:Composition;
fhir:nodeRole fhir:treeRoot;
fhir:Resource.id [ fhir:value "FAERSExample"];
fhir:Resource.meta [
fhir:Meta.profile [
fhir:value "http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/ibm-fda-icsr-composition";
fhir:index 0;
fhir:link <http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/ibm-fda-icsr-composition> ]
];
fhir:DomainResource.text [
fhir:Narrative.status [ fhir:value "extensions" ];
fhir:Narrative.div "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative</b></p><blockquote><p><b>AdditionalDocumentInformation</b></p><p><b>value</b>: false</p></blockquote><blockquote><p><b>ExpeditedReport</b></p><p><b>value</b>: false</p><p><b>value</b>: <span title=\"Codes: {urn:oid:2.16.840.1.113883.3.989.2.1.1.1003 2}\">Non-Expedited AE</span></p></blockquote><p><b>FirstSenderType</b>: <span title=\"Codes: {urn:oid:2.16.840.1.113883.3.989.2.1.1.3 2}\">Other</span></p><p><b>CombinationProductReport</b>: false</p><p><b>FirstReceiveDate</b>: 2021-01-05</p><p><b>MostRecentDate</b>: 2021-01-05</p><p><b>CaseIdentifier</b>: id: BEST_beafb541-3eab-eb9e-1bf1-5fa477d56e77</p><p><b>identifier</b>: id: BEST_beafb541-3eab-eb9e-1bf1-5fa477d56e77</p><p><b>status</b>: final</p><p><b>type</b>: <span title=\"Codes: {http://loinc.org 85893-6}\">Adverse event note</span></p><p><b>category</b>: <span title=\"Codes: {urn:oid:2.16.840.1.113883.3.989.2.1.1.2 1}\">Spontaneous report</span></p><p><b>date</b>: 2021-01-05</p><p><b>author</b>: <a href=\"PractitionerRole-BESTAuthorRole.html\">Generated Summary: <span title=\"Codes: {urn:oid:2.16.840.1.113883.3.989.2.1.1.6 1}\">Physician</span>; admin@admin.com</a></p><p><b>title</b>: ICSR Submission</p></div>"
];
fhir:DomainResource.extension [
fhir:index 0;
fhir:Element.extension [
fhir:index 0;
fhir:Extension.url [ fhir:value "availableFlag" ];
fhir:Extension.valueBoolean [ fhir:value "false"^^xsd:boolean ] ];
fhir:Extension.url [ fhir:value "http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/ibm-fda-icsr-ext-additionaldocumentinformation" ]
], [
fhir:index 1;
fhir:Element.extension [
fhir:index 0;
fhir:Extension.url [ fhir:value "localCriteriaFlag" ];
fhir:Extension.valueBoolean [ fhir:value "false"^^xsd:boolean ] ], [
fhir:index 1;
fhir:Extension.url [ fhir:value "localCriteriaReportType" ];
fhir:Extension.valueCodeableConcept [
fhir:CodeableConcept.coding [
fhir:index 0;
fhir:Coding.system [ fhir:value "urn:oid:2.16.840.1.113883.3.989.2.1.1.1003" ];
fhir:Coding.code [ fhir:value "2" ];
fhir:Coding.display [ fhir:value "Non-Expedited AE" ] ] ] ];
fhir:Extension.url [ fhir:value "http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/ibm-fda-icsr-ext-expeditedreport" ]
], [
fhir:index 2;
fhir:Extension.url [ fhir:value "http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/ibm-fda-icsr-ext-firstsendertype" ];
fhir:Extension.valueCodeableConcept [
fhir:CodeableConcept.coding [
fhir:index 0;
fhir:Coding.system [ fhir:value "urn:oid:2.16.840.1.113883.3.989.2.1.1.3" ];
fhir:Coding.code [ fhir:value "2" ];
fhir:Coding.display [ fhir:value "Other" ] ] ]
], [
fhir:index 3;
fhir:Extension.url [ fhir:value "http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/ibm-fda-icsr-ext-combinationproductreport" ];
fhir:Extension.valueBoolean [ fhir:value "false"^^xsd:boolean ]
], [
fhir:index 4;
fhir:Extension.url [ fhir:value "http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/ibm-fda-icsr-ext-firstreceivedate" ];
fhir:Extension.valueDateTime [ fhir:value "2021-01-05"^^xsd:date ]
], [
fhir:index 5;
fhir:Extension.url [ fhir:value "http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/ibm-fda-icsr-ext-mostrecentdate" ];
fhir:Extension.valueDateTime [ fhir:value "2021-01-05"^^xsd:date ]
], [
fhir:index 6;
fhir:Extension.url [ fhir:value "http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/ibm-fda-icsr-ext-caseidentifier" ];
fhir:Extension.valueIdentifier [
fhir:Identifier.system [ fhir:value "urn:oid:2.16.840.1.113883.3.989.2.1.3.2" ];
fhir:Identifier.value [ fhir:value "BEST_beafb541-3eab-eb9e-1bf1-5fa477d56e77" ] ]
];
fhir:Composition.identifier [
fhir:Identifier.system [ fhir:value "urn:oid:2.16.840.1.113883.3.989.2.1.3.1" ];
fhir:Identifier.value [ fhir:value "BEST_beafb541-3eab-eb9e-1bf1-5fa477d56e77" ]
];
fhir:Composition.status [ fhir:value "final"];
fhir:Composition.type [
fhir:CodeableConcept.coding [
fhir:index 0;
a loinc:85893-6;
fhir:Coding.system [ fhir:value "http://loinc.org" ];
fhir:Coding.code [ fhir:value "85893-6" ];
fhir:Coding.display [ fhir:value "Adverse event note" ] ]
];
fhir:Composition.category [
fhir:index 0;
fhir:CodeableConcept.coding [
fhir:index 0;
fhir:Coding.system [ fhir:value "urn:oid:2.16.840.1.113883.3.989.2.1.1.2" ];
fhir:Coding.code [ fhir:value "1" ];
fhir:Coding.display [ fhir:value "Spontaneous report" ] ]
];
fhir:Composition.subject [
fhir:Reference.reference [ fhir:value "Patient/BESTPatient" ]
];
fhir:Composition.date [ fhir:value "2021-01-05"^^xsd:date];
fhir:Composition.author [
fhir:index 0;
fhir:Element.extension [
fhir:index 0;
fhir:Extension.url [ fhir:value "http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/ibm-fda-icsr-ext-authorprimarysource" ];
fhir:Extension.valueBoolean [ fhir:value "true"^^xsd:boolean ] ];
fhir:Reference.reference [ fhir:value "PractitionerRole/BESTAuthorRole" ]
];
fhir:Composition.title [ fhir:value "ICSR Submission"];
fhir:Composition.section [
fhir:index 0;
fhir:Composition.section.title [ fhir:value "Reaction/Event" ];
fhir:Composition.section.code [
fhir:CodeableConcept.coding [
fhir:index 0;
fhir:Coding.system [ fhir:value "http://hl7.org/fhir/us/icsr-ae-reporting/CodeSystem/ICSRSectionCodeCS" ];
fhir:Coding.code [ fhir:value "ReactionEvent" ] ] ];
fhir:Composition.section.text [
fhir:Narrative.status [ fhir:value "generated" ];
fhir:Narrative.div "<div xmlns=\"http://www.w3.org/1999/xhtml\">Allergic transfusion reaction</div>" ];
fhir:Composition.section.entry [
fhir:index 0;
fhir:Reference.reference [ fhir:value "AdverseEvent/FAERSExampleEvent" ] ]
], [
fhir:index 1;
fhir:Composition.section.title [ fhir:value "Drug Information" ];
fhir:Composition.section.code [
fhir:CodeableConcept.coding [
fhir:index 0;
fhir:Coding.system [ fhir:value "http://hl7.org/fhir/us/icsr-ae-reporting/CodeSystem/ICSRSectionCodeCS" ];
fhir:Coding.code [ fhir:value "DrugInformation" ] ] ];
fhir:Composition.section.text [
fhir:Narrative.status [ fhir:value "generated" ];
fhir:Narrative.div "<div xmlns=\"http://www.w3.org/1999/xhtml\">Description code for blood products: E7003, Blood group and type: N/A Blood processing type: Apheresis PLATELETS|ACD-A>PAS-C/XX/20-24C|ResLeu:&lt;5E6|2nd container</div>" ];
fhir:Composition.section.entry [
fhir:index 0;
fhir:Reference.reference [ fhir:value "Procedure/FAERSExampleTransfusion" ] ], [
fhir:index 1;
fhir:Reference.reference [ fhir:value "MedicationAdministration/FAERSEpinephrine" ] ], [
fhir:index 2;
fhir:Reference.reference [ fhir:value "MedicationAdministration/FAERSDiphenhydramine" ] ]
], [
fhir:index 2;
fhir:Composition.section.title [ fhir:value "Case Summary Narrative" ];
fhir:Composition.section.code [
fhir:CodeableConcept.coding [
fhir:index 0;
fhir:Coding.system [ fhir:value "http://hl7.org/fhir/us/icsr-ae-reporting/CodeSystem/ICSRSectionCodeCS" ];
fhir:Coding.code [ fhir:value "CaseSummaryNarrative" ] ] ];
fhir:Composition.section.text [
fhir:Narrative.status [ fhir:value "generated" ];
fhir:Narrative.div "<div xmlns=\"http://www.w3.org/1999/xhtml\">Header: FDA CBER BEST Automated AE Reporting Prototype Case BEST Detection Phenotype Algorithm: Phenotype link: rules-cd BEST Certainty: Definite BEST Severity: Non-Severe BEST Imputability: Probable Form Type: 3500 Contact Method: Email Adverse Event: 1 Center to which the case is being routed to: CBER Whether the case is being sent to DQRS: false Whether the report is related to drugs or food/cosmetics: 1 Whether the blood report is of type Transfusion or Collection: 2 Patient Race Code: 2f, Blood group of patient: N/A, Onset location for reaction: MedStar Location Description code for blood products: N/A, Blood group and type: N/A Blood processing type: N/A Product available for evaluation: 2 Volume of transfusion: NI NHSN Workup: NI Preliminary investigation results: Developed rash &#38; stridor following transfusion prbc for anemia. Tx with benadryl &#38; epinephrine &#38; sx improved., Adverse Event Type Imputability: Blood Transfusion - Certainty: Definite; Notes: 1. notes, Eval+Plan Note, For admission to Hosp with Dx Anemia. Transfuse PRBC now., Date 20020109; 2. notes, Eval+Plan Note, Patient has developed a new maculopapular rash following transfusion. Will give Benadryl 25 mg., Date 20020109; 3. notes, Eval+Plan Note, New onset Stridor following transfusion. Will give Epinephrine .5mg, and do transfusion Rxn workup, Date 20020109; 4. notes, Eval+Plan Note, RN note - Administered Benadryl 25mg IV for skin sx. After 30 min pt. reports some improvement in skin symptoms, Date 20020109 Labs, Vitals, and Tests: 1. labs, Diastolic Blood Pressure, 75.918 mm[Hg], Date 20020109; 2. labs, Systolic Blood Pressure, 123.08 mm[Hg], Date 20020109; 3. labs, Physical findings of Skin, generalized rash, Date 20020109; 4. labs, Respiratory status finding, Stridor, Date 20020109; Illness at Time of Vaccination: 1. illness, Problem, Anemia, Date 20020109;</div>" ]
], [
fhir:index 3;
fhir:Composition.section.title [ fhir:value "Patient Information" ];
fhir:Composition.section.code [
fhir:CodeableConcept.coding [
fhir:index 0;
fhir:Coding.system [ fhir:value "http://hl7.org/fhir/us/icsr-ae-reporting/CodeSystem/ICSRSectionCodeCS" ];
fhir:Coding.code [ fhir:value "PatientInformation" ] ] ];
fhir:Composition.section.entry [
fhir:index 0;
fhir:Reference.reference [ fhir:value "Observation/BESTPatientAgeGroup" ] ]
], [
fhir:index 4;
fhir:Composition.section.title [ fhir:value "Relevant Medical History" ];
fhir:Composition.section.code [
fhir:CodeableConcept.coding [
fhir:index 0;
fhir:Coding.system [ fhir:value "http://hl7.org/fhir/us/icsr-ae-reporting/CodeSystem/ICSRSectionCodeCS" ];
fhir:Coding.code [ fhir:value "RelevantMedicalHistory" ] ] ];
fhir:Composition.section.text [
fhir:Narrative.status [ fhir:value "generated" ];
fhir:Narrative.div "<div xmlns=\"http://www.w3.org/1999/xhtml\">NI</div>" ]
].
# - ontology header ------------------------------------------------------------
a owl:Ontology;
owl:imports fhir:fhir.ttl.
IG © 2020+ Biomedical Research & Regulation WG. Package hl7.fhir.us.icsr-ae-reporting#0.1.0 based on FHIR 4.0.1. Generated 2021-08-05
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