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:Bundle;
fhir:nodeRole fhir:treeRoot;
fhir:Resource.id [ fhir:value "ConnectathonFAERSBundle"];
fhir:Resource.meta [
fhir:Meta.profile [
fhir:value "http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/ibm-fda-icsr-faers-bundle";
fhir:index 0;
fhir:link <http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/ibm-fda-icsr-faers-bundle> ]
];
fhir:Bundle.type [ fhir:value "message"];
fhir:Bundle.entry [
fhir:index 0;
fhir:Bundle.entry.fullUrl [ fhir:value "MessageHeader/beafb541-3eab-eb9e-1bf1-5fa477d56e77" ];
fhir:Bundle.entry.resource <MessageHeader/beafb541-3eab-eb9e-1bf1-5fa477d56e77>
], [
fhir:index 1;
fhir:Bundle.entry.fullUrl [ fhir:value "Composition/FAERSExample" ];
fhir:Bundle.entry.resource <Composition/FAERSExample>
], [
fhir:index 2;
fhir:Bundle.entry.fullUrl [ fhir:value "Organization/FDA" ];
fhir:Bundle.entry.resource <Organization/FDA>
], [
fhir:index 3;
fhir:Bundle.entry.fullUrl [ fhir:value "Organization/BESTPrototype" ];
fhir:Bundle.entry.resource <Organization/BESTPrototype>
], [
fhir:index 4;
fhir:Bundle.entry.fullUrl [ fhir:value "PractitionerRole/BESTAuthorRole" ];
fhir:Bundle.entry.resource <PractitionerRole/BESTAuthorRole>
], [
fhir:index 5;
fhir:Bundle.entry.fullUrl [ fhir:value "Practitioner/BESTAuthor" ];
fhir:Bundle.entry.resource <Practitioner/BESTAuthor>
], [
fhir:index 6;
fhir:Bundle.entry.fullUrl [ fhir:value "Patient/BESTPatient" ];
fhir:Bundle.entry.resource <Patient/BESTPatient>
], [
fhir:index 7;
fhir:Bundle.entry.fullUrl [ fhir:value "Observation/BESTPatientAgeGroup" ];
fhir:Bundle.entry.resource <Observation/BESTPatientAgeGroup>
], [
fhir:index 8;
fhir:Bundle.entry.fullUrl [ fhir:value "AdverseEvent/FAERSExampleEvent" ];
fhir:Bundle.entry.resource <AdverseEvent/FAERSExampleEvent>
], [
fhir:index 9;
fhir:Bundle.entry.fullUrl [ fhir:value "Procedure/FAERSExampleTransfusion" ];
fhir:Bundle.entry.resource <Procedure/FAERSExampleTransfusion>
], [
fhir:index 10;
fhir:Bundle.entry.fullUrl [ fhir:value "BiologicallyDerivedProduct/FAERSBloodProduct" ];
fhir:Bundle.entry.resource <BiologicallyDerivedProduct/FAERSBloodProduct>
], [
fhir:index 11;
fhir:Bundle.entry.fullUrl [ fhir:value "MedicationAdministration/FAERSEpinephrine" ];
fhir:Bundle.entry.resource <MedicationAdministration/FAERSEpinephrine>
], [
fhir:index 12;
fhir:Bundle.entry.fullUrl [ fhir:value "MedicationAdministration/FAERSDiphenhydramine" ];
fhir:Bundle.entry.resource <MedicationAdministration/FAERSDiphenhydramine>
].
<MessageHeader/beafb541-3eab-eb9e-1bf1-5fa477d56e77> a fhir:MessageHeader;
fhir:Resource.id [ fhir:value "beafb541-3eab-eb9e-1bf1-5fa477d56e77"];
fhir:Resource.meta [
fhir:Meta.lastUpdated [ fhir:value "2021-01-05T14:14:39+06:00"^^xsd:dateTime ];
fhir:Meta.profile [
fhir:value "http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/ibm-fda-icsr-faers-messageheader";
fhir:index 0;
fhir:link <http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/ibm-fda-icsr-faers-messageheader> ]
];
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><p><b>Message Processing Category</b>: notification</p><p><b>event</b>: <span title=\"{http://terminology.hl7.org/CodeSystem/v3-ActCode PAT_ADV_EVNT}\">Patient Adverse Event</span></p><h3>Destinations</h3><table class=\"grid\"><tr><td>-</td><td><b>Endpoint</b></td><td><b>Receiver</b></td></tr><tr><td>*</td><td><a href=\"http://example.org/ZZFDA\">http://example.org/ZZFDA</a></td><td><a href=\"#Organization_FDA\">See above (Organization/FDA)</a></td></tr></table><p><b>sender</b>: <a href=\"#Organization_BESTPrototype\">See above (Organization/BESTPrototype)</a></p><h3>Sources</h3><table class=\"grid\"><tr><td>-</td><td><b>Endpoint</b></td></tr><tr><td>*</td><td><a href=\"http://example.org/BEST-Pilot\">http://example.org/BEST-Pilot</a></td></tr></table><p><b>reason</b>: <span title=\"Codes: {http://hl7.org/fhir/us/medmorph/CodeSystem/us-ph-triggerdefinition-namedevents received-public-health-report}\">Indicates receipt of a public health report</span></p><p><b>focus</b>: <a href=\"#Composition_FAERSExample\">See above (Composition/FAERSExample)</a></p></div>"
];
fhir:DomainResource.extension [
fhir:index 0;
fhir:Extension.url [ fhir:value "http://hl7.org/fhir/us/medmorph/StructureDefinition/ext-messageProcessingCategory" ];
fhir:Extension.valueCode [ fhir:value "notification" ]
];
fhir:MessageHeader.eventCoding [
fhir:Coding.system [ fhir:value "http://terminology.hl7.org/CodeSystem/v3-ActCode" ];
fhir:Coding.code [ fhir:value "PAT_ADV_EVNT" ];
fhir:Coding.display [ fhir:value "Patient Adverse Event" ]
];
fhir:MessageHeader.destination [
fhir:index 0;
fhir:MessageHeader.destination.endpoint [ fhir:value "http://example.org/ZZFDA" ];
fhir:MessageHeader.destination.receiver [
fhir:Reference.reference [ fhir:value "Organization/FDA" ] ]
];
fhir:MessageHeader.sender [
fhir:Reference.reference [ fhir:value "Organization/BESTPrototype" ]
];
fhir:MessageHeader.source [
fhir:MessageHeader.source.endpoint [ fhir:value "http://example.org/BEST-Pilot" ]
];
fhir:MessageHeader.reason [
fhir:CodeableConcept.coding [
fhir:index 0;
fhir:Coding.system [ fhir:value "http://hl7.org/fhir/us/medmorph/CodeSystem/us-ph-triggerdefinition-namedevents" ];
fhir:Coding.code [ fhir:value "received-public-health-report" ] ]
];
fhir:MessageHeader.focus [
fhir:index 0;
fhir:Reference.reference [ fhir:value "Composition/FAERSExample" ]
].
<Composition/FAERSExample> a fhir:Composition;
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\">See above (PractitionerRole/BESTAuthorRole)</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>" ]
].
<Organization/FDA> a fhir:Organization;
fhir:Resource.id [ fhir:value "FDA"];
fhir:Resource.meta [
fhir:Meta.profile [
fhir:value "http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/ibm-fda-icsr-messageorganization";
fhir:index 0;
fhir:link <http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/ibm-fda-icsr-messageorganization> ]
];
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><p><b>DepartmentName</b>: Office of Surveillance and Epidemiology</p><p><b>active</b>: true</p><p><b>type</b>: <span title=\"Codes: {urn:oid:2.16.840.1.113883.3.989.2.1.1.7 2}\">Regulatory Authority</span></p><p><b>name</b>: FDA</p><p><b>telecom</b>: <a href=\"mailto:faersesub@fda.hhs.gov\">faersesub@fda.hhs.gov</a></p><p><b>address</b>: 10903 New Hampshire Avenue Silver Spring MD 20993 US </p><h3>Contacts</h3><table class=\"grid\"><tr><td>-</td><td><b>Name</b></td></tr><tr><td>*</td><td>FAERS </td></tr></table></div>"
];
fhir:DomainResource.extension [
fhir:index 0;
fhir:Extension.url [ fhir:value "http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/ibm-fda-icsr-ext-departmentname" ];
fhir:Extension.valueString [ fhir:value "Office of Surveillance and Epidemiology" ]
];
fhir:Organization.active [ fhir:value "true"^^xsd:boolean];
fhir:Organization.type [
fhir:index 0;
fhir:CodeableConcept.coding [
fhir:index 0;
fhir:Coding.system [ fhir:value "urn:oid:2.16.840.1.113883.3.989.2.1.1.7" ];
fhir:Coding.code [ fhir:value "2" ];
fhir:Coding.display [ fhir:value "Regulatory Authority" ] ]
];
fhir:Organization.name [ fhir:value "FDA"];
fhir:Organization.telecom [
fhir:index 0;
fhir:ContactPoint.system [ fhir:value "email" ];
fhir:ContactPoint.value [ fhir:value "faersesub@fda.hhs.gov" ]
];
fhir:Organization.address [
fhir:index 0;
fhir:Address.line [
fhir:value "10903 New Hampshire Avenue";
fhir:index 0 ];
fhir:Address.city [ fhir:value "Silver Spring" ];
fhir:Address.state [ fhir:value "MD" ];
fhir:Address.postalCode [ fhir:value "20993" ];
fhir:Address.country [ fhir:value "US" ]
];
fhir:Organization.contact [
fhir:index 0;
fhir:Organization.contact.name [
fhir:HumanName.given [
fhir:value "FAERS";
fhir:index 0 ] ]
].
<Organization/BESTPrototype> a fhir:Organization;
fhir:Resource.id [ fhir:value "BESTPrototype"];
fhir:Resource.meta [
fhir:Meta.profile [
fhir:value "http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/ibm-fda-icsr-messageorganization";
fhir:index 0;
fhir:link <http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/ibm-fda-icsr-messageorganization> ]
];
fhir:DomainResource.text [
fhir:Narrative.status [ fhir:value "generated" ];
fhir:Narrative.div "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative</b></p><p><b>active</b>: true</p><p><b>name</b>: BEST-Prototype</p></div>"
];
fhir:Organization.active [ fhir:value "true"^^xsd:boolean];
fhir:Organization.name [ fhir:value "BEST-Prototype"].
<PractitionerRole/BESTAuthorRole> a fhir:PractitionerRole;
fhir:Resource.id [ fhir:value "BESTAuthorRole"];
fhir:Resource.meta [
fhir:Meta.profile [
fhir:value "http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/ibm-fda-icsr-authorpractitionerrole";
fhir:index 0;
fhir:link <http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/ibm-fda-icsr-authorpractitionerrole> ]
];
fhir:DomainResource.text [
fhir:Narrative.status [ fhir:value "generated" ];
fhir:Narrative.div "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative</b></p><p><b>practitioner</b>: <a href=\"#Practitioner_BESTAuthor\">See above (Practitioner/BESTAuthor)</a></p><p><b>organization</b>: <a href=\"#Organization_BESTPrototype\">See above (Organization/BESTPrototype)</a></p><p><b>code</b>: <span title=\"Codes: {urn:oid:2.16.840.1.113883.3.989.2.1.1.6 1}\">Physician</span></p><p><b>telecom</b>: <a href=\"mailto:admin@admin.com\">admin@admin.com</a></p></div>"
];
fhir:PractitionerRole.practitioner [
fhir:Reference.reference [ fhir:value "Practitioner/BESTAuthor" ]
];
fhir:PractitionerRole.organization [
fhir:Reference.reference [ fhir:value "Organization/BESTPrototype" ]
];
fhir:PractitionerRole.code [
fhir:index 0;
fhir:CodeableConcept.coding [
fhir:index 0;
fhir:Coding.system [ fhir:value "urn:oid:2.16.840.1.113883.3.989.2.1.1.6" ];
fhir:Coding.code [ fhir:value "1" ];
fhir:Coding.display [ fhir:value "Physician" ] ]
];
fhir:PractitionerRole.telecom [
fhir:index 0;
fhir:ContactPoint.system [ fhir:value "email" ];
fhir:ContactPoint.value [ fhir:value "admin@admin.com" ]
].
<Practitioner/BESTAuthor> a fhir:Practitioner;
fhir:Resource.id [ fhir:value "BESTAuthor"];
fhir:Resource.meta [
fhir:Meta.profile [
fhir:value "http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/ibm-fda-icsr-authorpractitioner";
fhir:index 0;
fhir:link <http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/ibm-fda-icsr-authorpractitioner> ]
];
fhir:DomainResource.text [
fhir:Narrative.status [ fhir:value "generated" ];
fhir:Narrative.div "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative</b></p><p><b>identifier</b>: id: NI</p><p><b>name</b>: NI </p></div>"
];
fhir:Practitioner.identifier [
fhir:index 0;
fhir:Identifier.system [ fhir:value "http://hl7.org/fhir/sid/us-npi" ];
fhir:Identifier.value [ fhir:value "NI" ]
];
fhir:Practitioner.name [
fhir:index 0;
fhir:HumanName.family [ fhir:value "NI" ]
].
<Patient/BESTPatient> a fhir:Patient;
fhir:Resource.id [ fhir:value "BESTPatient"];
fhir:Resource.meta [
fhir:Meta.profile [
fhir:value "http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/ibm-fda-icsr-patient";
fhir:index 0;
fhir:link <http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/ibm-fda-icsr-patient> ]
];
fhir:DomainResource.text [
fhir:Narrative.status [ fhir:value "generated" ];
fhir:Narrative.div "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative</b></p><p><b>identifier</b>: id: 123456789</p><p><b>name</b>: CM </p><p><b>gender</b>: female</p><p><b>birthDate</b>: 1999-06-24</p></div>"
];
fhir:Patient.identifier [
fhir:index 0;
fhir:Identifier.system [ fhir:value "http://hl7.org/fhir/sid/us-ssn" ];
fhir:Identifier.value [ fhir:value "123456789" ]
];
fhir:Patient.name [
fhir:index 0;
fhir:HumanName.family [ fhir:value "CM" ]
];
fhir:Patient.gender [ fhir:value "female"];
fhir:Patient.birthDate [ fhir:value "1999-06-24"^^xsd:date].
<Observation/BESTPatientAgeGroup> a fhir:Observation;
fhir:Resource.id [ fhir:value "BESTPatientAgeGroup"];
fhir:Resource.meta [
fhir:Meta.profile [
fhir:value "http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/ibm-fda-icsr-patientagegroup";
fhir:index 0;
fhir:link <http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/ibm-fda-icsr-patientagegroup> ]
];
fhir:DomainResource.text [
fhir:Narrative.status [ fhir:value "generated" ];
fhir:Narrative.div "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative</b></p><p></p><p><b>code</b>: <span title=\"Codes: {http://loinc.org 46251-5}\">Age group</span></p><p><b>subject</b>: <a href=\"#Patient_BESTPatient\">See above (Patient/BESTPatient)</a></p><p><b>value</b>: <span title=\"Codes: {urn:oid:2.16.840.1.113883.3.989.2.1.1.9 5}\">Adult</span></p></div>"
];
fhir:Observation.status [ fhir:value "final"];
fhir:Observation.code [
fhir:CodeableConcept.coding [
fhir:index 0;
a loinc:46251-5;
fhir:Coding.system [ fhir:value "http://loinc.org" ];
fhir:Coding.code [ fhir:value "46251-5" ];
fhir:Coding.display [ fhir:value "Age group" ] ]
];
fhir:Observation.subject [
fhir:Reference.reference [ fhir:value "Patient/BESTPatient" ]
];
fhir:Observation.valueCodeableConcept [
fhir:CodeableConcept.coding [
fhir:index 0;
fhir:Coding.system [ fhir:value "urn:oid:2.16.840.1.113883.3.989.2.1.1.9" ];
fhir:Coding.code [ fhir:value "5" ];
fhir:Coding.display [ fhir:value "Adult" ] ]
].
<AdverseEvent/FAERSExampleEvent> a fhir:AdverseEvent;
fhir:Resource.id [ fhir:value "FAERSExampleEvent"];
fhir:Resource.meta [
fhir:Meta.profile [
fhir:value "http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/ibm-fda-faers-adverseevent";
fhir:index 0;
fhir:link <http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/ibm-fda-faers-adverseevent> ]
];
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><p><b>AgeAtTimeOfOnset</b>: 1 a</p><p><b>actuality</b>: actual</p><p><b>event</b>: <span title=\"Codes: {http://meddra.org 10066173}\">Allergic transfusion reaction</span></p><p><b>subject</b>: <a href=\"#Patient_BESTPatient\">See above (Patient/BESTPatient)</a></p><p><b>date</b>: 2000-01-01</p><blockquote><p><b>suspectEntity</b></p><p><b>instance</b>: <a href=\"#Procedure_FAERSExampleTransfusion\">See above (Procedure/FAERSExampleTransfusion)</a></p><h3>Causalities</h3><table class=\"grid\"><tr><td>-</td><td><b>ProductRelatedness</b></td></tr><tr><td>*</td><td>Suspect</td></tr></table></blockquote><blockquote><p><b>suspectEntity</b></p><p><b>instance</b>: <a href=\"#MedicationAdministration_FAERSEpinephrine\">See above (MedicationAdministration/FAERSEpinephrine)</a></p><h3>Causalities</h3><table class=\"grid\"><tr><td>-</td><td><b>ProductRelatedness</b></td></tr><tr><td>*</td><td>Concomitant</td></tr></table></blockquote><blockquote><p><b>suspectEntity</b></p><p><b>instance</b>: <a href=\"#MedicationAdministration_FAERSDiphenhydramine\">See above (MedicationAdministration/FAERSDiphenhydramine)</a></p><h3>Causalities</h3><table class=\"grid\"><tr><td>-</td><td><b>ProductRelatedness</b></td></tr><tr><td>*</td><td>Concomitant</td></tr></table></blockquote></div>"
];
fhir:DomainResource.extension [
fhir:index 0;
fhir:Extension.url [ fhir:value "http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/ibm-fda-icsr-ext-ageattimeofonset" ];
fhir:Extension.valueAge [
fhir:Quantity.value [ fhir:value "1"^^xsd:decimal ];
fhir:Quantity.system [ fhir:value "http://unitsofmeasure.org" ];
fhir:Quantity.code [ fhir:value "a" ] ]
];
fhir:AdverseEvent.actuality [ fhir:value "actual"];
fhir:AdverseEvent.event [
fhir:CodeableConcept.coding [
fhir:index 0;
fhir:Coding.system [ fhir:value "http://meddra.org" ];
fhir:Coding.code [ fhir:value "10066173" ];
fhir:Coding.display [ fhir:value "Allergic transfusion reaction" ] ]
];
fhir:AdverseEvent.subject [
fhir:Reference.reference [ fhir:value "Patient/BESTPatient" ]
];
fhir:AdverseEvent.date [
fhir:value "2000-01-01"^^xsd:date;
fhir:Element.extension [
fhir:index 0;
fhir:Extension.url [ fhir:value "http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/ibm-fda-icsr-ext-eventenddate" ];
fhir:Extension.valueDateTime [ fhir:value "2019-01-20"^^xsd:date ] ], [
fhir:index 1;
fhir:Extension.url [ fhir:value "http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/ibm-fda-icsr-ext-eventduration" ];
fhir:Extension.valueDuration [
fhir:Quantity.value [ fhir:value "19.05"^^xsd:decimal ];
fhir:Quantity.system [ fhir:value "http://unitsofmeasure.org" ];
fhir:Quantity.code [ fhir:value "a" ] ] ]
];
fhir:AdverseEvent.suspectEntity [
fhir:index 0;
fhir:AdverseEvent.suspectEntity.instance [
fhir:Reference.reference [ fhir:value "Procedure/FAERSExampleTransfusion" ] ];
fhir:AdverseEvent.suspectEntity.causality [
fhir:index 0;
fhir:AdverseEvent.suspectEntity.causality.productRelatedness [ fhir:value "Suspect" ] ]
], [
fhir:index 1;
fhir:AdverseEvent.suspectEntity.instance [
fhir:Reference.reference [ fhir:value "MedicationAdministration/FAERSEpinephrine" ] ];
fhir:AdverseEvent.suspectEntity.causality [
fhir:index 0;
fhir:AdverseEvent.suspectEntity.causality.productRelatedness [ fhir:value "Concomitant" ] ]
], [
fhir:index 2;
fhir:AdverseEvent.suspectEntity.instance [
fhir:Reference.reference [ fhir:value "MedicationAdministration/FAERSDiphenhydramine" ] ];
fhir:AdverseEvent.suspectEntity.causality [
fhir:index 0;
fhir:AdverseEvent.suspectEntity.causality.productRelatedness [ fhir:value "Concomitant" ] ]
].
<Procedure/FAERSExampleTransfusion> a fhir:Procedure;
fhir:Resource.id [ fhir:value "FAERSExampleTransfusion"];
fhir:Resource.meta [
fhir:Meta.profile [
fhir:value "http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/ibm-fda-icsr-transfusion";
fhir:index 0;
fhir:link <http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/ibm-fda-icsr-transfusion> ]
];
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><p><b>UsedProductAmount</b>: 1 unit</p><p><b>status</b>: completed</p><p><b>code</b>: <span title=\"Codes: {http://www.ama-assn.org/go/cpt 36430}\">36430</span></p><p><b>subject</b>: <a href=\"#Patient_BESTPatient\">See above (Patient/BESTPatient)</a></p><p><b>performed</b>: 2002-01-09</p><p><b>usedReference</b>: <span>Apheresis PLATELETS|ACD-A>PAS-C/XX/20-24C|ResLeu:<5E6|2nd container</span></p></div>"
];
fhir:DomainResource.extension [
fhir:index 0;
fhir:Extension.url [ fhir:value "http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/ibm-fda-icsr-ext-usedproductamount" ];
fhir:Extension.valueQuantity [
fhir:Quantity.value [ fhir:value "1"^^xsd:decimal ];
fhir:Quantity.unit [ fhir:value "unit" ];
fhir:Quantity.system [ fhir:value "http://unitsofmeasure.org" ];
fhir:Quantity.code [ fhir:value "{unit}" ] ]
];
fhir:Procedure.status [ fhir:value "completed"];
fhir:Procedure.code [
fhir:CodeableConcept.coding [
fhir:index 0;
fhir:Coding.system [ fhir:value "http://www.ama-assn.org/go/cpt" ];
fhir:Coding.code [ fhir:value "36430" ] ]
];
fhir:Procedure.subject [
fhir:Reference.reference [ fhir:value "Patient/BESTPatient" ]
];
fhir:Procedure.performedDateTime [ fhir:value "2002-01-09"^^xsd:date];
fhir:Procedure.usedReference [
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-usedproduct" ];
fhir:Extension.valueReference [
fhir:Reference.reference [ fhir:value "BiologicallyDerivedProduct/FAERSBloodProduct" ] ] ];
fhir:Reference.display [ fhir:value "Apheresis PLATELETS|ACD-A>PAS-C/XX/20-24C|ResLeu:<5E6|2nd container" ]
].
<BiologicallyDerivedProduct/FAERSBloodProduct> a fhir:BiologicallyDerivedProduct;
fhir:Resource.id [ fhir:value "FAERSBloodProduct"];
fhir:Resource.meta [
fhir:Meta.profile [
fhir:value "http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/ibm-fda-icsr-bloodproduct";
fhir:index 0;
fhir:link <http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/ibm-fda-icsr-bloodproduct> ]
];
fhir:DomainResource.text [
fhir:Narrative.status [ fhir:value "generated" ];
fhir:Narrative.div "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative</b></p><p><b>productCategory</b>: cells</p><p><b>productCode</b>: <span title=\"Codes: {https://iccbba.org/standardterminology E7003}\">Apheresis PLATELETS|ACD-A>PAS-C/XX/20-24C|ResLeu:<5E6|2nd container</span></p><h3>Collections</h3><table class=\"grid\"><tr><td>-</td><td><b>Extension</b></td></tr><tr><td>*</td><td></td></tr></table></div>"
];
fhir:BiologicallyDerivedProduct.productCategory [ fhir:value "cells"];
fhir:BiologicallyDerivedProduct.productCode [
fhir:CodeableConcept.coding [
fhir:index 0;
fhir:Coding.system [ fhir:value "https://iccbba.org/standardterminology" ];
fhir:Coding.code [ fhir:value "E7003" ];
fhir:Coding.display [ fhir:value "Apheresis PLATELETS|ACD-A>PAS-C/XX/20-24C|ResLeu:<5E6|2nd container" ] ]
];
fhir:BiologicallyDerivedProduct.collection [
fhir:Element.extension [
fhir:index 0;
fhir:Extension.url [ fhir:value "http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/ibm-fda-icsr-ext-donationIdentificationNumber" ];
fhir:Extension.valueIdentifier [
fhir:Identifier.system [ fhir:value "http://example.org/bloodDonationNumber" ];
fhir:Identifier.value [ fhir:value "G101610840386" ] ] ]
].
<MedicationAdministration/FAERSEpinephrine> a fhir:MedicationAdministration;
fhir:Resource.id [ fhir:value "FAERSEpinephrine"];
fhir:Resource.meta [
fhir:Meta.profile [
fhir:value "http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/ibm-fda-icsr-medicationadministration";
fhir:index 0;
fhir:link <http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/ibm-fda-icsr-medicationadministration> ]
];
fhir:DomainResource.text [
fhir:Narrative.status [ fhir:value "generated" ];
fhir:Narrative.div "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative</b></p><p><b>status</b>: completed</p><p><b>medication</b>: <span title=\"Codes: {http://www.nlm.nih.gov/research/umls/rxnorm 3992}\">Epinephrine</span></p><p><b>subject</b>: <a href=\"#Patient_BESTPatient\">See above (Patient/BESTPatient)</a></p><p><b>effective</b>: 2002-01-09</p></div>"
];
fhir:MedicationAdministration.status [ fhir:value "completed"];
fhir:MedicationAdministration.medicationCodeableConcept [
fhir:CodeableConcept.coding [
fhir:index 0;
fhir:Coding.system [ fhir:value "http://www.nlm.nih.gov/research/umls/rxnorm" ];
fhir:Coding.code [ fhir:value "3992" ];
fhir:Coding.display [ fhir:value "Epinephrine" ] ]
];
fhir:MedicationAdministration.subject [
fhir:Reference.reference [ fhir:value "Patient/BESTPatient" ]
];
fhir:MedicationAdministration.effectiveDateTime [ fhir:value "2002-01-09"^^xsd:date].
<MedicationAdministration/FAERSDiphenhydramine> a fhir:MedicationAdministration;
fhir:Resource.id [ fhir:value "FAERSDiphenhydramine"];
fhir:Resource.meta [
fhir:Meta.profile [
fhir:value "http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/ibm-fda-icsr-medicationadministration";
fhir:index 0;
fhir:link <http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/ibm-fda-icsr-medicationadministration> ]
];
fhir:DomainResource.text [
fhir:Narrative.status [ fhir:value "generated" ];
fhir:Narrative.div "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative</b></p><p><b>status</b>: completed</p><p><b>medication</b>: <span title=\"Codes: {http://www.nlm.nih.gov/research/umls/rxnorm 3498}\">Diphenhydramine</span></p><p><b>subject</b>: <a href=\"#Patient_BESTPatient\">See above (Patient/BESTPatient)</a></p><p><b>effective</b>: 2002-01-09</p></div>"
];
fhir:MedicationAdministration.status [ fhir:value "completed"];
fhir:MedicationAdministration.medicationCodeableConcept [
fhir:CodeableConcept.coding [
fhir:index 0;
fhir:Coding.system [ fhir:value "http://www.nlm.nih.gov/research/umls/rxnorm" ];
fhir:Coding.code [ fhir:value "3498" ];
fhir:Coding.display [ fhir:value "Diphenhydramine" ] ]
];
fhir:MedicationAdministration.subject [
fhir:Reference.reference [ fhir:value "Patient/BESTPatient" ]
];
fhir:MedicationAdministration.effectiveDateTime [ fhir:value "2002-01-09"^^xsd:date].
# - 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
Links: Table of Contents |
QA Report
| Version History |
Search |
|
Propose a change