HL7 FHIR Implementation Guide: Profiles for Transfusion and Vaccination Adverse Event Detection and Reporting
1.0.1 - STU 1 Technical Correction United States of America flag

HL7 FHIR Implementation Guide: Profiles for Transfusion and Vaccination Adverse Event Detection and Reporting, published by Biomedical Research & Regulation WG. This is not an authorized publication; it is the continuous build for version 1.0.1). This version is based on the current content of https://github.com/HL7/fhir-icsr-ae-reporting/ and changes regularly. See the Directory of published versions

Example Bundle: Minimum Transfusion Case Report Bundle

Bundle MinimumTransfusionReportBundle of type message

Entry 1 - fullUrl = Bundle/SampleTransfusionMessageHeader

Resource MessageHeader:

Generated Narrative: MessageHeader

Resource MessageHeader "US-IBM-Transfusion-fad94c04-29e7-5b37-e535-a8aad123cf9a"

Profile: ICSR MessageHeader

Message Processing Category: notification

event: Patient Adverse Event (Details: http://terminology.hl7.org/CodeSystem/v3-ActCode code PAT_ADV_EVNT = 'patient adverse event', stated as 'Patient Adverse Event')

Destinations

-EndpointReceiver
*http://example.org/CBERTransfusionOrganization/ReceiverOrganization "FDA"

sender: Organization/SenderOrganization "sender organization"

Sources

-Endpoint
*http://example.org/SENDER-IDENTIFIER

reason: Indicates receipt of a public health report (US Public Health TriggerDefinition Named Events#received-public-health-report)

focus: See above (Composition/SampleTransfusionReport)

Entry 2 - fullUrl = Composition/SampleTransfusionReport

Resource Composition:

Generated Narrative: Composition

Resource Composition "SampleTransfusionReport"

Profile: ICSR Composition

AdditionalDocumentInformation

url

availableFlag

value: false

ExpeditedReport

url

localCriteriaFlag

value: false

url

localCriteriaReportType

value: Non-Expedited AE (unknown#C53578)

FirstSenderType: Other (unknown#2)

CombinationProductReport: false

FirstReceiveDate: 2020-02-10 17:18:00-0500

MostRecentDate: 2020-02-10 17:18:00-0500

CaseIdentifier: id: US-IBM-aed059ac-ef25-6ded-cce2-a8912d6b76ee

PreviousCaseIdentifier: id: Other-case-identifier

ReportAmendment

url

amendmentType

value: 2 (unknown#2)

url

amendmentReason

value: Fixed some identifiers

identifier: id: US-IBM-94209fd1-9b0e-1adc-007a-4f5cecb8ce6a

status: FINAL

type: Adverse event note (LOINC#85893-6)

category: Spontaneous report (unknown#1)

date: 2020-02-10 17:18:00-0500

author: PractitionerRole/SampleAuthorRole

title: ICSR Submission