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

Profile Descriptions

FHIR ICSR Profiles

This IG specifies two overlapping sets of profiles for formatting an ICSR submission using FHIR resources. The first set is for a Vaccination Adverse Event case report that represents an ICSR R3 report as a Bundle of MessageHeaders pointing to a Composition. The other set is for a Transfusion Adverse Event case report that represents an ICSR R2 report as just a MessageHeader pointing to a Composition. Lastly, there is a set of common profiles applicable to both domains.

Vaccination Adverse Event Profiles

• Vaccination Adverse Event - the Adverse Event profile with a binding to Vaccination-related event codes
• Immunization

Transfusion Adverse Event Profiles

• Transfusion Adverse Event - the Adverse Event profile with a binding to Transfusion-related event codes
• Transfusion - the specific fields needed to represent a transfusion procedure
• Blood Product - information about the blood product that was used in a transfusion

For transfusions, we have three value sets to represent the specific transfusion and the specific blood product:

• Transfusion Procedure Codes
• Blood Product ISBT Codes
• Convalescent Plasma ISBT Codes

Common Profiles

• Case Report Bundle - representing a minimum set of constraints on a case report submission - a MessageHeader and a Composition
• Case Report MessageHeader - constraints on MessageHeader to allow for sending of case report sender and receiver information
• Composition - the header of an case report
• Case Report Author
  • Practitioner
  • PractitionerRole
  • RelatedPerson
• Patient
  • Patient Age Group Observation
  • Patient Height (in cm) Observation
  • Patient Weight (in kg) Observation
  • Patient Last Menstrual Period Start Date Observation
• Report Submission Organization - represents organizations that are senders/receivers of an ICSR report
• Adverse Event - the common fields needed to represent an Adverse Event
• Medication Administration - the specific fields needed to provide the required detail to report a medication administration
• Algorithm Count Observations
  • Adverse Event Count Observation - conveys the number of adverse events detected by the algorithm
  • Exposure Count Observation - conveys the number of exposures detected by the algorithm

Mapping Seriousness to FHIR Adverse Event

In the ICSR submissions, seriousness is represented by a set of boolean flags for a number of seriousness concepts as well as a free text for indicating Other. In the FHIR Adverse Event resource, there is a single coded field that represents the seriousness of the adverse event. For purposes of mapping the ICSR Seriousness, an extension has been added to the AdverseEvent.seriousness field that allows for each of the concepts that would be set to True in the ICSR report to be sent in the extension. The AdverseEvent.seriousness field is then restricted to simply stating whether the Adverse Event was serious or non-serious. If we need to say that the Adverse Event was ‘life threatening’ and ‘caused hospitalization’, we would send ‘Serious’ in the AdverseEvent.seriousness field and send two repetitions of the extension with the appropriate codes.

Hospitalization Codes

In the FDA Transfusion case report specification, there is one field that represents ‘Caused or Prolonged Hospitalization’. This is represented using the NCIT code of ‘33 - requires Inpatient Hospitalization’. For FDA vaccination case report, the same code is used, but there are also two extra fields to differentiate between ‘Hospitalization Required’ (C50414) and ‘Prolongation of Hospitalization’ (C102450). In the Vaccination case report, one would send the generic Hospitalization code as well as the more specific one. Although this could be done in one instance of a CodeableConcept, this guide requires that two instances be sent - one with the generic code and one with the specific code.

Additional Notes

The FHIR profiles conform to the HL7 FHIR US Core Implementation Guide where applicable and is subject to change with subsequent releases. See Relationship to US-Core for more information.

Must Support Requirements

All of the Profiles include elements that are marked as ‘Must Support’. For the purposes of this guide, Must Support is intended to represent those fields that will be present in the ICSR submission, if applicable to the specific submission instance. When sending information to the PLR server, client applications SHOULD be able to send any fields marked as Must Support, with the additional expectation that they SHALL send any fields that they collect if they are applicable to the specific submission.

Cross-Version Analysis

This is an R4 IG. None of the features it uses are changed in R4B, so it can be used as is with R4B systems. Packages for both R4 (hl7.fhir.us.icsr-ae-reporting.r4) and R4B (hl7.fhir.us.icsr-ae-reporting.r4b) are available.

Intellectual Property Statements

This publication includes IP covered under the following statements.

• ISO Maintains the copyright on the country codes, and controls it's use carefully. For futher details see the ISO 3166 web page: https://www.iso.org/iso-3166-country-codes.html
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  • ISO 3166-1 Codes for the representation of names of countries and their subdivisions — Part 1: Country code: AECountObservation, AdditionalDocumentInformation... Show 56 more, AgeAtTimeOfOnset, AgeAtVaccination, AuthorPractitioner, AuthorPractitionerRole, AuthorPrimarySource, AuthorRelatedPerson, COVID19VaccineCodeVS, CaseIdentifier, CombinationProductReport, DataSourceObservationCodeCS, DepartmentName, DonationIdentificationNumber, EventDuration, EventEndDate, EventSeriousness, ExpeditedReport, ExposureCountObservation, FirstReceiveDate, FirstSenderType, ICSRAESeriousness, ICSRAdverseEvent, ICSRBloodProduct, ICSRBundle, ICSRComposition, ICSRConvalescentPlasma, ICSRImmunization, ICSRMedicationAdministration, ICSRMessageHeader, ICSRPatient, ICSRSectionCodeCS, ICSRSectionCodeVS, ICSRSeriousness, ICSRTransfusion, ISBTBloodProductCodeVS, ISBTConvalescentPlasmaCodeVS, InfluenzaVaccineCodeVS, MedDRATransfusionAdverseEventVS, MedDRAVaccinationAdverseEventVS, MessageOrganization, MilitaryStatus, MostRecentDate, PatientAgeGroup, PatientAgeGroupVS, PatientHeight, PatientLastMenstrualPeriod, PatientMilitaryStatus, PatientWeight, PreviousCaseIdentifier, ReportAmendment, TransfusionAdverseEvent, TransfusionProcedureCodeVS, TransfusionVaccinationAdverseEventDetectionReporting, UsedProduct, UsedProductAmount, VaccinationAdverseEvent and VaccineCodeVS
• The UCUM codes, UCUM table (regardless of format), and UCUM Specification are copyright 1999-2009, Regenstrief Institute, Inc. and the Unified Codes for Units of Measures (UCUM) Organization. All rights reserved. https://ucum.org/trac/wiki/TermsOfUse
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  • Unified Code for Units of Measure (UCUM): Bundle/ConnectathonTransfusionBundle, Observation/SamplePatientHeight, Observation/SamplePatientWeight and Procedure/TransfusionExampleTransfusion
• This material contains content from LOINC. LOINC is copyright © 1995-2020, Regenstrief Institute, Inc. and the Logical Observation Identifiers Names and Codes (LOINC) Committee and is available at no cost under the license. LOINC® is a registered United States trademark of Regenstrief Institute, Inc.
  Show Usage
  • LOINC: Bundle/ConnectathonTransfusionBundle, Bundle/ConnectathonVaccinationBundle... Show 15 more, Bundle/MinimumTransfusionReportBundle, Bundle/MinimumVaccinationReportBundle, Composition/SampleTransfusionReport, Composition/SampleVaccinationReport, Composition/TransfusionExample, Composition/VaccinationExample, ICSRComposition, Observation/BESTPatientAgeGroup, Observation/SamplePatientHeight, Observation/SamplePatientLastMenstrualPeriod, Observation/SamplePatientWeight, PatientAgeGroup, PatientHeight, PatientLastMenstrualPeriod and PatientWeight
• Using RxNorm codes of type SAB=RXNORM as this specification describes does not require a UMLS license. Access to the full set of RxNorm definitions, and/or additional use of other RxNorm structures and information requires a UMLS license. The use of RxNorm in this specification is pursuant to HL7's status as a licensee of the NLM UMLS. HL7's license does not convey the right to use RxNorm to any users of this specification; implementers must acquire a license to use RxNorm in their own right.
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  • RxNorm: Bundle/ConnectathonTransfusionBundle, Bundle/ConnectathonVaccinationBundle, MedicationAdministration/TransfusionDiphenhydramine, MedicationAdministration/TransfusionEpinephrine and MedicationAdministration/VaccinationHydrocortisoneAdministration

Global Profiles

There are no Global profiles defined

IG Dependencies

This IG Contains the following dependencies on other IGs.

Package hl7.fhir.uv.extensions.r4#1.0.0 This IG defines the global extensions - the ones defined for everyone. These extensions are always in scope wherever FHIR is being used (built Sun, Mar 26, 2023 08:46+1100+11:00)

Package hl7.fhir.uv.bulkdata#1.0.1

Package us.nlm.vsac#0.3.0

Package hl7.fhir.us.core#4.0.0 The US Core Implementation Guide is based on FHIR Version R4 and defines the minimum conformance requirements for accessing patient data. The Argonaut pilot implementations, ONC 2015 Edition Common Clinical Data Set (CCDS), and ONC U.S. Core Data for Interoperability (USCDI) v1 provided the requirements for this guide. The prior Argonaut search and vocabulary requirements, based on FHIR DSTU2, are updated in this guide to support FHIR Version R4. This guide was used as the basis for further testing and guidance by the Argonaut Project Team to provide additional content and guidance specific to Data Query Access for purpose of ONC Certification testing. These profiles are the foundation for future US Realm FHIR implementation guides. In addition to Argonaut, they are used by DAF-Research, QI-Core, and CIMI. Under the guidance of HL7 and the HL7 US Realm Steering Committee, the content will expand in future versions to meet the needs specific to the US Realm. These requirements were originally developed, balloted, and published in FHIR DSTU2 as part of the Office of the National Coordinator for Health Information Technology (ONC) sponsored Data Access Framework (DAF) project. For more information on how DAF became US Core see the US Core change notes. (built Mon, Jun 28, 2021 19:09+0000+00:00)

Package hl7.fhir.us.core#3.1.0

Package hl7.fhir.us.medmorph#0.1.0 MedMorph describes a framework to enable submission of data from healthcare organizations to public health and research organizations. (built Wed, Dec 16, 2020 20:21+0000+00:00)

Package us.nlm.vsac#0.9.0