HL7 FHIR Implementation Guide: Profiles for Transfusion and Vaccination Adverse Event Detection and Reporting
1.0.1 - STU 1 Technical Correction
HL7 FHIR Implementation Guide: Profiles for Transfusion and Vaccination Adverse Event Detection and Reporting
1.0.1 - STU 1 Technical Correction
This page is part of the Profiles for ICSR Transfusion and Vaccination Adverse Event Detection and Reporting (v1.0.1: STU 1 Update) based on FHIR R4. This is the current published version. For a full list of available versions, see the Directory of published versions 
Contents:
This page provides a list of the FHIR artifacts defined as part of this implementation guide.
These are profiles on resources or data types that describe patterns used by other profiles, but cannot be instantiated directly. I.e. instances can conform to profiles based on these abstract profiles, but do not declare conformance to the abstract profiles themselves.
| ICSR Adverse Event |
The fields needed to submit an AdverseEvent for a ICSR Report. |
These define constraints on FHIR resources for systems conforming to this implementation guide.
| AECountObservation |
Recording the number of Adverse Events that were detected by the algorithm |
| Descriptive Age Group for the Patient |
A descriptive Age Group for the Patient |
| ExposureCountObservation |
Recording the number of Exposures that were detected by the algorithm |
| ICSR Blood Product |
The common fields needed to represent a blood product used in a transfusion. |
| ICSR Bundle |
The fields needed to create a Bundle for an ICSR Report. |
| ICSR Composition |
The fields needed to represent the document metadata of a ICSR Report. |
| ICSR Convalescent Plasma |
The common fields needed to represent convalescent plasma used in a transfusion. |
| ICSR Immunization |
The fields needed to submit an Immunization for a ICSR Report. |
| ICSR MedicationAdministration |
The common fields needed for either a transfusion or vaccination drug administration. |
| ICSR MessageHeader |
The fields needed to create a MessageHeader for an ICSR Report. |
| ICSR Patient |
The fields required to identify a patient for an ICSR Report. |
| ICSR Transfusion |
The common fields needed to represent a transfusion. |
| MessageHeader Organization |
The fields needed to specify the sender or receiver of an ICSR Report. |
| Patient Body Height in cm |
Patient Body Height in cm |
| Patient Body Weight in kg |
Patient Body Weight in kg |
| Patient's Date of Last Menstrual Period |
Patient’s Date of Last Menstrual Period |
| Practitioner Author |
Extra constraints on US Core Practitioner for the reporter of an ICSR Report. |
| PractitionerRole Author |
The fields needed to specify the reporter of an ICSR Report. |
| RelatedPerson Author |
The fields needed to specify the reporter of an ICSR report who is a related person to the patient. |
| Transfusion Adverse Event |
ICSR Adverse Event with a value set of transfusion-related events |
| Vaccination Adverse Event |
ICSR Adverse Event with a value set of vaccination-related events |
These define constraints on FHIR data types for systems conforming to this implementation guide.
| AdditionalDocumentInformation |
A set of information to indicate what additional documentation exists. |
| AgeAtTimeOfOnset |
The age of the patient when the event occurred. |
| AgeAtVaccination |
The patient’s age when the vaccination was given. |
| AuthorPrimarySource |
Whether an author is the primary source of a composition |
| CaseIdentifier |
Other identifiers used to identify the ICSR report |
| CombinationProductReport |
A flag to indicate whether the ICSR report is for a combination product |
| DepartmentName |
An organization’s department name |
| DonationIdentificationNumber |
Indicates the identifier for a donation |
| EventDuration |
The duration of the adverse event. |
| EventEndDate |
When the event ended. |
| EventSeriousness |
Additional codes that give more detail around the adverse event seriousness. |
| ExpeditedReport |
Information on whether the ICSR report meets criteria of an expedited report |
| FirstReceiveDate |
The date when the report was first received from the source |
| FirstSenderType |
Identifies the type of the first sender of the ICSR report |
| MilitaryStatus |
Information on the military status of the ICSR Patient |
| MostRecentDate |
The date of the most recent information for this report |
| PreviousCaseIdentifier |
Previous identifiers used to reference this case |
| ReportAmendment |
Information about report amendments that have been made |
| UsedProduct |
Include Biologically Derived Product as something that is used in the procedure |
| UsedProductAmount |
Indicates the amount of product (listed in usedReference or usedCode) that was used in the procedure |
These define sets of codes used by systems conforming to this implementation guide.
| COVID-19 Vaccine Codes |
CPT, CVX, NDC, and RxNorm codes for COVID-19 Vaccines |
| Codes that represent a transfusion procedure Value Set |
Codes that represent a transfusion procedure Value Set |
| ICSR Section Codes Value Set |
Codes for each of the sections in an ICSR report |
| ICSR Seriousness Codes |
The set of codes that are used to describe seriousness in ICSR submissions. |
| ICSR Top-Level Seriousness |
Used to indicate whether the event is serious or not. |
| ISBT Blood Product Codes |
All ISBT codes for Plasma, Cryoprecipitate, Granulocytes, Immune Plasma, Leukocytes, T-Cells, Lymphocytes, Platelets, and Red Blood Cells. For access to these codes, please see http://www.iccbba.org/tech-library/iccbba-documents/databases-and-reference-tables/product-description-codes-database2. |
| ISBT Convalescent Plasma Codes |
All ISBT Convalescent Plasma Codes. For access to these codes, please see http://www.iccbba.org/tech-library/iccbba-documents/databases-and-reference-tables/product-description-codes-database2. |
| Influenza Vaccine Codes |
CVX, NDC, and RxNorm codes for Influenza Vaccines |
| Patient Age Group |
Codes that represent a patient’s age group |
| Patient Military Status |
Codes that represent a patient’s military status |
| Transfusion-related Adverse Events |
MedDRA codes that represent the specific transfusion adverse events that are considered by this Implementation Guide |
| Vaccination-related Adverse Events |
MedDRA codes that represent the specific vaccination adverse events that are considered by this Implementation Guide |
| Vaccine Codes |
CVX, NDC, and CPT codes for Vaccines |
These define new code systems used by systems conforming to this implementation guide.
| ICSR Data Source Observation Codes Code System |
Codes to describe information about the ICSR data source |
| ICSR Section Codes Code System |
Codes for each of the sections in an ICSR report |
These are example instances that show what data produced and consumed by systems conforming with this implementation guide might look like.
| BEST Author Role of ICSR reports |
The role of the reporter in an ICSR report |
| BEST Author of ICSR Reports |
The author information for an ICSR report |
| BEST Patient Age Group |
The age group of the BEST Patient. |
| BEST Patient for Transfusion Sample |
A sample Patient for the Transfusion Sample Report. |
| Minimum Transfusion Case Report Bundle |
The Transfusion Case Report Bundle with the minimum set of values. |
| Minimum Vaccination Case Report Bundle |
The Vaccination Case Report Bundle with the minimum set of values. |
| Receiver Organization for FAERS |
How to represent FDA in ICSR FAERS submissions. |
| Sample Adverse Event Count Observation |
An example of an Adverse Event Count Observation |
| Sample Author Role of ICSR Report |
The role of the reporter in an ICSR report |
| Sample Blood Product |
Sample Transfusion Blood Product |
| Sample Convalescent Plasma |
An example of COVID-19 Convalescent Plasma as a blood product |
| Sample Exposure Count Observation |
An example of an Exposure Count Observation |
| Sample ICSR Report Patient |
A sample Patient for an ICSR Report. |
| Sample ICSR Transfusion Report |
A sample Composition that represents Transfusion ICSR header information. |
| Sample ICSR Vaccination Report |
A sample Composition that represents Vaccination ICSR header information. |
| Sample MessageHeader for Transfusion |
A sample MessageHeader for Transfusion ICSR submissions. |
| Sample MessageHeader for Transfusion report for Connecathon |
MessageHeader for Connectathon Transfusion ICSR submission. |
| Sample MessageHeader for Vaccination |
A sample MessageHeader for ICSR Vaccination submissions. |
| Sample MessageHeader for Vaccination report for Connecathon |
MessageHeader for Connectathon Vaccination ICSR submission. |
| Sample Patient Height Observation |
An example of a Patient’s Height in cm |
| Sample Patient Menstrual Period Date Observation |
An example of a Patient’s Last Menstrual Period Date |
| Sample Patient Weight Observation |
An example of a Patient’s Weight in kg |
| Sample Practitioner Author of ICSR Report |
The practitioner who is a reporter in an ICSR report |
| Sample Related Person Author of ICSR Report |
The related person who is a reporter in an ICSR report |
| Sample Sender Organization |
An organization that is sending ICSR submissions. |
| Transfusion BEST Prototype |
The BEST organization that is sending ICSR submissions. |
| Transfusion Bundle for Connectathon Sample |
The Transfusion Bundle for the Connecathon sample. |
| Transfusion Diphenhydramine Administration |
Diphenhydramine Administration for Connectathon Transfusion report. |
| Transfusion Epinephrine Administration |
Epinephrine Administration for Connectathon Transfusion report. |
| Transfusion FDA Organization |
How to represent FDA in ICSR Transfusion submissions. |
| Transfusion Sample Event |
Sample Transfusion Event created for Connectathon. |
| Transfusion Sample ICSR Report |
Connectathon Transfusion Sample Report. |
| Transfusion Suspect Transfusion |
Sample Transfusion Transfusion for Connectathon. |
| Vaccination Author Role of ICSR reports |
The role of the reporter in an ICSR report |
| Vaccination Author of ICSR Reports |
The author information for a Vaccination ICSR report |
| Vaccination Bundle for Connectathon Sample |
The Vaccination Bundle for the Connecathon sample. |
| Vaccination Hydrocortisone Administration |
Hydrocortisone Administration for Connectathon Vaccination report. |
| Vaccination Patient for Transfusion Sample |
A sample Patient for the Vaccination Sample Report. |
| Vaccination Sample Event |
Sample Vaccination Event created for Connectathon. |
| Vaccination Sample ICSR Report |
Connectathon Vaccination Sample Report. |
| Vaccination Sample Immunization for Connectathon Sample |
Sample Immunization information for Vaccination Sample |
| Vaccination Sending Organization |
Connecathon Vaccination Sender |
IG © 2020+ Biomedical Research & Regulation WG. Package hl7.fhir.us.icsr-ae-reporting#1.0.1 based on FHIR 4.0.1. Generated 2023-08-29
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