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 
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 |
| 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. |
| ExposureCountObservation |
Recording the number of Exposures that were detected by the algorithm |
| FAERS Adverse Event |
ICSR Adverse Event with a value set of transfusion-related events |
| FAERS Bundle |
The fields needed to create a Bundle for a FAERS ICSR Report. |
| FAERS MessageHeader |
The fields needed to create a MessageHeader for a FAERS ICSR Report. |
| ICSR Blood Product |
The common fields needed to represent a blood product used in a transfusion. |
| 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 FAERS or VAERS drug administration. |
| 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. |
| Descriptive Age Group for the Patient |
A descriptive Age Group for the Patient |
| Patient Body Height in cm |
Patient Body Height in cm |
| Patient's Date of Last Menstrual Period |
Patient’s Date of Last Menstrual Period |
| Patient Body Weight in kg |
Patient Body Weight in kg |
| VAERS Adverse Event |
ICSR Adverse Event with a value set of vaccination-related events |
| VAERS Bundle |
The fields needed to create a Bundle for a VAERS ICSR Report. |
| VAERS MessageHeader |
The fields needed to create a MessageHeader for a VAERS ICSR Report. |
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. |
| 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
| Anaphylaxis Diagnosis Codes |
Anaphylaxis Diagnosis Codes |
| Appendicitis Diagnosis Codes |
Appendicitis Diagnosis Codes |
| Bell's Palsy Diagnosis Codes |
Bell’s Palsy Diagnosis Codes |
| Covid-19 Preventable Outcome Diagnosis Codes |
Covid-19 Preventable Outcome Diagnosis Codes |
| COVID-19 Vaccine Codes |
CPT, CVX, NDC, and RxNorm codes for COVID-19 Vaccines |
| Disseminated Intravascular Coagulation (DIC) Diagnosis Codes |
Disseminated Intravascular Coagulation (DIC) Diagnosis Codes |
| Deep Vein Thrombosis Diagnosis Codes |
Deep Vein Thrombosis Diagnosis Codes |
| Encephalomyelitis Diagnosis Codes |
Encephalomyelitis Diagnosis Codes |
| Febrile Seizures Diagnosis Codes |
Febrile Seizures Diagnosis Codes |
| Guillain-Barre Syndrome Diagnosis Codes |
Guillain-Barre Syndrome Diagnosis Codes |
| Hemorrhagic Stroke Diagnosis Codes |
Hemorrhagic Stroke Diagnosis Codes |
| 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. |
| 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 Preventable Outcome Diagnosis Codes |
Influenza Preventable Outcome Diagnosis Codes |
| Influenza Vaccine Codes |
CVX, NDC, and RxNorm codes for Influenza Vaccines |
| Kawasaki Disease Diagnosis Codes |
Kawasaki Disease Diagnosis Codes |
| Multisystem Inflammatory Syndrome (MIS) Diagnosis Codes |
Multisystem Inflammatory Syndrome (MIS) Diagnosis Codes |
| Transfusion-related Adverse Events |
Transfusion-related Adverse Events from MedDRA |
| Vaccination-related Adverse Events |
Vaccination-related Adverse Events from MedDRA |
| Acute Myocardial Infarction Diagnosis Codes |
Acute Myocardial Infarction Diagnosis Codes |
| Myocarditis/Pericarditis Diagnosis Codes |
Myocarditis/Pericarditis Diagnosis Codes |
| Narcolepsy Diagnosis Codes |
Narcolepsy Diagnosis Codes |
| Non-hemorrhagic Stroke Diagnosis Codes |
Non-hemorrhagic Stroke Diagnosis Codes |
| Patient Age Group |
Codes that represent a patient’s age group |
| Pulmonary Embolism Diagnosis Codes |
Pulmonary Embolism Diagnosis Codes |
| Immune Thrombocytopenia (ITP) Diagnosis Codes |
Immune Thrombocytopenia (ITP) Diagnosis Codes |
| Codes that represent a transfusion procedure Value Set |
Codes that represent a transfusion procedure Value Set |
| Transverse Myelitis Diagnosis Codes |
Transverse Myelitis Diagnosis Codes |
| 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 of ICSR Reports |
The author information for an ICSR report |
| BEST Author Role of ICSR reports |
The role of the reporter in an ICSR report |
| BEST Patient for FAERS Sample |
A sample Patient for the FAERS Sample Report. |
| BEST Patient Age Group |
The age group of the BEST Patient. |
| FAERS BEST Prototype |
The BEST organization that is sending ICSR submissions. |
| FAERS Bundle for Connectathon Sample |
The FAERS Bundle for the Connecathon sample. |
| VAERS Bundle for Connectathon Sample |
The VAERS Bundle for the Connecathon sample. |
| Sample Blood Product |
Sample FAERS Blood Product |
| FAERS Diphenhydramine Administration |
Diphenhydramine Administration for Connectathon FAERS report. |
| FAERS Epinephrine Administration |
Epinephrine Administration for Connectathon FAERS report. |
| FAERS Sample ICSR Report |
Connectathon FAERS Sample Report. |
| FAERS Sample Event |
Sample FAERS Event created for Connectathon. |
| FAERS Suspect Transfusion |
Sample FAERS Transfusion for Connectathon. |
| FAERS FDA Organization |
How to represent FDA in ICSR FAERS submissions. |
| Minimum FAERS Bundle |
The FAERS Bundle with the minimum set of values. |
| Minimum VAERS Bundle |
The VAERS 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 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 Author Role of ICSR Report |
The role of the reporter in an ICSR report |
| 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 FAERS Report |
A sample Composition that represents FAERS ICSR header information. |
| Sample ICSR Report Patient |
A sample Patient for an ICSR Report. |
| 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 ICSR VAERS Report |
A sample Composition that represents VAERS ICSR header information. |
| Sender Organization for VAERS/FAERS |
An organization that is sending ICSR submissions. |
| Sample MessageHeader for FAERS |
A sample MessageHeader for FAERS ICSR submissions. |
| Sample MessageHeader for VAERS |
A sample MessageHeader for VAERS ICSR submissions. |
| Sample MessageHeader for VAERS report for Connecathon |
MessageHeader for Connectathon VAERS ICSR submission. |
| VAERS Author of ICSR Reports |
The author information for a VAERS ICSR report |
| VAERS Author Role of ICSR reports |
The role of the reporter in an ICSR report |
| VAERS Sample ICSR Report |
Connectathon VAERS Sample Report. |
| VAERS Sample Event |
Sample VAERS Event created for Connectathon. |
| VAERS Sample Immunization for Connectathon Sample |
Sample Immunization information for VAERS Sample |
| VAERS Hydrocortisone Administration |
Hydrocortisone Administration for Connectathon VAERS report. |
| VAERS Patient for FAERS Sample |
A sample Patient for the VAERS Sample Report. |
| VAERS Sending Organization |
Connecathon VAERS Sender |
| Sample MessageHeader for FAERS report for Connecathon |
MessageHeader for Connectathon FAERS ICSR submission. |
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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