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 
| Defining URL: | http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/ibm-fda-icsr-transfusion |
| Version: | 0.1.0 |
| Name: | ICSRTransfusion |
| Title: | ICSR Transfusion |
| Status: | Active as of 2021-08-05T14:34:06+00:00 |
| Definition: | The common fields needed to represent a transfusion. |
| Publisher: | Biomedical Research & Regulation WG |
| Source Resource: | XML / JSON / Turtle |
The official URL for this profile is:
http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/ibm-fda-icsr-transfusion
Description of Profiles, Differentials, Snapshots and how the different presentations work.
This structure is derived from USCoreProcedureProfile
This structure is derived from USCoreProcedureProfile
| Name | Flags | Card. | Type | Description & Constraints |
|---|---|---|---|---|
  Procedure | 0..* | USCoreProcedureProfile | An action that is being or was performed on a patient | |
  Slices for extension | 0..* | Extension | Extension Slice: Unordered, Open by value:url | |
 ibm-fda-icsr-ext-usedproductamount | 0..1 | Quantity | Extension URL: http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/ibm-fda-icsr-ext-usedproductamount | |
 code | 1..1 | CodeableConcept | Identification of the procedure Binding: Codes that represent a transfusion procedure Value Set (extensible) | |
 subject | 1..1 | Reference(ICSR Patient) | Who the procedure was performed on | |
| reasonCode | S | 0..* | CodeableConcept | Coded reason procedure performed |
 usedReference | ||||
  ibm-fda-icsr-ext-usedproduct | 0..1 | Reference(ICSR Blood Product | ICSR Convalescent Plasma) | Extension URL: http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/ibm-fda-icsr-ext-usedproduct | |
| Documentation for this format | ||||
| Name | Flags | Card. | Type | Description & Constraints |
|---|---|---|---|---|
| Procedure | 0..* | USCoreProcedureProfile | An action that is being or was performed on a patient | |
 id | Σ | 0..1 | string | Logical id of this artifact |
 meta | Σ | 0..1 | Meta | Metadata about the resource |
| implicitRules | ?!Σ | 0..1 | uri | A set of rules under which this content was created |
| language | 0..1 | code | Language of the resource content Binding: CommonLanguages (preferred) Max Binding: AllLanguages: A human language. | |
| text | 0..1 | Narrative | Text summary of the resource, for human interpretation | |
| contained | 0..* | Resource | Contained, inline Resources | |
| Slices for extension | 0..* | Extension | Extension Slice: Unordered, Open by value:url | |
| ibm-fda-icsr-ext-usedproductamount | 0..1 | Quantity | Extension URL: http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/ibm-fda-icsr-ext-usedproductamount | |
 modifierExtension | ?! | 0..* | Extension | Extensions that cannot be ignored |
| identifier | Σ | 0..* | Identifier | External Identifiers for this procedure |
| instantiatesCanonical | Σ | 0..* | canonical(PlanDefinition | ActivityDefinition | Measure | OperationDefinition | Questionnaire) | Instantiates FHIR protocol or definition |
| instantiatesUri | Σ | 0..* | uri | Instantiates external protocol or definition |
| basedOn | Σ | 0..* | Reference(CarePlan | ServiceRequest) | A request for this procedure |
| partOf | Σ | 0..* | Reference(Procedure | Observation | MedicationAdministration) | Part of referenced event |
| status | ?!SΣ | 1..1 | code | preparation | in-progress | not-done | on-hold | stopped | completed | entered-in-error | unknown Binding: EventStatus (required) |
| statusReason | Σ | 0..1 | CodeableConcept | Reason for current status Binding: ProcedureNotPerformedReason(SNOMED-CT) (example): A code that identifies the reason a procedure was not performed. |
| category | Σ | 0..1 | CodeableConcept | Classification of the procedure Binding: ProcedureCategoryCodes(SNOMEDCT) (example): A code that classifies a procedure for searching, sorting and display purposes. |
| code | SΣ | 1..1 | CodeableConcept | Identification of the procedure Binding: Codes that represent a transfusion procedure Value Set (extensible) |
| subject | SΣ | 1..1 | Reference(ICSR Patient) | Who the procedure was performed on |
| encounter | Σ | 0..1 | Reference(Encounter) | Encounter created as part of |
  performed[x] | SΣ | 1..1 | When the procedure was performed | |
 performedDateTime | dateTime S | |||
| performedPeriod | Period | |||
| performedString | string | |||
| performedAge | Age | |||
| performedRange | Range | |||
| recorder | Σ | 0..1 | Reference(Patient | RelatedPerson | Practitioner | PractitionerRole) | Who recorded the procedure |
| asserter | Σ | 0..1 | Reference(Patient | RelatedPerson | Practitioner | PractitionerRole) | Person who asserts this procedure |
| performer | Σ | 0..* | BackboneElement | The people who performed the procedure |
| id | 0..1 | string | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| function | Σ | 0..1 | CodeableConcept | Type of performance Binding: ProcedurePerformerRoleCodes (example): A code that identifies the role of a performer of the procedure. |
| actor | Σ | 1..1 | Reference(Practitioner | PractitionerRole | Organization | Patient | RelatedPerson | Device) | The reference to the practitioner |
| onBehalfOf | 0..1 | Reference(Organization) | Organization the device or practitioner was acting for | |
| location | Σ | 0..1 | Reference(Location) | Where the procedure happened |
| reasonCode | SΣ | 0..* | CodeableConcept | Coded reason procedure performed Binding: ProcedureReasonCodes (example): A code that identifies the reason a procedure is required. |
| reasonReference | Σ | 0..* | Reference(Condition | Observation | Procedure | DiagnosticReport | DocumentReference) | The justification that the procedure was performed |
| bodySite | Σ | 0..* | CodeableConcept | Target body sites Binding: SNOMEDCTBodyStructures (example): Codes describing anatomical locations. May include laterality. |
| outcome | Σ | 0..1 | CodeableConcept | The result of procedure Binding: ProcedureOutcomeCodes(SNOMEDCT) (example): An outcome of a procedure - whether it was resolved or otherwise. |
| report | 0..* | Reference(DiagnosticReport | DocumentReference | Composition) | Any report resulting from the procedure | |
| complication | 0..* | CodeableConcept | Complication following the procedure Binding: Condition/Problem/DiagnosisCodes (example): Codes describing complications that resulted from a procedure. | |
| complicationDetail | 0..* | Reference(Condition) | A condition that is a result of the procedure | |
| followUp | 0..* | CodeableConcept | Instructions for follow up Binding: ProcedureFollowUpCodes(SNOMEDCT) (example): Specific follow up required for a procedure e.g. removal of sutures. | |
| note | 0..* | Annotation | Additional information about the procedure | |
| focalDevice | 0..* | BackboneElement | Manipulated, implanted, or removed device | |
| id | 0..1 | string | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| action | 0..1 | CodeableConcept | Kind of change to device Binding: ProcedureDeviceActionCodes (preferred): A kind of change that happened to the device during the procedure. | |
| manipulated | 1..1 | Reference(Device) | Device that was changed | |
| usedReference | 0..* | Reference(Device | Medication | Substance) | Items used during procedure | |
| id | 0..1 | string | Unique id for inter-element referencing | |
| Slices for extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |
| ibm-fda-icsr-ext-usedproduct | 0..1 | Reference(ICSR Blood Product | ICSR Convalescent Plasma) | Extension URL: http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/ibm-fda-icsr-ext-usedproduct | |
| reference | ΣI | 0..1 | string | Literal reference, Relative, internal or absolute URL |
| type | Σ | 0..1 | uri | Type the reference refers to (e.g. "Patient") Binding: ResourceType (extensible): Aa resource (or, for logical models, the URI of the logical model). |
| identifier | Σ | 0..1 | Identifier | Logical reference, when literal reference is not known |
| display | Σ | 0..1 | string | Text alternative for the resource |
| usedCode | 0..* | CodeableConcept | Coded items used during the procedure Binding: FHIRDeviceTypes (example): Codes describing items used during a procedure. | |
| Documentation for this format | ||||
| Name | Flags | Card. | Type | Description & Constraints |
|---|---|---|---|---|
| Procedure | 0..* | USCoreProcedureProfile | An action that is being or was performed on a patient | |
| status | ?!Σ | 1..1 | code | preparation | in-progress | not-done | on-hold | stopped | completed | entered-in-error | unknown Binding: EventStatus (required) |
| code | Σ | 1..1 | CodeableConcept | Identification of the procedure Binding: Codes that represent a transfusion procedure Value Set (extensible) |
| subject | Σ | 1..1 | Reference(ICSR Patient) | Who the procedure was performed on |
| performed[x] | Σ | 1..1 | When the procedure was performed | |
| performedDateTime | dateTime | |||
| reasonCode | Σ | 0..* | CodeableConcept | Coded reason procedure performed Binding: ProcedureReasonCodes (example): A code that identifies the reason a procedure is required. |
| Documentation for this format | ||||
This structure is derived from USCoreProcedureProfile
Differential View
This structure is derived from USCoreProcedureProfile
| Name | Flags | Card. | Type | Description & Constraints |
|---|---|---|---|---|
| Procedure | 0..* | USCoreProcedureProfile | An action that is being or was performed on a patient | |
| Slices for extension | 0..* | Extension | Extension Slice: Unordered, Open by value:url | |
| ibm-fda-icsr-ext-usedproductamount | 0..1 | Quantity | Extension URL: http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/ibm-fda-icsr-ext-usedproductamount | |
| code | 1..1 | CodeableConcept | Identification of the procedure Binding: Codes that represent a transfusion procedure Value Set (extensible) | |
| subject | 1..1 | Reference(ICSR Patient) | Who the procedure was performed on | |
| reasonCode | S | 0..* | CodeableConcept | Coded reason procedure performed |
| usedReference | ||||
| ibm-fda-icsr-ext-usedproduct | 0..1 | Reference(ICSR Blood Product | ICSR Convalescent Plasma) | Extension URL: http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/ibm-fda-icsr-ext-usedproduct | |
| Documentation for this format | ||||
Snapshot View
| Name | Flags | Card. | Type | Description & Constraints |
|---|---|---|---|---|
| Procedure | 0..* | USCoreProcedureProfile | An action that is being or was performed on a patient | |
| id | Σ | 0..1 | string | Logical id of this artifact |
| meta | Σ | 0..1 | Meta | Metadata about the resource |
| implicitRules | ?!Σ | 0..1 | uri | A set of rules under which this content was created |
| language | 0..1 | code | Language of the resource content Binding: CommonLanguages (preferred) Max Binding: AllLanguages: A human language. | |
| text | 0..1 | Narrative | Text summary of the resource, for human interpretation | |
| contained | 0..* | Resource | Contained, inline Resources | |
| Slices for extension | 0..* | Extension | Extension Slice: Unordered, Open by value:url | |
| ibm-fda-icsr-ext-usedproductamount | 0..1 | Quantity | Extension URL: http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/ibm-fda-icsr-ext-usedproductamount | |
| modifierExtension | ?! | 0..* | Extension | Extensions that cannot be ignored |
| identifier | Σ | 0..* | Identifier | External Identifiers for this procedure |
| instantiatesCanonical | Σ | 0..* | canonical(PlanDefinition | ActivityDefinition | Measure | OperationDefinition | Questionnaire) | Instantiates FHIR protocol or definition |
| instantiatesUri | Σ | 0..* | uri | Instantiates external protocol or definition |
| basedOn | Σ | 0..* | Reference(CarePlan | ServiceRequest) | A request for this procedure |
| partOf | Σ | 0..* | Reference(Procedure | Observation | MedicationAdministration) | Part of referenced event |
| status | ?!SΣ | 1..1 | code | preparation | in-progress | not-done | on-hold | stopped | completed | entered-in-error | unknown Binding: EventStatus (required) |
| statusReason | Σ | 0..1 | CodeableConcept | Reason for current status Binding: ProcedureNotPerformedReason(SNOMED-CT) (example): A code that identifies the reason a procedure was not performed. |
| category | Σ | 0..1 | CodeableConcept | Classification of the procedure Binding: ProcedureCategoryCodes(SNOMEDCT) (example): A code that classifies a procedure for searching, sorting and display purposes. |
| code | SΣ | 1..1 | CodeableConcept | Identification of the procedure Binding: Codes that represent a transfusion procedure Value Set (extensible) |
| subject | SΣ | 1..1 | Reference(ICSR Patient) | Who the procedure was performed on |
| encounter | Σ | 0..1 | Reference(Encounter) | Encounter created as part of |
| performed[x] | SΣ | 1..1 | When the procedure was performed | |
| performedDateTime | dateTime S | |||
| performedPeriod | Period | |||
| performedString | string | |||
| performedAge | Age | |||
| performedRange | Range | |||
| recorder | Σ | 0..1 | Reference(Patient | RelatedPerson | Practitioner | PractitionerRole) | Who recorded the procedure |
| asserter | Σ | 0..1 | Reference(Patient | RelatedPerson | Practitioner | PractitionerRole) | Person who asserts this procedure |
| performer | Σ | 0..* | BackboneElement | The people who performed the procedure |
| id | 0..1 | string | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| function | Σ | 0..1 | CodeableConcept | Type of performance Binding: ProcedurePerformerRoleCodes (example): A code that identifies the role of a performer of the procedure. |
| actor | Σ | 1..1 | Reference(Practitioner | PractitionerRole | Organization | Patient | RelatedPerson | Device) | The reference to the practitioner |
| onBehalfOf | 0..1 | Reference(Organization) | Organization the device or practitioner was acting for | |
| location | Σ | 0..1 | Reference(Location) | Where the procedure happened |
| reasonCode | SΣ | 0..* | CodeableConcept | Coded reason procedure performed Binding: ProcedureReasonCodes (example): A code that identifies the reason a procedure is required. |
| reasonReference | Σ | 0..* | Reference(Condition | Observation | Procedure | DiagnosticReport | DocumentReference) | The justification that the procedure was performed |
| bodySite | Σ | 0..* | CodeableConcept | Target body sites Binding: SNOMEDCTBodyStructures (example): Codes describing anatomical locations. May include laterality. |
| outcome | Σ | 0..1 | CodeableConcept | The result of procedure Binding: ProcedureOutcomeCodes(SNOMEDCT) (example): An outcome of a procedure - whether it was resolved or otherwise. |
| report | 0..* | Reference(DiagnosticReport | DocumentReference | Composition) | Any report resulting from the procedure | |
| complication | 0..* | CodeableConcept | Complication following the procedure Binding: Condition/Problem/DiagnosisCodes (example): Codes describing complications that resulted from a procedure. | |
| complicationDetail | 0..* | Reference(Condition) | A condition that is a result of the procedure | |
| followUp | 0..* | CodeableConcept | Instructions for follow up Binding: ProcedureFollowUpCodes(SNOMEDCT) (example): Specific follow up required for a procedure e.g. removal of sutures. | |
| note | 0..* | Annotation | Additional information about the procedure | |
| focalDevice | 0..* | BackboneElement | Manipulated, implanted, or removed device | |
| id | 0..1 | string | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| action | 0..1 | CodeableConcept | Kind of change to device Binding: ProcedureDeviceActionCodes (preferred): A kind of change that happened to the device during the procedure. | |
| manipulated | 1..1 | Reference(Device) | Device that was changed | |
| usedReference | 0..* | Reference(Device | Medication | Substance) | Items used during procedure | |
| id | 0..1 | string | Unique id for inter-element referencing | |
| Slices for extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |
| ibm-fda-icsr-ext-usedproduct | 0..1 | Reference(ICSR Blood Product | ICSR Convalescent Plasma) | Extension URL: http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/ibm-fda-icsr-ext-usedproduct | |
| reference | ΣI | 0..1 | string | Literal reference, Relative, internal or absolute URL |
| type | Σ | 0..1 | uri | Type the reference refers to (e.g. "Patient") Binding: ResourceType (extensible): Aa resource (or, for logical models, the URI of the logical model). |
| identifier | Σ | 0..1 | Identifier | Logical reference, when literal reference is not known |
| display | Σ | 0..1 | string | Text alternative for the resource |
| usedCode | 0..* | CodeableConcept | Coded items used during the procedure Binding: FHIRDeviceTypes (example): Codes describing items used during a procedure. | |
| Documentation for this format | ||||
Other representations of profile: CSV, Excel, Schematron
| Path | Conformance | ValueSet |
| Procedure.language | preferred | CommonLanguages Max Binding: AllLanguages |
| Procedure.status | required | EventStatus |
| Procedure.statusReason | example | ProcedureNotPerformedReason(SNOMED-CT) |
| Procedure.category | example | ProcedureCategoryCodes(SNOMEDCT) |
| Procedure.code | extensible | TransfusionProcedureCodeVS |
| Procedure.performer.function | example | ProcedurePerformerRoleCodes |
| Procedure.reasonCode | example | ProcedureReasonCodes |
| Procedure.bodySite | example | SNOMEDCTBodyStructures |
| Procedure.outcome | example | ProcedureOutcomeCodes(SNOMEDCT) |
| Procedure.complication | example | Condition/Problem/DiagnosisCodes |
| Procedure.followUp | example | ProcedureFollowUpCodes(SNOMEDCT) |
| Procedure.focalDevice.action | preferred | ProcedureDeviceActionCodes |
| Procedure.usedReference.type | extensible | ResourceType |
| Procedure.usedCode | example | FHIRDeviceTypes |
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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