HL7 FHIR Implementation Guide: Profiles for Transfusion and Vaccination Adverse Event Detection and Reporting
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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

Resource Profile: ICSRComposition - Detailed Descriptions

Draft as of 2023-08-30

Definitions for the icsr-composition resource profile.

Guidance on how to interpret the contents of this table can be found here

0. Composition
2. Composition.extension
Control4..?
SlicingThis element introduces a set of slices on Composition.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators:
  • value @ url
4. Composition.extension:firstReceiveDate
Slice NamefirstReceiveDate
Control0..1
TypeExtension(FirstReceiveDate) (Extension Type: dateTime)
Must Supporttrue
6. Composition.extension:mostRecentInfoDate
Slice NamemostRecentInfoDate
Control0..1
TypeExtension(MostRecentDate) (Extension Type: dateTime)
Must Supporttrue
8. Composition.extension:additionalDocuments
Slice NameadditionalDocuments
Control1..1
TypeExtension(AdditionalDocumentInformation) (Complex Extension)
Must Supporttrue
10. Composition.extension:expeditedReport
Slice NameexpeditedReport
Control1..1
TypeExtension(ExpeditedReport) (Complex Extension)
Must Supporttrue
12. Composition.extension:otherCaseIdentifier
Slice NameotherCaseIdentifier
Control0..*
TypeExtension(CaseIdentifier) (Extension Type: Identifier)
Must Supporttrue
14. Composition.extension:firstSenderType
Slice NamefirstSenderType
Control1..1
TypeExtension(FirstSenderType) (Extension Type: CodeableConcept)
Must Supporttrue
16. Composition.extension:previousCaseIdentifier
Slice NamepreviousCaseIdentifier
Control0..*
TypeExtension(PreviousCaseIdentifier) (Extension Type: Identifier)
Must Supporttrue
18. Composition.extension:reportAmendment
Slice NamereportAmendment
Control0..1
TypeExtension(ReportAmendment) (Complex Extension)
Must Supporttrue
20. Composition.extension:combinationProductReport
Slice NamecombinationProductReport
Control1..1
TypeExtension(CombinationProductReport) (Extension Type: boolean)
Must Supporttrue
22. Composition.identifier
NoteThis is a business identifier, not a resource identifier (see discussion)
Control1..?
Must Supporttrue
24. Composition.identifier.system
Control1..?
Pattern Valueurn:oid:2.16.840.1.113883.3.989.2.1.3.1
26. Composition.identifier.value
Control1..?
28. Composition.status
Pattern Valuefinal
30. Composition.type
Pattern Value&lt;valueCodeableConcept&nbsp;xmlns=&quot;http://hl7.org/fhir&quot;&gt;<br/>&nbsp;&nbsp;&lt;coding&gt;<br/>&nbsp;&nbsp;&nbsp;&nbsp;&lt;system&nbsp;value=&quot;http://loinc.org&quot;/&gt;<br/>&nbsp;&nbsp;&nbsp;&nbsp;&lt;code&nbsp;value=&quot;85893-6&quot;/&gt;<br/>&nbsp;&nbsp;&nbsp;&nbsp;&lt;display&nbsp;value=&quot;Adverse&nbsp;event&nbsp;note&quot;/&gt;<br/>&nbsp;&nbsp;&lt;/coding&gt;<br/>&lt;/valueCodeableConcept&gt;<br/>
32. Composition.category
Control1..1
Must Supporttrue
34. Composition.subject
Control1..?
TypeReference(ICSR Patient)
Must Supporttrue
36. Composition.date
Must Supporttrue
38. Composition.author
Control0..1
TypeReference(PractitionerRole Author, ICSR Patient, RelatedPerson Author)
Must Supporttrue
Must Support TypesNo must-support rules about the choice of types/profiles
40. Composition.author.extension
Control1..?
42. Composition.author.extension:primarySource
Slice NameprimarySource
Control1..1
TypeExtension(AuthorPrimarySource) (Extension Type: boolean)
Must Supporttrue
44. Composition.title
Pattern ValueICSR Submission
46. Composition.section
Control3..13
Must Supporttrue
SlicingThis element introduces a set of slices on Composition.section. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators:
  • value @ code
48. Composition.section.title
Control1..?
Must Supporttrue
50. Composition.section.code
Control1..?
Must Supporttrue
52. Composition.section.text
Must Supporttrue
54. Composition.section.entry
Must Supporttrue
56. Composition.section:PatientInformation
Slice NamePatientInformation
Control0..1
Must Supporttrue
58. Composition.section:PatientInformation.title
Pattern ValuePatient Information
60. Composition.section:PatientInformation.code
Pattern Value&lt;valueCodeableConcept&nbsp;xmlns=&quot;http://hl7.org/fhir&quot;&gt;<br/>&nbsp;&nbsp;&lt;coding&gt;<br/>&nbsp;&nbsp;&nbsp;&nbsp;&lt;system&nbsp;value=&quot;http://hl7.org/fhir/us/icsr-ae-reporting/CodeSystem/ICSRSectionCodeCS&quot;/&gt;<br/>&nbsp;&nbsp;&nbsp;&nbsp;&lt;code&nbsp;value=&quot;PatientInformation&quot;/&gt;<br/>&nbsp;&nbsp;&lt;/coding&gt;<br/>&lt;/valueCodeableConcept&gt;<br/>
62. Composition.section:PatientInformation.entry
TypeReference(Patient Body Height in cm, Patient Body Weight in kg, Descriptive Age Group for the Patient, Patient's Date of Last Menstrual Period)
64. Composition.section:RelevantMedicalHistory
Slice NameRelevantMedicalHistory
Control0..1
Must Supporttrue
66. Composition.section:RelevantMedicalHistory.title
Pattern ValueRelevant Medical History
68. Composition.section:RelevantMedicalHistory.code
Pattern Value&lt;valueCodeableConcept&nbsp;xmlns=&quot;http://hl7.org/fhir&quot;&gt;<br/>&nbsp;&nbsp;&lt;coding&gt;<br/>&nbsp;&nbsp;&nbsp;&nbsp;&lt;system&nbsp;value=&quot;http://hl7.org/fhir/us/icsr-ae-reporting/CodeSystem/ICSRSectionCodeCS&quot;/&gt;<br/>&nbsp;&nbsp;&nbsp;&nbsp;&lt;code&nbsp;value=&quot;RelevantMedicalHistory&quot;/&gt;<br/>&nbsp;&nbsp;&lt;/coding&gt;<br/>&lt;/valueCodeableConcept&gt;<br/>
70. Composition.section:RelevantMedicalHistory.entry
TypeReference(Condition)
72. Composition.section:RelevantPastDrugHistory
Slice NameRelevantPastDrugHistory
Control0..1
Must Supporttrue
74. Composition.section:RelevantPastDrugHistory.title
Pattern ValueRelevant Past Drug History
76. Composition.section:RelevantPastDrugHistory.code
Pattern Value&lt;valueCodeableConcept&nbsp;xmlns=&quot;http://hl7.org/fhir&quot;&gt;<br/>&nbsp;&nbsp;&lt;coding&gt;<br/>&nbsp;&nbsp;&nbsp;&nbsp;&lt;system&nbsp;value=&quot;http://hl7.org/fhir/us/icsr-ae-reporting/CodeSystem/ICSRSectionCodeCS&quot;/&gt;<br/>&nbsp;&nbsp;&nbsp;&nbsp;&lt;code&nbsp;value=&quot;RelevantPastDrugHistory&quot;/&gt;<br/>&nbsp;&nbsp;&lt;/coding&gt;<br/>&lt;/valueCodeableConcept&gt;<br/>
78. Composition.section:RelevantPastDrugHistory.entry
TypeReference(MedicationStatement)
80. Composition.section:InCaseOfDeath
Slice NameInCaseOfDeath
Control0..1
Must Supporttrue
82. Composition.section:InCaseOfDeath.title
Pattern ValueIn Case of Death
84. Composition.section:InCaseOfDeath.code
Pattern Value&lt;valueCodeableConcept&nbsp;xmlns=&quot;http://hl7.org/fhir&quot;&gt;<br/>&nbsp;&nbsp;&lt;coding&gt;<br/>&nbsp;&nbsp;&nbsp;&nbsp;&lt;system&nbsp;value=&quot;http://hl7.org/fhir/us/icsr-ae-reporting/CodeSystem/ICSRSectionCodeCS&quot;/&gt;<br/>&nbsp;&nbsp;&nbsp;&nbsp;&lt;code&nbsp;value=&quot;InCaseOfDeath&quot;/&gt;<br/>&nbsp;&nbsp;&lt;/coding&gt;<br/>&lt;/valueCodeableConcept&gt;<br/>
86. Composition.section:InCaseOfDeath.entry
TypeReference(Observation)
88. Composition.section:ParentInformation
Slice NameParentInformation
Control0..1
Must Supporttrue
90. Composition.section:ParentInformation.title
Pattern ValueParent Information
92. Composition.section:ParentInformation.code
Pattern Value&lt;valueCodeableConcept&nbsp;xmlns=&quot;http://hl7.org/fhir&quot;&gt;<br/>&nbsp;&nbsp;&lt;coding&gt;<br/>&nbsp;&nbsp;&nbsp;&nbsp;&lt;system&nbsp;value=&quot;http://hl7.org/fhir/us/icsr-ae-reporting/CodeSystem/ICSRSectionCodeCS&quot;/&gt;<br/>&nbsp;&nbsp;&nbsp;&nbsp;&lt;code&nbsp;value=&quot;ParentInformation&quot;/&gt;<br/>&nbsp;&nbsp;&lt;/coding&gt;<br/>&lt;/valueCodeableConcept&gt;<br/>
94. Composition.section:ParentInformation.entry
TypeReference(Patient, Condition, MedicationStatement)
96. Composition.section:ReactionEvent
Slice NameReactionEvent
Control1..1
Must Supporttrue
98. Composition.section:ReactionEvent.title
Pattern ValueReaction/Event
100. Composition.section:ReactionEvent.code
Pattern Value&lt;valueCodeableConcept&nbsp;xmlns=&quot;http://hl7.org/fhir&quot;&gt;<br/>&nbsp;&nbsp;&lt;coding&gt;<br/>&nbsp;&nbsp;&nbsp;&nbsp;&lt;system&nbsp;value=&quot;http://hl7.org/fhir/us/icsr-ae-reporting/CodeSystem/ICSRSectionCodeCS&quot;/&gt;<br/>&nbsp;&nbsp;&nbsp;&nbsp;&lt;code&nbsp;value=&quot;ReactionEvent&quot;/&gt;<br/>&nbsp;&nbsp;&lt;/coding&gt;<br/>&lt;/valueCodeableConcept&gt;<br/>
102. Composition.section:ReactionEvent.entry
TypeReference(Vaccination Adverse Event, Transfusion Adverse Event)
104. Composition.section:RelevantLabTestResults
Slice NameRelevantLabTestResults
Control0..1
Must Supporttrue
106. Composition.section:RelevantLabTestResults.title
Pattern ValueRelevant Lab Test Results
108. Composition.section:RelevantLabTestResults.code
Pattern Value&lt;valueCodeableConcept&nbsp;xmlns=&quot;http://hl7.org/fhir&quot;&gt;<br/>&nbsp;&nbsp;&lt;coding&gt;<br/>&nbsp;&nbsp;&nbsp;&nbsp;&lt;system&nbsp;value=&quot;http://hl7.org/fhir/us/icsr-ae-reporting/CodeSystem/ICSRSectionCodeCS&quot;/&gt;<br/>&nbsp;&nbsp;&nbsp;&nbsp;&lt;code&nbsp;value=&quot;RelevantLabTestResults&quot;/&gt;<br/>&nbsp;&nbsp;&lt;/coding&gt;<br/>&lt;/valueCodeableConcept&gt;<br/>
110. Composition.section:RelevantLabTestResults.entry
TypeReference(Observation)
112. Composition.section:DrugInformation
Slice NameDrugInformation
Control1..1
Must Supporttrue
114. Composition.section:DrugInformation.title
Pattern ValueDrug Information
116. Composition.section:DrugInformation.code
Pattern Value&lt;valueCodeableConcept&nbsp;xmlns=&quot;http://hl7.org/fhir&quot;&gt;<br/>&nbsp;&nbsp;&lt;coding&gt;<br/>&nbsp;&nbsp;&nbsp;&nbsp;&lt;system&nbsp;value=&quot;http://hl7.org/fhir/us/icsr-ae-reporting/CodeSystem/ICSRSectionCodeCS&quot;/&gt;<br/>&nbsp;&nbsp;&nbsp;&nbsp;&lt;code&nbsp;value=&quot;DrugInformation&quot;/&gt;<br/>&nbsp;&nbsp;&lt;/coding&gt;<br/>&lt;/valueCodeableConcept&gt;<br/>
118. Composition.section:DrugInformation.entry
TypeReference(ICSR MedicationAdministration, ICSR Immunization, DeviceUseStatement, ICSR Transfusion)
120. Composition.section:Vaccines
Slice NameVaccines
Control0..1
Must Supporttrue
122. Composition.section:Vaccines.title
Pattern ValueVaccines given within 4 weeks
124. Composition.section:Vaccines.code
Pattern Value&lt;valueCodeableConcept&nbsp;xmlns=&quot;http://hl7.org/fhir&quot;&gt;<br/>&nbsp;&nbsp;&lt;coding&gt;<br/>&nbsp;&nbsp;&nbsp;&nbsp;&lt;system&nbsp;value=&quot;http://hl7.org/fhir/us/icsr-ae-reporting/CodeSystem/ICSRSectionCodeCS&quot;/&gt;<br/>&nbsp;&nbsp;&nbsp;&nbsp;&lt;code&nbsp;value=&quot;Vaccines&quot;/&gt;<br/>&nbsp;&nbsp;&lt;/coding&gt;<br/>&lt;/valueCodeableConcept&gt;<br/>
126. Composition.section:Vaccines.entry
TypeReference(ICSR Immunization)
128. Composition.section:CaseNarrative
Slice NameCaseNarrative
Control1..1
Must Supporttrue
130. Composition.section:CaseNarrative.title
Pattern ValueCase Summary Narrative
132. Composition.section:CaseNarrative.code
Pattern Value&lt;valueCodeableConcept&nbsp;xmlns=&quot;http://hl7.org/fhir&quot;&gt;<br/>&nbsp;&nbsp;&lt;coding&gt;<br/>&nbsp;&nbsp;&nbsp;&nbsp;&lt;system&nbsp;value=&quot;http://hl7.org/fhir/us/icsr-ae-reporting/CodeSystem/ICSRSectionCodeCS&quot;/&gt;<br/>&nbsp;&nbsp;&nbsp;&nbsp;&lt;code&nbsp;value=&quot;CaseSummaryNarrative&quot;/&gt;<br/>&nbsp;&nbsp;&lt;/coding&gt;<br/>&lt;/valueCodeableConcept&gt;<br/>
134. Composition.section:CaseNarrative.text
Control1..?
136. Composition.section:CaseNarrative.entry
Control0..0
138. Composition.section:CaseReporterComments
Slice NameCaseReporterComments
Control0..1
Must Supporttrue
140. Composition.section:CaseReporterComments.title
Pattern ValueCase Reporter's Comments
142. Composition.section:CaseReporterComments.code
Pattern Value&lt;valueCodeableConcept&nbsp;xmlns=&quot;http://hl7.org/fhir&quot;&gt;<br/>&nbsp;&nbsp;&lt;coding&gt;<br/>&nbsp;&nbsp;&nbsp;&nbsp;&lt;system&nbsp;value=&quot;http://hl7.org/fhir/us/icsr-ae-reporting/CodeSystem/ICSRSectionCodeCS&quot;/&gt;<br/>&nbsp;&nbsp;&nbsp;&nbsp;&lt;code&nbsp;value=&quot;CaseReporterComments&quot;/&gt;<br/>&nbsp;&nbsp;&lt;/coding&gt;<br/>&lt;/valueCodeableConcept&gt;<br/>
144. Composition.section:CaseReporterComments.text
Control1..?
146. Composition.section:CaseReporterComments.entry
Control0..0
148. Composition.section:CaseSenderDiagnosis
Slice NameCaseSenderDiagnosis
Control0..1
Must Supporttrue
150. Composition.section:CaseSenderDiagnosis.title
Pattern ValueCase Sender's Diagnosis
152. Composition.section:CaseSenderDiagnosis.code
Pattern Value&lt;valueCodeableConcept&nbsp;xmlns=&quot;http://hl7.org/fhir&quot;&gt;<br/>&nbsp;&nbsp;&lt;coding&gt;<br/>&nbsp;&nbsp;&nbsp;&nbsp;&lt;system&nbsp;value=&quot;http://hl7.org/fhir/us/icsr-ae-reporting/CodeSystem/ICSRSectionCodeCS&quot;/&gt;<br/>&nbsp;&nbsp;&nbsp;&nbsp;&lt;code&nbsp;value=&quot;CaseSenderDiagnosis&quot;/&gt;<br/>&nbsp;&nbsp;&lt;/coding&gt;<br/>&lt;/valueCodeableConcept&gt;<br/>
154. Composition.section:CaseSenderDiagnosis.entry
TypeReference(Condition)
156. Composition.section:CaseSenderComments
Slice NameCaseSenderComments
Control0..1
Must Supporttrue
158. Composition.section:CaseSenderComments.title
Pattern ValueCase Sender's Comments
160. Composition.section:CaseSenderComments.code
Pattern Value&lt;valueCodeableConcept&nbsp;xmlns=&quot;http://hl7.org/fhir&quot;&gt;<br/>&nbsp;&nbsp;&lt;coding&gt;<br/>&nbsp;&nbsp;&nbsp;&nbsp;&lt;system&nbsp;value=&quot;http://hl7.org/fhir/us/icsr-ae-reporting/CodeSystem/ICSRSectionCodeCS&quot;/&gt;<br/>&nbsp;&nbsp;&nbsp;&nbsp;&lt;code&nbsp;value=&quot;CaseSenderComments&quot;/&gt;<br/>&nbsp;&nbsp;&lt;/coding&gt;<br/>&lt;/valueCodeableConcept&gt;<br/>
162. Composition.section:CaseSenderComments.text
Control1..?
164. Composition.section:CaseSenderComments.entry
Control0..0
166. Composition.section:DataSourceInformation
Slice NameDataSourceInformation
Control0..1
Must Supporttrue
168. Composition.section:DataSourceInformation.title
Pattern ValueInformation about the Data Source of the AE information
170. Composition.section:DataSourceInformation.code
Pattern Value&lt;valueCodeableConcept&nbsp;xmlns=&quot;http://hl7.org/fhir&quot;&gt;<br/>&nbsp;&nbsp;&lt;coding&gt;<br/>&nbsp;&nbsp;&nbsp;&nbsp;&lt;system&nbsp;value=&quot;http://hl7.org/fhir/us/icsr-ae-reporting/CodeSystem/ICSRSectionCodeCS&quot;/&gt;<br/>&nbsp;&nbsp;&nbsp;&nbsp;&lt;code&nbsp;value=&quot;DataSourceInformation&quot;/&gt;<br/>&nbsp;&nbsp;&lt;/coding&gt;<br/>&lt;/valueCodeableConcept&gt;<br/>
172. Composition.section:DataSourceInformation.entry
TypeReference(AECountObservation, ExposureCountObservation)