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

: Sample ICSR Transfusion Report - JSON Representation

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{
  "resourceType" : "Composition",
  "id" : "SampleTransfusionReport",
  "meta" : {
    "profile" : [
      "http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/icsr-composition"
    ]
  },
  "text" : {
    "status" : "extensions",
    "div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: Composition</b><a name=\"SampleTransfusionReport\"> </a></p><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\">Resource Composition &quot;SampleTransfusionReport&quot; </p><p style=\"margin-bottom: 0px\">Profile: <a href=\"StructureDefinition-icsr-composition.html\">ICSR Composition</a></p></div><blockquote><p><b>AdditionalDocumentInformation</b></p><blockquote><p><b>url</b></p><code>availableFlag</code></blockquote><p><b>value</b>: false</p></blockquote><blockquote><p><b>ExpeditedReport</b></p><blockquote><p><b>url</b></p><code>localCriteriaFlag</code></blockquote><p><b>value</b>: false</p><blockquote><p><b>url</b></p><code>localCriteriaReportType</code></blockquote><p><b>value</b>: Non-Expedited AE <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (unknown#C53578)</span></p></blockquote><p><b>FirstSenderType</b>: Other <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (unknown#2)</span></p><p><b>CombinationProductReport</b>: false</p><p><b>FirstReceiveDate</b>: 2020-02-10 17:18:00-0500</p><p><b>MostRecentDate</b>: 2020-02-10 17:18:00-0500</p><p><b>CaseIdentifier</b>: id:\u00a0US-IBM-aed059ac-ef25-6ded-cce2-a8912d6b76ee</p><p><b>PreviousCaseIdentifier</b>: id:\u00a0Other-case-identifier</p><blockquote><p><b>ReportAmendment</b></p><blockquote><p><b>url</b></p><code>amendmentType</code></blockquote><p><b>value</b>: 2 <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (unknown#2)</span></p><blockquote><p><b>url</b></p><code>amendmentReason</code></blockquote><p><b>value</b>: Fixed some identifiers</p></blockquote><p><b>identifier</b>: id:\u00a0US-IBM-94209fd1-9b0e-1adc-007a-4f5cecb8ce6a</p><p><b>status</b>: final</p><p><b>type</b>: Adverse event note <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"https://loinc.org/\">LOINC</a>#85893-6)</span></p><p><b>category</b>: Spontaneous report <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (unknown#1)</span></p><p><b>date</b>: 2020-02-10 17:18:00-0500</p><p><b>author</b>: <a href=\"PractitionerRole-SampleAuthorRole.html\">PractitionerRole/SampleAuthorRole</a></p><p><b>title</b>: ICSR Submission</p></div>"
  },
  "extension" : [
    {
      "extension" : [
        {
          "url" : "availableFlag",
          "valueBoolean" : false
        }
      ],
      "url" : "http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/icsr-ext-additionaldocumentinformation"
    },
    {
      "extension" : [
        {
          "url" : "localCriteriaFlag",
          "valueBoolean" : false
        },
        {
          "url" : "localCriteriaReportType",
          "valueCodeableConcept" : {
            "coding" : [
              {
                "system" : "urn:oid:2.16.840.1.113883.3.989.2.1.1.1003",
                "code" : "C53578",
                "display" : "Non-Expedited AE"
              }
            ]
          }
        }
      ],
      "url" : "http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/icsr-ext-expeditedreport"
    },
    {
      "url" : "http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/icsr-ext-firstsendertype",
      "valueCodeableConcept" : {
        "coding" : [
          {
            "system" : "urn:oid:2.16.840.1.113883.3.989.2.1.1.3",
            "code" : "2",
            "display" : "Other"
          }
        ]
      }
    },
    {
      "url" : "http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/icsr-ext-combinationproductreport",
      "valueBoolean" : false
    },
    {
      "url" : "http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/icsr-ext-firstreceivedate",
      "valueDateTime" : "2020-02-10T17:18:00-05:00"
    },
    {
      "url" : "http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/icsr-ext-mostrecentdate",
      "valueDateTime" : "2020-02-10T17:18:00-05:00"
    },
    {
      "url" : "http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/icsr-ext-caseidentifier",
      "valueIdentifier" : {
        "system" : "urn:oid:2.16.840.1.113883.3.989.2.1.3.2",
        "value" : "US-IBM-aed059ac-ef25-6ded-cce2-a8912d6b76ee"
      }
    },
    {
      "url" : "http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/icsr-ext-previouscaseidentifier",
      "valueIdentifier" : {
        "system" : "urn:oid:2.16.840.1.113883.3.989.2.1.3.3",
        "value" : "Other-case-identifier",
        "assigner" : {
          "display" : "Case identifier source name"
        }
      }
    },
    {
      "extension" : [
        {
          "url" : "amendmentType",
          "valueCodeableConcept" : {
            "coding" : [
              {
                "system" : "urn:oid:2.16.840.1.113883.3.989.2.1.1.5",
                "code" : "2"
              }
            ]
          }
        },
        {
          "url" : "amendmentReason",
          "valueString" : "Fixed some identifiers"
        }
      ],
      "url" : "http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/icsr-ext-reportamendment"
    }
  ],
  "identifier" : {
    "system" : "urn:oid:2.16.840.1.113883.3.989.2.1.3.1",
    "value" : "US-IBM-94209fd1-9b0e-1adc-007a-4f5cecb8ce6a"
  },
  "status" : "final",
  "type" : {
    "coding" : [
      {
        "system" : "http://loinc.org",
        "code" : "85893-6",
        "display" : "Adverse event note"
      }
    ]
  },
  "category" : [
    {
      "coding" : [
        {
          "system" : "urn:oid:2.16.840.1.113883.3.989.2.1.1.2",
          "code" : "1",
          "display" : "Spontaneous report"
        }
      ]
    }
  ],
  "subject" : {
    "reference" : "Patient/SampleICSRPatient"
  },
  "date" : "2020-02-10T17:18:00-05:00",
  "author" : [
    {
      "extension" : [
        {
          "url" : "http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/icsr-ext-authorprimarysource",
          "valueBoolean" : true
        }
      ],
      "reference" : "PractitionerRole/SampleAuthorRole"
    }
  ],
  "title" : "ICSR Submission",
  "section" : [
    {
      "title" : "Reaction/Event",
      "code" : {
        "coding" : [
          {
            "system" : "http://hl7.org/fhir/us/icsr-ae-reporting/CodeSystem/ICSRSectionCodeCS",
            "code" : "ReactionEvent"
          }
        ]
      },
      "text" : {
        "status" : "generated",
        "div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\">No events</div>"
      }
    },
    {
      "title" : "Drug Information",
      "code" : {
        "coding" : [
          {
            "system" : "http://hl7.org/fhir/us/icsr-ae-reporting/CodeSystem/ICSRSectionCodeCS",
            "code" : "DrugInformation"
          }
        ]
      },
      "text" : {
        "status" : "generated",
        "div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\">No drugs taken</div>"
      }
    },
    {
      "title" : "Case Summary Narrative",
      "code" : {
        "coding" : [
          {
            "system" : "http://hl7.org/fhir/us/icsr-ae-reporting/CodeSystem/ICSRSectionCodeCS",
            "code" : "CaseSummaryNarrative"
          }
        ]
      },
      "text" : {
        "status" : "generated",
        "div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><div>No adverse event happened. Not sure why I'm sending this report.</div><div lang=\"fr\">il n'y a eu aucun événement indésirable</div></div>"
      }
    },
    {
      "title" : "Information about the Data Source of the AE information",
      "code" : {
        "coding" : [
          {
            "system" : "http://hl7.org/fhir/us/icsr-ae-reporting/CodeSystem/ICSRSectionCodeCS",
            "code" : "DataSourceInformation"
          }
        ]
      },
      "entry" : [
        {
          "reference" : "Observation/SampleAECountObservation"
        },
        {
          "reference" : "Observation/SampleExposureCountObservation"
        }
      ]
    }
  ]
}