HL7 FHIR Implementation Guide: Profiles for Transfusion and Vaccination Adverse Event Detection and Reporting
1.0.1 - STU 1 Technical Correction United States of America flag

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

: Transfusion Sample ICSR Report - JSON Representation

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{
  "resourceType" : "Composition",
  "id" : "TransfusionExample",
  "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=\"TransfusionExample\"> </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;TransfusionExample&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#2)</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>: 2021-01-05</p><p><b>MostRecentDate</b>: 2021-01-05</p><p><b>CaseIdentifier</b>: id:\u00a0BEST_beafb541-3eab-eb9e-1bf1-5fa477d56e77</p><p><b>identifier</b>: id:\u00a0BEST_beafb541-3eab-eb9e-1bf1-5fa477d56e77</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>: 2021-01-05</p><p><b>author</b>: <a href=\"PractitionerRole-BESTAuthorRole.html\">PractitionerRole/BESTAuthorRole</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" : "2",
                "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" : "2021-01-05"
    },
    {
      "url" : "http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/icsr-ext-mostrecentdate",
      "valueDateTime" : "2021-01-05"
    },
    {
      "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" : "BEST_beafb541-3eab-eb9e-1bf1-5fa477d56e77"
      }
    }
  ],
  "identifier" : {
    "system" : "urn:oid:2.16.840.1.113883.3.989.2.1.3.1",
    "value" : "BEST_beafb541-3eab-eb9e-1bf1-5fa477d56e77"
  },
  "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/BESTPatient"
  },
  "date" : "2021-01-05",
  "author" : [
    {
      "extension" : [
        {
          "url" : "http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/icsr-ext-authorprimarysource",
          "valueBoolean" : true
        }
      ],
      "reference" : "PractitionerRole/BESTAuthorRole"
    }
  ],
  "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\">Allergic transfusion reaction</div>"
      },
      "entry" : [
        {
          "reference" : "AdverseEvent/TransfusionExampleEvent"
        }
      ]
    },
    {
      "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\">Description code for blood products: E7003, Blood group and type: N/A Blood processing type: Apheresis PLATELETS|ACD-A&gt;PAS-C/XX/20-24C|ResLeu:&amp;lt;5E6|2nd container</div>"
      },
      "entry" : [
        {
          "reference" : "Procedure/TransfusionExampleTransfusion"
        },
        {
          "reference" : "MedicationAdministration/TransfusionEpinephrine"
        },
        {
          "reference" : "MedicationAdministration/TransfusionDiphenhydramine"
        }
      ]
    },
    {
      "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\">Header: FDA CBER BEST Automated AE Reporting Prototype Case BEST Detection Phenotype Algorithm: Phenotype link: rules-cd BEST Certainty: Definite BEST Severity: Non-Severe BEST Imputability: Probable Form Type: 3500 Contact Method: Email Adverse Event: 1 Center to which the case is being routed to: CBER Whether the case is being sent to DQRS: false Whether the report is related to drugs or food/cosmetics: 1 Whether the blood report is of type Transfusion or Collection: 2 Patient Race Code: 2f, Blood group of patient: N/A, Onset location for reaction: MedStar Location Description code for blood products: N/A, Blood group and type: N/A Blood processing type: N/A Product available for evaluation: 2 Volume of transfusion: NI NHSN Workup: NI Preliminary investigation results: Developed rash &amp;#38; stridor following transfusion prbc for anemia. Tx with benadryl &amp;#38; epinephrine &amp;#38; sx improved., Adverse Event Type Imputability: Blood Transfusion - Certainty: Definite; Notes: 1. notes, Eval+Plan Note, For admission to Hosp with Dx Anemia. Transfuse PRBC now., Date 20020109; 2. notes, Eval+Plan Note, Patient has developed a new maculopapular rash following transfusion. Will give Benadryl 25 mg., Date 20020109; 3. notes, Eval+Plan Note, New onset Stridor following transfusion. Will give Epinephrine .5mg, and do transfusion Rxn workup, Date 20020109; 4. notes, Eval+Plan Note, RN note - Administered Benadryl 25mg IV for skin sx. After 30 min pt. reports some improvement in skin symptoms, Date 20020109 Labs, Vitals, and Tests: 1. labs, Diastolic Blood Pressure, 75.918 mm[Hg], Date 20020109; 2. labs, Systolic Blood Pressure, 123.08 mm[Hg], Date 20020109; 3. labs, Physical findings of Skin, generalized rash, Date 20020109; 4. labs, Respiratory status finding, Stridor, Date 20020109; Illness at Time of Vaccination: 1. illness, Problem, Anemia, Date 20020109;</div>"
      }
    },
    {
      "title" : "Patient Information",
      "code" : {
        "coding" : [
          {
            "system" : "http://hl7.org/fhir/us/icsr-ae-reporting/CodeSystem/ICSRSectionCodeCS",
            "code" : "PatientInformation"
          }
        ]
      },
      "entry" : [
        {
          "reference" : "Observation/BESTPatientAgeGroup"
        }
      ]
    },
    {
      "title" : "Relevant Medical History",
      "code" : {
        "coding" : [
          {
            "system" : "http://hl7.org/fhir/us/icsr-ae-reporting/CodeSystem/ICSRSectionCodeCS",
            "code" : "RelevantMedicalHistory"
          }
        ]
      },
      "text" : {
        "status" : "generated",
        "div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\">NI</div>"
      }
    }
  ]
}