HL7 Version 3 Adverse Event Assessment CMET Specification

1. HL7 Version 3 Adverse Event Assessment CMET Specification Jennifer Neat Project Leader, City of Hope August 7, 2007

2. Project Context: Lifecycle of an Adverse Event HL7 V3 Lab-Based Adverse Event Assessment CMET Specification

3. Lab-Based Adverse Event Assessment Domain Analysis Model Current CT-Lab Message Content Person Specimen - identifier: String - accessionNumber: int - firstName: String 1 1..* - collectionDateTime: dateTime - lastName: String Proposed New CMET Content 1 1..* LabTestType - identifier: string LabTestResult AdverseEventCategory - name: string Entry Point - resultValue: float - name: String - unitOfMeasure: string 1 1..* - lowerLimitNormal: float - upperLimitNormal: float 1 1 1..* 0..* ExceptionMessage AdverseEventAssessment AdverseEventTerm - exceptionMessageText: String - assessmentRuleKind: String - name: String 0..* 1 1..* 0..1 - assessmentStatus: String 1 «Invariant» 0..* {XOR} Grade GradeAnnotation - CTCAEGrade: String - conditionalGradeDescription: String 1 0..* HL7 V3 Lab-Based Adverse Event Assessment CMET Specification

4. Current CT Laboratory Message RMIM HL7 V3 Lab-Based Adverse Event Assessment CMET Specification

5. CMET Addition to the CT-Laboratory Message HL7 V3 Lab-Based Adverse Event Assessment CMET Specification

6. Proposed CMET Specification The adverse event (AE) assessment CMET communicates the following: Adverse Event Assessment: The process of evaluating the observation of a clinical finding, including a laboratory test result, to detect the presence and severity of an abnormal condition, and assign the corresponding adverse event (AE) category, term and grade. (When a laboratory test result is within normal limits/reveals no abnormal condition, the AE for which the laboratory test is evaluated is assessed as Not Present.) Assessment Exception: An exception message indicating that an adverse event assessment could not be executed or completed and providing the reason for the failure. Adverse Event Grade: The level of severity for an assessed AE Grade Annotation: The additional information regarding a grade returned with an AE assessment • The status of each laboratory test result evaluation and AE assessment; AND • The assessment outcome for each laboratory test result, which includes either: • An error/exception message; OR • An AE category, term, grade, and if applicable, grade annotation HL7 V3 Lab-Based Adverse Event Assessment CMET Specification

7. Proposed Changes to the CT-Laboratory Message • Change datatype of Range.value from PQ to IVL<PQ>. • Add AdverseEventAssessment CMET with an ActRelationship to Base Unitary Result HL7 V3 Lab-Based Adverse Event Assessment CMET Specification

8. Next Steps Create BRIDG-derived DAM Identify vocabulary harmonization changes Review proposed changes with Laboratory Results for CT group Harmonize with BRIDG HL7 V3 Lab-Based Adverse Event Assessment CMET Specification

9. Questions / Comments HL7 V3 Lab-Based Adverse Event Assessment CMET Specification