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

2. HL7 V3 Lab-Based Adverse Event Assessment CMET Specification2 of 9 Project Context: Lifecycle of an Adverse Event

3. August 7, 2007HL7 V3 Lab-Based Adverse Event Assessment CMET Specification3 of 9 Lab-Based Adverse Event Assessment Domain Analysis Model Current CT-Lab Message Content Proposed New CMET Content

4. August 7, 2007HL7 V3 Lab-Based Adverse Event Assessment CMET Specification4 of 9 Current CT Laboratory Message RMIM

5. August 7, 2007HL7 V3 Lab-Based Adverse Event Assessment CMET Specification5 of 9 CMET Addition to the CT-Laboratory Message

6. August 7, 2007HL7 V3 Lab-Based Adverse Event Assessment CMET Specification6 of 9 Proposed CMET Specification 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 1)The status of each laboratory test result evaluation and AE assessment; AND 2)The assessment outcome for each laboratory test result, which includes either: a)An error/exception message; OR b)An AE category, term, grade, and if applicable, grade annotation The adverse event (AE) assessment CMET communicates the following:

7. August 7, 2007HL7 V3 Lab-Based Adverse Event Assessment CMET Specification7 of 9 Proposed Changes to the CT-Laboratory Message 1.Change datatype of Range.value from PQ to IVL. 2.Add AdverseEventAssessment CMET with an ActRelationship to Base Unitary Result

8. August 7, 2007HL7 V3 Lab-Based Adverse Event Assessment CMET Specification8 of 9 Next Steps Create BRIDG-derived DAM Review proposed changes with Laboratory Results for CT group Harmonize with BRIDG Identify vocabulary harmonization changes

9. August 7, 2007HL7 V3 Lab-Based Adverse Event Assessment CMET Specification9 of 9 Questions / Comments