1. Ballot Reconciliation Meeting Notes 1.Ballot Tally & Reconciliation a.CTLaboratory Release 3 / HL7 Version 3 Standard: Periodic Reporting of Clinical Trial Laboratory Data, Release 2; Abnormality Assessment Extension b.A_AbnormalityAssessment CMET universal (COCT_RM420000) 2.Vocabulary 3.Next Steps HL7 Working Group Meeting RCRIM Technical Committee January 15, 2008

2. HL7 January 2008 WGM | Ballot Reconciliation 2 of 8 Ballot Tally CTLaboratory Release 3  Quorum achieved  % affirmative achieved  Affirmative ballots: 38  Negative ballots: 0  Abstain with comments: 1 Abnormality Assessment CMET  Quorum achieved  % affirmative achieved for provisional pass  Affirmative ballots: 35  Negative ballots: 7  5 refer to same issue  1 refers another CMET  1 refers to comments by another voter, who voted Affirmative, no comments  Abstain: 6  No return: 3

3. January 15, 2008 HL7 January 2008 WGM | Ballot Reconciliation 3 of 8 Ballot Reconciliation: Abnormality Assessment CMET Negative – Minor AbnormalityAssessment.code* CD CNE Proposed:AbnormalityAssessment.code* CD CWE Comment:CNE inappropriate for universal realm in this context.

4. January 15, 2008 HL7 January 2008 WGM | Ballot Reconciliation 4 of 8 Ballot Reconciliation: Abnormality Assessment CMET Recommended Disposition Persuasive Change coding strength: AbnormalityAssessment.code* CD CWE

5. January 15, 2008 HL7 January 2008 WGM | Ballot Reconciliation 5 of 8 Affirmative – Suggestion Code on the observations do not have their domains constrained. Suggest proposing new domains for AssessmentException.code, AbnormalityGrade.code, and GradeAnnotation.code (perhaps they should be constrained to fixed values if I understand this correctly). Recommended Disposition: considered for future use Affirmative – Question Is SC really appropriate here? The focus is on the string, the code is really optional information). SC is normally used where coding is exceptional, and code is frequently a local code (this from the ADT Spec). I would think you always need a code, and the text may be optional (and in that case the originalText field of CD would be used. Recommended Disposition: not persuasive Ballot Reconciliation: Abnormality Assessment CMET

6. January 15, 2008 HL7 January 2008 WGM | Ballot Reconciliation 6 of 8 Abnormality Assessment CMET: additional items for re-ballot 1.Appendage ActRelationship: reverse direction (based on HL7 RIM definition of APND ActRelationship 2.Add support for capturing performer/author of the abnormality assessment

7. January 15, 2008 HL7 January 2008 WGM | Ballot Reconciliation 7 of 8 Abnormality Assessment CMET Vocabulary Vocabulary needs met through  Existing concepts in the HL7 RIM  Existing and new concepts within the NCI Thesaurus  New draft terminology subset is being created in the NCI Thesaurus. Proposed terminology name: RCRIM Abnormality Assessment Terminology  Terminology subset consists of five code lists containing existing and new proposed concepts.

8. January 15, 2008 HL7 January 2008 WGM | Ballot Reconciliation 8 of 8 Next Steps  Announce intent to ballot Implementation Guide  Identify early adopter of DSTU and commence testing and implementation CT Laboratory Release 3  Determine re-ballot timeframe  Announce intent to ballot Implementation Guide  Identify early adopters and commence testing and implementation AbnormalityAssessment CMET