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

HL7 January 2008 WGM | Ballot Reconciliation 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 January 15, 2008 HL7 January 2008 WGM | Ballot Reconciliation

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. January 15, 2008 HL7 January 2008 WGM | Ballot Reconciliation

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

Ballot Reconciliation: Abnormality Assessment CMET 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 January 15, 2008 HL7 January 2008 WGM | Ballot Reconciliation

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

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. January 15, 2008 HL7 January 2008 WGM | Ballot Reconciliation

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