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

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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

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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.

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Ballot Reconciliation: Abnormality Assessment CMET

Recommended Disposition

Persuasive Change coding strength: AbnormalityAssessment.code* CD CWE

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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

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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

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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.

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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