Project Summary for Clinical Genomics - Genetic Variation (Fully LOINC-Qualified Genetic Variation Model)
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Project Details
Number | 692 View Ballot Items List (with NIBs) |
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Name | Clinical Genomics - Genetic Variation (Fully LOINC-Qualified Genetic Variation Model) |
Sponsor(s) | Clinical Genomics Work Group |
Co-Sponsor(s) | Orders and Observations Work Group |
Steering Division | Clinical |
Description | To foster early utilization of genomic data in HL7 v2 messaging and meet clinical needs in this emerging field, the CG group will create an HL7 v2 laboratory message which supports the transmission of genetic data for use in clinical laboratory reporting of genetic tests, which is consistent with the v3 Genetic Variation model. To that end the group published an informative implementation guide: 'HL7 Version 2 Implementation Guide: Clinical Genomics; Fully LOINC-Qualified Genetic Variation Model, Release 1, September, 2009'. New use cases have surfaced resulting in additional requirements for the HL7 v2 laboratory message. As such, this project will focus on release 2 of the 'HL7 Version 2 Implementation Guide: Clinical Genomics; Fully LOINC-Qualified Genetic Variation Model'. These use cases include support for translational medicine and large genotyping tests. Note the CG group views work in HL7 v2 as a stepping stone and testbed: implementers that are required to use existing v2 messaging systems can use structured genomic data in v2 and migrate later to v3. Fully qualifying the genetic data, using LOINC, has resulted in portability of these data from v2 to v3, e.g., by using of the newly-created LOINC codes in v3 models. |
Project Facilitator | Rick Haddorff |
Status | Archived |
SD Approval Date | Jul 9, 2010 |
TSC Approval Date | Aug 2, 2010 |
Type | Ballot - Informative |
Objectives / Deliverables | Complete modeling and review - Target: August 2010 COMPLETE Complete first draft of release 2 implementation guide for ballot comments - Target: September 2010 COMPLETE Incorporate recommended modifications and re-ballot - Target: December 2010 COMPLETE Reconcile votes and publish - Target: February 2011 COMPLETE Sept 2011 Update: We would like to extend the dates for the following project to Jan 2012 and May 2012, giving us time for informative balloting and reconciliation. MAY 2011 - Adding deliverables Adding tumor profiling to the implementation guide - ballot September 2011 |
Next Milestone Date | 2013 May WGM |
Project End Date | 2013 May WGM |
Project Intent | Supplement to a Current Standard, Implementation Guide |
Project Need | Clinical genomics is a rapidly emerging field with increasing use in patient care and clinical research. If Healthcare IT standards do not keep pace with new testing platforms and use cases, then robust standards will not be available for structuring of these genetic data within our healthcare environments. Structured data enables clinical decision support, outcomes analysis etc... and may result in improved patient care and support appropriate healthcare spending. |
Implementers | 1) Mollie Ullman-Cullere 2) Grant Wood |
Security Risks | |
External Drivers | |
Common Names / Keywords/ Aliases | |
Lineage | |
Dependancies | |
Project Document Repository | http://www.hl7.org/Special/committees/clingenomics/docs.cfm |
Backwards Compatibility | Yes |
External Vocabularies | |
Products | V2 Messages-Clinical |
Joint Copyright? | |
External Pjt Collaborators | |
Realm | Realm Specific - Enter "U.S." or name of HL7 Affiliate below |
HL7 Affiliate | U.S. |
Stakeholders | Clinical and Public Health Laboratories |
Vendors | EHR, PHR; Health Care IT; Lab; HIS |
Providers | Clinical and Public Health Laboratories; Healthcare Institutions (hospitals, long term care, home care, mental health) |
Ballot Cycle Info | 2012 Jan Ballot Cycle Info: INFORMATIVE Ballot results: Met basic vote requirements. 1 Negatives to reconcile Document Name: HL7 Version 2 Implementation Guide: Clinical Genomics; Fully LOINC-Qualified Genetic Variation Model, Release 2 (US Realm) Ballot Code: V2IG_CG_LOINCGENVAR_R2_I1_2012JAN NIB Submitted By: Mollie Ullman-Cullere 2011 Sept Ballot Cycle Info: INFORMATIVE Ballot results: Postponed Document Name: HL7 Version 2 Implementation Guide: Clinical Genomics; Fully LOINC-Qualified Genetic Variation Model, Release 2 (US Realm) Ballot Code: V2_CG_LOINCGENVAR_R2_I1_2011SEP NIB Submitted By: Don Lloyd 2011 May Ballot Cycle Info: INFORMATIVE Ballot results: Postponed Document Name: HL7 Version 2 Implementation Guide: Clinical Genomics; Fully LOINC-Qualified Genetic Variation Model, Release 2 - US Realm Ballot ID: V2_CG_LOINCGENVAR_R2_I1_2011MAY NIB Submitted By: Mollie Ullman-Cullere |
Misc Notes | April 2013: ANSI Acknowledgement for the Registration of a Technical Report effective as of: 5/5/2013 for HL7 V2IG CG LOINCGENVAR, R2-2012 Feb 2013: TSC approved publication of HL7 Version 2 Implementation Guide: Clinical Genomics; Fully LOINC-Qualified Genetic Variation Model, Release 2 as an informative document and registration with ANSI as a Technical Report. Created by splitting Project #196 into two projects for better tracking of deliverables. |
U.S. Govt Interest? | |
USRSC Approval | |
FMG Approval | |
ARB Approval | |
Start Date | Jun 2, 2010 |
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