12/07/11 LRI Validation Suite Wiki Cystic Fibrosis Draft Test Messages v1 HL7 Messages for CFTR (Cystic Fibrosis) Gene Mutation Analysis Lab Orders/Results CFTR gene mutation analysis in Blood or Tissue by Molecular genetics method Nominal 21654-9 Example of reporting in A2 format This draft test message has NOT been mapped to the LRI IG. Timing Scenario: The CFTR specimen was collected from patient on November 30, 2011, at 11:30P EST in Ann Arbor. The specimen was analyzed on November 30, 2011, at 1:05P EST. The result report was composed on November 30, 2011, at 1:25P EST, and the result message was created/transmitted on November 30, 2011, at 1:25P EST. MSH|^~\&|Lab1^1234^CLIA|Reliable^1234^CLIA|ELR^2.16.840.1.113883.19.3.2.3^ISO |SPH^2.16.840.1.113883.19.3.2^ISO|201111301325540500||ORU^R01^ORU_R01|20111130132554000005|P^T|2.5.1|||NE|NE|USA||||USELR 1.0^^2.16.840.1.113883.19.9.7^ISO SFT|1|Level Seven Healthcare Software, Inc.^L^^^^&2.16.840.1.113883.19.4.6^ISO^XX^^^1234|1.2|An Lab System|56734||20080817 PID|1||36363636^^^MPI&2.16.840.1.113883.19.3.2.1&ISO^MR^A&2.16.840.1.113883.1 9.3.2.1&ISO~444333333^^^&2.16.840.1.113883.4.1^ISO^SS||Everyman^Adam^A^^^ ^L^^^^^^^BS|Mum^Martha^M^^^^M|19750602|M||21063^White^CDCREC^^^^04/24/2007|2222 Home Street^^Ann Arbor^MI^99999^USA^H||^PRN^PH^^1^555^5552004|^WPN^PH^^1^955^5551009|eng^E nglish^ISO6392^^^^3/29/2007|M^Married^HL70002^^^^2.5.1||||||N^Not Hispanic or Latino^HL70189^^^^2.5.1||||||||N|||2008081510000700|Reliable^2.16.840.1.113883.19.3.1^ISO ORC|RE|23456^EHR^2.16.840.1.113883.19.3.2.3^ISO|9700123^Lab^2.16.840.1.113883 .19.3.1.6^ISO|||||||||1234^Admit^Alan^A^III^Dr^^^&2.16.840.1.113883.19.4. 6^ISO^L^^^EI^&2.16.840.1.113883.19.4.6^ISO^^^^^^^^MD||^WPN^PH^^1^555^5551 005|||||||Level Seven Healthcare, Inc.^L^^^^&2.16.840.1.113883.19.4.6^ISO^XX^^^1234|1005 Healthcare Drive^^Ann Arbor^MI^99999^USA^B|^WPN^PH^^1^555^5553001|4444 Healthcare Drive^Suite 123^Ann Arbor^MI^99999^USA^B OBR|1|23456^EHR^2.16.840.1.113883.19.3.2.3^ISO|9700123^Lab^2.16.840.1.113883. 19.3.1.6^ISO|21654-9^CFTR gene mutation analysis in Blood or Tissue by Molecular genetics method Nominal^LN^1244^CTFR gene Mutation List^99RLI^2.36^1^Cystic Fibrosis Gene mutation List|||2011113011300500||||||fever|||1234^Admit^Alan^A^III^Dr^^^&2.16.840.1.113883.19.4.6^IS O^L^^^EI^&2.16.840.1.113883.19.4.6^ISO^^^^^^^^MD|^WPN^PH^^1^555^5551005|| |||2011113013250500|||F||||||1235&Slide&Stan&S&&Dr&MD&&DOC&2.16.840.1.113883.19.4.6&ISO OBX|1|CWE|21654-9^CFTR gene mutation analysis in Blood or Tissue by Molecular genetics method Nominal^LN^1244^CTFR gene Mutation List^99RLI^2.36^1^Cystic Fibrosis Gene mutation List ||260385009^Negative^SCT^NEG^negative^99RLI^20110731^1^negative||||||F||| 201111301130-0500|||||201111301305-0500||||Reliable Labs, Inc^L^^^^CLIA&2.16.840.1.113883.19.4.6&ISO^XX^^^1236|3434 Industrial Loop^^Ann Arbor^MI^99999^USA^B|9876543^Slide^Stan^S^^^^^NPPES&2.16.840.1.113883.19. 4.6&ISO^L^^^NPI NTE|1|L|Molecular analysis report has been mailed. NTE|2|L|The assay provides information intended to be used for carrier screening in adults of reproductive age, as an aid in newborn screening, 1 12/07/11 LRI Validation Suite Wiki Cystic Fibrosis Draft Test Messages v1 and as a confirmatory test for another medically established diagnosis in newborns and children. The test is not indicated for use in fetal diagnostic testing, pre-implantation screening, or for any stand-alone diagnostic purposes without confirmation by another medically established diagnostic product or procedure. SPM|1|23456&EHR&2.16.840.1.113883.19.3.2.3&ISO^9700122&Lab&2.16.840.1.113883. 19.3.1.6&ISO||119297000^BloodSpecimen^SCT^^^^20080131|||||||P^Patient^HL6 0369^^^^2.5.1||||||201111301130-0500|201111301130-0500 CFTR gene mutation analysis in Blood or Tissue by Molecular genetics method Narrative 38404-0 Example of reporting in A3 format (Per LabCorp and Quest, this format is not used often) This draft test message has NOT been mapped to the LRI IG. Timing Scenario: The CFTR specimen was collected from patient on November 30, 2011, at 11:30P EST in Ann Arbor. The specimen was analyzed on November 30, 2011, at 1:05P EST. The result report was composed on November 30, 2011, at 1:25P EST, and the result message was created/transmitted on November 30, 2011, at 1:25P EST. MSH|^~\&|Lab1^1234^CLIA|Reliable^1234^CLIA|ELR^2.16.840.1.113883.19.3.2.3^ISO |SPH^2.16.840.1.113883.19.3.2^ISO|201111301325540500||ORU^R01^ORU_R01|20111130132554000005|P^T|2.5.1|||NE|NE|USA||||USELR 1.0^^2.16.840.1.113883.19.9.7^ISO SFT|1|Level Seven Healthcare Software, Inc.^L^^^^&2.16.840.1.113883.19.4.6^ISO^XX^^^1234|1.2|An Lab System|56734||20080817 PID|1||36363636^^^MPI&2.16.840.1.113883.19.3.2.1&ISO^MR^A&2.16.840.1.113883.1 9.3.2.1&ISO~444333333^^^&2.16.840.1.113883.4.1^ISO^SS||Everyman^Adam^A^^^ ^L^^^^^^^BS|Mum^Martha^M^^^^M|19750602|M||21063^White^CDCREC^^^^04/24/2007|2222 Home Street^^Ann Arbor^MI^99999^USA^H||^PRN^PH^^1^555^5552004|^WPN^PH^^1^955^5551009|eng^E nglish^ISO6392^^^^3/29/2007|M^Married^HL70002^^^^2.5.1||||||N^Not Hispanic or Latino^HL70189^^^^2.5.1||||||||N|||2008081510000700|Reliable^2.16.840.1.113883.19.3.1^ISO ORC|RE|23456^EHR^2.16.840.1.113883.19.3.2.3^ISO|9700123^Lab^2.16.840.1.113883 .19.3.1.6^ISO|||||||||1234^Admit^Alan^A^III^Dr^^^&2.16.840.1.113883.19.4. 6^ISO^L^^^EI^&2.16.840.1.113883.19.4.6^ISO^^^^^^^^MD||^WPN^PH^^1^555^5551 005|||||||Level Seven Healthcare, Inc.^L^^^^&2.16.840.1.113883.19.4.6^ISO^XX^^^1234|1005 Healthcare Drive^^Ann Arbor^MI^99999^USA^B|^WPN^PH^^1^555^5553001|4444 Healthcare Drive^Suite 123^Ann Arbor^MI^99999^USA^B OBR|1|23456^EHR^2.16.840.1.113883.19.3.2.3^ISO|9700123^Lab^2.16.840.1.113883. 19.3.1.6^ISO|38404-0^CFTR gene mutation analysis in Blood or Tissue by Molecular genetics method Narrative^LN1234^CTFR gene Analysis Report^99RLI^2.36^1^Cystic Fibrosis Gene mutation Report|||2011113011300500||||||fever|||1234^Admit^Alan^A^III^Dr^^^&2.16.840.1.113883.19.4.6^IS O^L^^^EI^&2.16.840.1.113883.19.4.6^ISO^^^^^^^^MD|^WPN^PH^^1^555^5551005|| |||20080818300700|||F||||||1235&Slide&Stan&S&&Dr&MD&&DOC&2.16.840.1.113883.19.4.6&ISO OBX|1|TX|38404-0^CFTR gene mutation analysis in Blood or Tissue by Molecular genetics method Narrative^LN^1234^CTFR gene Analysis Report^99RLI^2.36^1^Cystic Fibrosis Gene mutation Report||Testing of the submitted blood sample revealed presence of the ∆F508 2 12/07/11 LRI Validation Suite Wiki Cystic Fibrosis Draft Test Messages v1 allele.|||A|||F|||201111301130-0500|||||201111301305-0500||||Reliable Labs, Inc^L^^^^CLIA&2.16.840.1.113883.19.4.6&ISO^XX^^^1236|3434 Industrial Loop^^Ann Arbor^MI^99999^USA^B|9876543^Slide^Stan^S^^^^^NPPES&2.16.840.1.113883.19. 4.6&ISO^L^^^NPI SPM|1|23456&EHR&2.16.840.1.113883.19.3.2.3&ISO^9700122&Lab&2.16.840.1.113883. 19.3.1.6&ISO||119297000^BloodSpecimen^SCT^^^^20080131|||||||P^Patient^HL6 0369^^^^2.5.1||||||201111301130-0500|201111301130-0500 3