LRI Validation Suite Meeting September 06, 2011

Agenda Test data update – Selection of core message set Update Review validation discussion page – Mapping lab results and LOINC Review of EHR Test Plan Template Update on LIS Test Plan Template Face-to-Face Questionnaire NIST/LMCO meeting Tooling Juror Document/Spreadsheet Analysis – Identify other MU requirements we can leverage (e.g., usability) – Mapping CLIA requirements to HL7 Elements – Identifying Reportable Conditions to PH Lab Results Planning

Categorization of Tests The 144 individual tests in the final version of the list can be clinically organized into six clinical lab test categories. These are: 1)Common Hematology tests (16), 2)Urinalysis test (1), 3)Common Chemistry tests (34), 4)Special Chemistry tests (27), 5)Microbiology tests (50), plus antibiotic susceptibility tests (7), and 6)Other Clinical Lab tests (9).

20 Common Tests 1.CBC and WBC Differential/Morphology, 2.Urinalysis, and 3.Comprehensive Metabolic Panel (CMP) – Quest Diagnostics Directory of Services and Specimen Collection Guide of May, 2008 the CMP included 17 items: – Calcium; BUN; Creatinine; BUN/Creatinine Ratio (a calculated value); Total Protein; Albumin; Globulin; Albumin/Globulin Ratio (a calculated value); Bilirubin, Total; Glucose; Alkaline Phosphatase; AST; ALT; Sodium; Potassium; Chloride; CO2.

LOINC-RELMA List for Hemoglobin LOINC #ComponentProperty Time Aspect SystemScale Ex. UCUM UnitsEx. UnitsClassLong Common Name Order/ObsType Oxyhemoglobin/Hemoglobin.totalMFrPtBldQn %CHEMFractional oxyhemoglobin in Blood Observation Oxyhemoglobin/Hemoglobin.totalMFr8H^maxBldAQn %PULMFractional oxyhemoglobin in 8 hour maximum Arterial blood Oxyhemoglobin/Hemoglobin.totalMFr8H^minBldAQn %PULMFractional oxyhemoglobin in 8 hour minimum Arterial blood Oxyhemoglobin/Hemoglobin.totalMFrPtBld.preductalQn% %PULMFractional oxyhemoglobin in Blood Preductal Oxyhemoglobin/Hemoglobin.totalMFrPtBld.postductalQn% %PULMFractional oxyhemoglobin in Blood Postductal Oxyhemoglobin/Hemoglobin.totalMFrPtBldAQn %CHEMFractional oxyhemoglobin in Arterial blood Observation Oxyhemoglobin/Hemoglobin.totalMFrPtBldCQn %CHEMFractional oxyhemoglobin in Capillary blood Observation Oxyhemoglobin/Hemoglobin.totalMFrPtBldVQn %CHEMFractional oxyhemoglobin in Venous blood Observation Oxyhemoglobin/Hemoglobin.totalMFrPtPlasQn %CHEMFractional oxyhemoglobin in Plasma Observation Oxyhemoglobin/Hemoglobin.totalMFrPtBldCoVQn % of totCHEMFractional oxyhemoglobin in Venous cord blood Observation Oxyhemoglobin/Hemoglobin.totalMFrPtBldCoAQn % of totCHEMFractional oxyhemoglobin in Arterial cord blood Observation Oxyhemoglobin/Hemoglobin.totalMFrPtBldMVQn % of totCHEMFractional oxyhemoglobin in Mixed venous blood Observation1 No Method listed in RELMA for any of these tests

Testing Options/Policy LOINC #ComponentProperty Time Aspect SystemScaleEx. UCUM Units Ex. UnitsClassLong Common NameOrder/Obs Type Oxyhemoglobin/Hemoglobin.totalMFrPtBldQn% %CHEMFractional oxyhemoglobin in BloodObservation Oxyhemoglobin/Hemoglobin.totalMFr8H^maxBldAQn% %PULMFractional oxyhemoglobin in 8 hour maximum Arterial blood Oxyhemoglobin/Hemoglobin.totalMFr8H^minBldAQn% %PULMFractional oxyhemoglobin in 8 hour minimum Arterial blood 2 OBR|1|111325^EHR^ ^ISO| ^Lab^ ^ISO|718- 7^Hemoglobin^LN||| |||||||||100^Hippocrates^Harold|||||| ||CH| F|NA&Not Applicable&LB OBX|1|NM| ^Hemoglobin.Total^LN||^12.4|g/dL^grams per deciliter^UCUM|12.0 to 16.0||||F||| |||||||||Effective Labs, Inc^^^^^DRSD& &ISO^XX^^^6543|3434 Test Loop^^Ann Arbor^MI^48103^^B Depending on what the order is, what are possible test results? Are there more than one valid test result base on local conventions, etc.? Potential Test Case Policy: In the data sheet (test case) we can allow any of these to be selected. This assumes that nothing else in the message needs to be changed. It would be an easy way to provide the capability to tests all of these LOINC codes with minimal effort. The Long Common Name is the differentiator. One of the determining factors likely will be whether or not the same result value can be used for all of the various versions of Oxyhemoglobin/Hemoglobin.total. Issues/Comments: Other data elements in the HL7 message might also need to be test-specific. For example, if data for the SPM-4: Specimen Type and SPM-8: Specimen Source are included in the message, then the same message probably could not be used for all of the versions of Oxyhemoglobin/Hemoglobin.total. OBX-7: Reference Range also might be a limiting factor if venous blood and arterial blood result values have normal ranges that don’t overlap. The LOINC code is the anchor that discretely and accurately identifies the lab test that was ordered/performed. No matter what a hospital or physician chooses to call the test, the LOINC code is the one constant that tells everyone which it test was. For our purposes, we’ll need to be sure that all of the data for the data elements in the HL7 message are appropriate for the test indicated by the LOINC code.

Reporting Format Requirement 1.Tests and/or components with numeric results, units, and normal ranges 2.Tests and/or components with a limited set of textual results with or without normal ranges 1.positive/negative/indeterminate, resistant/intermediate/susceptibility 2.cytology / anatomic pathology 3.mutation type and location 4.organism name 3.Tests with defined structure in Observation Result Segment OBX-3 through OBX-8 for the reporting of Culture Results and Antimicrobial Sensitivities 4.Semi Structured or Unstructured components or results Tests and/or components reported in a PDF or data blob 1.The 4th reporting format may be utilized in the cases where structured data does not apply (e.g. images).

Note on the use of LOINC The list of tests has been organized by order panel or, for micro related tests, by target organism for easier readability. The LOINC terms included here are considered examples only – though they may be the more common LOINC terms, each laboratory needs to be sure to map their own tests to the most appropriate LOINC, even if it is NOT on this list. This is NOT an exclusive list of LOINC terms – ANY valid LOINC should be accepted in data exchange projects based on this specification.

Action List: Initial Set of Test Data Select at least one test from first 5 clinical test categories – Category 6 is “others” Include: – CBC and WBC Differential/Morphology, (2 results) – Urinalysis, and (1 result) – Comprehensive Metabolic Panel (CMP) (17 Results) Include test to cover the 4 (3 ??) reporting formats – However, the second format is not in the test list Create coverage mapping table of tests/LOINC codes – Results (1 to many LOINC codes—how do we handle, document?) Get sample messages – Example from IG – NIST Related set of test data – Messages to be verified Finish test case for one simple message

Examples From IG LEAD LABORATORY RESULT MESSAGE CAMPYLOBACTER JEJUNI ANIMAL RABIES HEPATITIS C VIRUS Example: Minimal Message Culture Results – stool culture – Three pathogens: Campylobacter jejuni, Salmonella and Shigella. Examples of Culture and Susceptibility Results LINKING PARENT AND CHILD RESULTS

LEAD LABORATORY RESULT MESSAGE MSH|^~\&|Lab1^1234^CLIA|^1234^CLIA|ELR^ ^ISO|SPH^ ^ISO| ||ORU^R01^ORU_R01| |P^T|2.5.1|||NE|NE|USA||||USELR1.0^^ ^ISO SFT|1|Level Seven Healthcare Software, Inc.^L^^^^& ^ISO^XX^^^1234|1.2|An Lab System|56734|| PID|1|| ^^^MPI& &ISO^MR^A& &ISO~ ^^^& ^ISO^SS||Everyman^Adam^A^^^^L^^^^^^^BS|Mum^Martha^M^^^^M| |M|| ^White^CDCREC^^^^04/24/2007|2222 Home Street^^Ann Arbor^MI^99999^USA^H||^PRN^PH^^1^555^ |^WPN^PH^^1^955^ |eng^English^ISO6392^^^^3/29/2007|M^Marrie d^HL70002^^^^2.5.1||||||N^Not Hispanic or Latino^HL70189^^^^2.5.1||||||||N||| |Reliable^ ^ISO NK1|1|Mum^Martha^M^^^^L|MTH^Mother^HL70063^^^^2.5.1| 444 Home Street^Apt B^Ann Arbor^MI^99999^USA^H|^PRN^PH^^1^555^ PV1|1|O|4E^234^A^Good Health Hospital& &ISO^N^N^Building 1^4^Nursing unit 4 East^1234&& &ISO^& &ISO|R|||||||||||||||||||||||||||||||||||||||| | PV2|||1^Sick^99AdmitReason|||||||||||||N||||||||Level Seven Healthcare, Inc.^L^^^^& ^ISO^XX^^^1234||| ||| ORC|RE|23456^EHR^ ^IS O| ^Lab^ ^ISO|||||||||1234^Admit^Alan^A^III^Dr^^^& ^ISO^L^^^EI^& ^ISO^^^^^^^^MD||^WPN^PH^^1^555^ |||||||Level Seven Healthcare, Inc.^L^^^^& ^ISO^XX^^^1234|1005 Healthcare Drive^^Ann Arbor^MI^99999^USA^B|^WPN^PH^^1^555^ |4444 Healthcare Drive^Suite 123^Ann Arbor^MI^99999^USA^B OBR|1|23456^EHR^ ^ISO| ^Lab^ ^ISO| ^Lead BldC- mCnc^LN^ ^Blood lead test^99USI^2.24||| ||||||diarrhea|||1234^Admit^Alan^A^III^Dr^^^& ^ISO^L^^^EI^& ^ISO^^^^^^ ^^MD|^WPN^PH^^1^555^ ||||| |||F||||||787.91^ DIARRHEA^I9CDX^^^^07/09/2008|1235&Slide&Stan&S&&Dr&MD&&DOC& &ISO OBX|1|NM| ^Lead BldC-mCnc^LN^^^^2.24|1|50|ug/dL^micro-gram per deci-liter^UCUM^^^^1.6|<10 ug/dL|H|||F||| ||||| ||||Lab^L^^^^CLIA& &ISO^XX^^^1236|3434 Industrial Loop^^Ann Arbor^MI^99999^USA^B| ^Slide^Stan^S^^^^^NPPES& &ISO^L^^^NPI SPM|1|23456&EHR& &ISO^ &Lab& &ISO|| ^Capillary blood specimen^SCT^BLDC^Blood capillary^HL70070^ ^2.5.1||HEPA^Ammonium heparin^HL70371^^^^2.5.1|CAP^Capillary Specimen^HL70488^^^^2.5.1| ^Venous structure of digit^SCT^^^^ |||P^Patient^HL60369^^^^2.5.1|50^uL&MicroLiter&UCUM&&&&1.6||||| | OBX|2|NM| ^Age at specimen collection^LN^^^^2.24||3|a^year^UCUM^^^^1.6|||||F||| ||||| ||||Lab^L^^^^CLIA& &ISO^XX^^^1236|3434 Industrial Loop^^Ann Arbor^MI^99999^USA^B| ^Slide^Stan^S^^^^^NPPES& &ISO^L^^^NPI

CAMPYLOBACTER JEJUNI MSH|^~\&|Lab1^1234^CLIA|^1234^CLIA|ELR^ ^ISO|SPH^ ^ISO| ||ORU^R01^ORU_R01| |P^T|2.5.1|||NE|NE|USA||||USELR1.0^^ ^ISO SFT|1|Level Seven Healthcare Software, Inc.^L^^^^& ^ISO^XX^^^1234|1.2|An Lab System|56734|| PID|1|| ^^^MPI& &ISO^MR^A& &ISO~ ^^^& ^ISO^SS||Everyman^Adam^A^^^^L^^^^^^^BS|Mum^Martha^M^^^^M| |M|| ^White^CDCREC^^^^04/24/2007|2222 Home Street^^Ann Arbor^MI^99999^USA^H||^PRN^PH^^1^555^ |^WPN^PH^^1^955^ |eng^English^ISO6392^^^^3/29/2007|M^Marrie d^HL70002^^^^2.5.1||||||N^Not Hispanic or Latino^HL70189^^^^2.5.1||||||||N||| | Reliable^ ^ISO PV1|1|O|4E^234^A^Good Health Hospital& &ISO^N^N^Building 1^4^Nursing unit 4 East^1234&& &ISO^& &ISO|R|||||||||||||||||||||||||||||||||||||||| | PV2|||1^Sick^99AdmitReason|||||||||||||N||||||||Level Seven Healthcare, Inc.^L^^^^& ^ISO^XX^^^1234||| ||| ORC|RE|23456^EHR^ ^ISO| ^Lab^ ^ISO|||||||||1234^Admit^Alan^A^III^Dr^ ^^& ^ISO^L^^^EI^& ^ISO^^^^^^^^MD||^WPN^PH^^1^555^ |||||||Level Seven Healthcare, Inc.^L^^^^& ^ISO^XX^^^1234|1005 Healthcare Drive^^Ann Arbor^MI^99999^USA^B|^WPN^PH^^1^555^ |4444 Healthcare Drive^Suite 123^Ann Arbor^MI^99999^USA^B OBR|1|23456^EHR^ ^ISO| ^Lab^ ^ISO|625-4^Bacteria identified^LN^ ^ CULTURE, STOOL^99USI^2.26||| ||||||diarrhea|||1234^Admit^Alan^A^III^Dr^^^& ^ISO^L^^^EI^& ^ISO^^^^^^ ^^MD|^WPN^PH^^1^555^ ||||| |||F||||||787.91^ DIARRHEA^I9CDX^^^^07/09/2008|1235&Slide&Stan&S&&Dr&MD&&DOC& &ISO OBX|1|CWE|625-4^Bacteria identified:Prid:Pt:Stool:Nom:Culture^LN^^^^2.26|1| ^Campylobacter jejuni^SCT^^^^January 2007||||||P||| |||0086^Bacterial identification^OBSMETHOD^^^^ || ||||GHH Lab^L^^^^CLIA& &ISO^XX^^^1236|3434 Industrial Loop^^Ann Arbor^MI^99999^USA^B| ^Slide^Stan^S^^^^^NPPES& &ISO^L^^^NPI SPM|1|23456&EHR& &ISO^ &Lab& &ISO|| ^Stool specimen^SCT^^^^ |||||||P^Patient^HL60369^^^^2.5.1|10^g&gram&UCUM&&&&1.6||||| |

Example: Minimal Message MSH|^~\&|Lab1^1234^CLIA|^1234^CLIA|ELR^ ^ISO|SPH^ ^ISO| ||ORU^R01^ORU_R01| |P^T|2.5.1|||NE|NE|USA||||USELR1.0^^ ^ISO SFT|1|Level Seven Healthcare Software, Inc.^L^^^^& ^ISO^XX^^^1234|1.2|An Lab System|56734|| PID|1|| ^^^MPI& &ISO^MR^A& &ISO~ ^^^& ^ISO^SS||Everyman^Adam^A^^^^L^^^^^^^BS|Mum^Martha^M^^^^M| |M|| ^White^CDCREC^^^^04/24/2007|2222 Home Street^^Ann Arbor^MI^99999^USA^H||^PRN^PH^^1^555^ |^WPN^PH^^1^955^ |eng^English^ISO6392^^^^3/29/2007|M^Marrie d^HL70002^^^^2.5.1||||||N^Not Hispanic or Latino^HL70189^^^^2.5.1||||||||N||| | Reliable^ ^ISO ORC|RE|23456^EHR^ ^ISO| ^Lab^ ^ISO|||||||||1234^Admit^Alan^A^III^Dr^ ^^& ^ISO^L^^^EI^& ^ISO^^^^^^^^MD||^WPN^PH^^1^555^ |||||||Level Seven Healthcare, Inc.^L^^^^& ^ISO^XX^^^1234|1005 Healthcare Drive^^Ann Arbor^MI^99999^USA^B|^WPN^PH^^1^555^ |4444 Healthcare Drive^Suite 123^Ann Arbor^MI^99999^USA^B OBR|1|23456^EHR^ ^ISO| ^Lab^ ^ISO| ^Lead BldC- mCnc^LN^ ^Blood lead test^99USI^2.24||| ||||||diarrhea|||1234^Admit^Alan^A^III^Dr^^^& ^ISO^L^^^EI^& ^ISO^^^^^^ ^^MD|^WPN^PH^^1^555^ ||||| |||F||||||787.91^DIARRHEA^I9CDX^^^^07/09/2008|1235&Slide&Stan&S&&Dr&MD&&DOC& &ISO OBX|1|NM| ^Lead BldC-mCnc^LN^^^^2.24||50|ug/dL^micro-gram per deci-liter^UCUM^^^^1.6|<10 ug/dL|H|||F||| ||||| ||||Lab^L^^^^CLIA& &ISO^XX^^^1236|3434 Industrial Loop^^Ann Arbor^MI^99999^USA^B| ^Slide^Stan^S^^^^^NPPES& &ISO^L^^^NPI SPM|1|23456&EHR& &ISO^ &Lab& &ISO|| ^Capillary blood specimen^SCT^BLDC^Blood capillary^HL70070^ ^2.5.1||HEPA^Ammonium heparin^HL70371^^^^2.5.1|CAP^Capillary Specimen^HL70488^^^^2.5.1| ^Venous structure of digit^SCT^^^^ |||P^Patient^HL60369^^^^2.5.1|50^uL&MicroLiter&UCUM&&&&1.6||||| |