1. LRI Validation Suite Meeting August 16, 2011

2. Agenda Review of LRI Validation Suite Charter/Overview Acquiring test data update Review of proposed test flows EHR capabilities: testing assumptions – Example juror document – Elements EHR required/expected to display – Access to DB – Access to configuration – Automated via CDA/V2 Messages LRI EHR Test Harness test plan LMCO CLIA test tool review Future meetings planning

3. LRI Validation Suite WG Charter Overview Ambulatory EHR ONC S&I Framework Test Data LIS LRI Validation Tool EHR LRI Test Harness NIST LRI Test Tool 1.Suite scope limited to the requirements specified in the LRI IG 2.Develop test data 1.provided & verified by the S&I Framework community 3.LIS LRI Validation Tool 1.Used to validate vendor LIS systems & Test Harness 2.Develop a test plan 3.Capture and validate LIS LRI messages 4.EHR LRI Test Harness 1.Used to validate EHR systems 2.Develop a test plan 3.Simulation of an LIS system 4.Manage, Send, Receive LRI Messages 5.Targets 1.LMCO Reference Implementation 2.Pilots 3.Vendor Products (MU Certification) LRI ORU R01 LRI ACK R01 LMCO EHR RI EHR Pilots Vendor Product EHRs LMCO CLIA Test Tool EHR Centric Tools and Systems 1.LMCO EHR Reference Implementation 1.Develop or adapt an EHR to handle LRI functionality 2.Verifies LRI IG can be implementedprovide feedback 3.Source code could be used by implementers 4.Help verify EHR LRI test cases and testing tool 2.EHR Pilots 1.Draft standard trial use (implementation) 2.Verifies LRI IG can be implementedprovide feedback 3.Can use LRI test harness for testing 4.Function of the S&I Framework LRI Pilots WG 3.Vendor Product EHRs 1.Not in scope for this Validation Suite WG 2.LRI Test Harness expected to be used for MU certification 4. LMCO CLIA Test Tool 1.CLIA requirements tested as part of LRI VS test plan 2.Tool to focus on automation (screen scraper/capture) Part of validation suite deliverablesAnticipated users of validation suite products

4. Test DataRequest & Plan for Use Test data/cases need to be: – Synthetic (probably not anonymized) – Realistic – Relevant (the 137 tests identified by the vocabulary WG) – Identify special test points – Mapped to IG HL7 profile elements – Verified to be valid Initially select a core set of the most important lab tests *types* – Roll out test cases in phasesdevelop template, focus on core set to start – Categorize/group the tests in terms of what they cover with respect to the conformance requirements Will allow us to more effectively select the core set and map test cases to conformance requirements – Acquire and verify test data for identified set – Vary this test data (structure and content) to test the spectrum of technical requirements specified in the IG Remainder of the 137 lab tests would be used to ensure full coverage – limit testing of this set to only the requirements not already address in the exhaustive testing – will allow us to test all requirements in an efficient manner – pilot doesnt have to run through all the 137 different lab result types but collectively should – concern is can we get the community to provide verified test data for all 137 lab results in a timely manner Should seek and leverage existing test plans and test data

5. LIS LRI Validation Tool Test Flow Testing the LIS Use Case Test Case Vendor LIS System LIS Test Tool select test case Validation Report Test Data Sheet Manual entry of test data Load Cut/paste Send HL7 V2 Lab Results Message

6. LIS Test Harness Test Flow Testing the EHR – Model 1 Use Case Test Cases Test Data Juror Document Report Test Message EHR Lab Message ACK Validation LIS Test Harness Inspection Testing can be performed by: 1.On-site inspection 2.Over a webex like technology 3.Screen-scraper or screen-capture (include clock) Inspection Testing Techniques 1.EHR display screens 2.Database access 3.Configuration files Communication Automated Testing 1.Acknowledgement Message 2.Limited Utility

7. LIS Test Harness Test Flow Testing the EHR – Model 2 Use Case Test Case Test Data Juror Document Report Test Message EHR Lab Message ACK Validation CDA Validator Report LIS Test Harness Communication Test data sheet for additional requirements Lab Results CDA Automated Testing 1.Acknowledgement Message 2.Limited Utility Inspection Testing Techniques 1.EHR display screens 2.Database access 3.Configuration files Automated Testing 1.CDA Document 2.High Utility

8. LIS Test Harness Test Flow Testing the EHR – Model 3 Use Case Test Case Test Data Juror Document Report Test Message EHR Lab Message ACK Validation HL7 V2 Validator Report LIS Test Harness Communication Test data sheet for additional requirements HL7 V2 Public Health Message Inspection Testing Techniques 1.EHR display screens 2.Database access 3.Configuration files Automated Testing 1.Acknowledgement Message 2.Limited Utility Automated Testing 1.HL7 Message 2.High Utility

9. Example Juror Form Test ElementPFIN Inspection MethodAutomated Conf Req ID Tester Comment EHR Display DB Query ConfigCDA HL7 V2 to PH Test Type Test Name Test Result Value Test Result Unit of Measure Units Identifier Units Text Units Coding System Date/Time Test Performed Normal Range Abnormal Flag Result Status Specimen Source Specimen Condition Specimen Disposition Susceptibility LOINC Code Date/Time Order Entered Results Rpt/Status Chng - Date/Time Etc. P: Pass F: Fail I: Inclusive N: Not Applicable Proposed Plan: 1.List all primitive data elements in IG 2.Categorized into 5 possible groups 1.EHR Display 2.Access to DB 3.Configuration Inspection 4.CDA Document 5.HL7 V2 Message 3.Separate discussion on how to test vocabulary to come