1. LRI Validation Suite LRI Prototype Tool Demonstration Rob Snelick—NIST January 31st, 2011

2. Overview Validation Tool for LRI (Prototype for trial use) – http://lri.sipilotdevelopment.org/lri-phase-2/ Web Application – Firefox; Chrome; IE9 (in compatibility view enabled) Source code will be public domain Joint effort of NIST and LMCO (ONC) Wiki Page—Validation Suite Resources Google Group – Discussion forum for LRI IG, Pilots, Validation Tool, Tool and Resources Updates, Release Notes, etc – http://groups.google.com/group/hl7v2_lri_testing

3. Timeline Demonstration of “proof of concept” validation tool – Tuesday December 20 th, 2011 – Not for use (review in validation suite meetings) – Based on Ballot 1+ IG version Prototype for trial use – Goal is early February (~2 weeks before HIMSS)—Week of Feb. 13th – Based on IG version 0.15 (locked for Pilots) – Not all functionality and IG requirements included On-going updates – development will continue with periodic releases – Will include errata to IG Version 0.15 Version 1 (“Production Ready”) – 3 months after publication of IG (after ballot 1—i.e., stable IG)** – Not complete number of test cases (5-7 core messages with variation) Version for MU testing—if in ONC rule?? – Fall 2012 (Dependent on final publication of IG)** – 3 Months after final publication **assuming current level of resources

4. LRI Validation Suite Meetings Agenda – Tool updates and status – User Questions/Comments – Test case/message reviews (Users can request test cases to add) – Other topics as needed Current Schedule – February 28 th – March 27 th – April 24 th – May 22 nd Tuesdays, 1:00 PM EST Additional meetings to be added if necessary HL7V2_LRI_Testing Google Group will be used for notification

5. Validation Suite Products (Drafts) Test Case Management Spreadsheet Test Messages Test Plans – LIS Test Plan, EHR Test Plan Testing Methodologies (approach to testing) Vocabulary Spreadsheets (value sets for the IG), XML, and GUI – Including HL7, UCUM, in-scope LOINC, in-scope SNOMED to come – Categorized in-scope LOINC to support testing XML Conformance Profile – Message Template capturing most message constraints (requirements) – LRI IG  MWB  HL7 V2.5.1 XML + CP + CS + Len  HL7 V2.7.1 LRI IG XML Validation Tool (Focus on LRI—i.e., not a general HL7 V2 tool) – LIS Mode Context-Free (test any LRI message) Context-Based (Generated Data Sheets from Test Cases – Scenarios) – Associated with test cases (i.e., test data) – EHR Mode Generated Data Sheets and Juror Documents from Test Cases – Scenarios – Support for NG and GU Profiles (NG initially) Provide feedback to implementation guide analysis group

6. 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.Inherently provides CLIA Testing 6.Targets 1.S & I Framework EHR Pilots 2.Vendor EHR Products 3.MU Certification LRI ORU R01 LRI ACK R01 S & I Framework EHR Pilots Vendor EHR Products Ambulatory EHR Systems 1.EHR Pilots 1.Draft standard trial use (implementation) 2.Verifies LRI IG can be implemented—provide feedback 3.Use LRI test harness to perform conformance testing 4.Function of the S&I Framework LRI Pilots WG 2.Vendor Product EHRs 1.Can use LRI test harness to perform conformance testing 2.LRI Test Harness expected to be used for MU certification Part of validation suite deliverablesAnticipated users of validation suite products

7. LRI Validation – High Level Overview LIS Mode – Context-Free – Context-Based (Generated Data Sheets from Test Cases – Scenarios) EHR Mode – Generated Data Sheets and Juror Documents from Test Cases – Scenarios Conformance Profile Browser Vocabulary Browser

8. LIS (or Proxy) LIS Test Tool  Load  Cut/paste  Send HL7 V2 Lab Results Message Validation Report Context Free Testing: 1.Context free testing will validate a LRI message created by the LIS 2.The context (e.g., the type and results of the lab test) is unknown to the validation tool 3.Therefore not all conformance requirements of the LRI implementation guide can be assessed 4.However, the validation provides a simple and convenient method for testing message structure and most vocabulary Process: 1.An LRI message is created by the vendor’s LIS 2.The message is sent, pasted, or loaded in the test tool 3.A validation is performed LIS Context-Free Testing

9. Phase 1 Core Test Messages Erythrocyte sedimentation rate – 30341-2 OBR.4 LN code – Valid Minimally Populated Message – Final Results – Valid Typically Populated Message – Final Results – Valid Typically Populated Message – Corrected Results – Valid Maximally Populated Message – Final Results CBC W Auto Differential panel in Blood – 57021-8 OBR.4 LN code – Valid Typically Populated Message – Final Results – 27 Results (OBXs) Lipid 1996 panel in Serum or Plasma – 24331-1 OBR.4 LN code – Valid Typically Populated Message – Final Results – 4 Results (OBXs)

10. LIS LIS Test Tool select test case Test Data Sheet Manual entry of test data  Load  Cut/paste  Send HL7 V2 Lab Results Message Use Case Test Case Validation Report EHR transmits Hemoglobin blood test order to the LIS for John Doe along with pertinent demographic and order request data Lab Results Data Sheet John Doe DOB: 05/23/1959 Gender: M Result: 13.7 g/dL Range 13.2 – 16.2 Status: Final and more… A lab test is ordered for a patient The specimen is collected, and is received and processed in the lab The lab result is produced and stored in the LIS database The lab result message is created The lab result is transmitted to an ambulatory EHR The lab result is viewed in the ambulatory EHR Process: 1.A technician enters lab results data into LIS based off the data sheet provided 2.The message is sent, pasted, or loaded in the test tool 3.A validation is performed Context-based Testing: 1.Context-based testing will validate a LRI message created by the LIS 2.The context (e.g., the type and results of the lab test) is known to the validation tool 3.Therefore all conformance requirements of the LRI implementation guide can be assessed 4.Supports various scenarios (F  C, rejected specimen) LIS Context-based Testing

11. EHR Lab Message ACK Validation LRI EHR 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) 4.Printed Reports Inspection Testing Techniques 1.EHR display screens 2.Database access 3.Configuration files Communication Automated Testing Acknowledgement Message Limited Utility LRI Test Message Validation Report Test Data Test Case Use Case Juror Document ACK LRI EHR Testing – Test Harness

12. Conformance Profile Machine processable version of the LRI implementation guide HL7 V2.7.1 Standard Conformance Profile – XML – Chapter 2B – Captures most of the LRI IG requirements Message Structure, usage, cardinality, condition predicates, conformance statements, lengths, etc. – Key differences from V2.5.1 (and not handled by the MWB) Min/max length C(a/b) – configurable conditionals Conformance Statements – NIST added elements for handling condition predicates and conformance statements (not defined in 2.7.1—NIST will propose for V2.9) Support for min/max shortly LRI IG  MWB  HL7 V2.5.1 XML + CP + CS + Length  HL7 V2.7.1 LRI IG XML +

13. Test Case Management Spreadsheet Processor Message Generation Engine Tab Delimited Text File LRI Test Message Generation Context File (XML) Test Data Test Cases Use Case Juror Document (XML) Test Case Management Spreadsheet Validation Context File (XML) EHR Data Sheet (XML) LIS Data Sheet (XML) Message Validation Engine Validation Report LIS Test Plan and LRI Test Tool Message Profile (XML) EHR Test Plan EHR Test Plan and LRI Test Tool LRI Test Tool Message Model Juror Document (HTML Tables) Modifies Message Model Validation Context File (XML) Regenerate Test Case Filter LRI Test Message User Configuration Test Case Management Spreadsheet Processing – Priming the Validation Tool

14. LIS LIS Test Tool select test case Test Data Sheet Manual entry of test data  Load  Cut/paste  Send HL7 V2 Lab Results Message Use Case Test Case Validation Report EHR transmits Hemoglobin blood test order to the LIS for John Doe along with pertinent demographic and order request data Lab Results Data Sheet John Doe DOB: 05/23/1959 Gender: M Result: 13.7 g/dL Range 13.2 – 16.2 Status: Final A lab test is ordered for a patient The specimen is collected, and is received and processed in the lab The lab result is produced and stored in the LIS database The lab result is transmitted to an ambulatory EHR The lab result is viewed in the ambulatory EHR 1.Local code 2.No code—text 3.LOINC code No LOINC given for results Test tool inspects OBX.3 for a specific LOINC code Inspect for 718-7 only or inspect for one of 718-7, 20509-6, 30313-1, 30352-9, 30351-1, and 30350-3? For Discussion: 1.No suggested method given (Should we?) 2.With no method given we should expect one from a set of valid LOINC codes for this order (Lab dependent?) 3.If a specific method is given (is this typical/possible?) then should we look for a specific LOINC code in the sent message? For Discussion: 1.Does the LAB expect a local code for the order in a electronic order request? 2.Use Cases to consider: agreement/no agreement between LIS and EHR for local codes It is assumed Lab has capabilities for manual entry Data Entry DB Message

15. EHR Lab Message ACK Validation LRI EHR Test Harness Communication LRI Test Message Validation Report Test Data Test Case Use Case Juror Document ACK 718-7 (LN) SNameValueREF Range FHemoglobin13.713.2 – 16.2 g/dL For Discussion: 1.What are the requirements on the EHR with regards to LOINC— given the LRI IG, CLIA, and meaningful use? 2.What are the EHR display (GUI) requirements for the received lab results? 3.What are the EHR storage requirements for the received lab results? 4.Given that the LOINC code is likely to be translated into the EHR internal representation, what lab test names need to be displayed in exact form and what lab test names can be displayed in an equivalence text (same concept)? 5.What qualifies as “equivalence—same concept”? How is that determined? Can it be? Expert inspector only? Should displaying of the LOINC text (only) be the requirement—i.e., no mapping? 6.What is the impact of sending only the LOINC code (i.e., no local code) on testing? Translated into internal representation Displayed as internal display text representation