1. LRI Validation Suite LRI Validation Suite Meeting Rob Snelick—NIST April 24th, 2012

2. Agenda Tool status and plans LRI DSTU Version—demonstration of use – LIS validation is focus today LRI DSTU Errata Schedule -- Tuesdays, 1:00 PM EST – Next meeting: May 22nd (focus is EHR validation) – Additional meetings to be added if necessary – HL7V2_LRI_Testing Google Group will be used for notification

3. Tool Status and Plans Validation Tool for LRI (Release 1 for trial use) LRI IG DSTU Version – lri-dstu– – http://lri.sipilotdevelopment.org/lri-dstu/ http://lri.sipilotdevelopment.org/lri-dstu/ Notes: – Addresses LRI IG DSTU version submitted for ballot April 9 th, 2012 (Plus Errata) – All technical requirements for LIS validation incorporated – More testing needed and some odds and ends need addressed – Next target is May 22 nd —EHR functionality and Test Plan updated – Start to move into the phase of adding test cases However, the framework is in place – Changes to the tool will still be made; notice of such changes to be announced on the LRI Testing Google Group

4. Resources Tool Documentation Tab – Test plans, messages, profiles, and other testing artifacts Wiki Page—Validation Suite Resources – Latest version of test plans, messages, meeting minutes, etc 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

5. Plans Update EHR Validation – Test Plan, Juror Documents, Work flow, Communication Testing the validation tool – We need community feedback! – Get a head start on MU-2 certification More Test Cases (Test Coverage Matrix) – Lab Test Scope (to cover vocabulary recommendations) – Scenario test cases (e.g., P  F  C) – Technical requirements (e.g., Snapshot processing) – “Negative” testing User’s Guide and other documentation Exploring/Considering LOI and Compendium Validation – Depending on NIST resources/time

6. LRI Validation Tool Highlights Web Application LIS and EHR Validation Context-free and context-based testing Test Plans and Test Cases for LIS and EHR Example/Test messages Conformance Profile Browser (on-line requirements) Vocabulary Browser (Searchable) Supports IG vocabulary – HL7, LONIC, UCUM, SNOMED, & external tables Support IG Profile Variations – Globally and Non-globally Unique Identifiers Profiles – Order Placer/Filler Number Unique and Order Placer/Number non-unique Profiles

7. Phase 1 Core Test Cases/Messages Supports both NG and GU versions: 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 – Valid Specimen Reject Message 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) Culture Results Reporting (Relating OBX segments) – Final review needed – 625-4 OBR.4 LN code Culture and Susceptibility Results Reporting (Parent/Child Relationships) – Final Review Needed – 625-4 OBR.4 LN code – RU and RN Profile Versions

8. Tool Demonstration Big Picture – Validation Options – Profile Viewer – Vocabulary Browser – Documentation LIS Context-free Message Validation – Supported Profiles LIS Context-based Validation – Test Plan/Test Cases Overview – Data Sheet – Expected Validation Results

9. 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 1.Test any LRI message created by the LIS 2.Select “Message Validation” Tab 3.Select profile version (e.g., 4.Enter test messages into validation tool 5.Validation results appear

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. 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

13. 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

14. 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