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LRI Validation Suite Meeting

LRI Validation Suite Meeting. Prototype Tool Demonstration December 20th, 2011. Agenda. Administrative Validation Suite Products Overview Tool Demonstration – Early Prototype Joint effort of NIST and LMCO (ONC). Timeline. Demonstration of “proof of concept” validation tool

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LRI Validation Suite Meeting

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  1. LRI Validation Suite Meeting Prototype Tool Demonstration December 20th, 2011

  2. Agenda • Administrative • Validation Suite Products Overview • Tool Demonstration – Early Prototype • Joint effort of NIST and LMCO (ONC)

  3. Timeline • Demonstration of “proof of concept” validation tool • Tuesday December 20th, 2011 • Not for use (review in validation suite meetings) • Ballot 1+ IG version • Prototype for trial use • Goal is early February (~2 weeks before HIMSS) • Ballot 1++ IG version (locked for Pilots—Today??) • Version 1 • 3 months after publication of IG (after ballot 1) • Limited number of test cases • Version for MU testing • Fall 2012 (Dependent on final publication of IG) • 3 Months after final publication

  4. Validation Suite Products (Drafts) • Test Case Management Spreadsheet • Test Messages • LIS Test Plan • EHR Test Plan • Testing Methodologies • Vocabulary Spreadsheet (value sets for the IG) • Including HL7, UCUM, in-scope LOINC, in-scope SNOMED to come • Categorized in-scope LOINC to support testing • XML Conformance Profile • LRI IG  MWBHL7 V2.5.1 XML + CP + CS  HL7 V2.7.1 LRI IG XML • Validation Tool • 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 • Provide feedback to implementation guide analysis group

  5. LRI Validation Suite WG Charter Overview NIST LRI Test Tool Ambulatory EHR ONC S&I Framework Test Data LRI ORU R01 S & I Framework EHR Pilots LIS LRI Validation Tool EHR LRI Test Harness LRI ACK R01 Vendor EHR Products • NIST LRI Test Tool • Suite scope limited to the requirements specified in the LRI IG • Develop test data • provided & verified by the S&I Framework community • LIS LRI Validation Tool • Used to validate vendor LIS systems & Test Harness • Develop a test plan • Capture and validate LIS LRI messages • EHR LRI Test Harness • Used to validate EHR systems • Develop a test plan • Simulation of an LIS system • Manage, Send, Receive LRI Messages • Inherently provides CLIA Testing • Targets • S & I Framework EHR Pilots • Vendor EHR Products • MU Certification • Ambulatory EHR Systems • EHR Pilots • Draft standard trial use (implementation) • Verifies LRI IG can be implemented—provide feedback • Use LRI test harness to perform conformance testing • Function of the S&I Framework LRI Pilots WG • Vendor Product EHRs • Can use LRI test harness to perform conformance testing • LRI Test Harness expected to be used for MU certification Part of validation suite deliverables Anticipated users of validation suite products

  6. 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

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

  8. LIS Context-based Testing • Context-based Testing: • Context-based testing will validate a LRI message created by the LIS • The context (e.g., the type and results of the lab test) is known to the validation tool • Therefore all conformance requirements of the LRI implementation guide can be assessed • 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 Use Case Test Case EHR transmits Hemoglobin blood test order to the LIS for John Doe along with pertinent demographic and order request data Manual entry of test 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… Test Data Sheet LIS HL7 V2 Lab Results Message • Load • Cut/paste • Send • Process: • A technician enters lab results data into LIS based off the data sheet provided • The message is sent, pasted, or loaded in the test tool • A validation is performed LIS Test Tool select test case Validation Report

  9. LRI EHR Testing – Test Harness Use Case • Inspection Testing can be performed by: • On-site inspection • Over a webex like technology • Screen-scraper or screen-capture (include clock) • Printed Reports LRI EHR Test Harness Test Case Inspection Testing Techniques EHR display screens Database access Configuration files Test Data Juror Document LRI Test Message Lab Message EHR Communication ACK ACK Automated Testing Acknowledgement Message Limited Utility Validation Report Validation

  10. 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, CP, CS, • Key differences from V2.5.1 (and not handled by the MWB) • Min/max length • C(a/b) – configurable conditionals • 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 +

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

  12. 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 • For Discussion: • Does the LAB expect a local code for the order in a electronic order request? • Use Cases to consider: agreement/no agreement between LIS and EHR for local codes Use Case Test Case Manual entry of test data EHR transmits Hemoglobin blood test order to the LIS for John Doe along with pertinent demographic and order request data It is assumed Lab has capabilities for manual entry Local code No code—text LOINC code DB Lab Results Data Sheet John Doe DOB: 05/23/1959 Gender: M Result: 13.7 g/dL Range 13.2 – 16.2 Status: Final • 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? Test Data Sheet LIS Data Entry Message No LOINC given for results HL7 V2 Lab Results Message • Load • Cut/paste • Send • For Discussion: • No suggested method given (Should we?) • With no method given we should expect one from a set of valid LOINC codes for this order (Lab dependent?) • If a specific method is given (is this typical/possible?) then should we look for a specific LOINC code in the sent message? LIS Test Tool select test case Validation Report

  13. For Discussion: • What are the requirements on the EHR with regards to LOINC—given the LRI IG, CLIA, and meaningful use? • What are the EHR display (GUI) requirements for the received lab results? • What are the EHR storage requirements for the received lab results? • 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)? • 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? • What is the impact of sending only the LOINC code (i.e., no local code) on testing? Use Case LRI EHR Test Harness Test Case Test Data Juror Document 718-7 (LN) LRI Test Message 718-7 (LN) Lab Message EHR Communication Displayed as internal display text representation ACK 718-7 (LN) ACK Validation Report Validation Translated into internal representation

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