1. Lab Results Interface Validation Suite WG July 28, 2011

2. Agenda Purpose Review of Architecture Workgroup Administration Timeline Next Steps

3. Purpose –Provide Specifications and Project Management for the LRI Validation Suite –Provide a suite of HL7 v2 validation tools for testing LRI conformance –Provide a set of test data (LRI-compliant HL7 v2 lab result reports) –Provide tools for evaluating CLIA compliance of lab test reports (42 CFR §493.1291)

4. High Level Architecture CLIA Specifications Checklist Tool

5. Workgroup Administration Workgroup Meeting Time Committed Member Registration –Workgroup Co-Chairs Rob Snelick (NIST) TBD (volunteer needed) –Join S&I Framework Wikispaces Site –Register as committed member –Join LRI Validation Suite Work Group to support NIST Tool CLIA Specification Checklist Tool –Requirements Definition and Development Test data, test cases, and testing Consensus Process for Document Approval

6. Volunteer Opportunities Programming Analysis & Design Specific tool knowledge Domain expertise –HL7 v2 –Vocabularies: UCUM, LOINC, OIDs, SNOMED CT –CLIA Requirements –Meaningful Use Requirements Test data and test cases Validation of results User-acceptance

7. LRI Timeline Jul 2011 May 2011 Jun 2011 Immediate Next 90 Days Short Term 3 to 9 months Long Term 9 to 36 months Initiative LRI Validation Suite Workgroup Lab Results Interface Initiative (other WGs) Immediate Initiatives Short Term Initiatives Long Term Initiatives LRI Arch WG Artifacts Aug-Sep 2011 Oct-Nov 2010 4Q 20111Q 2012 2Q 2012 LRI Use Case finalized Stage 2 Meaningful Use - Final Software Architectural Design Validation Suite Code Development Stage 2 MU -Draft Lab Test Tool -R1 LRI Vocab WG Artifacts LRI Implementation Guide Draft delivered LRI Pilots Test Plan Test Data- Set 1 Lab Test Tool Prototype Test Data- Set 2 Lab Test Tool -Final

8. Planned Activities Types of Tasks –Analysis –Design –Development –Verification Areas of Focus –Testing Methodologies –Test Plans –Test Data –Vocabulary –LIS Test System –EHR LRI Reference Implementation For each area of focus we’ll perform an analysis and design to identify specific tasks Some areas of focus will become sub-groups (e.g., test data)

9. Overview of Focus Areas I Testing Methodologies –LIS systems and EHRs supporting the LRI implementation guide –Approaches Inspection Testing, Automated Tested, Combination How do we test vocabulary? Test Plans –LIS systems and EHRs supporting the LRI implementation guide –End-to-end process –Range of test cases Test Data –Identify common-typical use cases from in-scope lab results –Support the range of message content (e.g., multiple results in a single message) –Data must be relevant and realistic (e.g., use correct code for result) –Community to decide level that is important, breadth, and depth

10. Overview of Focus Areas II Vocabulary –Collect and organize all specified vocabulary –Develop a common format to represent and provide APIs to access –Common component for tooling Lab System Test Tools –LIS Validation Engine –LIS Simulation Test Harness to test EHR systems Generate/Send messages to EHR System Create/Generate testing artifacts EHR Reference Implementation –At minimum capable of parsing, mapping, and displaying received lab results –Verify that the LRI IG is implementable –Phase 2 may add functionality (e.g., generate a PH lab message)

11. Topics for Next Meeting Clarify questions on architecture Determine code contribution process Communication channels and collaboration Present draft detailed design

12. Homework Sign up for Wiki and Work Group –Indicate where you can help out Review LRI Architecture Review existing NIST Meaningful Use HL7 v2 tools Post feedback on Discussion tab

13. VIRTUAL ROUND – QUESTIONS, COMMENTS, CONCERNS?