July 8, 2011

1. Lab Results Interface Validation Suite Workgroup and Pilots WorkgroupVision, Charter, NIST Collaboration, July 8, 2011 1

2. LRI Validation Suite and Pilots Vision • 100 % Open-source, hosted at OHT, re-using existing open-source packages • LRI Validation Suite Tools • NIST Lab Test Tools (including LRI-compliant LIS) • EHR Implementation based on new LRI Implementation Guide and LRI Use Case: consuming, decomposing/parsing, understanding and displaying HL7 V2 test result messages • Visual Validation Tool capable of ensuring CLIA compliance prior to LIS/EHR Certification • Pilot Testing ensures correct usage of new vocabularies: UCUM, LOINC and SNOMED 2

3. Charter of the LRI Validation Suite Workgroup • Purpose • The primary purpose of the Lab Results Interface (LRI) Validation Suite Workgroup is to test whether the LRI specifications, as represented in the LRI Implementation Guide (IG), are readily implementable by Laboratory Information Systems (LISs) and Electronic Health Records (EHRs). The results are needed before the LRI IG is recommended by ONC for incorporation into the Meaningful Use (MU) Stage 2 final rule. • The secondary purpose of the LRI Validation Suite Workgroup is to produce a set of tools useful to makers of LISs and EHRs for the purpose of integrating the functionality specified in the LRI IG into their products. • Scope • The scope of the LRI Validation Suite will be to support the LRI pilots by providing validation suite tools that accurately consume, process, and display LRI-compliant HL7 V2 messages. The laboratory results messages will be generated by a Lab Test Tool to be used by an EHR System. Additionally a Validation Suite EHR Implementation will successfully consume, process and display the HL7 messages (in a CLIA-compliant fashion) based upon laboratory results messages electronically generated by the LIS System. • Objectives • Short-Term 1. Specify, design and implement the LIS/EHR Laboratory Test Interface for the LRI , and make it available to LRI Pilots. • 2. Integrate the Validation Suite EHR Implementation with the Lab Test Tool, which will generate the LRI-compliant HL7 V2 messages. • 3. Design and implement the CLIA Visual Validation Tool, for testing whether LRI EHRs are compliant with CLIA requirements. • 4. Provide feedback to the LRI IG Workgroup and the LRI Vocabulary Workgroup on the results of the ONC EHR RI testing. Of particular importance is accessing whether the OIDS, UCUM, SNOMED CT and LOINC vocabulary constraints in the LRI message conformance profiles are implementable. • Long-Term 1. Support ONC NHIN as they draft the MU Stage 2 requirements. 3

4. Charter of the LRI Pilots Workgroup • Purpose • The LRI Pilots Workgroup will support the LIS and EHR community in integrating and demonstrating the toolset provided by the LRI Validation Suite to (1) validate the ability of LIS and EHR systems to send and receive LRI-compliant lab test messages and (2) to determine the extent of EHR compliance with the CLIA requirements. • Scope • The scope of the LRI Pilots will be to demonstrate at a production level the transport of LRI-compliant laboratory results from LISs to ambulatory EHRs. • Objectives • Short-Term 1. Pilot testing of the LISs and EHRs that have agreed to implement the LRI IG specifications. • 2. Pilot LIS and EHR systems may use the LRI Validation Suite • 3. Build a list of potential Pilot participants • 4. Capture best practices from existing Lab Pilots • Long-Term 1. Support ONC NHIN as they draft the MU Stage 2 requirements 4

5. NIST – LRI Workgroup Collaboration NIST develops the Lab test tool (suitable for both testing Validation Suite EHR implementation and for MU Phase 2 certification) LRI Workgroups develop the Validation Suite EHR Implementation (aka ‘ONC EHR RI’ above) LRI Workgroups provide expertise on realistic lab data for creating test messages; NIST can manage the test data and has initial test data that needs to be verified LRI Workgroups can help validate the test procedure, methodology, and Lab test tool LRI Conformance Message Profiles (XML documents) are generated from the new LRI Implementation Guide (e.g., by using Message Workbench) NIST MU Test Procedures and ATCB Test Scripts for MU Phase 2 Certification have longer timeline Lab Test Tool design and development leveraged to meet LRI Pilot testing requirements 5

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7. LRI Validation Suite and Pilots – LRI Architecture WG Dependencies • LRI Architecture WG Deliveries • Validation Suite • LRI Abstract Model • LRI Policies and Services based on Use Cases and Implementation Guide • LRI Deployment Models • LIS and EHR Architecture (NIST will contribute to LIS Architecture) • Additional TBD (i.e., CLIA Specification Requirements) • Pilots • LRI Abstract Model • LRI Policies and Services based on Use Cases and Implementation Guide • LRI Deployment Models 7

8. LRI Validation Suite and Pilots – NIST Dependencies • NIST Deliveries • Current NIST Lab Test Tool Architecture • NIST provides Lab Test Tool and shared source code • XML Conformance Profiles generated from the LRI Implementation Guide 8