1. EHR-S Functional Requirements IG: Lab Results Interface Laboratory Initiative

2. Meeting Etiquette Remember: If you are not speaking keep your phone on mute Do not put your phone on hold – if you need to take a call, hang up and dial in again when finished with your other call This meeting, like all of our meetings, is being recorded –Another reason to keep your phone on mute when not speaking! Feel free to use the “Chat” or “Q&A” feature for questions or comments Please announce your name prior to making comments or suggestions during the meeting NOTE: This meeting will be recorded and posted to the S&I wiki From S&I Framework to Participants: Hi everyone: remember to keep your phone on mute 2

3. Agenda Welcome & Introductions S&I Framework Overview Purpose and Goals Deliverables Meeting Logistics Q&A 3

4. Welcome and Introductions Welcome to the launch of the EHR-S Functional Requirements for Laboratory Data sub-workgroup Continues the collaborative efforts of ONC and HL7 in establishing standards in support of US healthcare goals SWG leadership and support team members –John Feikema – Initiative Coordinator –Bob Yencha – Initiative Facilitator –Riki Merrick – Community Co-lead/ HL7 O&O Workgroup Co-Chair –Bob Dieterle – Community Co-lead

5. Background Although specifications exist for the content of exchange, there are no formal standards that describe how systems should consume, manage, interpret and present laboratory information. Lessons learned indicate further guidance is required for interoperability across the US healthcare eco-system –Variability in the way systems implement the specifications puts a burden on exchange partners to support multiple interfaces and mediate merging within the patient record Certification criteria for EHR products under Meaningful Use and other regulatory rules (CLIA, HIPAA, etc.) introduce overlapping system and data requirements while providing minimal or no guidance on how to consistently manage data across organizations Development of test tools is challenging given the potential multiple interpretations of the specifications 5

6. Purpose and Goals Undertake the development of the “EHR System (EHR-S) Functional Requirements Implementation Guide: Laboratory Results Interface (LRI)” –Provide clarity for EHR technology vendors on the expectations for incorporation of data elements sent within a lab results message Establish standardized functional requirements and implementation guidance for an EHR-S in receipt of laboratory results using the HL7 Version 2.5.1 Implementation Guide: S&I Framework Lab Results Interface, Release 1 – US Realm (LRI)HL7 Version 2.5.1 Implementation Guide: S&I Framework Lab Results Interface, Release 1 – US Realm Describe the minimum system functional requirements for the handling of results data based on: –Patient safety –Best clinical practices –Regulatory requirements 6

7. Purpose and Goals (cont) The set of requirements are considered a base, not a limit –Expect products to provide additional functionality and capabilities Initial focus are laboratory results sent from an LIS to an EHR-s using an HL7 V2.5.1 Message that conforms to the LRI IG Subsequent phases will cover laboratory orders sent from an EHR-S to an LIS and the receipt and proper use of a laboratory’s electronic Directory of Services (eDOS) –HL7 Version 2.5.1 Implementation Guide: S&I Framework Laboratory Orders from EHR, Release 1 US Realm (LOI)HL7 Version 2.5.1 Implementation Guide: S&I Framework Laboratory Orders from EHR, Release 1 US Realm –HL7 Version 2.5.1 Implementation Guide: S&I Framework Laboratory Test Compendium Framework R2, Release 1.1 - US Realm (eDOS)HL7 Version 2.5.1 Implementation Guide: S&I Framework Laboratory Test Compendium Framework R2, Release 1.1 - US Realm 7

8. Deliverables HL7 EHR Functional Model Profile: Laboratory-related Information –Based on the HL7 EHR Functional Model, this artifact will define an EHR functional model Profile for laboratory-related data and will inform the development of the Functional Requirements IG –Will be submitted for comment and revision via the HL7 Ballot process. EHR System (EHR-S) Functional Requirements Implementation Guide: Laboratory Results Interface (LRI) –This artifact will be submitted for comment and revision via the HL7 Ballot process with expectation of submitting as DSTU to ONC for consideration in a future rule Input to the HL7 conformance framework for assessment –As the IG and Functional Model Profile are developed, the SWG will provide feedback to the HL7 Conformance and Guidance for Implementation Testing (CGIT) WG and to test tool developers (NIST, et al) on specific needs to enable validation of implementations that declare conformance to these artifacts 8

9. Meeting Logistics Title: EHR-S Functional Requirements IG: Lab Date and Time: Every Monday 1:30PM – 3:00PM ET Dial In: +1-650-479-3208 Access code: 662 898 104 (code is the same every week) https://siframework1.webex.com/siframework1/onstage/g.p hp?t=a&d=662898104https://siframework1.webex.com/siframework1/onstage/g.p hp?t=a&d=662898104 Updates and discussion materials will be posted to the EHR-S Functional Requirements Implementation Guide - Lab Results Interface wiki EHR-S Functional Requirements Implementation Guide - Lab Results Interface We encourage you to “join the activity” by completing the form accessed via the “Join the Initiative” tab at the above site 9

10. Q&A