S&I Framework Laboratory Initiatives Update June 6, 2013

2 Laboratory Orders Interface ENBLING Mission: The Laboratory Orders Interface Initiative is focused on the creation of an Implementation Guide (IG) for the ambulatory setting that builds on the architecture and design of the California HealthCare Foundation’s (CHCF) EHR-Lab Interoperability and Connectivity Specification (ELINCS) Laboratory Orders and the Health Level Seven (HL7) Version Implementation Guide: S&I Framework Lab Results Interface, Release 1 - US Realm (July 2012)(LRI IG). Further, the Initiative seeks to revise HL7’s Electronic Directory of Service (eDOS) Implementation Guide to be consistent with the above mentioned guides (to be covered in future slide) Status: Submitted a DSTU and addressing first round of comments. Received 400 comments back and have responded to 98% of them. Summary of Accomplishments: The Laboratory Orders Initiative has developed an IG that, when broadly adopted by clinical laboratories and ambulatory EHR systems, will obviate the requirement to define a new specification each time an EHR system-LIS orders interface is implemented. Main Deliverables: HL7 V Implementation Guide: S&I Framework Lab Orders Interface, Release 1 – US Realm DSTU - The Laboratory Orders Interface implementation guidance for electronic ordering of laboratory tests in the US Realm.

3 Laboratory Orders Interface ENBLING Relationship to Meaningful Use: While there are no criteria in the 2014 Edition Standard & Certification Criteria related to lab order interfaces, it is hoped that there may be related criteria in the 2016 Edition S&CC. If those objectives were to include standards derived from the LOI Initiative, they would likely reference the HL7 V Implementation Guide: S&I Framework Lab Orders Interface, Release 1 – US Realm DSTU and a future version of the HL7 Version 2 Implementation Guide: Laboratory Test Compendium Framework, Release 1HL7 Version 2 Implementation Guide: Laboratory Test Compendium Framework, Release 1

Laboratory Orders Interface – eDOS Mission: The eDOS sub workgroup is focussed in providing an electronic interchange of a laboratory’s Directory of Services (DOS) in a structured format based on HL7’s master file update found in Chapter 8 of version This implementation guide, initially developed by the members of the American Clinical Laboratory Association’s (ACLA) in conjunction with their Health Information Technology (HIT) Committee, is intended to provide all necessary information to help an Ordering Provider properly request laboratory tests consistent to aide patient diagnosis. The eDOS work effort will: o Validate that the current Informative Implementation Guide meets the objective through a pilot of eDOS o Align the IG with the in-scope tests in the Lab Result Interface (LRI) IG o Incorporate pilot findings to update the Implementation Guide to develop a normative document to be balloted based on HL7’s ANSI process. o The Normative IG is intended to support the efforts of the Lab Order Interface (LOI) IG and the Lab Result Interface (LRI) IG by providing the services necessary to meet the needs of the users of those guides. 4

Overall Lab Initiatives Goals & Assumptions Goal Sync LRI, LOI, eDOS, and ELR IGs and produce Normative versions of each by July 2014  Preference is to pursue Normative as a simultaneous effort, but “July 2014” is tentative and may change  The goal of pilots, is to inform errata for the normative Assumptions 1.The DSTU will serve as the primary for the sync process  LRI IG will be the source reference for format guidance  Lessons learned will be captured for each DSTU 2.Syncing the 4 IGs will be a continuation of the current effort between ONC and HL7 OO 3.The syncing of all 4 IGs will begin after completion of each DSTU and simultaneously with the pilot process 5

Status of Laboratory Implementation Guides  HL7 Version Implementation Guide: S&I Framework Lab Results Interface, Release 1 – US Realm (LRI IG) o Published July 2012  HL7 Version Implementation Guide: Laboratory Orders Interface for US Realm, Release 1 – US Realm (LOI IG) o 1st ballot was Jan 2013 and ballot reconciliation is in progress now o Target to re-ballot end of June 2013  HL7 Version 2 Implementation Guide: Laboratory Test Compendium Framework, Release 2 – US Realm (eDOS IG) o Target to ballot with LOI (end of June 2013) 6

Laboratory Initiatives NIST Testing Status NIST has released the test framework for LRI for compliance testing NIST is extending this tool/environment to include compliance testing for LOI and eDOS These should be released for testing in ~4 weeks The intention is time the final release in concert with the LOI and eDOS IGs releases 7