1. eDOS Workgroup Kickoff Laboratory Orders Interface 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 each time prior to making comments or suggestions during the Q&A portion of the meeting NOTE: This meeting is being recorded and will be posted on the eDOS wiki page after the meeting From S&I Framework to Participants: Hi everyone: remember to keep your phone on mute 2

3. Agenda Introductions LOI Initiative Timeline eDOS Introduction Questions & Answers Next Steps 3

4. The eDOS project is a component of the Lab Order Interface (LOI) Initiative

5. eDOS Summary eDOS: Provides 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 2.6. 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: –Validate that the current Informative Implementation Guide meets the objective through a pilot of eDOS –Align the IG with the in-scope tests in the Lab Result Interface (LRI) IG –Incorporate pilot findings to update the Implementation Guide to develop a normative document to be balloted based on HL7’s ANSI process. –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.

6. Background eDOS, or the Laboratory Test Compendium Framework, provides an electronic interchange of a laboratory’s directory of services in a structured format based on HL7’s master file update. –An Implementation Guide was developed by the members of the American Clinical Laboratory Association (ACLA) in conjunction with their Health Information Technology (HIT) Committee to provide all necessary information to help an Ordering Provider properly request laboratory tests consistent to aide patient diagnosis. –The eDOS IG is available as an informative document from HL7 The LOI Tiger Team identified the importance of coordinating the LOI and eDOS efforts so that LOI can validate the eDOS IG as part of the LOI alignment activities To ensure that the eDOS efforts don’t delay the LOI Initiative, the Tiger Team decided to spin off a separate eDOS Work Group to focus on eDOS 6

7. Background The initial work group efforts outlined focus on kicking off pilots to validate the Implementation Guide with the goal of creating a normative document to be balloted based on HL7’s ANSI process To ensure successful validation and pilots, a Use Case and Functional Requirements will be developed to validate existing industry requirements and the current informative IG –Real-world scenarios will help create specific pilot test conditions and metrics for use in Pilot validation of the IG –Clearly defined functional and data set requirements facilitate eDOS & LOI coordination and alignment –A well-articulated Use Case supports awareness of the clinical and implementer communities’ real-world needs 7

8. Challenge Statement eDOS: Currently providers must manage their directory of service (DOS) manually. Automating the process will save time and money over manual processes, and allow laboratories to roll out new tests to providers more expediently. Additionally, information included in the directory of service which may be appropriate for inclusion on the lab order will be readily available for inclusion. Pilot the implementation: Given other competing work efforts, finding participants to pilot the eDOS IG may be a challenge. The delivery mechanism was not addressed in the IG for two reasons, outlined below, and requires definition for the pilot process: –It is anticipated that existing technologies used for lab order and results messages already exist and can be adopted to accommodate an additional message to be delivered. The Office of the National Coordinator (ONC) will provide guidance in the future regarding an approved ARRA/HITECH communication solution. –It is believed that eDOS will support the solution proposed by ONC and that the Implementation Guide for communications would be a separate document.

9. Value Statement The development of a framework for the Laboratory Test Compendium and associated capability of electronic exchange of Directory of Services (eDOS) content as outlined in the IG is a critical step in the increased interoperability required between Electronic Health Record (EHR) systems, Hospital Laboratory Information System (HLIS), Health Information Exchange (HIE) vendors, Laboratory Information systems (LIS), and laboratory providers. –This development effort fills a gap in the current electronic data exchange and enables the reduction of costs for providers, laboratories and vendors while further decreasing error rates by simplifying the exchange of data related to test directory of service –Piloting the eDOS implementation guide through the ONC S&I Framework also supports alignment with the list of in-scope tests currently defined in the Lab Result Interface (LRI) initiative, and in the to be developed Lab Order Interface (LOI) initiative.

10. Scope Statement The Laboratory Test Compendium Framework defines the format to deliver the laboratory order codes for systems that support the electronic laboratory ordering and/or resulting functionality. Highlights of the Laboratory Test Compendium Framework include: –Codes used to order the laboratory tests, Description of the laboratory test, Effective date, Preferred name for test, Orderability of test (is the test orderable (y/n), Nature of test (profile, single observation, etc), Specimen requirements (including collection, storage and transportation instructions), Processing priorities (ability to order as stat, routine, or other priorities), Observation requirements (ask at Order Entry requirements), Reflex observations (list of what could be reflexed for this test), Test grouping requirements, Test components (analytes that will be included in the test), Procedure codes This content supports the initial Laboratory Test Compendium build for a provider, as well as on-going maintenance updates throughout the life of the interface. The laboratory, in coordination with the client, will determine if a complete eDOS or a subset based on the provider’s ordering history is appropriate for the provider’s specific interface implementation. The laboratory will also provide maintenance updates to the provider EHR system.

11. Target Goals & Outcomes The goal is to provide a message specification implementation guide that, when broadly adopted by clinical laboratories, providers, and EHR systems will obviate the need to define a costly “point to point” custom specification for each Laboratory-to-EHR Directory of Service interface that is implemented. Validate that the current Informative Implementation Guide meets the objectives through a pilot. Incorporate pilot findings/update the Implementation Guide to develop a normative document to be balloted based on HL7’s ANSI (American National Standards Institute) process.

12. Timeline Date(s)Task May, 2012Pre-Discovery Initial work conducted by LOI Tiger Team and eDOS co-chairs with support of S&I Framework staff June 19, 2012Kick-off June, 2012Discovery June-August 2012Implementation Including eDOS Alignment September 2012 – March 2013Pilot May, 2013Normative Ballot of updated Implementation Guide May-June 2013Ballot Reconciliation September, 2013, January, 2014Re-ballot (if needed) No later than February, 2014Publication of Normative Implementation Guide

13. Standards Implementation Guide: American Clinical Laboratory Association’s ( ACLA) Test Compendium Framework (eDOS), Release 1 –published June 2011 HL7 V2.6 messaging standards –published October 2007

14. Stakeholders Provider Organizations (Ordering Provider) Laboratories LIS Vendors Hospital LIS Vendors EHR Vendors Standards Organizations Health Information Exchange (HIE) Federal Agencies

16. High Level Activities by Phase (adapted) PhaseTypical Activities Pre-Discovery Initiative Synopsis Initiative Charter Definition of Goals & Project Outcomes Discovery Creation of Use Cases, User Stories & Functional Requirements Identify interoperability gaps, barriers, obstacles and costs Identify alternative approaches and conduct feasibility tests and prototypes Identify existing standards, models and artifacts for harmonization Implementation Create Harmonized specification Create Reference Implementations Documentation revelation to specifications and reference implementations such as guides, design documents Pilot Revised harmonized specifications Revised reference implementations Transition plan to open source communities Create pilot technology and document policy lessons Ballot revised implementation in HL7 as a Normative Implementation Guide Evaluation Measure initiative success against goals and outcomes Identify best practices learned from pilots for wider scale deployment Identify hard and soft policy tools that could be considered for wider scale deployments

17. Laboratory Pilots Community Options for Piloting 17 Option One: Individual Initiative Pilots aka Pilots I Point of Contact: Bob Dieterle Details: Participants will pilot LRI LRI LOI eDOS LRI LOI eDOS Option Three: eDOS Only Pilots Point of Contact: Freida Hall Details: Participants will pilot eDOS eDOS Option Two: “Pilots II” Point of Contact: Bob Dieterle & Freida Hall Details: Participants will pilot LRI AND LOI with the option to additionally pilot eDOS LRI LOI

18. Q&A

19. Next Steps Sign up as a Committed Member for the Workgroup (link)link Review the Workgroup Charter prior to 6/26 Workgroup meeting (link)link The next eDOS Workgroup meeting will be held on June 26 from 2:00 – 3:00 PM ET 19

20. Background Slides

21. Overview (excerpted from the eDOS IG) This guide leverages three HL7 trigger events to communicate all Electronic Directory of Service information: M08 – Master File Notification – Test/Observation: listing each reportable observation M10 – Master File Notification – Test/Observation Batteries: listing each orderable battery (group test, panel, profile, etc) M04 – Master File Notification – Charge Description: listing procedure codes to compliment the orderable items

22. IG Development History - ACLA Initial draft developed by the American Clinical Laboratory Association (ACLA) membership ACLA solicited public comments, resulting in 101 Line Item comments representing the following organizations: –American Association of Veterinary Laboratory Diagnosticians –Cgate Health –Ignis Systems Corporation –McKesson –National Library of Medicine –Regenstrief Institute, Inc

23. IG Development History – HL7 The IG was successfully balloted through HL7’s Orders and Observation Work Group September, 2010. 133 participants registered in the ballot pool representing the following constituency: –25 Affiliate (International) – 9 Consultant – 4 Government/Non-Profit – 6 Payor – 8 Pharmaceutical –50 Provider –31 Vendor

24. IG Development History – HL7 cont. Comments were submitted from the following: –Axolotl Corporation –Carestream Health, Inc. –College of American Pathologists –GE Healthcare Integrated IT Solutions –Kaiser Permanente –National Library of Medicine –McKesson Provider Technologies –Microsoft –OntoReason –Regenstrief Institute, Inc. –SAIC –Siemens Healthcare –United Health Group –US Department of Veterans Affairs

25. IG Development History – HL7 cont. Additional participants who voted but did not submit ballot comments: –Albany Medical Center –Alschuler Associates, LLC –American Assoc. of Veterinary Lab Diagnosticians –ARUP Laboratories, Inc –Cerner Corporation –Diagnostic Radiology and Oncology Services –Epic Systems Corporation –Gordon Point Informatics Ltd. –HL7 Canada –HL7 Germany –HL7UK –Icode Solutions –Intermountain Healthcare –Laboratory Corporation of America (LabCorp) –New York-Presbyterian Hospital –Novartis –Oracle Healthcare –Pathology Associates Medical Laboratories –Quest Diagnostics, Incorporated –Ramsey Systems –Reagent, LLC –Semantically Yours, LLC –Sentillion, Inc. –U.S. Department of Defense, Military Health System –Washington State Department of Health –Wellpoint, Inc.