1. Laboratory Pilots/Deployment May 15, 2012 1

2. Participants Coordination of Effort Validation Suite Vocabulary Group Implementation Guide Analysis Support Team 2 Pilot I Project Participants Atlas Development CAP Halfpenny Technologies KHIE LabLynx Pilot II Project Participants Conversations Lab System and EHR Vendor (2) Lab System Vendor (1) EHR Vendor (3) Commercial Laboratories (2) Provider Based Commercial Labs (3) Pilot II Project Participants Allscripts athenahealth Cerner OptumInsight RML

3. LRI Validation Suite WG Test Cases -- Review May 15, 2012

4. NIST Validation Suite Considerations Reporting Scenarios 1)Preliminary Report 2)Partial Report 3)Final Report 4)Cumulative Report (for recurring draws?) 5)Corrected Report / Amended Report 6)Cancel due to ………….. (e.g. specimen quality) 7)Error conditions (e.g. R, RE, C,CE misuse invalid syntax) 8)Reflex Testing 9)Add-on Tests/results 10)Addenda Report (is this a valid HL7 report type/status? 4 Test Types 1)Single numeric result with reference rangeA1 2) Single alpha result from limited response list (e.g. Positive, Negative, …)A2 3)Panel testing with combinations of 1) and 2)A1&A2 4)Textual ResultsA4 5)PDF as payloadA4 6)Textual with tabular dataA4 7)Combinations of 1) and 2) e.g. susceptibility MIC and InterpA3 Errata 1)NTE 2)PID text 3)Multiple OBR 4)Addon 5)Multiple OBR 6)Additional OBX 7)Reflex testing 8)Multiple OBR 9)Additional OBX 10)Add OBX for specific result types from order (e.g. total urine volume) 11)Multiple testing locations 12)Non-standard abnormal flags

5. Needed from all participants Testers and feedback for current version of Validation Suite tool http://lri.sipilotdevelopment.org/lri-dstu/ Volunteers for 1-on-1 Webex testing –Especially EHR systems –Validation Suite to be ready in June 2012

6. Laboratory Pilot/Deployment Overview  The goal of the Laboratory Pilot/Deployment effort is to create reference implementations (e.g. production or pre-production versions) of the laboratory results, orders and test compendium transactions based on the specifications in the LRI, LOI, and eDOS implementation guides. The purpose of these reference implementations is to:  Verify the specifications in the implementation guides in an operational setting to determine and document any exceptions, errors, or omissions that will facilitate the future revisions of the guide.  Validate and enhance the validation tools that will be used to aid in certification testing of these interfaces  Verify interoperability of the these reference implementations outside of the proposed ecosystems  Take the reference implementations to production use/deployment in 2012/2013 6

7. Ecosystem  Each participant will propose a complete ecosystem for reference implementation purposes  The recommended ecosystem should consist of a laboratory, LIS/interface vendor (may be in-house effort), provider organization, and EHR vendor  To the extent third parties integrators are required to create and/or support the reference implementation, they will be considered part of the proposed ecosystem  If participants are unable to assemble the entire ecosystem, Laboratory Pilot/Deployment leadership will assist in making introductions where possible 7

8. Laboratory Results Interface (LRI)  Each participant shall develop/implement and test a production or pre-production interface compliant with the Draft Standard for Trial Use (DSTU) version of the LRI IG for the exchange of laboratory results between the LIS and EHR.  Utilize the online validation suite to test all supported use cases applicable to the specific ecosystem.  Each laboratory/LIS and EHR should participate in an S&I Laboratory Pilot coordinated virtual interoperability forum to be established among the Laboratory Pilot II participants.  The resulting pre-productions LRI implementations are expected to be taken to production use by the end of 2012 and where possible rolled out to additional implementations in early 2013. 8

9. Laboratory Orders Interface (LOI)  Contribute to the LOI workgroup effort to develop the DSTU specification for LOI IG.  Each participant shall develop/implement and test a production or pre- production interface compliant with the DSTU version of the LOI IG for the exchange of laboratory orders between the EHR and LIS.  Utilize the online validation suite to test all supported use cases applicable to the specific ecosystem.  Each EHR and laboratory/LIS should participate in an S&I Laboratory Pilot coordinated virtual interoperability forum to be established among the Laboratory Pilot II participants  The resulting pre-productions LOI implementations are expected to be taken to production use by the end of 2012 and where possible, rolled out to additional implementation in early 2013 9

10. Electronic Directory of Services (eDOS)  Contribute to the LOI/eDOS sub-workgroup effort to align the eDOS and LOI specifications.  Each participant shall develop/implement and test a production or pre- production interface compliant with the current Informative version of the eDOS IG for the exchange of Test Compendium between the LIS and EHR.  If available, utilize the online validation suite to test all supported use cases applicable to the specific ecosystem.  Each EHR and laboratory/LIS should participate in an S&I Laboratory Pilot coordinated virtual interoperability forum to be established among the Laboratory Pilot II participants  The resulting pre-productions eDOS implementations are expected to be taken to production use by the end of 2012 and where possible, rolled out to additional implementations in early 2013 10

11. Value to Participants While the Laboratory Pilot II effort is a significant commitment of time and resources on the part of each participant, it provides each organization with the opportunity to take a leadership role in establishing interoperability standards for the laboratory testing industry. Broad adoption of these standards will substantially reduce the cost and time to implement and support electronic interfaces to communicate test compendiums, laboratory orders and results. Specifically the value to each of the participants includes: Prepare for Meaningful Use 2 (MU2) and the 2014 EHR certification requirements Feed-back on the specific uses cases and testing scenarios for the online validation suite before it is incorporated as part of the official EHR certification process Participate in the validation and implementation process to provide valuable feedback on the implementation guides to ensure that laboratory requirements are full represented Substantially reduced time and cost via national standardization to implement laboratory interfaces for test compendium, orders and results Reduced order errors based on electronic exchange of test compendium Minimize ongoing interface maintenance effort and cost Increase the number of implemented electronic interfaces between laboratories and ambulatory provider EHRs to reduce cost and errors introduced by manual processes Improve turn-around-time (TAT) for the delivery of laboratory results to the ordering/using clinician Improved patient care through the reduction in errors and reduced TAT Reduction in the management cost to support multiple different interfaces for EHRs Early market presence with laboratory interfaces compliant with ONC S&I Framework standards 11

12. Next Steps / Questions Next Steps Continue recruiting Pilot II participants Work on expanded scenarios for validation suite Schedule Pilot calls for coordination every other week at same time next call 5/29 Continue work with Validation Suite on 5/22 Start participation in LOI and compendium effort based on LOI calendar For questions, please feel free to contact Bob Dieterle: rdieterle@enablecare.usrdieterle@enablecare.us 12