1. Labs Early Adoption Program Template Insert the Name of Your Implementation / Organization Here MM/DD/YYYY

2. Goals of the Early Adoption Program Encourage market adoption of the Lab US Realm suite of Implementation Guides –HL7 US Realm Laboratory Results R1 DSTU R2 (LRI) –Laboratory Orders R1 DSTU R2 (LOI) –electronic Directory of Services R2 DSTU R2 (eDOS) More than a pilot or proof of concept, ONC seeks to encourage production support and implementations in LIS and EHR systems Builds on the constrained HL7 V2 messages in MU, now harmonized for US Realm Participants will have opportunity to provide real-world deployment feedback to SDO for IG updates in support of evolving requirements 2

3. Harmonized “round-trip” LIS Create eDOS eDOS EHR Consume eDOS Create Order LOI LIS Consume Order Create Result LRI EHR Consume Result 3 Together the IGs provide a minimum level of end-to-end interoperability that can be extended via optional profiles. Respondents are encouraged to cover as much as makes sense for their operations, partnering is encouraged.

4. Benefits Reduced interface analysis and negotiation with trading partners –Detailed specifications provided in the harmonized suite reduces the points of negotiation between trading partners in establishing an implementable profile. Incremental use of standardized vocabulary and terminologies –Examples: Common order sets, LOINC for AOEs – all are supported alongside local codes to support migration to standard codes –The use of coded elements has been defined to provide incremental transition from local code sets and values to LOINC, SNOMED CT, UCUM, et al, within context of the organization 4

5. Benefits The College of American Pathologists (CAP) is partnering with ONC to provide guidance and assistance to pilots with CLIA and regulation conformance inquiries. In addition, the CAP will offer insights into trends and directions in clinical laboratory reporting within the HL7 v2.x message structure to inform future versions of the standards. 5

6. Scale to Fit Demonstration A - Basic Functionality – eDOS –Create and send conformant messages, EHR receives and accepts –Any valid method for creation, e.g., not a requirement that an LIS generate, can be from DB, other apps/sources. Demonstration B - Basic Functionality of LOI and/or LRI for Clinical Tests –All minimum requirements must be met for messages –Does not require Demonstration A 6

7. Scale to Fit: Options Support eDOS consumption (EHR) Advanced Vocabulary – support of recommended code systems, e.g., SNOMED, LOINC, UCUM Microbiology – support Parent/Child linking with new data type for OBX grouping Narrative reporting – adopt best practice on use of NTEs and HL7 formatting commands for free-text. Support Public Health Profiles 7

8. Submission Instructions The following slides contain the information sought in each proposal. Submit a non-binding Letter of Intention to submit and a completed proposal presentation templates and budget information to the ESAC Program Manager Mike Flanigan (mike.flanigan@esacinc.com) –April 19, 2016 - Letters of Intention due COB –May 6, 2016 – Proposals due by COB The non-binding Letter of Intention should contain at minimum: –Scope of pilot (Demonstration A, B, options) –Names of partners (if any) –Estimated length of activity Questions may be submitted to Mike Flanigan (mike.flanigan@esacinc.com). 8

9. Implementations Team (Lead Organization) Identify the members of your organization who will be supporting this pilot. If possible include the role he/she will play in the pilot and contact information 9 NameRoleEmail

10. Early Adoption Program Team (Roles) Please use this section to identify which role your organization (and any partner organizations) will take on. Please also include any organizations you may partner with who could fill additional roles. 10 RoleDescriptionOrganization Name

11. Full Disclosure? Please document any items you believe should be shared with the community or other Implementations and project teams, in the spirit of ‘full disclosure’. You may also use this section to document any other risks or concerns you may have. 11

12. Configuration Describe the technical environment for the demonstration(s) –Platforms, exchange/communications protocols, other applications, etc. Examples: –Electronic Health Record (EHR) system products –Form/Template repository –Database(s) –Interface engines –New interfaces (to be developed as part of the demonstration) 12

13. Timeline What is your proposed timeline? Guidance: ~3 months minimum / ~8 months maximum Evaluation: starts @ 6-8 months / final evaluation when proposal activities are complete Milestones/Activities are examples. Please feel free to edit as needed. Milestone / ActivityTarget DateResponsible Party Kickoff Design Development QA and Test Demonstration Evaluation 13

14. Success Criteria What will you/your organization use to determine the success of this pilot? This needs to be quantitative and not subjective in as much as possible. –Example: Establish a process within your organization where XX% of their conformant messages are using standardized vocabularies/code sets. 14

15. In Scope / Out of Scope If you already know what will be in and out of scope for your Implementation (beyond the Implementation Guidance (IG) or the Use Case) please document it here. 15

16. Risks & Challenges Please identify any risks or challenges. Be sure to include proposed mitigations/solutions for each risk. 16

17. Cost Estimates Please provide a cost estimate for the resources you believe will be required to complete the proposed Implementation activities. We are seeking project proposals which address all of the major transactions as described in the Harmonized Roundtrip (see Slide 5). If you do not intend to address all transactions, please include costing for those you intend to address At a minimum, please provide the labor categories, rates, and estimated number of labor hours for each team member for the period of performance, along with any additional, non-labor costs you anticipate. IMPORTANT: cost information should be provided along with this proposal template to Caroline Coy (caroline.coy@hhs.gov)caroline.coy@hhs.gov 17

18. Questions Please include those items you wish to consider any questions you have or hope the early adoption activities addresses. Questions may be submitted to Mike Flanigan (mike.flanigan@esacinc.com). 18

19. Useful Links Labs Early Adopters Wiki –http://wiki.siframework.org/Lab+US+Realm+Early+Adopters+Programhttp://wiki.siframework.org/Lab+US+Realm+Early+Adopters+Program Reference Specifications –HL7 Version 2.5.1 Implementation Guide: S&I Framework Laboratory Test Compendium Framework R2 DSTU R2 (eDOS) http://www.hl7.org/implement/standards/product_brief.cfm?product_id=151 –HL7 Version 2.5.1 Implementation Guide: S&I Framework Lab Orders from EHR R1 DSTU R1 - US Realm (LOI) http://www.hl7.org/implement/standards/product_brief.cfm?product_id=152www.hl7.org/implement/standards/product_brief.cfm?product_id=152 –HL7 Version 2.5.1 Implementation Guide: S&I Framework Lab Results Interface Implementation Guide R1 DSTU R2- US Realm (LRI) http://www.hl7.org/implement/standards/product_brief.cfm?product_id=279 –HL7 Version 2 Implementation Guide: Laboratory Value Set Companion Guide R1 – US Realm http://www.hl7.org/implement/standards/product_brief.cfm?product_id=413 19