1. Achieving Meaningful Use: Lab Results Session 8 April 13, 2010

2. Agenda Introduction –An overview of how Direct can be used to meet MU and State HIE Program requirements to deliver structured lab results Panelists –Will Ross, Project Manager, Redwood MedNet, Inc. –Kim Long, Program Manager, MedPlus, a Quest Diagnostics Company Q&A Poll 2

3. Meaningful Use Requirements Meaningful Use: Stage 1 Final Rule (italics optional Stage 1) and Proposed Objectives for Stages 2 and 3 Stage 1 Final Rule Stage 1 Final Rule MeasureProposed Stage 2Proposed Stage 3 Incorporate lab results as structured data 40% (for both eligible providers (EPs) and auth. providers of eligible hospitals (EHs) Move current measure to core, but only where results are available 90% of lab results are stored as structured data in the EHR and are reconciled with structured lab orders, where results and structured orders available Submit lab results to public health agencies One test (EH only)EH: Move Stage 1 to core EP: Lab reporting menu. For EPs, ensure that reportable lab results and conditions are submitted to public health agencies either directly or through their performing labs (if accepted and as required by law). Mandatory test. EH: Include complete contact information (e.g., patient address, phone and municipality) in 30% (EH) of reports. Submit reportable lab results and reportable conditions if accepted and as required by law. EP: Ensure that reportable lab results and reportable conditions are submitted to public health agencies either directly or through performing labs (if accepted and as required by law) 3

4. State HIE Program Responsibilities The Program Information Notice to State HIE grantees (dated July 6, 2010) outlined key responsibilities that states and SDEs must address in 2011, specifically to address and enable three priority areas: e-prescribing, receipt of structured lab results, and sharing patient care summaries across unaffiliated organizations. Multi-stakeholder process Convene stakeholders with interest in lab interoperability (inc. independent labs, national labs, etc. Conduct environmental scan to determine lab metrics Perform gap analysis Monitor/track MU capabilities Set baseline, monitor & track various lab metrics: % clinical lab sending results electronically % health departments receiving notifiable lab results electronically Strategy to fill MU gaps Use phased approach Use policy or reg. levers to require electronic sharing of labs Consider Direct to help rapidly enable the electronic exchange of structured lab results Work with REC to start with gaps among small providers, independent labs, etc. Consistency with national policies /standards Ensure consistency with national standards, NWHIN specifications, federal policies and guidelines Work with CLIA administrators Join State HIE Lab Interoperability CoP Participate in S&I Framework lab results interface initiative Implement a flexible approach Alignment with Medicaid and public health Establish an integrated approach that represents Medicaid and public health programs Work with Medicaid and private payers to include interfaces as part of their contractual agreements with labs 4

5. Why Direct for Lab Results? MU-compliant. Direct use cases tied to MU priority areas, including labs. Standardized. Direct provides a standardized transport mechanism for labs. Simple. Simplicity helps adoption among low volume practices and small, independent labs. Scalable. Direct can be utilized beyond 2011 in meeting future stages of meaningful use requirements and other business goals. 5

6. Lab Sends Lab Results to Ordering Provider LIMS In-House Lab Hospital, Clinic, or Provider Office LIMS Lab External/Reference Lab Order Result EHR System Physical transport of specimen Perspective: A clinical testing laboratory has a preliminary, final or amended test result to deliver. Context: The laboratory has made the determination that it is clinically and legally appropriate to send the result to the ordering (or cc) provider. Workflow Steps: 1.Provider issues test order to external lab. 2.External lab’s LIMS receives test order. 3.Based on test result delivery instructions, the LIMS sends test results to the ordering provider 4.Ordering provider’s LIMS confirms receipt to conform with laboratory regulations. 5.Ordering provider’s LIMS sends test result to EHR system for incorporation into the patient record. Acknowledgment 6

7. Lab Sends Results to Public Health Public Health Agency LIMS Lab Hospital or Clinic Lab Result Perspective: A testing laboratory has a preliminary, final or amended test result to report to Public Health. Context: The laboratory has made the determination that it is clinically and legally appropriate to send the test result to Public Health. Each state has laws mandating the reporting of positive and/or negative test results for specific conditions to Public Health. Typically either statute or regulation specifies both the timing and method of reporting test results, and the appropriate jurisdiction to receive the report. Currently there is a wide mix of electronic and manual reporting approaches, with a gradual migration towards electronic reporting as LIS, HISP and Federal, State and Local electronic reporting systems become common. Ultimately, the LIS incorporates a condition reporting process which meets Public Health requirements. Workflow Steps: 1.The testing lab’s LIMS sends a test result to Public Health. 2.Public Health confirms receipt to conform with laboratory regulations. Acknowledgment 7

8. Redwood MedNet Presentation

9. Redwood MedNet A local Health Information Exchange –In three rural Northern California counties 5,000 square miles 400,000 population Small, independent, non-aligned healthcare facilities –Began production in 2008 between small district CAH facilities and small FQHCs, RHCs and private practices –Currently serving 50 providers, all independent and not aligned –Received expansion grant from Cal eConnect, will expand to 200+ providers over a wider area in 2011-2012

10. Redwood MedNet Founded by independent physicians, our assignment as an HIE is to make interoperability easy for providers Business model = supported by subscription for HIE services Technology solutions –Classic HIE interfaces between halthcare facilities –CONNECT Gateway to other HIEs or federal partners –Direct Messaging HISP available to any other HISP –Bidirectional link to Microsoft HealthVault

11. Redwood MedNet Direct Pilot Three use cases tied to meaningful use: Push patient summaries between unaffiliated health care facilities Push structured laboratory test results into eligible provider EHR Receive unsolicited immunization messages for batch submission to regional registry Key project features: Demonstrate how California providers can meet meaningful use measures with or without a formal HIE in their local region. Includes participation from small practices, community clinics, small hospitals and long term care facilities All technical solutions or participation agreements developed for the Direct Project are placed in the public domain as community assets. ContentParticipantsTiming Care SummariesHospitals, Long Term CareSummer 2011 Lab ResultsHospitalsto be decided ImmunizationCommunity Clinics, School-based ClinicsSummer 2011

12. Direct delivery workflows Direct messaging is an option when –Both sender and receiver have access to HISP functionality –It is clinically and legally appropriate for the transaction –Certificates have been exchanged so that HISPs can reach each other Redwood MedNet can send a Direct clinical message to any local partner with HISP functionality at their EHR Redwood MedNet can send a Direct clinical message for any local facility with no HISP functionality in their EHR

13. Direct delivery option for Labs Legacy point-to-point interfaces –Lab builds individual interface into the EHR at each practice –Most expensive, resource intensive solution HIE networks –HIE service enables re-use of interfaces –Can provision one end of a HISP communication process –More efficient sharing of interface expenses Direct messaging –see next slide...

14. Direct delivery option for Labs Direct messaging –If the lab has a HISP Direct Message sending option, then laboratory test results can be delivered via Direct –If a provider EHR has a HISP Direct Message receiving option, then laboratory test results can be received –Potentially the most efficient, resource conserving solution

15. MedPlus Presentation

16. MPS Pilot Overview (CT) Direct User Stories : 1. Primary care provider refers patient to specialist including summary care record 2. Primary care provider refers patient to hospital including summary care record 3. Specialist sends summary care information back to referring provider 4. Hospital sends discharge information to referring provider 5. Laboratory sends lab results to ordering provider Key project features: Enable MPS physicians to receive lab results from Middlesex Hospital and Quest Diagnostics, to exchange referrals with Middlesex Hospital, and to exchange referrals and summary care information among MPS primary care and specialty physicians Physicians will have the ability to securely send lab results and care summaries to their patients via Microsoft HealthVault. 16

17. MedPlus HIT Subsidiary of Quest Diagnostics Developers of Care360 network touching more than 160,000 physicians in over 70,000 locations Core EHR and connectivity products for ambulatory physicians and hospitals –Care360 Labs Base product supplied to Quest customers for free –Care360 EHR Meaningful Use Certified in 2010 –Care360 Data Exchange Enable connectivity from your hospital environment to any EHR to grow community referral networks 17

18. Lab Delivery-Pre Direct 18

19. Lab Delivery via Direct Lab result delivery to any Direct address on any client that is Direct enabled and Trust is Established in the MedPlus HISP Clients supported by MedPlus HISP –Email Client –EHR using REST Interface (Care360 EHR or 3 rd Party EHR) Required Changes –Creation of the MedPlus HISP –MedPlus Result Hub and HISP integration 19

20. Lab Delivery-Post Direct 20

21. Lab Delivery via Direct Setup Two Simple Steps 1.Direct Client Application Setup 1.Email client configuration or configuration within a Direct enabled EMR 2.Configure Trust for Direct client and/or associated Healthcare Domain 1.Establish/configure credentials for secure communication between client and MedPlus HISP 2.Configure trust anchors for Healthcare Domains the provider will be communicating with via Direct messaging 21

22. Step 1: Direct Recipient Configuration Configuration of MedPlus Result Hub to push results to a provider using a specified Direct address Direct Recipient Options –Receive PDF lab result –Receive HL7 lab result –Receive both PDF and HL7 –HL7 Version Used – Not sure if this is needed but if it is then it should be clarified Enter Recipients Direct Address 22

23. Step 2: Establish Trust Receive certificate from recipient Direct address and import into our HISP Recipient must receive MedPlus’ certificate and import into their HISP Note: Trust may already be established if another user is already in the same trust circle 23

24. Lab Delivery via Email 24

25. PDF Lab Result 25

26. HL7 Would normally not be sent to an email client Typically sent to an EHR or other system that can process the HL7 file 26

27. Lab as Report of Record As with today, requires validation and certification of lab result delivery process to meet CLIA and CAP regulations. If only a copy of the lab result is being sent, it does not require such rigor. 27

28. Real-world Lessons Learned Vendors are all on different timelines for product changes to support Direct Some vendors are installed at individual provider offices. Therefore, an upgrade has to be requested and completed at each office once the software is available which increases the timeline even more. 28

29. Real-world Lessons Learned Quest Diagnostics lab results - Recruiting pilot participants who can participate meaningfully has been challenging due to: –Existing Quest customers already have mechanisms in place (non-Direct) to receive lab results –New customers who you would try to target with Direct don't yet have EHRs that can accept and process Direct messages 29

30. Real-world Lessons Learned When moving forward with vendors, be aware of implementation details –MPS “backbone” – standard SMTP+MIME implementation. Some vendors also implemented additional TLS encryption which was not foreseen and complicated communication. –Some vendors currently only have SOAP+XDR Direct support.

31. Additional Lab Resources

32. S&I Framework Lab Results Interface (LRI) Initiative The LRI Initiative was launched to address the challenge of lab reporting to ambulatory primary care providers. –It aligns with the Meaningful Use goal to incorporate lab results into EHR as structured data –Also supports objectives for Decision Support, Quality Reporting and Transitions in Care Initiative Scope: –Requirements driven primarily by the needs of internal medicine, family practice and pediatrics, but may also be leveraged by other providers and settings –Optionally: enable pilots that demonstrate electronic results delivery through the agreed-upon standard, including linkages with directories and transport Workgroups focused on: –Identifying and developing the use cases and functional requirements supporting the business needs for exchange and interoperability –Selecting the appropriate subset of tests to be included in the standard, as well as the corresponding vocabulary –Identifying the assumptions behind existing standards and elements to be harmonized across existing implementation guides To stay informed, access deliverables and see the current outputs of the initiative, visit http://www.siframework.org, click on "S&I Framework Initiatives", and select "Lab Results Interface (LRI) Initiative" 32

33. State HIE Lab Interoperability CoP The State HIE Lab Interoperability CoP is comprised of approximately 70 members, including State HIT Coordinators and other key state stakeholders working to advance lab interoperability in their state. Short-term objectives focus on lab results delivery, including: –Developing standardized contract language for EHR contractors and lab IT procurements, specifically for lab-to-EHR exchange requirements and vendor selection –Identifying common levers for Medicaid, private payers and others –Defining CLIA and other regulations that relate to or may potentially hinder laboratory participation in HIE –Standardizing content specifications for results reporting, including HL7, LOINC®, ELINCS (content and vocabulary) as well as policy levers to encourage use of standardized laboratory codes Long-term objectives focus on lab orders Contact Greg Farnum (gfarnum@aplusgov.com), ONC Facilitator for the Lab Interoperability CoP, for more information.gfarnum@aplusgov.com 33

34. Q&A

35. Poll 35