California’s Medical Laboratory Assessment and Planning Project

1. California’s Medical Laboratory Assessment and Planning Project Presentation to S&I Framework LRI Group Robert Dieterle Technical Architect Cal eConnect, Inc. June 14, 2011 Washington DC

2. BACKGROUND • A California-based nonprofit • Created by the State of California • Purpose: to guide the private and secure delivery of electronic health information – when and where it is needed.

3. To collaboratively establish policies, services, and innovations that make possible the appropriate, secure, and efficient exchange of electronic health information for the purpose of improving health and health care safety, quality, access, and efficiency for all Californians. Our Mission

4. Primary Objectives

5. Core or Foundational Activities

6. History of the Laboratory Assessment Projectand the S&I Framework LRI Workgroup

7. Scope of the California Project “Conduct a comprehensive assessment of the laboratory and provider landscape related to electronic laboratory ordering and results delivery between ambulatory providers and California’s laboratories. • Purpose: • To understand current state of lab to ambulatory EHR data exchange, including readiness to adopt a highly constrained implementation guide • To develop a roadmap for how Cal eConnect can help labs and ambulatory providers adopt a standard for electronic lab reporting • Focus: electronic reporting of lab results to ambulatory EHR • Readiness of labs (interfaces, current version of HL7, etc.) • Barriers to adoption • Policy and regulatory levers • Best practices • Support needed to adopt an electronic messaging standard for structured results reporting

8. HospitalLab Scope of the Project -- Electronic Lab Result Reporting and Meaningful Use Criteria “Incorporate clinical lab test results into EHR as structured data” “Capability to submit electronic data on reportable (as required by state or local law) lab results to public health agencies (directly from EP/EH or through performing lab)’’ A IndependentLab HospitalEHR Implementation Guide AmbulatoryEHR Cal eConnect / Cambria Project CID CSRB CLPPB GDB CA Dept. of Public Health A. Meaningful Use – Stage 1/2/3 – to EHR B-1. Meaningful Use – Stage 1/2/3 – to PH B-2. Meaningful Use – Stage 2/3 – to PH CID = Center for Infectious Disease CSRB = Cancer Surveillance Reporting Branch CLPPB = Childhood Lead Poisoning Prevention Branch GDB = Genetic Disease Branch

9. HITSP-C36 ELINCS ELR2PH Background -- What is the relationship between Implementation Guides and HL7? HL7 HL7 v2.x HL7 v3.0 HL7Standard HL7 v2.5.1 HL7 v2.3, v2.3.1, etc. HL7 v2.5.1 -ORU^R01 Message HL7 v2.5.1 -ADT, OML, etc. Messages HL7ImplementationGuides

10. Appendix B: Background -- What are the intended uses of the various implementation guides?

11. Appendix B: Background -- Do the implementation guides have similar specifications?

12. Background -- Who has already implemented ELINCS in California? • ~40 sites currently utilize a version of ELINCS • 11 sites in California currently using ELINCS HL7-R1 for lab reporting

13. Our approach was to gather and analyze data, develop initial findings, and then refine our conclusions to build a roadmap         

14. The assessment focused on labs’ readiness to adopt a lab data exchange implementation guide

15. Our study revolved around the following 5 areas and resulted in 22 key findings

16. Market Findings: While there are ~20,000 CLIA certified labs in California, we estimate the target lab population to be ~9,000. Physician Office Labs are the majority of California labs (50-60% of labs), but their estimated test volume is only ~10%. Hospital Labs only represent ~5% of California labs, but they appear to account for the largest % of test volume. Independent Labs only represent ~4% of California labs, but likely account for ~33% of test volume. Rural labs make up 20% of the lab population; yet their volume is unknown. • Key Take-Away: • The lab population is too large for Cal eConnect to significantly support all labs in their adoption – need to focus on segmenting and prioritizing the population. • Addressing hospitals and large, independent commercial labs first, will yield a high % of the overall tests being transmitted electronically.

17. Lab Readiness Findings: Several labs are unaware of existing standards, definitions, available resources, and California’s overall direction. Many small labs do not have the existing infrastructure to exchange data electronically. Labs will adopt a new standard or implementation guide only if their trading partners are ready for the standard. Some labs appear to be reliant on their LIS vendors for guidance with adoption of an HL7 standard or implementation guide. Since a variety of LIS and EHR systems are being used in California, many labs must build their own interface(s).

18. Lab Readiness Findings (continued): The majority of labs who are transmitting data electronically today appear to be able to transmit in HL7 2.3.1. The larger the lab (volume), the higher the likelihood that it is ready to transmit in HL7 2.5.1. Many labs need to support multiple HL7 versions based on the interfaces with their trading partners. Labs are not motivated to adopt a HL7 messaging standard due to the high cost, without an incentive or mandate. Volume of Medi-Cal tests is not a determining factor of readiness to adopt a HL7-compliant messaging standard. • Key Take-Aways: • A coordinated communication plan and program is needed by Cal eConnect, CDPH, and DHCS to raise awareness among labs • Designation of a specific implementation guide would be welcomed by labs, especially if the guide supports a bi-directional (order and results) interface • To capture the greatest volume of lab results in a compliant format, focus on the large independent labs and large hospital labs • A centralized translation service may reduce the complexity of interfacing with multiple trading partners

19. Barriers to Adoption: Based on lab type, size, and other factors, each lab faces its own unique challenges and barriers to adoption. • Key Take-Away: • A key strategy is developing a tiered incentive and support approach

20. Policy and Regulatory Levers: Encouraging Implementation Guide adoption among Medi-Cal FFS labs would require significant changes to the Medicaid Program Administration (MCPA). Encouraging Implementation Guide adoption via the Managed Care contracts would have a high cost and low impact. Standardization would help but is difficult to enforce and monitor. • Key Take-Away: • To facilitate adoption of a HL7 compliant lab messaging implementation guide (for lab to ambulatory EHR and lab to Public Health report), a specific authority to mandate and enforce a standard is likely needed Best Practices: Some states have adopted and communicated a statewide standard/specification (and implementation guide). In addition to standards and specific implementation guides, states have implemented translation services to support labs who cannot meet the standard. Other states have implemented financial and technical assistance programs to facilitate adoption. • Key Take-Away: • There are precedents for state HIE agencies to provide financial and/or technical assistance to help labs adopt standards and integrate with data-exchange hubs • However, we are unaware of any state as large and varied as California that has attempted such a program

21. High-level recommendations

22. KEY •  = High Applicability/Probability of barrier •  = Medium Applicability/Probability of barrier • = Low Applicability/Probability of barrier • (n) = a need barrier (driver/reason to implement ) • (a) = an ability barrier (ability to implement) Barriers to electronic lab reporting and standard messaging - Summary • Key Takeaways: • Generally, smaller labs have more reasons/barriers not to adopt electronic lab reporting • For low volume, few customer labs – they have less reason to adopt electronic reporting, but if they did, have a relatively higher capability of adopting electronic reporting • For low volume, many customer labs – they have more reason to adopt electronic reporting, but they have a higher financial burden to do so • Generally, for labs already sending compliant electronic results, the need or reason to adopt a specific standard can be a barrier while heir technology and financial burden to begin sending standard messages is not

23. Implementation options/strategies for electronic lab reporting and standard messaging – Summary

24. Regulatory Inventory – Summary

25. Recommendations to the S&I LRI Framework Group

26. Cal eConnect is committed to partnering with other states, the federal government, and the industry to facilitate the adoption of a common implementation guide that fills the required gaps that are currently impeding exchange. For more information about this project or Cal eConnect, visit: www.caleconnect.org