ONC State HIE Cooperative Agreement Technical Assistance Program Laboratory Interoperability: Requirements, Challenges

1. ONC State HIE Cooperative Agreement Technical Assistance ProgramLaboratory Interoperability: Requirements, Challenges & Strategies May 13, 2011

2. Agenda Introduction Importance of Lab Interoperability Actions for States Eligible Professionals (Structured Labs into EHR) Meaningful Use Requirements Challenges and Strategies CLIA Regulations State Innovations Eligible Hospital (Electronic Lab Report (ELR)) Meaningful Use Requirements Challenges and Strategies State Innovations Resources and Tools for Eligible Professionals and Eligible Hospitals 2 For other slide decks, we have used a graphic that shows each of these topics , then highlight at the beginning of that section which topic is being addressed. That helps the viewer keep the bigger picture in mind and the specific details in context. Would that work somehow for these sections?For other slide decks, we have used a graphic that shows each of these topics , then highlight at the beginning of that section which topic is being addressed. That helps the viewer keep the bigger picture in mind and the specific details in context. Would that work somehow for these sections?

3. Introduction 3

4. Why is Lab Interoperability Important? Clinical decisions are often made or influenced significantly by lab results. Lab results can represent up to 70-80% of all health care information for patients and providers. Key component of longitudinal Electronic Health Record. Lab information needs to be shared among providers who may not be directly linked or related for smooth healthcare delivery (Public/Pop Health-CM). Over 200,000 Certified Clinical Labs in the US. Effective exchange of laboratory information will help reduce redundancy of effort and its associated costs. 4

5. Actions for States 5

6. Initiate a Transparent Multi-Stakeholder Process Convene a representative group of stakeholders with a specific interest in lab interoperability, including providers, labs and lab organizations, payors and consumers to participate in the following activities: Conduct a scan of the environment to determine number and type of labs in the state, as well as the percentage of laboratories sending results electronically and using LOINC� standards. Perform a gap analysis. Determine how to address gaps to ensure that one or more options are available to eligible providers to meet Stage 1 MU by focusing on delivery of structured lab results. 6

7. Monitor and Track MU HIE Capabilities in the State and Set Strategy to Meet Gaps Set the baseline, monitor and report on the following measures: % of clinical laboratories sending results electronically. % of health departments receiving notifiable lab results electronically. Develop and implement a strategy and work plan to address gaps in the delivery of structured lab results, as identified in the environmental scan: States and providers should expect to address gaps in an incremental manner. Consider that the size and type of lab can impact their ability and willingness to participate in information exchange and facilitate interoperability. Smaller and independent labs may need help from state agencies and/or RECs. 7

8. Ensure Consistency with National Policies and Standards Ensure consistency with national standards, NW-HIN specifications, federal policies and guidelines: Identify state regulations and statutes affecting lab interoperability. Work with CLIA administrators. Advocate for changes to local laws and regulations (see KY). RECs should encourage adoption of EHRs that support the NW-HIN Direct Specifications and/or offer lab interfaces with their systems. Utilize technologies that are adaptable and flexible for future requirements, including cross-border information exchange: Some states, such as: New York, Maryland, Virginia and the District of Columbia, where patients often live in one jurisdiction and seek treatment in another will benefit from studying the regulations of neighboring states to foster consistency where patients� lab records cross state lines. Cross-border HIE will become more important, prevalent and complex as full interoperability is implemented. 8

9. Align with Medicaid and Public Health Programs Establish an integrated approach that represents Medicaid and public health programs. Work with Medicaid and private payors to include interfaces as part of their contractual agreements with labs. 9

10. ELIGIBLE PROFESSIONALS (Structured labs into EHR) 10

11. Eligible Professionals - MU Requirements Meaningful Use (MU) requires that at least 40% of test results ordered by eligible or authorized professionals must be recorded as structured results in the provider EHR: Applies to results that are either in a positive/negative or numerical format. Must be incorporated into EHR as structured data. Methodology should be in place prior to MU stage 1 deadlines: End of 2011 should be adequate to meet 2012 goals. Results must be in both machine and human-readable format. Codes must be electronically displayed in human-readable format; if tests have been received with LOINC� codes. Patient records must be updated in a timely manner, based on received lab results. Eligible Hospitals must comply with all Eligible Professional Requirements for structured labs into certified EHRs. 11

12. Workflow and HIE Options 12

13. ELIGIBLE PROFESSIONALS CHALLENGES AND STRATEGIES 13

14. Challenges and Strategies: Policy 14

15. Challenges and Strategies: Policy 15

16. Challenges and Strategies: Policy 16

17. Challenges and Strategies: Standards 17

18. Challenges and Strategies: Standards 18

19. Challenges and Strategies: Transport 19

20. CLIA REGULATIONS FOR ELIGIBLE PROFESSIONALS 20

21. CLIA Regulations � CMS Guidance Review Visual inspection: Routine checks should be conducted to verify accurate, timely and reliably conveyed results. CLIA does not specify the method or frequency. Laboratories should establish protocols that are reasonable based on the transmission mechanisms they use. Transmission of lab data through an HIE is acceptable under CLIA: The key CLIA attribute is accuracy of information. Electronic transmission of data need not be a barrier. Information transmitted from laboratories should be accurately, timely and reliably sent to the final report destination. 21

22. CLIA Regulations � CMS Guidance Review Encourages use of standards: Does not require a particular standard. CMS encourages the use of recognized standards such as HL7 as a data transmission standard and LOINC� for laboratory test vocabulary. Retention requirements unchanged: Laboratory records must be retained for at least two years. CLIA does not specify the form in which records are to be retained, rather, CLIA specifies that reports must be retrievable upon request for defined periods of time. 22

23. CLIA Regulations � Differences Among States 20 states have incorporated language in their statutes referencing CLIA, including NH, AZ, and GA. Many other states are considering changes to state laws that were originally designed to mirror CLIA and need to be adjusted to reflect new approaches. Certain states, including NY, set their own state-level standards for certain kinds of laboratories. These standards are adjunctive or more stringent than the CLIA regulations. Laboratory records have been converted to electronic formats in many locations across the nation. 23

24. CLIA Regulations � Differences Among States Release of results to provider: Laboratory results must be released to an �authorized individual�. The definition by statute varies from state to state. Release of results to patients: Subject to the laws in each state. The statutes vary widely by state. Release of results directly to EHR: If one of the following conditions is met, it is permissible to release lab results directly to an EHR, which can then be accessed directly by authorized providers or patients: The regulations in that state allow for release of lab records directly from the lab to a patient. Consent for patient or secondary provider access has been obtained prior to release of the lab records. 24

25. STATE INNOVATIONS FOR ELIGIBLE PROFESSIONALS 25

26. Delaware � Encouraging Lab Participation Overview: An early implementer of HIE in 2007. 75% of all Delaware hospitals and providers participating. Most major national, regional and hospital-based laboratories are participating. 80-90% of all lab tests flow though a single system. Encouraging lab participation: Interfaces: Standardized lab result data to ensure smooth exchange of information. Negotiated standard/maximum rates with vendors. Currently a maximum of $1,500 which includes bidirectional interface, upgrades and services. State HIE team certifies vendors. REC supports providers to validate the DHIN EHR interface to ensure data integrity of all DHIN data displayed in the EHR. 26

27. Delaware � Encouraging Lab Participation Building consensus - a key attribute for success: Convened multiple stakeholders and did not act without consensus; �all for one and one for all�. No initial �go-live� until everyone was on board. Public-private multi-stakeholder groups, including a Board of Directors. Project managers from all organizations contributing data meet weekly to support technical/functional enhancements. Avoided the use of �policy levers� and all participation is voluntary. Challenges: Sustainability is evolutionary and coincides with value-added services. Private sector funds are match by State funds. EHR vendor willingness to load and maintain orders compendium for each DHIN participating lab. 27

28. Minnesota � Preparing for Laboratory Interoperability The MN e-Health Initiative and Public Health Laboratory provide leadership by: Fostering the development of a state-wide laboratory network. Using a robust database to identify participating labs. Facilitating communication with all labs. Bringing together stakeholders to raise awareness and create understanding through communication channels. 28

29. Minnesota � Preparing for Laboratory Interoperability To foster laboratory interoperability, MN is: Identifying the status, barriers, and gaps for lab interoperability through various survey tools. Minnesota Clinical E-Laboratory Assessment for HIT Adoption and use (statewide survey of 180 labs developed by Public Health Laboratory and Office of Health Information Technology). AHA Annual Survey Information Technology Supplement with Minnesota Specific Questions. MN Health Information Technology (HIT) Ambulatory Clinic Survey. Providing oversight of Minnesota Health Information Exchange Service Providers as required by MN Statute (62J.498-62J.4982) including monitoring volume and type of HIE transactions conducted. Identifying ways to leverage HITECH resources to provide technical assistance to labs and exchange partners. 29

30. Minnesota � Preparing for Laboratory Interoperability Future Issues: Continuing to develop a standard-based interface for messaging. Developing tools and methods to provide technical assistance. Identifying/providing incentives to achieve interoperability. Incorporating the recommendations and activities from the MN. e-health Initiative, including the Standards & Interoperability Workgroup, as well as the Adoption and Meaningful Use Workgroup relating to laboratory interoperability. To learn more about the MN e-Health Initiative go to: www.health.state.mn.us/e-health/index.html 30

31. California � Multi-Pronged, Incremental Approach Medi-Cal: Currently assessing the feasibility of contracting/requirements for electronic lab results. Analyze claims and assess and prioritize labs by volume and market. Interoperability standards: Ensure adoption and use of uniform lab interoperability reporting standards and implementation guides. Cal eConnect- State-Level Governance Entity: The implementation plan prioritizes the development of lab services as its most important value-added service (outside of Meaningful Use). Aids labs in routing lab results. Potential to provide translation services for lab data. Outgoing messages must match incoming messages highlighting importance of translation services.  31

32. Kentucky � Standardizing Semantic Interoperability Developed detailed use cases first. Milestones and lessons: Regulations: A group of stakeholders successfully lobbied the KY legislature to ease the consent restrictions for secondary providers seeking to obtain lab results from the HIE. Standards: Transformation of lab results to conform to required coding and transport standards was quite a challenge for labs not already using LOINC� coding. Successfully negotiated lab contract with lab supplier LabCorp. Initially attempted to have the HIE convert EHR data to CCD. May be problematic in that many EHRs are not capable of parsing the lab data back out properly. It may make more sense to use the HIE as a simple conduit of data using HL7 messages. Current status: Routing lab results from state lab to physician � in testing. Delivering electronic lab results to physicians who order electronically � though still in early phases. 32

33. North Carolina � Beginning a Direct Pilot NC is a Direct Pilot Implementation Geography: Decision was made in December 2010 during a meeting with LabCorp, the REC, the HIE, and HIT Coordinator. Noted in the Operational Plan. Two phases to accommodate NC�s Operational Plan, which calls for more web-based exchange of results, and the use of Direct so that results can be exchanged quickly: Direct � LabCorp already has the interfaces so this work can begin now. XDR for "web-based" push of lab results � Cannot start until the HIE is operational (by end of 2011). Created two groups to tackle issues: Steering Committee that addresses policy issues. Technical group, which has developed a work plan. Identified practices volunteering as test cases, and gained support of their EHR vendors to participate in the pilot. 33

34. New Jersey � Developing Regulations NJ plans to implement regulation to compel all labs to send results electronically as a requirement for payment of claims. Working with Quest to implement this plan: Quest believes it can comply with such a regulation and advised NJ to include the standard processing of orders in the regulation. NJ is awaiting sample language from Quest. The Department of Banking and Insurance, a key stakeholder, is in full support. NJ plans to follow S&I framework (lab initiative) recommendations on specifications when addressing the interoperability issues around labs. 34

35. Wisconsin � Providing Technical Assistance for Lab Interoperability WI conducted a survey to identify HIE �white space� and found: Of 739 reference labs in Wisconsin, about 168 don�t deliver any results electronically and about 350 only deliver results electronically to providers within their legal entity. WI plans to target outreach efforts and HIE technical assistance (TA) for implementing Direct secure messaging to reference labs, including labs in critical access hospitals, who are not presently delivering electronic results to the providers they serve in their community. Used lab tests volume (from claims data) and the number of providers served by a lab to help prioritize labs receiving subsidized TA. 35

36. Wisconsin � Providing Technical Assistance for Lab Interoperability There are several stakeholders involved in this activity: The WI Statewide Health Information Network (WISHIN) is the state-level governing body and maintains all programmatic responsibilities (though it is not the recipient of the Cooperative Agreement). The REC is collaborating with WISHIN by identifying critical access hospitals with reference labs that need HIE assistance. The state-level HISP is a sub-recipient to WISHIN and serves as the resource center for HIE TA and for Direct services. TA includes access to website resources, telephone consultations, and potentially an initial site visit. Beyond that, WI plans to subsidize HIE TA with Cooperative Agreement Program funding, where the labs will have to pay a fee for onsite TA received. 36

37. Eligible Hospitals 37

38. Eligible Hospitals: MU Requirements Eligible Hospitals must comply with all Eligible Professional Requirements for structured result into their EHR. In addition Eligible Hospitals must: Select one of three public health measures. Electronically record, retrieve, and transmit reportable clinical lab results to public health agencies: Stage 1 requirement is for a single test, and then submission, if tested successfully and if agency can receive. Must use HL7 v2.5 and appropriate implementation guide which requires LOINC� and SNOMED. EHR/HIE vendors should provide secure, encrypted and auditable transport services (e.g., Direct). Must use certified option for sending labs to public health. In many cases, this requires a separate certification process for the eligible hospital if sending directly from LIMS. 38

39. Workflow and Meaningful Use ELR Certification Scenarios 39

40. Challenges and Strategies forEligible Hospitals 40

41. Challenges and Strategies: Policy

42. Challenges and Strategies: Technical

43. State innovations For Eligible Hospitals 43

44. CDC Cooperative Agreement Surescripts  Overview: Collaboration with American Hospital Association and College of American Pathologists. Technical Assistance directly with hospitals. Enable 500 Hospitals to achieve Meaningful Use for ELR: Includes 100 Critical Access Hospitals. 44

45. Massachusetts ELR Reporting Overview: MA ELR reporting went into production with June 2004. Web service end point to send SOAP messages. Plan to migrate to centralized Statewide HL7 Gateway. 40 of 76 of hospitals laboratories send HL7 2.3.1 messages with local codes. Upgrades to accept HL7 2.5.1 message by June 2011. HL7 messages directly consumed by MAVEN (Statewide disease surveillance system). ELR transformation services: Local codes for laboratory tests and results translated to standard LOINC� and SNOMED. Other local codes (race, sex, etc.) translated to standard HL7 vocabularies. HL7 2.3.1 messages for hospitals already transmitting to be transformed to HL7 2.5.1 (certification process to be determined). 45

46. California � Multi-Pronged, Incremental Approach Public health: Assess public health capability to accept electronic lab results under ONC�s standards and specifications for EHR. California Department of Public Health developing an implementation guide to assist hospitals (and laboratories) submit lab results to public health in order to meet Meaningful Use. Align public health lab reporting requirements with ambulatory and hospital lab reporting requirements wherever possible. Work with state laboratory field services to ensure licensing and certification of labs in California do not hamper interoperability. 46

47. New Mexico HIE � ELR Reporting Overview: NMHIC was created in 2004, and is operated by LCF Research. NMHIC is New Mexico�s State Designated Entity (SDE), and designated by NM Department of Health as the official agent for ELR reporting. ELR reporting went into production with NM-DOH in June 2010. 33 % of all New Mexico hospitals laboratories are participating, including the three largest healthcare delivery systems in the state. 66 % major national and regional laboratories are participating, including the two largest independent reference laboratories in the state. As NMHIC adds hospitals and labs to the HIE, ELR reporting to NM-DOH will increase. ELR transformation services: Filtering, Coding, Message Transformation and Forwarding: NMHIC HIE inbound lab interfaces are customized to filter out reportable labs. NMHIC performs appropriate LOINC� and SNOMED code mapping. NMHIC transforms message type from v. 2.x to 2.3.1 for NM-DOH. NMHIC forwards all reportable labs to the NM-Electronic Disease Surveillance. System (NM-EDSS), which is connected to CDC-NEDSS. 47

48. Resources and Tools for Eligible providers and Eligible Hospitals 48

49. State HIE Lab Interoperability CoP The State HIE Lab Interoperability Community of Practice (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@hln.com), ONC Facilitator for the Lab Interoperability CoP, for more information. 49

50. Regional Extension Center (REC) Functional Interoperability Community of Practice The REC Program supports a Community of Practice (CoP) focused on functional interoperability and HIE. The Lab Workgroup within this CoP is tasked with aligning the REC program tasks with Lab/Meaningful Use Stage 1 requirements: This work group will collaborate with the other groups working on lab interoperability and will report back to the CoP on a bi-weekly basis.� � 50

51. Standards and Interoperability Framework Lab Results Interface (LRI) Initiative The LRI initiative was launched to incorporate lab results into EHR as structured data. This aligns with the goals of MU to: Achieve cost savings of up to 90% due to lab interface development improvements by 2015. Reduce total lab interface implementation time by up to 20% by 2013. The initiative is focused on: Addressing this challenge for the subset of lab reporting to primary care (internal medicine, family practice, pediatrics). Optionally: Enable pilots that demonstrate electronic results delivery through the agreed-upon standard, including linkages with directories and transport. The group held its first meeting on February 1, 2011. To stay informed, access deliverables and see outputs of the Use Case and Requirements (UCR) Workgroup visit: S&I LRI Initiative 51

52. Resources and Tools State HIE Program Website: http://www.statehieresources.org CLIA Laws: https://www.amia.org/files/shared/290-05-0015_Final_508_State_CLIA_Law_Report.pdf http://www.chcf.org/~/media/Files/PDF/E/ElectronicLabResultsExchangePolicy.pdf http://www1.cms.gov/SurveyCertificationGenInfo/downloads/SCLetter10-12.pdf Releasing Clinical Laboratory Test Results: Preliminary Report on Survey of State Laws: https://www.amia.org/files/shared/290-05-0015_Final_508_State_CLIA_Law_Report.pdf 52