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 June 20, 2011

2. Agenda Introduction Importance of Lab Interoperability Eligible Professionals (Structured Labs into EHR) Meaningful Use Requirements / Workflow options Challenges and Strategies CLIA Regulations State Innovations Eligible Hospital (Electronic Lab Report (ELR)) Meaningful Use Requirements / Workflow options 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. 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. 3

4. 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 professionals are not required to incorporate clinical lab test results into a certified EHR technology as structure data for stage 1 meaningful use (but will most likely be expected to do so for stage 2 and 3). Eligible professionals could elect to incorporate clinical lab test results as one of their five (stage 1) menu set objectives.   4

5. Workflow and HIE Options 5

6. Eligible Professionals: Challenges and Strategies 6 Policy Lack of standardized contract language Weak business case for low volume practices Little coordination among small, independent lab partners No long-term economic model for sustainability Transport Lab results must be transported reliably from the lab to the provider Challenges with bi-directional exchange Standards Need for coordination between lab partners to support standards Differences in interpretation of CLIA regulations

7. 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. 7

8. 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. 8

9. 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. 9

10. 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. 10

11. STATE INNOVATIONS FOR ELIGIBLE PROFESSIONALS 11

12. 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. 12

13. 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. 13

14. 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. 14

15. 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. 15

16. 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. 16

17. 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. 17

18. 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. 18

19. Workflow and Meaningful Use ELR Certification Scenarios 19

20. Eligible Hospitals Challenges and Strategies 20 Policy Lack of Public Health Readiness Clinical work flow for disease reporting is more complex than lab result reporting alone Inconsistent documentation of reportable conditions by state Technical Multiple, inconsistent transport protocols Lab reports submitted directly from LIMS may not be a certified EHR solution Lack of uniform use of standards for laboratory vocabulary: Codes may need to be translated to a standardized form Semantic interoperability is required for data transmissions to be understood

21. State innovations For Eligible Hospitals 21

22. Update on CDC Cooperative Agreement with 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. 22

23. 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). 23

24. 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. 24

25. Resources and Tools for Eligible providers and Eligible Hospitals 25

26. 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. 26

27. 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.    27

28. 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 28

29. Resources and Tools State HIE Program Website: http://www.statehieresources.org CLIA Laws: http://www.nashp.org/sites/default/files/ElectronicLabResultsExchangePolicy.pdf https://www.cms.gov/SurveyCertificationGenInfo/downloads/SCLetter10-12.pdf 29