Lab Results Interface (LRI) The Flexible Implementation Guide (IG) Standards and Interoperability Framework Initiative (ONC)

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Lab Results Interface (LRI) The Flexible Implementation Guide (IG) Standards and Interoperability Framework Initiative (ONC) Ken McCaslin, FHL7 Director, Healthcare Standards Quest Diagnostics Co-chair Orders/Observations Work Group - HL7 Co-Chair HIT Committee - American Clinical Laboratory Association (ACLA) Co-chair LRI IG Work Group Standards and Interoperability Framework Initiative 1 Change is the law of life. And those who look only to the past or present are certain to miss the future. ~ John F. Kennedy

Overview The scope: Lab results to an EHR in an ambulatory setting Has flexibility to support public health and acute settings The initiative was tasked by S&I Framework with producing a single, comprehensive IG IG has flexibility through constraining profiles to support various levels of structure able to be adjusted to support various levels of identification processes 2

Implementation Guide Principles Highly scoped Focused on single care concern within domain Reduce the business level discussion Drive Interoperability between parties Broader scope Within a domain handle all possible care concerns Business level discussion necessary Drive Flexibility 3

How the LRI IG Balanced Flexibility HITSP HL7 IG Standard: HL7 2.5.1 Designed for broad set of use cases Flexibility Interoperability 4 Interoperability ELINCS HL7 IG Standard: HL7 2.5.1 Designed for narrow use case S&I Framework LRI IG Standard: HL7 2.5.1 Extensible base with required profiles to enable constraints Constrained vocabularies

IG Approach & Requirements Provides a path from slightly structured to very structured without rewriting the IG Profiles that constrain the guide based on what the sender and receivers can support Each profile further constrains the previous profile Yes Yes No LRI IG Profile constraint 1 Profile constraint 2 Profile constraint X No Yes Yes Base Profile Profiles well defined and documented Further Constrained Each profile given an identifier so that sender and receivers can be specific about what is supported 5 Message format 1 Message format N

The Path to Consensus Consensus by broad and deep community of 90 active participants Support from proponents of ELINCS, HITSP and Public Health Key issues considered: Based on a standard (HL7 2.5.1) with 200+ lab/ehr deployments Reviewed by vendors for clarity and implementer-friendliness Testable conformance parameters in conjunction with NIST Adoption of standard terminologies (LOINC, SNOMED Micro- Organism identification) 6

Lab Results Interface Timeline 7

Key Recommendations LOINC vocabulary is required as is applicable to the list of In-Scope Tests for the initial LRI Use Case SNOMED is recommended as a required vocabulary Micro organism results only at this time Items to be piloted for future Meaningful Use Requirements: UCUM for units of measure OIDs for globally unique identifiers SNOMED for other areas of lab reporting Getting EHR and LIS vendors to agree that they can implement the IG and use it to transmit and consume lab results while minimizing customization and translation Developing resources and tools to providers that conform to the new LRI IG, facilitated by Meaningful Use, State HIEs, RECs, and broad product availability 8

Piloting the IG An interim version of the IG was published in December 2011 The pilot will determine whether the LRI IG, the vocabulary concepts, and the Lab Results are implementable The pilot will validate vocabularies to confirm that they are appropriate and relevant. A Validation Tool Suite has been provided by NIST to validate messaging standards 9

To improve is to change; to be perfect is to change often. ~ Winston Churchill Questions? 10