Laboratory Validation Interface (Concept)

1. Laboratory Validation Interface(Concept) Tuesday July 16, 2013 3:00 – 5:00 pm eastern

2. Participants • ONC • CAP • CMS/DLS • CDC/LPSB • LabCorp • Methodist Hospital • Quest Diagnostics • API • Cerner Corporation • Meditech • Epic • Sunquest Information Systems • Others

3. Laboratory Validation Interface EHR consumes, translates and stores result information LIS requests Validation Transaction Laboratory EHR responds with Validation Transaction for specific ORC Physician office LIS or HIS system EHR EHR collects display versions of data and populates LVI transaction

4. Validation Response from EHR • Functionality on LIS Side (elicit, receive and analyze) • Something in MSH indicates this is a validation message • Ability to receive and consume the response message compliant with the “LRI validation IG” • Out of scope • Validate that EHR internal representation is appropriate • Functionality on EHR side (consume, respond) • Recognize the MSH validation message indicator • Generate and send the response message compliant with the “LRI validation IG” • Can we include a “screen capture” as part of the response data?

5. EHR internal functionality • Interest is to compare the “required fields” (CLIA, best practice, and _________) • Patient Data (name, ID, age, gender) • Order Information (order id, • Test detail information • Test code (LOINC) • Test code display • Result • Interpretation • Units • Specimen information

6. Standards • Update LRI IG MSH element definition for validation message • Standard for the EHR validation response (LRI, mod LRI, ERL, new)

7. LVI Discussion EHR Certification -- LVI • Required (Regulatory) (MU3) – recommended • Optional (NIST offered optional certification) Screen Capture of reference test report • Optional • Required -- recommended • Automated (virtual) • Manual Interaction CLIA • Issue guidance that for certified EHRs that meet the recommendations and use of LVI meet EHR interface validation criteria

8. Issues • “Middleware” issues with • Application level acknowledgement • LVI • Splitting of transactions • Example is patient portal • Only primary transaction should support • Application level acknowledgement • LVI • Validation across multiple systems is a challenge • Middleware if not splitting should not change any of the HL7 segments and not respond to request for Application Level acknowledgement

9. Sections and Elements (1)

10. Sections and Elements (2)

11. Sections and Elements (3)