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Meeting Details

Date: June 2, 2023

Time: 1PM ET

Coordinates:  Join Zoom meeting: https://zoom.us/j/5100467805 | Meeting ID: 510 046 7805 | +1 929-436-2866-US (New York)

Attendees: 


Chair: 

Scribe: 

  • Quorum (Co-Chair + 4) Met 

AGENDA

  • Standing Topics 
    • Special Topics
    • COW/Workflow updates
  • Impact Assessment - DeviceAssociation resource
  • JIRAs Triage
  • Other agenda items?

Meeting Resources

JIRA Dashboards:

JIRA Grouping Tags:

  • OO-Lab - to indicate when the JIRA Ticket should be reviewed by the OO Lab SMEs, especially when the issue is not assigned to the Resource owner.

Meeting Minutes

Previous Meeting Notes

Standing Topics

TODAY – eSignature Update

  • Follow-up date
    • No updates
  • Follow-up date: No updates yet.

From Chat:

Andrea Pitkus:  Regarding e-sig, I came across this CLIA doc (see #5):  https://www.cms.gov/files/document/qso-21-10-clia-revised.pdf

eSignature Update

2023-02-24 OO - LAB/LIVD

TODAY – Health Data, Technology, and Interoperability: Certification Program Updates, Algorithm Transparency, and Information Sharing

Link: https://www.federalregister.gov/documents/2023/04/18/2023-07229/health-data-technology-and-interoperability-certification-program-updates-algorithm-transparency-and

  • SVAP is out for comment also
    • Consider adding:  More automatic inclusion of HL7 published newer version of standards in ISA, so they are available for SVAP



NPRM - ONC 

April 28, 2023 - Need to follow up on the May 19, 2023 LAB call


FROM WGM MM: ONC NPRM Lab RFI Feedback

  • OO ONC NPRM Response Draft. - Orders & Observations - Confluence (hl7.org)
  • Replaced "While FHIR elements needed for laboratory orders and reporting are generally available, profiles, implementation guides, US Core, and other needs to implement and support laboratory data exchange in accord with CLIA supporting the full laboratory ordering and resulting workflow, including formal laboratory results reporting, need further development and testing in order to be sufficiently mature." with "Although FHIR profiles are available for basic display and sharing of laboratory data, these profiles and implementation guides are generally insufficient for laboratory orders and reporting in a clinical context. FHIR elements, profiles, implementation guides, like US Core, and others needs further development and testing in order to be sufficiently mature."
  • Replaced "Other than for new interfaces, including the HL7 v2 LOI and LRI (including the latest guidance for ELR reporting to Public Health) in ONC's Certification would not yield the advancements expected.  The benefits of replacing existing interfaces in full do not outweigh the cost of such an upgrade, even though the guides provide a fully aligned set of implementation guides addressing CLIA requirements and establish consistent use of HL7 v2 for various complex interoperability use cases.  For existing interfaces, a more targeted approach, which the guides also support, introducing individual profiles that can be used with any existing HL7 v2 laboratory order or result message can advance data quality and consistency at a lower cost by focusing on use of the aligned value sets.  At the same time focus incentives on new interfaces to adopt the full guides would be essential to progressively achieve further alignment.   It is important though that both sides of the workflow (since either system will be the source for data in the order and result reporting workflow) align on the same version of the IGs.Consequently, without clear benefits, only adopting the respective HL7 v2 LOI and LRI guides beyond those already adopted (clearly recognizing that FHIR is not yet ready to support the actual laboratory ordering and results workflow, including reporting to public health considering as well public health's readiness to support FHIR based reporting) will not be successful, rather let IG's sit on the shelf, or only adopted by mostly one side of the workflow.  It is important though that both sides of the workflow as the source of either the order or the results report, to align on the same versions of the standard and implementation guides.  Currently, ONC can require primarily EHRs to adopt certain capabilities as CMS requires the use of CEHRT for certain payment programs, but there is not equivalent for LIS-s to be certified to an ONC Certification Programs and laboratories to be incented to adopt such LIS to meet their requirements, e.g., CLIA. " with "

    Reporting electronic laboratory results supporting CLIA requirements has been based on multiple versions of  HL7 v2 messages well before ONC started its certification program.

    Other than for new interfaces, including the HL7 v2 LOI and LRI (including the latest guidance for ELR reporting to Public Health) in ONC's Certification would not yield the advancements expected.  The benefits of replacing existing interfaces in full do not outweigh the cost of such an upgrade, even though the guides provide a fully aligned set of implementation guides addressing CLIA requirements and establish consistent use of HL7 v2 for various complex interoperability use cases.  For existing interfaces, a more targeted approach, which the guides also support, introducing individual profiles that can be used with any existing HL7 v2 laboratory order or result message can advance data quality and consistency at a lower cost by focusing on use of the aligned value sets. Focusing on more consistent adoption of standard vocabularies (in particular LOINC, SNOMED, UCUM) would likely have more benefit than promoting the adoption of up to date LOI/LRI versions when other HL7 v2 interfaces have been widely adopted."

  • Will continue on Monday in Specimen call and if needed HCP for final vote.

New Rule on Race/Ethnicity from OMB/CDC

  • Follow-up date  

New Rule on Race/Ethnicity from OMB/CDC

TODAY – CPT-PLA

  • Follow-up date  
  • Need to follow-up with AMA representative

CPT-PLA

2023-02-03 OO - LAB/LIVD

2023-02-24 OO - LAB/LIVD

Update from FHIR Lab Workflow call

Meeting Notes

  • Reminder: LIVD call to restart June 15 biweekly for a short period of time to finish updates to the LIVD IG
  • See notes above on NPRM discussion and addition of the  OO ONC NPRM Response Draft Confluence page
    • To be discussed this week.
  • Device Association - Lab-related Resources to review impact of change to Device/DeviceAssociation (notes will be moved to confluence page):
    • BodyStructure
      • Does not need to change distanceFromLandmark.device from reference(Device) to reference(DeviceAssocation)
      • While BodyStructure and DeviceAssociation have references to each other, the deviceAssociation only generally points to a Device being present, the BodyStructure indicates a relative position to a specific device.
    • DiagnosticReport
    • DocumentReference
    • Observation
    • Specimen
  • See May WGM carry-over FHIR JIRA Tickets below




JIRA Triage

V2 Lab JIRAs (link)

The following JIRA Tickets need to be reviewed by the Lab members as carry over from May 2023 WGM:

FHIR Lab JIRA (link)

The following JIRA Tickets need to be reviewed by the Lab members as carry over from May 2023 WGM:



Next Meeting: June 9, 2023