eSignature Update

•  Follow-up date 06 Oct 2023

No updates today

New Rule on Race/Ethnicity from OMB/CDC

•  Follow-up date 06 Oct 2023 

No updates today

COW/FOE Update

• Finished simple Potassium workflow – without transport
• Still need to consider how to do updates of final reports

CPT-PLA

•  01 Sep 2023 
• OO Lab and CPT PLA
  • The 2 bullets seem to properly distinguish between LOINC and CPT PLA codes
  • Need to have terminology pages
    • Kathy + Andrea prefer to have separate pages for LOINC update (under existing Laboratory Ordered Test) and CPT PLA (a new page under Procedures) in the ISA
    • The second page option does not represent the AMA perspective
    • Nancy + Rob + Hans prefer same page on the “Laboratory Test Ordered”, as more pages creates more confusion than is helpful
  • The PLA codes are also used for billing – so may be also to the Administrative?
    • That is not currently covering any vocabulary standards as part of that group
    • CPT / ICD – all of those are listed in their respective domains
  • We will provide both perspectives, since as HL7 community we should comment, since the clarification is important rather than not commenting at all
  • Individual folks can also submit their comments for the recommendation of their choice
  • Also update to remove the reference to ORC-16, since that is NOT using LOINC or CPT PLA or other codes, as it represents the reason for the order, not the order itself
  • Comments on the ISA are entered by the submission system in the order of receipt – however the full HL7 PAC comment will not be on this page
  • For the ORC-16 may be better for ONC to make that clarification
  • It is helpful to ONC to get supportive comments
  • How are changes that we are proposing helping implementers understand them
  • Motion to submit the italicized comment to the HL7 PAC – Riki Merrick, Marti Velezis, no further discussion, against:2, abstain: 1, in favor: 7
    • For completeness, the text is:

    • Currently, the ONC ISA represents CPT-PLA as an available vocabulary for laboratory orders in the Representing Laboratory Test Ordered | Interoperability Standards Advisory (ISA) (healthit.gov) section in Section I: Vocabulary/Code Set/Terminology Standards and Implementation Specifications | Interoperability Standards Advisory (ISA) (healthit.gov).  This placement is raising concerns as it could be interpreted as appropriate for use when ordering a lab test, yet the consensus of the HL7 OO workgroup is that CPT-PLA is not intended for actual ordering lab tests, rather focused on reporting lab tests ordered for reimbursement purposes in certain situations. See https://www.ama-assn.org/about/cpt-editorial-panel/help-create-cpt-proprietary-laboratory-analyses-codes for further context.

      When mapping a laboratory test order, the preferred encoding is a LOINC(R) code.  The current language in the ISA is not making this distinction, thus could lead the reader to believe that CPT-PLA is an appropriate alternative to LOINC codes for placing orders for lab tests.  We suggest that either the existing Representing Laboratory Test Ordered is updated as follows:

      • Update the Limitations, Dependencies, and Preconditions for Consideration to replace the current language with:
        1. LOINC codes are used to provide the clinical concept that the test ordered represents enabling consistent interpretation across systems and organizations regardless of an internal code specific to a laboratory that is typically used to actually order a test.  The LOINC code used as part of the order may not be the same LOINC code as the one for the performed test when the performed test code is more specific in one of the LOINC parts (e.g., method or system) or when the order combines multiple tests into a panel.  
        2. CPT-PLA classifies/encodes lab tests ordered for the relevant internal and reimbursement processes that require conveyance of the clinical information contained in the CPT-PLA code. CPT-PLA codes identify the specifics of the procedure used to perform the test as developed by a particular laboratory or in vitro diagnostics (IVD) vendor.

      Alternatively, some would suggest that ONC should consider adding a new page instead, preferably under Procedures to be named Representing Laboratory Test Procedures where the existing Representing Laboratory Test Ordered only includes references to LOINC with the limitation suggested per (1) above, while the new Representing Laboratory Test Procedures pages would focus on the CPT-PLA encoding using the suggested limitation text per (2) above.

      Lastly, considering the confusion that the comments referencing ORC-16.  We suggest that ONC adds a statement on the page in response to various comments referencing ORC-16 to state:

      • References in the comments on the use of ORC-16 do not accurately reflect the use of that field.  We refer the reader to the HL7 implementation guides for laboratory orders clarifying that ORC-16 represents the reason for the order, not a code such as LOINC, SNOMED, or CPT-PLA.  Further guidance on how and when to communicate LOINC and/or CPT-PLA codes would be identified in that guide as well.

      While HL7 could submit a comment to this end, we believe that having this clarification by ONC would be more clear.  If ONC believes that HL7 should make that comment instead of or in addition to ONC's statement directly on this page, please let us know.

ISA Comments

Merge with CPT-PLA comments

• .See above

USCDI feedback

• USCDI units of measure use only UCUM listed
  • Need to look at US Core and CCDA IGs as to what certified EHR-s must support – US Core lists SHOULD for UCUM – which is base FHIR R4
• For Lab should really clean up the mentioned dates:
  • CLIA requires specimen collection date/time – and it provides the clinical context (patient safety / trending)
  • Specimen condition acceptability comingles 2 concepts, both are CLIA requirements, but the way they are
• Keep in mind that USCDI is focused on HIT, not just EHR-s – currently all HIT have to support all of USCDI for certification
• We will create a confluence to collect draft recommendations by September 8 
  • OO Comments for USCDI v5 draft Consideration - Orders & Observations - Confluence (hl7.org)
  • then we then finalize during the WGM during these quarters Tue Q1?, Wed second half of Q2
• Our focus is on fixing/clarifying USCDI (United States Core Data for Interoperability (USCDI) | Interoperability Standards Advisory (ISA) (healthit.gov)), Laboratory (Laboratory | Interoperability Standards Advisory (ISA) (healthit.gov)), and any other pages that involve OO data classes/elements