update the HHS to more clearly identify tANSI Anti-Trust Policy:  Professional Associations, such as HL7, which bring together competing entities are subject to strict scrutiny under applicable antitrust laws. HL7 recognizes that the antitrust laws were enacted to promote fairness in competition and, as such, supports laws against monopoly and restraints of trade and their enforcement. Each individual participating in HL7 meetings and conferences, regardless of venue, is responsible for knowing the contents of and adhering to the HL7 Antitrust Policy as stated in §05.01 of the Governance and Operations Manual (GOM).

Meeting Details

Date: February 24, 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: Ralf Herzog (Roche), Hans Buitendijk (Oracle), Scott Fradkin (Flexion), Nancy Spector (AMA), Sheryl Taylor (NIST), Christopher Harrison (Quest Diagnostics), Kathy Walsh (Labcorp), Joan Kegerize (ACLA), Andrea Pitkus (UW), Alex Mays (Mitre), Marti Velezis (Sonrisa / FDA), Ana Szarfman (FDA), Rob Hausam (Hausam Consulting), Sara Armson (ONC), Riki Merrick (Vernetzt, LLC / APHL), Victoria Derbyshire (FDA)

Co-chair: Hans Buitendijk

Scribe: Riki Merrick

  • Quorum (Co-Chair + 4) Met 


  • Standing Topics 
    • Special Topics
    • Workflow updates
  • JIRAs Triage
  • Other?

Meeting Resources

JIRA Dashboards:

Meeting Minutes

Previous Meeting Notes

Standing Topics

eSignature Update:

  • PAC Submission due on 2/24/2023
  • OO - CMS Health Care Attachments Response - Draft review
  • ACLA aligns with this draft so far, ACLA has member meeting later today at 3 PM – if there is something that might need to get added from HL7 side
  • Quest also agreed with this draft
  • Did we address that they did not put the proposed standard in the regulatory text?
    • Since there was no discussion about alternatives we should just know?
    • These lab orders flow into attachments, eSignature is defined for attachments here, but lab orders already have signature
    • Not sure we want a reference to v2 in this rule
  • On the actual attachment that might be a point – some folks may push back, if they name a required standard later
  • Do we need to add eSignature as mentioned in CLIA?
    • CLIA does not have a definition of electronic signature
    • If they don’t have that, then we can stick to the definitions we have used
    • Not sure about mentioning alignment with CLIA interpretation of eSignature
    • With the ambiguity around electronic signature, Quest suggested a meeting with ONC, HHS, CMS, CLIA Advisory (that meeting has been requested since the beginning of 2022 but that has not yet happened) – update the reference to the meeting with HHS to more clearly identify the agencies needed
    • Do we need to include Medicaid – even though that is state specific, but is there a national organization to get that input – National Association of Medicaid Medical Directors; folks on this call have not have much interaction with them, so leave them out for this comment
    • Upgrade “We welcome” to “We urge” or “Strongly recommend”
    • If updates are needed, will send to the lablist
    • PAC may send some questions back next week

eSignature Update:


  • The following CMS rule has been released: Title: Adoption of Standards for Health Care Attachments Transactions and Electronic Signatures, and Modification to Referral Certification and Authorization Transaction Standard; Scheduled Pub. Date: 12/21/2022; Permalink: https://www.federalregister.gov/d/2022-27437.   
  • it does include commerce law language allowing a symbol as substitute as described to us by John Moehrke
  • ACLA had a call with ONC representative to remind them that we still have to resolve this – it will affect ALL existing interfaces in the orders and the results
  • Hans to give PAC a heads up that OO will provide feedback on this
  • Comments Due March 21, 2023 (when are comments due to PAC?) 

[2023-02-03 Discussion] 

  • Scope is vague for lab orders - and need to continue discussion next two calls (time permitting)
  • General definition - currently v2 should work and no changes need to be made. 

[2023-02-10 Discussion]

  • PAC knows something is coming
  • Goal is to comment on attachment rule to get CMS engaged in conversation about electronic orders for lab around signature
    • General definition of what a signature requirement is (starting on page 78449, section C) – but on page 78450 mentions electronic signature is vague
      • Focus on how the process is defined and describe the flow as it currently happens 
      • Lab orders produce attachments exchanges, so then are covered here
        • Attachments is wider than just document – it includes – if that includes request for claim to be paid – that would include orders to substantiate the claim
        • Reference to CLIA is helpful
      • Also include CLIA definition of electronic signature
      • You are implying that lab orders have signatures based on statement from 2011 which supposes that existing v2 is working
      • Claims not being paid when missing signature for the last 2 years and needs to get reversed
      • For a claim to be submitted, can send attachment with submission or later – then have rules on what needs to be in the attachment
      • If an order is required in the attachments – how do we recognize the authorized electronically signed order – attachments include the clinical data

[2023-02-17 Discussion] ALL TO REVIEW

  • Feel free to fix typos and grammar
  • Use in-line comments for suggested changes in content
  • Feel free to reach out to Christopher, if you have more feedback / questions about Freida’s document, he is distilling 38 pages of research into Quest comments:
  • ACLA has similar comments, they will continue to provide member feedback
New Rule on Race/Ethnicity from OMB - Have 75 days from 1/27/2023, so due date is April 19, 2023  
  • Not discussed today

New Rule on Race/Ethnicity from OMB - Have 75 days from 1/27/2023, so due date is April 19, 2023


  • Federal Register :: Initial Proposals For Updating OMB's Race and Ethnicity Statistical Standards  https://www.federalregister.gov/documents/2023/01/27/2023-01635/initial-proposals-for-updating-ombs-race-and-ethnicity-statistical-standards  
  • <from prior call chat> Hans mentioned “trickle down” - the reason we had race and ethnicity terms added in HL7 started with V2 is because CDC requested Patient Administration (Chpt. 3) to add (HL7 V2.4 I think) because CDC had to conform to federal requirements.  The same terms used for Census Bureau data ‘trickled over’ to other federal agencies.  If this new request for comment proceeds to a new proposed then final rule, it would probably “trickle down” eventually impacting CDC, ONC, CDC (thus eventually healthcare standards) etc.  See 1997 link and you will recognize correlation to HL7 V2 of race and ethnicity.  Revisions to the Standards for the Classification of Federal Data on Race and Ethnicity | The White House (archives.gov) https://obamawhitehouse.archives.gov/omb/fedreg_1997standards


  • For ISA CPT-PLA codes were added at some point
  • For the existing LOI and LRI these could be sent as alternative codes
  • Not sure that PLA codes would replace local codes used in the catalog
  • Local codes MUST be specific to the test (if there is more than one that can be mapped to LOINC / CPT-PLA code) per CLIA, so that the lab test has a unique local code e.g to accommodate different use cases for clinical care
  • AMA wants to make sure developers are aware that they exist and may be applicable to their use case
  • CPT-PLA codes are uploaded to HHS PAMA site - not sure this is at patient level
    • This is not just for tacking utilization and payment
    • They are not used for certification
  • Is the ISA vocabulary that is to be common across organizations, so that it can be consistently interpreted
  • If it is included we want to make sure we identify the type of exchanges where it can be used and highlight that
  • While ISA is a list of standards, but it does create a grouping by use case of ordering / reporting, so should there be additional use cases for billing – the question is are the CPT-PLA codes really used in the ordering space
  • ISA layout is not limited to just clinical data exchange, so we could expand the specific use cases
  • If CPT-PLA codes are associated with the order, but not the code used to actually order the test
    • There is one health system that uses the PLC codes internally for their ordering
  • ISA and relationship with USCDI
    • The USCDI specifies the clinical data elements and which vocabularies are sued for these data elements that need to be able to be exchanged – applies to ALL certified HIT components (not just EHR-s) – at the moment for sure for EHI
    • ISA is collection of what is available
    • Not sure if this is a place for developers, but may be useful for newbies, but also intended for policy makers (though that gives an incomplete picture, as the maturity and implementation level are correct)
    • USCDI data elements are NOT enough to implement data exchange – that is where the Implementation guides are needed
  • Would you consider CPT-PLA codes part of EHI?
    • Not for addition to USCDI
      • Maybe the + versions of USCDI – one for PH and one for clinical quality – maybe create one for billing analytics?
  • Consider submitting a comment to add a new category that better describes the use of CPT-PLA codes


2023-02-03 OO - LAB/LIVD

  • Proposal being prepped by: Nancy Spector, Ana Szarfarm, Kathy Walsh, Andrea Pitkus, Hans Buitendijk, Dan Rutz
  • OO Lab and CPT PLA
    • PLA = Proprietary Laboratory Analyses
    • It is not messaged between healthcare organization
    • Nancy will ask AMA to review this content
    • Discuss should this be on this webpage?
      • Any data that is associated with a patient outside of internal analytics in a specific system that will be exchanged
      • Laboratories that have inventory / catalog and submit this to CMS, so this has applicability to interoperability – so yes, we agree it should be in the ISA
      • May need to evaluate if this is in the right use case
        • One health system uses the PLA codes internally for ordering of lab
        • We may need to make clear that LOINC is the primary code and that PLA codes can be used similar to local codes – this could be done in the LOI guide?
          • No, we don’t want to have everyone’s option explained in the LOI – this would be explaining how NOT to use PLA codes …

Update from FHIR Lab Workflow call

  • DME update
    • PSS passed TSC, FMG requested review against ALL other FHIR IGs that deal with workflow - Bob compiled list of ALL FHIR IGs and is reviewing, we shared our list
    • Will review the applicable IGs on next Monday's (2/27/2023) specimen call 2-3 PM ET to clarify scope
    • plan on re-starting DME calls Mondays 12 -1 PM ET the week after, if FMG approves IG update
  • FHIR COW IG Update
    • collecting options for grouping orders and will draft pros/cons for each approach (need volunteer to do that work)

From Chat

  • Andrea Pitkus 1:09 PM
    • Have CLIA aspects been included?
    • electronic signature appears 3 times in CLIA.
  • Andrea Pitkus 1:12 PM
    • "Tissue pathology reports must be signed by an individual qualified as specified in paragraph (b) or, as appropriate, paragraph (c) of this section. If a computer report is generated with an electronic Tissue pathology reports must be signed by an individual qualified as specified in paragraph (b) or, as appropriate, paragraph (c) of this section. If a computer report is generated with an electronic signature, it must be authorized by the individual who performed the examination and made the diagnosis."
    • Great! Thanks Christopher!
  • Hans Buitendijk 1:27 PM
    • Have a look at the updated last sentence in the e-sig comment and see whether it fits.
      • Christopher Harrison 1:31 PM
        • perhaps change the first including to comprising?
  • Alex Mays 1:28 PM
    • Is there essentially any negative to putting stuff on the ISA? To my mind it doesn’t have any regulatory impact, it’s just a public-facing compendium.
  • Andrea Pitkus 1:30 PM
    • that is true Alex. The concern is when developers don't understand how they are to be implemented and grab them from ISA (or other places) and use them for unintended purposes.  I don't have a problem listing them in ISA (if clear that they are used for the HHS PAMA use case), but my understanding is ISA is for patient instance related use cases.  Hence the discussion/some of the confusion, etc.
  • Hans Buitendijk 1:32 PM
    • There are lots of standards in ISA that we don't want implementers just pull from the ISA and then end up applying it incorrectly. Not until it gets into a program (certification, etc.) will it become really clear what is supposed to be used and when.
  • Andrea Pitkus 1:32 PM
  • Alex Mays 1:36 PM
    • Count me as in favor of efforts that generally improve the usability of ISA; my low threshold for including things at this time is also based in my opinion that it’s already all over the place
  • Andrea Pitkus 1:37 PM
    • Thank you for the clarification, Nancy on how it's being used

Call Adjourned 2:00 PM ET

Next Meeting:  March 10, 2023

  • Topics for next week’s call?
    • QA work from R5
    • Review Stale Jiras that are lab specific (FHIR and V2)


  • Will pick LIVD back up 3/10
  • In general Ed is taking Fridays off in April – maybe we can flip with specimen on Mondays 2 PM?

JIRA Triage

R5 Ballot JIRA - None on the agenda (unless someone identifies a critical item)

  • JIRA on Task 
    1. FHIR-39324 - Add example value set for Task.businessStatus for Lab TRIAGED
      1. Example codes (we'll continue in the next call)
        1. Specimen collected ← Not clear whether we need this - it's in specimen
        2. IG prepped ← TBD
  • https://jira.hl7.org/browse/FHIR-32154 - Definition for preliminary
    • Please review the comment
    • Decided that we would not add partial at this time.
    • We will update the definition of Observation.status to mirror that of DiagnosticReport.