ANSI 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).

Administrivia

Approve Minutes

• • 2023-03-16+Main

    • Motion to approve as posted – Riki Merrick, Lorraine Constable – no further discussion, against: 0, abstain: 1, in favor: 15
  • 2023-03-23 Main
    • Motion to approve as posted – Marti Velezis, Ralf Herzog – no further discussion, against: 0, abstain: 3, in favor: 13

Key Topics for Today

• GTIN

• WGM Agenda review
• For consideration:
  • mCode is going to ballot May 2023– we don’t own, but changes in alignment with UScore and ClnicalGenomics and how they uses DiagnosticReport might warrant folks taking a look
  • R5 has been published, so now we need to do QA on STU version for these IGs:
    • Catalog
    • Cancer Pathology Reporting
    • SDC on FHIR
  • At-Home Test Result Reporting IG has been published
  • Co-Chair Elections for June

OO Project Proposal Triage

• Phenomics Exchange for Research and Diagnostics IG (Pheno IG)
  • left note that we might want to be interested party, not co-sponsor
  • will review at PSS stage, when more detail is available

Other (Project Approvals, NIBs, Expiring standards, etc.) - nothing pressing - do next week

• Expiration of standards:
  • HL7 Version 3 Standard: Clinical Statement Pattern, Release 1 - August 2024 - Re-affirmation or Withdrawal for May 2024 Ballot - Hans to check with Riki.
• Update to Charter
  • We reviewed and made updates during WGM - we will have to re-create based on the latest version here (OO Mission and Charter - Pre-Publication) and the notes from the WGM minutes https://confluence.hl7.org/pages/viewpage.action?pageId=139660361#id-2022091923WGM-Mission/CharterReview
  • And we need to change Vocabulary to Terminology Infrastructure
  • Here is the version for review and approval to send to Anne: 

• Early bird registration is April 15, 2023
• Hotel rooms are hard to come by, as it is also Jazz week
• 5/1 (or week before) - Final date to withdraw rooms if not needed.
• OO WGM 202305 - Agenda
  • Updates to the agenda were posted (link above)

    • Added agenda items during the call

    • Need to start assigning topics to Quarters – 

      • Joint meeting topics – e.g., Vision Prescription

      • Add topics to the agenda for consideration/review

  • Need to follow-up with BR&R with a list of topics (Marti Velezis) and date/time  
    • Would like to follow up on all of the "product" related IGs (i.e., SPL, ePI, etc) 
    • Tues Q1, Q3 or Q4???
    • Discuss next time??
• WGM+ Schedule (NEW LINK)
  • Monday Q1 - SHALL not schedule WGM 
  • Tuesday Q1 - SHOULD not schedule WGM (ONC/USCDI, Argonaut, Gravity)
  • Rob Hausam (not available TH  Q1/Q2)
  • WGM+ meeting has virtual option for all days
  • Combined meeting with Health BPM Wed + Thu, may run into Friday
  • Spell out ETOR
  • Riki to check on Gender Harmony Mon Q4 and update accordingly
  • FHIR-I session
    • Module discussions
      • What can be in what module and can we have more modules
    • R6
    • IG QA issues as WG health metrics?

• The e-signature draft was submitted to the PAC.  I did get a request from Christopher at Quest to quote a paragraph and am following up with PAC on when we are locked in enough to do so.

UP-44 -no value set content defined for v2 table 963 value set 

• We had discussed and taken a vote on this back on 2022-06-10, but I'm not sure at this point if that is still what we actually still will want to do.  If we discuss it again together hopefully we can decide if that is what we want or we can figure out a good alternative plan.

Add "GTIN", "serialized GTIN" and other UDI Types to UniveralIDType (http://terminology.hl7.org/CodeSystem/v2-0301) to be able to specify that a Universal ID is of "GTIN" Universal ID Type.

This would help to apply to HD Data, EI Data, EIP Data, etc. the Universal ID Type "GTIN", examples are:

HD based Data (HD-2 (Universal ID) is of "GTIN" Universal ID Type:

• MSH-3 (Sending Application), 
• MSH-5 (Receiving Application), 

EI based Data (EI-3 (Universal ID) is of "GTIN" Universal ID Type:

• SAC-3 (Container Identifier), 
• SAC-4 (Primary (Parent) Container Identifier)
• PRT-10 (Device ID)
• PRT-16 (UDI Device Identifier)

EIP based Data (EIP-1-3 and EIP-2-3 (Universal ID) is of "GTIN" Universal ID Type:

• SPM-2 (Specimen ID), 
• SPM-3 (Specimen Parent IDs), etc.
  • Both of these are related to the work GS1 is currently discussing to maybe create a "serialized" GTIN for all containers which would be a worldwide unique code (would be default barcode on tubes, slides, tags etc.) 

CX datatype uses HL70203 for example in PID-3 (not applicable), but maybe in OBX-5.

Discussion today:

• What kind of things exists in UDI
  • Different type of organizations assigning UDI
  • model number vs serial number
  • in FHIR we have the data element of UDI carrier, where this is covered by the issuer and the jurisdiction
    • need to check in messageHeader.sender, if that works there, too
  • in GS1
    • GTIN is the DI part of the UDI
    • UDI is the DI +Production identifier = in FHIR that is reported in the UDI carrier element
  • There are 6 production identifiers FDA cares about
    • Those are separately covered as data elements
  • PRT segment is most aligned with the pattern
    • We discovered a misalignment between PRT and FHIR – PRT is missing deviceName – will discuss this on tomorrow’s lab call
  • Next Step:
    • Review the V2 elements that are currently used and how we could align that with FHIR or what types we will need, if we cannot do that
    • Reserve some time at WGM Friday Q1
• GS1 proposal for having unique identifiers for ALL containers in the international space
  • That way all labs have the same container identifier
  • Each lab may still assign its own ID for each sample in the container and use both in conjunction
  • Some containers are regulated, so they will still have a UDI
    • A group of containers will have GTIN – this unique identifier would be a more specific production Identifier – this should be done at source per this proposal
    • If that is not done at source, then I must use a different ID, I cannot use the manufacturer assigned GTIN you cannot add a PI to that
    • In the IHE discussions has CAP accreditation been brought up
  • Next Step:
    • Have more discussions at IHE
    • Reserve some time at WGM for this maybe also

• V2 Dashboard 

JIRA 

• JIRA Backlog Cleanup -

• • Plan of attack to cleanup stale JIRAs.
  • Need to triage the older tickets to see if they are still relevant/valid (any volunteers???)
    • We may just want to create block votes for any tickets that are no longer relevant/valid
  • We have been getting 6-12 tickets per meeting if we have prepared the tickets in advance
  • We will continue to work through the backlog

The following are draft pages to organize and author content for each of our health care product resources: 

• BiologicallyDerivedProduct
• Devices
• Nutrition Product

OO Resource Coverage

• Need to discuss developmental roadmap for each of the OO resources for R6
• Added R6 planning to WGM agenda
• Need to discuss what needs to be done prior to WGM to prep for discussions

Notes

• Marti revised related resource for each topic area to where the resources align to current modules
• Definitional resources were in workflow (pattern is still there) but those are now in administrative – Marti and Jose to take off-line

FROM CHAT

Dan Rutz 1:03 PM

"Sharing is chairing"?

Andrea Pitkus  to  Everyone 1:06 PM

maybe mCode too?

Hans Buitendijk  to  Everyone 1:12 PM

Early bird registration is available through Saturday, April 15, 2023.

Ballot Sign up closes today Mar 30, 2023

Andrea Pitkus 1:22 PM

We need to work through UDIs in LIVD, lab reporting, etc, especially where multiple 5+ UDIs are involved in collecting, storing, and exchanging across information systems.

Hans Buitendijk 1:30 PM

When using HL7 v2 PRT, you can have multiple, and in FHIR as well.  So 5+ devices that are relevant to communicate the EUA platform, components, and re-agents (if they have a UDI too) could be done.

Interesting question is then whether a re-agent is a device.....

Andrea Pitkus 1:40 PM

CAP Lab Accreditation also requires: GEN.40825 Specimen ID Phase II

There is a system to positively identify all patient specimens, specimen types, and

aliquots at all times.

NOTE: Each specimen container must identify the patient uniquely. This may be text-based,

numeric, bar-coded, etc. The form of this system is entirely at the discretion of each laboratory,

so long as all primary collection containers and their aliquots have a unique label which one

can audit back to full particulars of patient identification, collection date, specimen type, etc.

Practical considerations of container size may limit the extent of such details. There must be an

appropriate, consistently applied accessioning system."

Neil PIPER - GS1 Global Office 1:42 PM

I am happy to help contribute to any documentation you may need to create that refers to GS1 standards.

Andrea Pitkus 1:54 PM

ETOR is more CDC/PH terminology