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Administrivia

Approve Minutes

• 2023-08-17 Main - Next week

OO Project Proposal Triage 

• 2 PSSs to review - not looked at these

Today's topics:

New Draft PSS from Preston Lee: OpenCDx 

• OpenCDx
  • Scope: OpenCDx is a public-private partnership that improves the health and welfare of all Americans by supporting and enabling a clinical results data sharing network that is trusted, that scales, and that enhances quality of care and health outcomes. OpenCDx supports an open source reference implementation, a robust legal and policy framework consisting of a common trust agreement, implementation guides and technical specifications developed by a multi-stakeholder process stewarded by OpenCDx. The OpenCDx framework is voluntary and consensus based. The framework allows different electronic health information technology vendors, platforms, the private sector, federal agencies and others to achieve clinical results interoperability.
  • Need: Population-wide availability of patient-administered self tests, such as over-the tests or prescription diagnostic devices, requires interoperability across a broad continuum of stakeholder systems when administered at home. A patient administering a lateral flow test, for example, may be doing so by order of a telehealth provider, need to capture results via a personal device (i.e. phone camera) part of a longer clinical protocol, while also subject to reporting at the local and/or federal level. Guidance on the interplay of FHIR-based information exchange is critical for a broad class of emerging connected diagnostic use cases including COVID, HIV/AIDS, and more generally the detection and monitoring of diseases requiring national management.
  • Discussion:
    • looking for OO to be the primary sponsor
    • reporting self-administered diagnostics that are part of clinical workflow – telehealth visit with prescribed at home test – how results get defined after that
    • not for profit spun up defining national level endorsed exchange standards
    • How is this different from the At home testing guide = https://build.fhir.org/ig/HL7/home-lab-report/StructureDefinition-Device-at-home-in-vitro-test.html
      • Broader than just testing
    • Not a good name – too close to CDex
      • Rename Project to Connected Diagnostics – the product will be Open CDx – for jira spec needs to be thought through
    • Diagnostics described are IVD test kits – if broader than lab, need to describe scope
    • For covid-testing there is detail around CLIA requirements based on the setting (if proctored)
    • Need to be migrated into jira – needs to be a proposal first
    • Ballot goal – if May MUST have WG acceptance by
    • Can this be a second release of the at-home IG instead?
      • The current project covers mail-in to the lab – which then triggers other rules
    • Expanding scope on existing project will be easier for the logistics
    • Single project that produces more than one IG is frowned upon – but we could tackle that when we have the different use cases, but will that be a problem to split this off into separate projects
    • Physician generated order acquisition – medico-legal is different (closer to COW project) from patient bought tests (At-Home IG)
    • Mentioned it is an FDA supported project – Marti Velezis and Eric Heflin to take it off-line for FDA sponsorship
    • Take back up at WGM - chat indicates that scheduling will be forthcoming.

Reaffirmation PSS for Cross Paradigm IG: UDI Pattern R2

• UDI Pattern R2 Reaffirmation PSS
• January 2024 Ballot cycle
  • Motion to approve the re-affirmation PSS.  Riki Merrick, Marti Velezis
    • Against: 0; Abstain: 3; In Favor: 12
  • Hans to forward to Lynn.

OO WGM 202309 - Agenda - Orders & Observations - Confluence (hl7.org)

• Open:
  • Discussion on Panel (Q4?)  In order Tuesday, Thursday, Wednesday
    • Ideally Tuesday Q2, so , so we can use his input for the planned quarters - Marti checked with Grahame - prefers Q2 for this and JIRA Families discussion
    • Families discussion may need to happen in several quarters (Patient Care, FHIR-I and Patient Admin) 

  • Need to work with FHIR-I or Vocab on the following: 

    • FHIR-40437 - Link missing -  Note this is the expansion list

    • Robert Hausam will be checking it out to see where it should land.
  • Add V2.9.1 ballot recon to Tues Q1 - if any items for OO, should get those done then
  • OpenCDx Project proposal needs to be added to the agenda

FMG - Extensions

Feedback on this IG needed - deadline is January (Hans Buitendijk ) - did I get this right?

FHIR JIRAs (link to below)

• Pulls from the July Block-Vote:
  • FHIR-33042
    • Appended – a new test / result info added – may be better at the report level
    • Amended – changes made to the report, but the result of the OBX is not changed
    • Elliot’s concern would be how to actually apply it in the real world
    • If we make changes we need to make changes in both FHIR and V2
    • HOMEWORK: Add into the comments the definitions for both appended and amended with other references and suggest how #2 should be worded

ADJOURNED 2:04 PM ET  - BELOW NOT DISCUSSED

• QA on Catalog
  • Fixes so far still falling within last week's motion to progress.

• Updated status 

  • Reviewed status – need to work on making progress on JIRAs via block votes if we cannot make progress during WGM
  • Tags to use for inclusion: OO-FHIR-Block-Vote  August-2023
  • Anything as of Thursday 24 will then be voted on.
  • OO FHIR Block Vote - August 2023

• Pulled Block Vote JIRAs from May/June 2023

  • To be added to the WGM agenda if we do not get to it before then.

• [FHIR-34194] Add businessEvent extension - Jira (hl7.org)
  • Agreement that ORC-1 concept needs to enabled through Task (possibly) in some way, e.g., how to request a cancelation of an existing service request.
  • COW/FOE should follow-up to identify best step forward, 
  • Line up topic with Panel Discussion to get a good mix of FHIR-I, Pt Care, and OO participation.

Update on FHIR Tracker related to Family/Household attributes

• Confluence page: OO Families/Household/Workplace/Event JIRAs
• Will ask Grahame whether he can make Wed Q1 or Thu Q2 and then ask everybody else to join that one.

From Chat

Andrea Pitkus, PhD, MLS(ASCP)CM, FAMIA. UW-Madison to Everyone (Aug 24, 2023, 1:08 PM)
Will calls be canceled Mon Sept 4th?
 
Riki Merrick to Everyone (Aug 24, 2023, 1:08 PM)
to folks new on this call - please add your organization to your name on zoom - for the minutes, please :)
 
Ralf Herzog to Everyone (Aug 24, 2023, 1:09 PM)
Canceled Catalog tomorrow and v2-to-FHIR on Monday.

David Barwin to Everyone (Aug 24, 2023, 1:09 PM)
https://confluence.hl7.org/display/OO/OpenCDx

Andrea Pitkus, PhD, MLS(ASCP)CM, FAMIA. UW-Madison to Everyone (Aug 24, 2023, 1:11 PM)
How is this different from the At home testing guide?
https://build.fhir.org/ig/HL7/home-lab-report/StructureDefinition-Device-at-home-in-vitro-test.html

Andrea Pitkus, PhD, MLS(ASCP)CM, FAMIA. UW-Madison to Everyone (Aug 24, 2023, 1:19 PM)
Also id Point of Care testing by health professionals, then LOI, LRI, ELR, etc could apply
if
It seems like direct overlap with multiple O&O guides/projects

Dan Rutz to Everyone (Aug 24, 2023, 1:22 PM)
Other initiatives which will probably work with "how to communicate diagnostic lab results with FHIR" are active in EU, Netherlands, Belgium, Denmark, Australia, and within OO (FOE/COW).
 
Andrea Pitkus, PhD, MLS(ASCP)CM, FAMIA. UW-Madison to Everyone (Aug 24, 2023, 1:23 PM)
It would also help to understand is this ordering of the IVD tests, resulting, reporting to PH or all of the above?
 
Elliot Silver (ResMed) to Everyone (Aug 24, 2023, 1:24 PM)
I also wonder if this would work as a second release of the at-home testing IG, rather than a separate project.
 
Andrea Pitkus, PhD, MLS(ASCP)CM, FAMIA. UW-Madison to Everyone (Aug 24, 2023, 1:25 PM)
@Elliot Silver (ResMed) Unclear with current info about project.
It may overlap completely too per your point
 
Lorraine Constable to Everyone (Aug 24, 2023, 1:30 PM)
I have to drop
 
Andrea Pitkus, PhD, MLS(ASCP)CM, FAMIA. UW-Madison to Everyone (Aug 24, 2023, 1:32 PM)
If health professional performed, seems like it would be a scenario under COW on FHIR per Dan's comment

Elliot Silver (ResMed) to Everyone (Aug 24, 2023, 1:32 PM)
In Zulip discussion related to this, I think we uncovered deficiencies in the base resources for these uses too.
 
Andrea Pitkus, PhD, MLS(ASCP)CM, FAMIA. UW-Madison to Everyone (Aug 24, 2023, 1:32 PM)
If patient initiated, then would be more at home test guide.
@eliot do you have the zulip link?
which FDA area?
 
Elliot Silver (ResMed) to Everyone (Aug 24, 2023, 1:35 PM)
https://chat.fhir.org/#narrow/stream/179256-Orders-and-Observation-WG/topic/HIV.20Self-testing.20.26.20DiagnosticReport
 
Andrea Pitkus, PhD, MLS(ASCP)CM, FAMIA. UW-Madison to Everyone (Aug 24, 2023, 1:35 PM)
thanks

Preston Lee to Everyone (Aug 24, 2023, 1:57 PM)
@Hans Buitendijk Which day/quarter would you prefer to discuss the Open Connected Diagnostics work?

Andrea Pitkus, PhD, MLS(ASCP)CM, FAMIA. UW-Madison to Everyone (Aug 24, 2023, 1:58 PM)
there was an extensive discussion ~10 yrs ago w Eric Haas with v2 guides about appended, amended, etc.

Hans Buitendijk to Everyone (Aug 24, 2023, 1:58 PM)
@Preston Lee: Not sure yet.  Any one(s) that would not work for you?

Preston Lee to Everyone (Aug 24, 2023, 1:59 PM)
@Hans Buitendijk Also not sure yet.. 🙂
 
Andrea Pitkus, PhD, MLS(ASCP)CM, FAMIA. UW-Madison to Everyone (Aug 24, 2023, 1:59 PM)
agree with Kathy append is to add something without change.  Most labs amend reports when additional info comes in after a prelim or final report.

Andrea Pitkus, PhD, MLS(ASCP)CM, FAMIA. UW-Madison to Everyone (Aug 24, 2023, 2:00 PM)
http://www.captodayonline.com/Archives/q_and_a/qa_0502.html
#2 is actually amended
demographics have potential to change ref ranges too

• Check back in August for progress

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

• Leaving UP-44 open for now – so that the new tickets and this one can be linked

• V2 Dashboard

FHIR Discussion Topics: 

JIRA 

Block Vote Pulled JIRA

JIRA

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

• BiologicallyDerivedProduct
• Devices
• Nutrition Product
• VisionPrescription

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
• Add Resource reorg comments to module pages

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