2023-06-06 SHIELD Steering Committee Meeting notes

Date

06 Jun 2023

Attendees (bolded = present)

Stakeholder group	SHIELD organization	Name of SHIELD member	organization designation
Industry Entity	Labgnostic, Inc.	Aaron Green	primary
			alternate
	Epic	Dan Rutz	primary
			alternate
	Biomerieux	Xavier Gansel	primary
			alternate
	Roche	Nick Decker	primary
	Roche	Yue Jin	alternate
Healthcare Provider	Indiana University/Indiana University Health/Association for Molecular Pathology	Mehdi Nassiri, MD	primary
	University of Wisconsin-Madison	Andrea Pitkus, PhD, MLS(ASCP)CM, FAMIA	primary
	UT Southwestern Medical Center	Hung Luu	primary
	UNMC	Scott Campbell	primary
	Tufts Medical Center	Nanguneri Nirmala	primary
	Sonic Healthcare	Eric Crugnale	primary
	Former Quest Diagnostics	Collom, Craig D	primary
Standards Organization	SNOMED International	James T. Case	primary
	SNOMED International	Monica Harry	alternate
	Regenstrief Institute	Marjorie Rallins	primary
	Regenstrief Institute	Eza Hafeza	alternate
	HL7	Julia Skapik	primary
	HL7		alternate
Professional Organization	Association of Public Health Laboratories	Riki Merrick	primary
	Association of Public Health Laboratories	Dari Shirazi	alternate
	Graphite Health	Stan Huff	primary
	Graphite Health		alternate
	CAP	Raj Dash	primary
	CAP		alternate
	AMP	Robyn Temple	primary
	AMP		alternate
Governmental - non Voting	CMS	Serafina Brea	primary
	CMS		alternate
	ONC	Sara Armson	primary
	ONC		alternate
	CDC	Hubert Vesper (/DDNID/NCEH/DLS)	primary
	CDC	Jasmine Chaitram	alternate
	NLM		primary
	NLM		alternate
	FDA		primary
	FDA		alternate

Agenda and Notes

Agenda Item	Notes
Quorum evalution (two-thirds (2/3) of the Voting Representatives shall be necessary to constitute a quorum for the transaction of business)	Currently we have 18 named members, so 2/3 = 12 (excluding chair and government members)
Open Meeting
Feedback from FDA , specifically Collaborative Community leadership in CDRH on our Charter	They recommended that the percentages of various groups be more “fungible”… In that what happens if you are not able get the exact percent representation from particular groups? So anticipate that somehow by saying that is a goal, and that leadership can approve deviations from those numbers, or have the documents say that they are guidelines, not absolute. Suggested change since current SC numbers are close, but not exact – so probably change: “according to” to “approximately”: Discuss and vote For the SHIELD projects, they want to see some goals that are long-term sustaining projects. Not projects that look like they will wrap up in 1-2 years… The question being is this a temporary type group that we might support in the short term more as an focus group, or is this a longer term group that is worth FDA planning to be in partnership with for a long time. We will need to write a statement of intent with quotes from the roadmap, that make clear that SHIELD is a long-term community, with projects that will become permanent fixtures in the healthcare ecosystem - any volunteers to pull this together?
Call schedule in the summer	June 13th - Andrea will lead - topics: final comments on NRPM and maybe vote / or do by email June 20 - Andrea will lead June 27 - ALL SHIELD call July 4 - need to reschedule - move to July 11th or just cancel?
Meetings	https://loinc.org/conference/atlanta-2023/ October 17-20 Plan to submit session - Andrea to do by due date June 7th
HT1-NPRM Comment Collection
Feedback from ONC on Roadmap (FINAL VERSION)	Was mentioned on May 30 call - here are the comments: The roadmap mission section describes a broad vision of lab interoperability. However, the roadmap proposed solution is limited to the FDA use cases around In-vitro diagnostics (IVD) data, specifically populating the IVD data hub. ONC suggests clearly describing the roadmap scope so the proposed solutions can be discussed within that context. The roadmap identifies training and education needs around using LOINC as a barrier to interoperability. ONC suggests clarifying how the roadmap addresses this barrier. ONC recognizes that terminologies require training and education, and replacing LOINC with another standard will not address the barrier. There are several solutions proposed, including repositories and tools, which need to be further evaluated before ONC could fully support the roadmap. ONC suggests the roadmap be updated to include details around feasibility, scalability and how the proposed changes can be integrated into the current laboratory ecosystem (e.g., regulation and industry). - any volunteers to draft a response / suggested updates in the roadmap?
Review Working Group Committee list and establish SC representation	Working Groups Created Confluence pages for the 4 priority groups Leads will find call time and invite interested people
Next call	June 20. 2023 12 -1 PM EDT
Adjourned

For recording access (SC members only) reach out to Riki

Future Agenda Items:

Document decision workflow
Logistics of publishing community approved work products
Charter updates: Draft non-participation clause for SC
Prioritization of projects to ensure external milestones are met
- qualitative result value set - Standards WG item
  - guidance on use of sensitivity concepts (as opposed to other results)
    - in general: have HL7 maintained code system for use in OBX-8 / observation.interpretation in both CDA and FHIR: https://terminology.hl7.org/CodeSystem-v3-ObservationInterpretation.html vs use of OBX-5 / observation.value
    - for the US specifically

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