2024-11-05 Steering Committee Meeting Notes

Date

05 Nov 2024

Attendees

(bolded names indicate attendance)

Stakeholder group	SHIELD organization	Name of SHIELD member	organization designation
Industry Entity	Labgnostic, Inc.	Steve Box	primary
		Andy Harris	alternate
	Epic	Dan Rutz	primary
			alternate
	Biomerieux	Xavier Gansel	primary
			alternate
	Roche	Nick Decker - regrets	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
Patient Advocate		Stacy Lange	individual
Standards Organization	SNOMED International	Jim Case - regrets - regrets	primary
	SNOMED International	Monica Harry	alternate
	Regenstrief Institute	Marjorie Rallins - regrets	primary
	Regenstrief Institute	Eza Hafeza - regrets	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	Michael Smalara	primary
	CMS	Open	alternate
	ONC	Sara Armson	primary
	ONC		alternate
	CDC	Hubert Vesper (/DDNID/NCEH/DLS)	primary
	CDC		alternate
	NLM	John Snyder	primary
	NLM		alternate
	FDA	Keith Campbell	primary
	FDA	Victoria Derbyshire - regrets	alternate

Agenda and Notes

Item	Notes
Quorum evaluation (two-thirds (2/3) of the Voting Representatives shall be necessary to constitute a quorum for the transaction of business)	Currently we have 19 named members, so 2/3 = 12 (excluding chair and government members).
Open Meeting	12:0 PM ET
SHIELD Presentation at ASCLS June 8-12 in Sacramento, CA	Submitted proposal - ended up counting OOO notices as abstain in order to get to quorum
ADLM presentation	Looking for presenters Draft of submission was sent out
CAP video and Article citing SHIELD work	https://infobeta.cap.org/shield/ https://doi.org/10.3343/alm.2024.0323
ONC Annual Meeting December 4-5, 2024 Omni Shoreham in Washington, DC	https://www.astpannualmeeting.com/Agenda Is this in-person only? December 5th 2:15 – 3:15 pm is Enhancing Laboratory Interoperability: Insights and a Path Forward
Administrative things	Review SC Composition, terms and requirements for re-voting: Representative first 3 year terms expire 12/20/2025 Chair and Vice Chair 2 year terms expire 3/14/2025 90 days would be 12/14/2024 for call for nominations for Chair and Vice-Chair, so folks, start thinking about who might want to take the reins Steering Committee attendance review consider changing timeslot
Roadmap section updates in response to ONC comments on the SHIELD roadmap	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. Updated language draft: Roadmap update: ONC Feedback Discussion: Where exactly in the roadmap the new text lands - Hung? Anything else needed on this one? 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. Update from Standards and Vocab WG about re-write of this section - from their March 18^th call (notes here, recording here) Concepts around Healthcare IT (HIT) standards needs to be conveyed earlier in training for healthcare providers as use and application of standards in vended applications is the major gap. Decision making to use Health IT standards are less likely left up to IT analysts as they mainly follow the requirements and then they generally use vendor supplied implementation guidance. However, a vendor may not support functionality for standards or only partially support. Regulatory requirements (such as CLIA) may pose a hurdle to implementation of data standards. Implementation guidance is often not well read. Training resources may not be well publicized or readily available. Perhaps conformance testing tools need to be made more widely available? What might be helpful is to look at standards implementation from a data lifecycle standpoint across all users (end to end across ecosystem), rather than just training on a single standard for a single use case. Last paragraph on page 4 of the road map final version could be augmented with these points. Discussion: Need to find the exact space for these points, too 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). Identify components that could improve the ecosystem infrastructure, and then highlight the places where these components can be advanced / sustained or made easier to implement. Would SHIELD be willing to consider to provide an example implementation - create the structures and bound terminologies to showcase how each element would be properly represented be working. For each of the Consideration sections we could certainly add a section on feasibility / requirements (e.g. continued funding for LIDR, better describing the intended use of ANY data element added, overall goal of LIDR, clearly delineate what is commonly used and is minimum, provide best practice and alternatives (non-preferred) - example would be metadata around the value sets in VSAC (curation / usage etc) to be able to ascertain quality) and highlight that other mechanisms are needed to achieve for adoption.
Review Working Groups progress	Setting milestones for deliverables should be NEXT for WGs: they will be captured here: SHIELD WG Deliverables and Milestone Grid Laboratory Interoperability Data Registry (LIDR) Working Group Work continues on white paper - review final draft before sending to SC IVD Data Hub no update Standards Updates and Vocabulary Working Group No new updates Communications and Branding Working Group working on a survey to SHIELD members to better understand what makes folks participate / not attend calls / better understand each stakeholders' perspective - for next SC call
Antimicrobial result reporting	Placeholder to get back to later Related work at HL7 Europe:
Next calls	All SHIELD Calls November 26^th December 17^th General Updates: 2024 - WG Chairs please make sure we have material for updates (at least notes we can link to) Special Topic: December 10^th - Clinical Architecture LOINC survey Steering Committee: November 19^th December 3^rd
Adjourned

From Chat:

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