Edit - SHIELD Coordination

Date

Aug 15, 2023

Attendees (bolded = present), (Green=Approval via email)

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 - regrets	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 - regrets	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 - regrets (/DDNID/NCEH/DLS)	primary
	CDC	Jasmine Chaitram - regrets	alternate
	NLM	John Snyder	primary
	NLM		alternate
	FDA		primary
	FDA		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 18 named members, so 2/3 = 12 (excluding chair and government members).
Open Meeting	12:03 PM ET (got quorum a little later, but we didn’t take votes today)
Updates	Proposed new members for the SC: Patient Advocate position: Stacy Lange has been in patient advocacy for over 10 years - Synensis sent her our way FDA representative coming soon FDA now has a SHIELD website: https://www.fda.gov/medical-devices/diagnostic-data-program/systemic-harmonization-and-interoperability-enhancement-laboratory-data-shield Members leaving the SC Serafina Brea will move to different branch in CMS effective 8/25 - will notify us of replacement member as soon as possible - will go through CDC for now New group engagement for SHIELD: Riki met with Pfizer’s evidence creation team they may be joining the ALL SHIELD calls and also let them know about the working groups they are working on feedback on package inserts that are patient facing https://www.fda.gov/drugs/fdas-labeling-resources-human-prescription-drugs/patient-medication-information#:~:text=Patient%20Medication%20Information%20would%20be,drug%20products%20safely%20and%20effectively. - this might push the FDA towards a more structured data approach in other package inserts, too New LOINC release is out: https://loinc.org/news/loinc-version-2-75-adds-almost-2000-new-concepts/
Established SHIELD Calendar	Thanks to Eric for coming up with the idea - we now have calendar of all the calls, including call info for all the open calls (not the SC call)
Goal of the outreach to IVD vendors	General need is to get more IVD vendors to produce LIVD files Differences in testing to better understand how those affect results / data structure / how many UDI needed to cover all of their results / coder more domains hematology micro chemistry blood-bank
Review Working Groups progress	https://aphlinformatics.atlassian.net/wiki/spaces/SC/pages/1938718763 finalizing scope by end of August outline of white paper working on use cases - identifying the need and what data elements for each created parking lot Still need input from MDIC on RWE data element starter list https://aphlinformatics.atlassian.net/wiki/spaces/SC/pages/1938784418 first call mainly around logistics waiting for FDA representative biweekly calls starting end of August first focus will be WG scope identify use cases and data elements for each coordinate which of those go in LIDR ask Standards & Vocabulary WG to identify how to represent each of the elements (in both RWE work and LIDR) https://aphlinformatics.atlassian.net/wiki/spaces/SC/pages/1938620497 finshed reviewing scope will start with vocab standards in next meeting
LOINC Conference presentation	Other SHIELD member presentations Christine Spisla, W. Scott Campbell, PhD, MBA, Stephen Powell, DHA, MSc, and Raja Cholan, MS - Deloitte Thinking Outside the Box: Using an Integrated Knowledge Management Environment to model LOINC terms John Snyder - National Library of Medicine Automating the curation of reference terminologies Pamela Banning - 3M Health Information Systems In-roads: Advancing LOINC Adoption in Clinical Trials Data Stanley Huff - Graphite Health Semantic Interoperability: The Vision of What Could Be Stephen Powell - Synensys, LLC Results from a System Safety Analysis of the U.S. Laboratory Data Ecosystem: How LOINC Impacts System Safety? Christina Gallegos & Ed Heierman, Ph.D - Association of Public Health Laboratories & IICC Collaborative Development of LOINC In Vitro Diagnostic (LIVD) Test Code Mapping for SARS-CoV-2 Andrea Pitkus, Riki Merrick - SHIELD SHIELD as a mechanism to support the adoption of LOINC and SNOMED CT standards for laboratory data interoperability: Submitted abstracts bios and headshots Discuss outline (will not be shared here, so we don’t publish before the conference)
SNOMED Conference presentations from SHIELD members	https://issuu.com/snomed/docs/snomed_ct_expo_2023_program?fr=sZTk5OTQ2NTE4OTU Micky Tripathy Opening Keynote Keith Campbell James Read Memorial Lecture Keynote Scott Campbell How to depply and use SNOMED CT encoded cancer pathology data sets/synoptic reports James Campbell, Stan Huff, Oliver Bodenreiter Workshop on Interoperation and analytics of EHR data: Use cases for problem list, laboratory results, anatomic pathology and medications Shaun Shakib Implementing SNOMED CT in nationally notifiable disease reporting and pathogen surveillance Rob Hausam Further experiences with incorporating the SNOMED CT IPS terminology (sub-ontology) in the FHIR IPS specification
Roadmap section updates in response to ONC comments on the SHIELD roadmap	We will talk about approach to updates in general and these specific comments in particular next call - sorry - Riki didn’t get the prep done related to the ONC comments
Next call	Sep 5, 2023 - will cancelation August 29th is our Topic call: Naming Convention Sep 19, 2023 12 -1 PM EDT
Adjourned	12:34 PM ET

Recording:

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