2022-04-18 SHIELD Leadership Minutes

Ana Szarfman

FDA

John Snyder

NLM

Andrea Pitkus

UW

Jasmine Chaitram

CDC

Andrew Northrup

ONC

Scott Campbell

UNMC

Carmela Courderc

ONC

Ken Gersing

NIH

Hung Luu

Children’s Hospital

Lawrence Callahan

FDA

Keith Campbell

FDA

Leonie Misquitta

NIH

Kevin Schap

CAP

Molly Pollen

AACC

Stacey Borenstein

FDA

Serafina Brea

CMS

Colin Shepard

CDC

Jeff Smith

 Kaiser Permanente

Riki Merrick

APHL

Marion Peyton

Deloitte (FDA suport)

Rob Hausam

MITRE

Ed Heierman

Abbott / IICC

Serge Jonnaert

IICC

Welcome and Agenda Review

Riki Merrick

• No other agenda Items

Update on the strategic plan

Riki Merrick

• Send to editor this week (sorry for the delay)

• Create a short overview video to share with partners

  • 10 minutes ppt slides with more background

  • video of current state and then after SHIELD implementation

Confluence Page Review

Riki Merrick

Reviewing the confluence pages
SHIELD 2.0 - What do we want to be when we grow up?
Organization of Committees for Implementation

•SHIELD Charter

Working on Charter page under In-Scope / Out-Of_scope

Adding Question section / could also be called later phase or parking lot

HOMEWORK: Review the charter page and add to the above sections

NEXT CALLS

ALL SHIELD: Tuesday April 26, 2022 1 - 2 PM EDT

Leadership: Monday May 16, 2002 12:30 - 1 PM EDT

From Chat:

12:42:22 From Andrea Pitkus PhD, MLS(ASCP)CM : https://www.harmonization.net/measurands/
12:45:44 From Andrea Pitkus PhD, MLS(ASCP)CM : D-dimer indicates harmonization is needed so not starting with that.
12:45:52 From Andrea Pitkus PhD, MLS(ASCP)CM : is the proposal
12:47:55 From Leonie Misquitta : For CMS - would this be for claims data for standard labs via Shield?
12:49:35 From Serafina Brea : Do you mean reimbursement?
12:51:06 From Ana.Szarfman@fda.hhs.gov : Two issues to consider:

1. The manufacturers of lab instruments include calibration reagents for each lab test within their instruments. Therefore, we have calibration reagents. The problem is that we have too many of these calibration reagents for each equivalent test.

a. A solution is to select the best, most widely used calibration reagent for each equivalent test, and compel its use across the country.

1. Is CMS actively involved in SHIELD?

a. CMS is the ultimate payer, and may appreciate the increased interpretation value and resulting cost reductions of connecting the currently fragmented patient lab test results for equivalent tests across the country.
12:51:46 From Ana.Szarfman@fda.hhs.gov : LOINC needs higher level terms
12:58:48 From Andrea Pitkus PhD, MLS(ASCP)CM : good question. panel orders may involve results from IVD instruments and non IVD instrument results. So it is conceivable, a CBC or Urinalysis does have non instrument results. I'd assume we'd include all them.
12:59:20 From Scott Campbell : @Andrea, I agree and appropriately stated
12:59:43 From Leonie Misquitta : I have to drop off for another meeting. Thanks all.
12:59:44 From Jeff Smith : Suggestion: Chemistry, Special Chemistry/ Serology, Toxicology, communicable disease NAA/PCR, Hematology, Coagulation Medicine, Urinalysis, Transfusion Medicine, Molecular genomics. Secondary, esoteric reference lab testing Quest, Lab Corp, Mayo, ARUP etc. 85% by volume of all lab testing is "general" lab.
13:01:00 From Ana.Szarfman@fda.hhs.gov : Do we certify tests that are centrally calibrated