Hung Luu

Children’s

Riki Merrick

Vernetzt, APHL

Andrea Pitkus

UW

Pam Banning

3M

Xavier Gansel

Biomerieux

Amy McCormick

Epic

Dan Rutz

Epic

Rob Rae

CAP

Sandy Jones

CDC

Stan Huff

Graphite

Ed Heierman

Abbott / IICC

Andrew Quinn

Laurent Lardin

Biomerieux

Anthony Killeen

UMN

Craig Collom

Walter Sujansky

FDA

Susan Downer

JMC

Ralf Herzog

Roche

Cornelia Felder

Roche

Daniel Golson

JMC

Andrea Prada

JMC

UDI from instruments / Follow up to Cornelia’s presentation

Discussion around multiple UDIs for Abx on a card

UDI+LOINC provide the unique Identification of the

Distinction is that some items are added by the lab – for interpretations of reference ranges

LIDR would provide you the data you need to identify the

It would be useful to get the FDA to help us better understand what their expectations of the UDI regulations are – what can labs expect from the UDI – ask FDA to join us.

This proposal is just addressing the communication between the instrument and the LIS – still a lot of work to be done after that for the systems to actually be able to produce, receive

Intention is to share the DI and PI – the DI would be in the LIDR, but not the PI

There are 3-4 authorities that can create UDIs – GS1 has 80% of the marketshare

Do we need to consider character limits for this data element?

Need to understand, that when we don’t have UDI, then we will only get the DI part even with the patient result instance

Reagents are in different segments (INV) in IHE LAW – those are not linked to individual OBX segments however

Some calculated values come off the instrument – see https://ltd.aruplab.com/Tests/Pub/2012618  

Another example of ROMA: https://www.accessdata.fda.gov/cdrh_docs/pdf10/k103358.pdf

How would the UDIs look like for the calculated value? Just the UDI for the instrument for that?

If a calculation has a UDI it could be sent – it could be associated with the version of the calculation / algorithm used on the instrument

For sure calculations that are done in the LIS, those are NOT from the manufacturer

Are there still instrument that offer different methods for measuring the same analyte? Would need to ask how those are handled

What about hematology analyzers – they only measure a few items, and then they report several calculated values.

Describe each of the cases we discussed and our recommendations about what to expect for UDI from the instrument – create a table and have example results report and expected HL7 snippets

Maybe we can also ask Ed about the Abbott hematology LIVD – see this list: https://ivdconnectivity.org/supported-instruments/

Next Steps:

·       Hung will create the examples for hematology and ROMA

·       Riki to ask FDA for a UDI presentation and their expectations from manufacturers etc

·       Reach out to get participation from Sysmex – Hung will ask Dr. deBaca

·       Riki to ask Ed about the Abbott hematology LIVD available