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

Use case page

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Presentation from Cornelia

slides:

How are we moving his data across the data streams?
UDI is attached to the thing (instrument or reagent) that creates the result
If you have more than 1 instrument of the same model – they will have 2 different UDIs – with the same DI, but different to the
GS1 is for ANY product, not just IVD
GS1 is one of the formats for the UDI – is internationally
In LIVD we consider 1 instrument and 1 reagent – but need to be able to accommodate more complex scenarios
Currently not capturing washing, buffers or calibrators
HL7 UDI pattern document uses PRT segment, which is not currently in LAW and AUTO-16
LAW uses OBX-18 instead (that was the only way available at the time) – first repeat are manufacturer and model = kind (could also be the DI) – and then the instance for second repeat (these are both required) – these were intended for the instrument – the field repeats, so could add more
Slide 12: currently do not have the complete UDI, but in 2 pieces; concatenation from 2 places should work
We should consider what is the easiest now vs in the future – might need to have more than one solutions for the interim, as long as each version is identifiable (MSH-21 profile ID)
Biomerieux and Roche’s new instruments support this, but no request in the field – not yet in beaker
What to update and when, to accommodate existing analyzers
Slide 13: for reagents use INV segment – here also you will have to concatenate from multiple fields
Slide 14: Use OBX-18 and use the full UDI
Slide 15: also have to look at length restrictions on some of the fields in OBX-18 and INV fields
Need to make sure we get request for features – if standard is not requested by users, why should instrument vendors implement it
IHE LAW hasn’t been implemented widely that is not already available in the legacy systems – but if we make clear how to communicate device and reagents (and make sure folks understand why that is important) in the new standard that should drive adoption (in addition / over regulation) – need to get more buy-in from EHR vendors, too
How updatable is software on instruments that are already in production?
Abbotts alinity is using LAW, but none are sending UDI now
If IVD datahub wants UDI, it won’t come off the instrument for a while – so would need to have that information elsewhere to be assembled elsewhere
Why would the instrument need to transmit the UDI to the LIS – wouldn’t the LIS already know which instrument is being used; if this information is in LIVD -> LIDR could this be where folks get that from?

Next Steps:
For LIDR / LIVD we need mapping options until instruments can send the UIDs and they need to be in specifications
Other questions:
Figure out what is encoded from instrument vs calculated