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LIDR White Paper - need to review comments and decide what to send back to the SC
OPEN ACTIONS - no update on any of these:
Review Figure 6 and associated text against Figure 8 and associtated text and combine / adjust as needed @riki.merrick
Add in Reference to AUTO 16 and provide the mapping between LIDR entries and instance data @riki.merrick
Review the LIVD/LIDR requirements section to ensure we have the proper vendor view - confirmed ok as written by both Xavier and Ed
Will see, if we can just get this published as is - Hung will clean up the White Paper references and then we will send it back to the SC for vote
Hung will draft a first manuscript based on the LIDR White Paper
Next Steps for LIDR tooling
IKE has launched
The tool is open source, so we could use it
We could check if the Biomerieux dataset is included and then we could continue the pilot
LIDR Patterns
eGFR - calculated based on values produced by instruments and patient demographics; but knowing which formula is being used - it does affect the selection of the LOINC (though not the patient’s sex)
Patient demographics comes across separately with the patient
We are trusting the lab to select the correct reference range for all results
some labs do set up the testing for males vs females
we did mention that input for calculation values should be included with the results, so then you can understand
Do we need to include formula information in the LIDR file?
the formula is the LOINC method, so it is covered by that, so we need this = https://loinc.org/98979-8
To have additional attributes of sex and serum creatinine level in LIDR
against: 6, abstain: 1, in favor: 1
Question was are the vendors changing over to the new reagents? - How can we know?
LIDR WG will need to develop the content for calculations
High Sensitivity Troponin
different values in formula also for male / female in the instance data - this is applied by the lab for the calculated value example panel https://loinc.org/89576-3 - the 67151-1 comes off the instrument - declared by the vendor; the lab applies the patient’s sex and then reports 89575-5 as the overall interpretation
LIDR provides the information about the kind of tests perfromed, when you do analytics / decision support on instnace data from that kind of test, if there are additional attributes, like patient demographics or serum levels or anything else in the instance record that needs to be taken into account at time of implementation is OUTSIDE of LIDR, but absolutely important - need to think whetehr this is something we need to communicate and if we decide we do, figure out how
Follow up on UDI representation
Update from IICC meeting:
Still interested - the initial presentation was in 2023
Overall points to consider:
need to define the format of UDI we need to capture for LIDR and LIVD and the IVD datahub
do we use the full human readable format or do we split it out into the individual parts
Once we have that, need to review if LIVD spec (Support for GTIN) and IHE-LAW support that for instrument (DI = mandatory is manufacturer, model and and optionally the GTIN and mandatory serial number for the PI in OBX-18) - when this is known a UDI can be created from this
need to decide if testkit is needed - how would that be represented in IHE-LAW?
in V2 we have PRT segment also, which would have all elements for each device, the PRT segment can repeat
IVD->Middleware/LIS->EHR->PH systems
stakeholder check for what is feasible - who is reaching out to whom?
IVD vendors - Xavier & Ed = IICC
middleware vendors - Pam will try to get some contact
LIS/EHR-s vendors - ask Dan & Dr. Agassi - EHRA
Laboratories - Matt?
Public Health - Riki to ask CSTE / ASTHO
Public Health surveillance system vendors - Riki to see, if she can find some contacts
Cancer registry software vendors?
Figure out what the secondary users are looking for - is UDI fit for the intended purpose?
If changes are needed to CLSI AUTO 16, need to bring this to Automation and Informatics Expert panel at CLSI (updated version should come out - will have some editoral updates for IHE LAW, too)
Once LIVD FHIR IG has been published, need to see, if any changes are needed there with proposed approach
How to handle derived observations (e.g. calculated results like eGFR, which is then calculated in LIS, which includes instrument data and data from other sources, like urine volume received as Ask at Collection question with the order / specimen - also depends on what the lab includes in the final reports)
NEXT STEPS:
Reach out to more IVD vendors to see, if they can produce LIVD files (and/or share mappings), which will help the labs the most
Decide on the best format to use for instance data (patient level observations)
invite more stakeholder representatives to the LIDR WG call in November
Riki reached out to APHL and CSTE for feedback on what devices for what use and what format, waiting for feedback
presenting on CDC interoperability forum in January to gauge interest with rest of stakeholders - Riki reached out to Jasmine - ANSWER IS YES!
Next call
Tuesday Nov 11, 2025 9 - 10 AM ET
Cancel 11/18 due to AMIA and 11/25 due to Thanksgiving
Reviewing minutes from the last call - Action Item Follow up
Pull out the definitions from LIVD for test kit and equipment and put here: SHIELD Glossary
Review operational definition of “equivalence”
Will look for a CLSI defintion
also check IFCC definition
Outreach to Dr. DeBaca
Hung will check for more info and maybe see, if she could participate in SHIELD