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Introductions
Background – see ppt: <ADD>
View file name SHIELD Community LIDR Committee.pptx USCDI V3 is what is the latest adopted version in 2023 – V4 has more lab related data elements, but still missing some like specimen collection date
Do not trend results from tests that are not done on the same instrument as the rule, UNLESS you have a harmonization indicator
Discussion around proposed LIDR data elements
Specimen as per package insert or the specimen that is used in the lab
When specimen are collected by the laboratory the appropriate SCT code is associated with the concept
Need to make sure we collect details when we submit the specimen on the patient sample (vs what are the allowable specimen types for an IVD)
Also need to ensure we deal with derived specimen (isolates)
Some of the elements would be submitted from different sources - like CLIA numbers would not
Should LIDR include all the challenge info or calculated results?
How will we prioritize the elements for discussion on calls
Committee Priorities Discussion
Open Access vs Restricted (not behind a paywall)
Some vendors may want to only have customers access to their codes
May need to abstract a requirement from this
Content vs Infrastructure
Should decide on the first set of data elements to be represented in LIDR
Identify the data elements needed for the digital fingerprint of a lab test
Repository vs Standard
LIDR is not a separate data standard, but building on existing ones to transmit the content out of LIDR
Repository of information and updates the standards where we need to use them
Amalgamation of supported data standards to provide guidance on what to use
Identify where these are gaps in existing standards
Create a set of user stories we want to cover
Should not create a brand new standard
Committee Product Discussion
Journal Article
White Paper
CLSI Document
Other
Originally thought to have a list of requirements
What we want in it
What we want it to do (like must be free (not pay for access)
Create this so that it can be adopted by the community
Also need a user manual
What would the journal be used for?
Promote adoption of LIDR
Helpful to have something that can be cited
Collaboration Discussion
FDA – Requirements Document (Walter Sujansky, Marti Velezis)
For the knowledge management platform
Need to get alignment with them.so invite them to a future call
Sequoia Project
Working on requirements and best practice around laboratory data
Open Discussion
Exclude LDTs
Discuss what lab areas to focus on – set up a priority list
Where does blood bank, clinical genomics, etc fits in?
We are not doing the mapping, but we need to describe the path we would use to get from the list of requirements and the tool to that actual content creation
What if we have panels that include calculations, or what if have the automated instrument that if the result is not achievable, then add in the manual
Scope for starters is IVD instrument created
Goal should be a minimal viable product
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