During COVID-19 crises new use cases for the IICC LIVD Digital Format for Publication of LOINC to Vendor IVD Test Result Version 1.0 arose which led to various small adoption/change proposals.  

• Add LOINC version to LOINC mapping tab and remove LOINC Version from publication tab ; link it to the ‘publication version’

• Add Document Identifier, Publication Date, Publisher URL, and Publication Statement to the LIVD Publication content

new use cases

1. allow merging of LIVD content from various manufacturers or 
2. update LIVD mapping in case new product/assays are released with new LOINC codes assigned which are published in a different Relma Version or still in pre-release status
3. Update LOINC version for existing mappings, which also requires updating the publication version

• Introduction of Product Reference UDI and  Product Reference UDI Type

new use case 

 Allow publication/mapping not only on equipment base but also product/assay specific for example for research assays or utility channel where a customer made assay is used on a equipment from an other manufacturer 

In addition the changes shall be made in the Digital Format handbook, see attachment for full detail/scope

• Update content 

• Define Naming for tab's in LIVD excel table format

- When a LOINC mapping is specified, the Cardinality for the code, LCN and each of the 6 major parts is 1..1, but Method should be 0..1 since not every LOINC term has a Method value. (earlier change request Swapna)

• Ensure field length do match with current specification from Regenstrief Institute, update page 11 of LIVD Specification:  (earlier change request Swapna)

Proposal is in the draft Digital Format handbook with red lines attached.