Submitted by rbaker@cdisc.org on
Clarify description of Lot Number
Clarify description of Lot Number
Existing text is defined as:
"Sequence of characters representing a specific quantity of manufactured material within a batch."
Recommend:
Lot Number (NCIt Code C70848)
NCIt- A distinctive alpha-numeric identification code assigned by the manufacturer or distributor to a specific quantity of manufactured material or product within a batch.
Rationale:
For "Immunization Lot Number" it seems like this would be the same for a "Medication Lot Number", should there be a differentation in the definition specific to the type of Lot Number?
If keeping generic, consider adding to the Data Classes "Medications", and "Medical Devices" as well because there are use cases there too. It would not be necessary for medications to be mandatory (just in instances where research necessitates it).
This will enable lot #s for study drugs, study devices, pacemakers, pacemaker wires, and post market devices currently being tracked for safety.
The Loinc code is generic https://loinc.org/74714-7 and does not appear to be defined.
Submitted by nedragarrett_CDC on
CDC's Comment for draft USCDI v5
Lot number remains important from the immunization perspective and CDC supports the inclusion of Lot number in USCDIv5 for a broad applicability. Lot number might be different for Unit of Use (UoU) versus Unit of Sale (UoS) NDCs for the same vaccine in some instances. Are associating Lot number to a particular NDC (UoU or UoS)? Is there guidance that this is a reported Lot number for UoS or UoU?