Record of vaccine administration.

Data Element
Lot Number
Description

The lot number for immunizations.
Submitted By: Sandi Mitchell / J P Systems, Inc.
Data Element Information
Use Case Description(s)
Use Case Description This will ensure patient safety in the effect of a recall. This will also support FHIR resources, data exchange, and immunization registry tracking.
Estimate the breadth of applicability of the use case(s) for this data element Level 1
ONC Priority
  • None of the above
Maturity of Use and Technical Specifications for Data Element
Applicable Standard(s) LOINC
https://loinc.org/74714-7
Additional Specifications https://hl7-definition.caristix.com/v2/HL7v2.3/Fields/RXG.19
Current Use (Level 1) Captured, stored, or accessed in at least one production EHR or HIT module
Extent of exchange (Level 1) Between two production EHRs or other HIT modules using available interoperability standards
Supporting Artifacts HL7
https://hl7-definition.caristix.com/v2/HL7v2.3/Fields/RXG.19
Potential Challenges
Restrictions on Standardization (e.g. proprietary code) None
Restrictions on Use (e.g. licensing, user fees) None
Privacy and Security Concerns Standard HIPAA concerns.
Estimate of Overall Burden Minimal burden to implement since the data element is already being exchanged. This data element impacts patient safety to ensure clinicians understand the lot number of patient's immunizations to avoid duplicates.
Other Implementation Challenges N/A
ONC Evaluation Details
Each submitted Data Element has been evaluated based on the following criteria. The overall Level classification is a composite of the maturity based on these individual criteria. This information can be used to identify areas that require additional work to raise the overall classification level and consideration for inclusion in future versions of USCDI
Criterion #1
Maturity - Current Standards		 Level 2 - Data element is represented by a terminology standard or SDO-balloted technical specification or implementation guide.
Criterion #2
Maturity - Current Use 		Level 2 - Data element is captured, stored, or accessed in multiple production EHRs or other HIT modules from more than one developer.
Criterion #3
Maturity - Current Exchange		 Level 2 - Data element is electronically exchanged between more than two production EHRs or other HIT modules of different developers using available interoperability standards.
Criterion #4
Use Case(s) - Breadth of Applicability		 Level 2 - Use cases apply to most care settings or specialties.

Comment

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?

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 pwilson@ncpdp.org on

NCPDP Comments on USCDI draft v5

  • NCPDP SCRIPT Standard v2017071 and NCPDP SCRIPT Standard v2023011 support Lot Number, but it is not used in claims transactions for billing. NCPDP supports the utilization of Lot Number for immunization purposes.

Log in or register to post comments