Record of vaccine administration.

Data Element

Applicable Vocabulary Standard(s)

Immunizations

  • CDC IIS: Current HL7 Standard Code Set, CVX -- Vaccines Administered, updates through January 31, 2020
  • CDC National Drug Code (NDC) Directory – Vaccine NDC Linker Table, updates through January 31, 2020

Data Element

Applicable Vocabulary Standard(s)

Immunizations

  • IIS: Current HL7 Standard Code Set, CVX -- Vaccines Administered, updates through April 6, 2021
  • Vaccine National Drug Code (NDC) Directory – Vaccine NDC Linker Table, updates through May 18, 2021

Data Element

Applicable Vocabulary Standard(s)

Immunizations

Vaccine product administered, planned, or reported.

Both standards are required

  • IIS: Current HL7 Standard Code Set, CVX – Vaccines Administered, updates through June 15, 2022
  • Vaccine National Drug Code (NDC) Directory – Vaccine NDC Linker Table, updates through June 16, 2022

Data Element

Applicable Vocabulary Standard(s)

Immunizations

Vaccine product administered, planned, or reported.

Both standards are required:

  • IIS: Current HL7 Standard Code Set, CVX –
    Vaccines Administered, updates through June 6, 2023
  • Vaccine National Drug Code (NDC) Directory – Vaccine
    NDC Linker Table, updates through June 7, 2023

Data Element

Applicable Vocabulary Standard(s)

Immunizations

Vaccine product administered, planned, or reported.

Both standards are required:

  • CVX – Vaccines Administered, updates through December 14, 2023
  • National Drug Code (NDC), updates through January 16, 2024
Lot Number

Sequence of characters representing a specific quantity of manufactured material within a batch.

Comment

Comment

Recommend adding Lot Number as a data element. This will ensure patient safety in the effect of a recall. This will also support FHIR resources, data exchange, and immunization registry tracking.

Data Class: Immunizations

Level 2 Data Element: Vaccination Administration Date

Level 2 Data Element: Vaccination Event Record Type

Level 2 Data Element: Immunization Status

Level 2 Data Element: Reason Immunization Not Performed

Level 2 Data Element: Immunization Code

IMO supports the inclusion of the proposed Level 2 data elements in USCDI V3.  Many technical specifications with a wide range of maturity were cited for inclusion of this data class and data elements. This information is routinely exchanged between clinical environments and state, tribal, local, or territorial (STLT) public health agencies, and are supported by ONC Certified HIT.

USCDI defines this as “the…

USCDI defines this as “the record of an administration of a vaccination or a record of a vaccination as reported by a patient, a clinician, or another party.” The HL7 Event code DE Immunization Status addresses a single visit that is fulfilled by the following value set:
• completed
• entered-in-error
• not-done
The last valid value “not-done” might benefit from having a reason why not done and offering ‘entered-in-error’ as one of the reasons. The expanded valid values in the HL7 Immunization Status Reason Codes for the reason immunization not performed does not capture most reasons why the patient might have declined the vaccine. The CDC message mapping guide (MMG) for case notifications uses a larger value set as seen in this here.  
Additionally, the USCDI Immunization Data Class does not capture critical information regarding a vaccine series or booster status which are available in immunization registries. MMGs with vaccine information captures a patient’s vaccine history including booster shots, dose number, and whether a series was completed by the appropriate date.  These vaccine data elements used by CDC for case notification include:
• Vaccine Dose Number
• Vaccine Manufacturer
• Vaccine Lot Number
• Vaccine Expiration Date
We recommend assessing if more information such as boosters and additional series information can be captured to fulfill a more complete use case for Immunization Status. The other DEs from this data class are compatible with the current DEs CDC requests for case notifications. 

This field is for general comments on this specific data class. To submit new USCDI data classes and/or data elements, please use the USCDI ONDEC system: https://healthit.gov/ONDEC

USCDI_Version_2_DSAT_Comments_20210413.docx

a status reason why the vaccine was not given; When the vaccine

This field is for general comments on this specific data class. To submit new USCDI data classes and/or data elements, please use the USCDI ONDEC system: https://healthit.gov/ONDEC

Hi,

My question is related to the Immunizations data class. If the "status" is - "not done". How do we find out the "date" when the vaccine was not given? I am asking this since both "Status" & "Date" are mandatory fields in the FHIR data model.

Thanks,

Priti

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