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 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 June 12, 2024
  • National Drug Code (NDC), updates through July 12, 2024
Lot Number

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

Data Element

Applicable Vocabulary Standard(s)
Immunizations

Vaccine product administered, planned, or reported.

Both standards are required:

  • CVX – Vaccines Administered, updates through July 23, 2025
  • National Drug Code (NDC), updates through July 23, 2025
Lot Number

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

Data Element

Applicable Vocabulary Standard(s)
Immunization

Vaccine product administered, planned, or reported.

Both standards are required:

  • CVX – Vaccines Administered
  • National Drug Code (NDC)
Immunization Lot Number

Sequence of characters representing a specific quantity of manufactured material within a batch of a vaccine product.
Immunization Status

State of an immunization event.
Immunization Record Source

Immunization event information source.

Examples include but are not limited to facility administering the immunization and an external record.

Comment

Submitted by LisaRNelsonRI on

Generalize data elements where possible

Immunization Record Source

Immunization event information source.

Examples include but are not limited to facility administering the immunization and an external record.

Comment: This data element needs to be defined in a way that reflects what would be accurate Provenance for the “Record Source” for health information.  A Location (facility) is not a viable legal entity.  The Organization that manages/owns the operation of the facility is actually the source of the information, not the facility. 

As a basic Provenance principle, a facility can’t be the information source.  The information source needs to be an organization or a personnel member in the context of the organization they are working for, or possibly a patient or someone related to a patient, or a device in the context of Organization employing it to perform a specific role or healthcare service. 

This is another example where the USCDI data element could be further generalized for greater usability. Record Source, as a data element, would be way more useful as a Health Information Attribute. Creating this one narrow data element only relevant to Immunization Information offers much less utility and reusability.

Recommendation: Change the data element name to Record Source and move it to the Health Information Attribute data class. Change the data element definition to: 

Event information source.

Examples include but are not limited to the Organization responsible for the facility administering the immunization and an external record. An Information source can be an organization or a personnel member of an organization, or a device that is operated by an organization, personnel of an organization, or the patient themselves, or a patient or someone related to a patient.

Additional Note: Immunization Event Record Source could be provided as one specific example of the more broadly applicable data element. Other examples could also be included to show a broad range of uses for the Record Source data element.

Additional Note: Reason Not Performed already has been generalized to the Reason Not Performed data element in the new Health Information Attributes data class. It doesn't need to be duplicated here. The whole point of this new data class is to eliminate bloat in USCDI. Data elements defined in the Health Information Attributes data class can be reused where needed.

Submitted by mturchioe on

ANI's comment on USCDI draft v7: Immunizations

The Alliance for Nursing Informatics (ANI)  strongly supports the addition of both Immunization Status and Immunization Record Source to the Immunizations data class. Immunization administration is a foundational nursing function across virtually every care setting, and these two elements together address distinct but complementary clinical needs. Immunization Status enables point-of-care clinical decision support for nurses administering vaccines, surfacing whether a patient's status for a given vaccine is current, overdue, or contraindicated; this information is critical to preventing both duplicate vaccinations and missed immunization opportunities. Immunization Record Source is equally important: knowing whether a record originates from a patient's self-report, a state immunization information system (IIS), an imported EHR record, or a directly administered dose enables nurses to apply appropriate clinical judgment about data reliability. These elements are particularly significant for patients who receive immunizations across multiple settings, which may include primary care, retail pharmacy, occupational health, and school health, where care coordination across systems is essential to maintaining an accurate and complete immunization history.

Submitted by mbkurilo@immre… on

Definitions and Language.

We appreciate the care and thought that went into the latest version of USCDI; common data elements are foundational to smooth interoperability. We continue to encourage ONC to reconsider the Data Class and the Data Element naming conventions. We are concerned that it is confusing to have the same name of “Immunization(s)” for both the class and the element. The Data Class seems appropriately named. The Data Element should be changed from “Immunization” to “Vaccine Type” to be more descriptive – especially since the value set describes different vaccines. Further comments are provided in the attached. Thank you. 

Submitted by csnewman on

Clarify data element descriptions

Examples (or better yet defined values) should be given for Immunization Status (presumably at least "complete" and "not performed" should be called out assuming that the scope of "record of a vaccine administration" includes refusals of vaccines)

The description of lot number is odd in its use of "specific quantity of manufactured material of a batch of vaccine product" - Quantity doesn't seem quite right and may cause confusion regarding the amount of vaccine administered. Perhaps "instance" would be better than "quantity".

Submitted by david_rocha on

"Immunizations" listed as a data class and data element

"Immunizations" listed as a data class and data element 

This would be an issue if ASTP decided to transform USCDI into an ontology.

The data element should be more specific than the data class.

Data element example would be "Immunizations Details"  - subject to stakeholder feedback and working group committee decision.

Submitted by CDC_DSMH_WG on

Rename the data element Immunizations to Vaccine Code

The inclusion of the vaccine code in USCDI v6 is essential for enhancing the clarity and effectiveness of immunization data management across healthcare platforms. Currently, within the immunizations data class, there exists an immunizations data element that captures information about the type of vaccine administered, using CVX or NDC codes. However, the term immunizations has often led to confusion, as it does not intuitively refer to vaccine code for those working with vaccination data. 

 To address this issue, CDC proposes renaming the immunizations data element to vaccine code. This change will resolve the ambiguity associated with the term “Immunizations” and ensure that discussions about immunization data within USCDI are clear and precise.                                                                                                                                       

The vaccine code data element will provide a more descriptive and accurate representation of the type of vaccine administered, aligning with common terminology used in public health and healthcare settings. This adjustment will also eliminate the confusion caused by the duplicate use of the term immunizations, which currently refers both to a data class and a data element. 

By adopting vaccine code as the standardized term, we also ensure consistency with US Core, further promoting interoperability and clarity across different health information systems. 

In summary, renaming the data element immunizations to vaccine code will enhance the precision, understanding, and consistency of immunization data within USCDI, ultimately supporting better public health outcomes. 

Submitted by kelly.clarke@j… on

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.

Submitted by aphillips@imoh… on

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.

Submitted by CDC_DSMH_WG on

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

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