Record of vaccine administration.

Data Element
Vaccination Event Record Type
Description

Indicates whether the vaccination event is based on a historical record (e.g., second hand knowledge of the vaccination event) or was administered at the facility submitting the data.
Submitted By: Nedra Garrett / Centers for Disease Control and Prevention
Data Element Information
Data Element Description Indicates whether the vaccination event is based on a historical record (e.g., second hand knowledge of the vaccination event) or was administered at the facility submitting the data.
Use Case Description(s)
Use Case Description Knowing whether a vaccination was administered or was a historical record is helpful when providers are evaluating a patient’s immunization status to determine when the next vaccination in a series should be given. This information helps the IIS and other health IT systems identify, prevent, and resolve duplicate vaccination events using an automated process, thus ensuring that a patient is vaccinated according to the ACIP schedule. Additionally, this information could increase vaccination rates, a Healthy People 2030 goal, by ensuring patients are vaccinated on time.
Estimate the breadth of applicability of the use case(s) for this data element "There are multiple stakeholders that would capture, access, use or exchange this data element or data class including: • Electronic Health Records
• Immunization information systems and local and state departments of public health
• Providers
• Research and academic institutions, especially those running clinical trials "
Link to use case project page https://www.cdc.gov/vaccines/programs/iis/index.html
Use Case Description Additionally, determining whether a vaccination was administered or was a historical record is helpful when performing public health analyses. Vaccine efficacy analyses use this information to determine immunization population coverage. Statistical analyses help to identify underserved populations so that resources redirected appropriately and used efficiently.
Estimate the breadth of applicability of the use case(s) for this data element "There are multiple stakeholders that would capture, access, use or exchange this data element or data class including:
• Electronic Health Records
• Immunization information systems and local and state departments of public health
• Providers
• Research and academic institutions, especially those running clinical trials "

AIRA: https://www.immregistries.org/ Immunization Action Collition: https://www.immunize.org/
Link to use case project page https://www.immunize.org/
Healthcare Aims
  • Improving the health of populations
  • Improving provider experience of care
Maturity of Use and Technical Specifications for Data Element
Applicable Standard(s) LOINC:30952-6- Date and time of vaccination: https://loinc.org/30952-6/

PHINVAD Immunization Information Source
https://phinvads.cdc.gov/vads/ViewCodeSystem.action?id=2.16.840.1.114222.4.5.293
Additional Specifications This information is in various technical specifications including:
• The HL7 2.5.1 Implementation Guide for Immunization Messaging and the HL7 2.8.2 Implementation Guide: Immunization Messaging (see RXA-3)
• FHIR r4 (see immunization.occurrence)
• Clinical Decision Support for Immunizations FHIR IG
• CDC Nationally Notifiable Disease Surveillance System (NNDSS) Message Mapping Guides (MMGs) for Vaccine Preventable Diseases (VPDs)
Current Use In limited use in production environments
Supporting Artifacts Similar information has been collected in various artifacts including the HL7 v2.5.1 Implmentation Guide for Immunization Messaging, the HL7 2.8.2 Implementation Guide: Immunization Messaging, and various public heatlh reporting forms.

https://www.cdc.gov/vaccines/programs/iis/technical-guidance/hl7.html
Extent of exchange N/A
Potential Challenges
Restrictions on Standardization (e.g. proprietary code) None
Restrictions on Use (e.g. licensing, user fees) None
Privacy and Security Concerns None
Estimate of Overall Burden The overall burden to implement this data element is low, as most healthcare IT information systems most likely have this data element stored and messaged in their system already.
Other Implementation Challenges One possible challenge for implementation is ensuring that the correct information is captured, as depending on the timing of the administration, there could be confusion about whether the vaccination was administered or reported. For example, some EHRs would consider a vaccination event given on the same day by a provider outside of their EHR system a historical record, even though they were given on the same day, even within a matter of a few hours.
ASTP 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 david_rocha on

NUVA

The ONC should consider NUVA for representation of immunization data.

https://www.syadem.com/en/solutions/nuva

 

The below text is from the attached PDF from NUVA:

CORE COMPONENTS OF NUVA CATALOGUE

Commercial and generic vaccine names

Multilingual entries covering active, inactive, country-specific or historical vaccines

STRUCTURING

Decomposition of vaccines into valences

Linkage to diseases,valences and international/national codifications

Extended NUVA according to AMM dates, commercialisations and laboratories

PIVOT TERMINOLOGY

Intermediary layer for mapping across national coding systems (CIS/CIP, CVX...) and international (ATC, SNOMED CT...)

Enables seamless integration into electronic health records (EHRs), digital vaccine records(DVRs), immunisation registries, and VADES engines

 

NUVAUSE CASES

Harmonisation of vaccination records across borders or systems

Interoperability with Immunisation Information Systems (IIS)

Automatic enrichment of Digital Vaccination Records (DVRs)

Valence-driven interpretation in Vaccine Decision Support Systems (VADES)

Dashboards, coverage calculations, and logistical auditing

Search of vaccines by valency or target disease

Submitted by BLampkins_CSTE on

Vaccination Event Record Type - CSTE Comment

CSTE supports the inclusion of Immunization Record Source or Vaccination Event Record Type in USCDI v7 and supports AIRA's comment re: clarifying definition and data element name.

Submitted by CDC_DSMH_WG on

CDC's comment for inclusion in USCDI v7

CDC recommends the inclusion of the "Vaccine Administration Event Record Type" element in USCDI v7, as it is a pivotal proposition aimed at improving the precision and uniformity with which immunization information is managed across various healthcare platforms. This element introduces a standardized method for documenting vaccine administration, i.e., vaccination, occurrences, for example, as part of a new immunization record or a historical immunization record, which is essential for achieving interoperability of data, a foundational aspect that supports thorough patient care and enhances safety measures. This “Vaccine Administration Event Record Type” element is a distinctly different key (taking on values such as “new immunization record” or “historical immunization record”) than the “Immunization Record Source” element in Draft USCDI v7 (https://isp.healthit.gov/taxonomy/term/1706/draft-uscdi-v7) (taking on values such as facility administering the immunization and an external record).

Integration of the "Vaccine Administration Event Record Type" into health records allows clinicians to precisely track immunization schedules, ensuring timely administration of vaccines according to established protocols. This uniformity is essential for optimizing patient outcomes and maintaining adherence to vaccination guidelines. Furthermore, this data element directly addresses the issue of duplicate vaccination records. By establishing a clear and consistent record type, it reduces the risks associated with incorrect vaccination dosing—critical for patient safety—and decreases the administrative burden of reconciling records.

From a public health standpoint, the "Vaccine Administration Event Record Type" is invaluable for effective disease surveillance and management. It facilitates real-time tracking of immunization trends within populations, enabling swift responses to public health emergencies. During mass immunization campaigns against diseases like influenza or COVID-19, a standardized record type streamlines reporting processes, minimizes errors, and informs equitable vaccine distribution based on precise community needs.

Additionally, this data element is foundational for research by providing high-quality data essential for assessing vaccine effectiveness and safety. Researchers can utilize this information to draw informed conclusions that influence future vaccine development and policymaking.

In summary, incorporating the "Vaccination Event Record Type" into USCDI v7 promises substantial improvements in healthcare quality through enhanced data precision and reliability. It strengthens public health surveillance systems and response mechanisms while prioritizing patient safety. Consequently, its inclusion is not merely beneficial but critical for advancing healthcare delivery and safeguarding public health at both individual and population levels.

Submitted by rdillaire on

CMS-CCSQ Supports Vaccination Event Record Type for USCDI v7

Recommendation:  CMS CCSQ recommends the Vaccination Event Record Type element be added to final USCDI v7.

Rationale:  The Vaccination Event Record Type data element provides critical information about whether a vaccination has ever been administered or reported. The current Immunizations data element is insufficient to identify whether the vaccination is based on the historical record or was administered at the facility submitting the vaccination record. By adding Vaccination Event Record Type for immunizations, ASTP can also ensure data elements necessary to determine whether vaccinations are current, and whether any vaccinations need to be administered. Since this information helps improve accuracy of vaccine reporting, it can benefit many existing CMS vaccination quality measures. It can already be exchanged via Health Level 7 International  (HL7) v2.5.1 Implementation Guide for Immunization Messaging and v2.8.2 Implementation Guide: Immunization Messaging, Release 1 - US Realm.

Submitted by CDC_DSMH_WG on

CDC's comment for proposed inclusion in USCDI v7

The inclusion of the “Vaccination Event Record Type” in USCDI v7 would represent a critical advancement toward enhancing the accuracy, consistency, and interoperability of immunization data across healthcare systems nationwide. This data element establishes a standardized framework for documenting vaccination events, which is essential for seamless data exchange, comprehensive patient care, and robust safety protocols.
By integrating the Vaccination Event Record Type into electronic health records and Immunization Information Systems, clinicians gain the ability to precisely track vaccine administration events, ensuring adherence to recommended immunization schedules and protocols. This uniformity not only optimizes individual patient outcomes but also mitigates risks associated with duplicate or incorrect dosing, thereby safeguarding patient safety and reducing the administrative burden of record reconciliation.
From a public health perspective, this standardized record type is indispensable for real-time disease surveillance and immunization management. It enables health authorities to monitor vaccination coverage and trends with greater accuracy, facilitating rapid and informed responses during public health emergencies such as influenza outbreaks or COVID-19 vaccination campaigns. Moreover, it supports equitable vaccine distribution by providing clear, actionable data on community immunization needs.
In addition to clinical and public health benefits, the Vaccination Event Record Type underpins high-quality research by delivering reliable data critical for evaluating vaccine effectiveness and safety. This evidence base informs vaccine development, policy decisions, and future immunization strategies.
In summary, incorporating the Vaccination Event Record Type into USCDI v7 will significantly elevate healthcare quality by enhancing data precision, interoperability, and patient safety. It strengthens public health infrastructure and empowers research, making its inclusion essential for advancing healthcare delivery and protecting population health at every level.

Submitted by CDC_DSMH_WG on

CDC's Comment for draft USCDI v6

Including "Vaccination Event Record Type" in USCDI v6 is a crucial step toward enhancing the accuracy and consistency of immunization data across healthcare platforms. This standardized method for documenting vaccinations is vital for achieving data interoperability, which underpins comprehensive patient care and safety.

By integrating this record type into health systems, clinicians can effectively monitor immunization schedules, ensuring timely vaccine administration according to established protocols. This uniformity optimizes patient outcomes, and addresses duplicate vaccination records, reducing risks associated with incorrect dosing and alleviating administrative burdens.

From a public health perspective, the "Vaccination Event Record Type" plays a key role in disease surveillance and management. It enables real-time tracking of immunization trends, facilitating rapid responses to public health emergencies. During mass vaccination campaigns for diseases like influenza or COVID-19, this standardized record streamlines reporting processes minimizes errors and supports equitable vaccine distribution based on community needs.

Moreover, this data element is essential for research by providing high-quality information for evaluating vaccine effectiveness and safety. Researchers can leverage this data to draw informed conclusions that shape future vaccine development and policy decisions.

In summary, incorporating the "Vaccination Event Record Type" into USCDI version 6 promises significant improvements in healthcare quality through enhanced data precision and reliability. It strengthens public health surveillance systems while prioritizing patient safety, making its inclusion critical for advancing healthcare delivery and safeguarding public health at individual and population levels.

Submitted by rdillaire on

CMS-CCSQ Supports Vaccination Event Record Type for USCDI v6

Recommendation: CMS CCSQ recommends the Vaccination Event Record Type element be added to final USCDI v6.

Rationale: The Vaccination Event Record Type data element provides critical information about whether a vaccination has ever been administered, planned, or reported. The current Immunizations data element is insufficient to identify whether the vaccination is based on the historical record or was administered at the facility submitting the vaccination record. By adding Vaccination Event Record Type for immunizations, ASTP can also ensure data elements necessary to determine whether vaccinations are current, and whether any vaccinations need to be administered. Since this information helps improve accuracy of vaccine reporting, it can benefit many existing CMS vaccination quality measures. It can already be exchanged via Health Level 7 International 7 (HL7) v2.5.1 and 2.8.2 IGs.

Submitted by CDC_DSMH_WG on

Vaccination Event Record Type

The inclusion of the "Vaccination Event Record Type" in USCDI v6 will improve the precision and uniformity with which immunization information is managed across various healthcare platforms. This element introduces a standardized method for documenting vaccination occurrences, which is essential for achieving interoperability of data—a foundational aspect that supports thorough patient care and enhances safety measures.

Integration of the "Vaccination Event Record Type" into health records allows clinicians to evaluate patient’s immunization histories more accurately, ensuring timely administration of vaccines according to established protocols. This uniformity is essential for optimizing patient outcomes and maintaining adherence to vaccination guidelines. By establishing a clear and consistent understanding if the vaccination was administered or historical, it can reduce the risks associated with incorrect vaccination dosing—critical for patient safety—and decreases the administrative burden of reconciling records.

From a public health standpoint, "Vaccination Event Record Type" is invaluable for effective disease surveillance and management. It facilitates tracking of immunization information within populations, enabling swift responses to public health emergencies. During mass immunization campaigns against diseases like influenza or COVID-19, a standardized record type streamlines reporting processes, minimizes errors, and informs equitable vaccine distribution based on precise community needs.

Additionally, this data element is foundational for research by providing high-quality data essential for assessing vaccine effectiveness and safety. Researchers can utilize this information to draw informed conclusions that influence future vaccine development and policymaking.

 In summary, incorporating "Vaccination Event Record Type" into USCDI version 6 promises substantial improvements in healthcare quality through enhanced data precision and reliability. It strengthens public health surveillance systems and response mechanisms while prioritizing patient safety. Consequently, its inclusion is not merely beneficial but critical for advancing healthcare delivery and safeguarding public health at both individual and population levels.

Submitted by BLampkins_CSTE on

CSTE Comment - v6

CSTE supports inclusion of this data element in USCDI V6. Please see previously submitted CSTE comments for additional recommendations.

Log in or register to post comments

FormGuide

Help

1. Optional: Background Text / Cover Letter

The "Optional Background Text / Cover Letter" field provides space for additional context or introductory information related to your comment.

If you wish to provide context, explanation, or an introduction to your comment, enter this information in the field labeled "Optional Background Text / Cover Letter." This is entirely optional and is most useful when submitting multiple related comments or when additional background would help reviewers understand your feedback.

If you are only commenting on a single data class or element, you may leave this field blank.

2. Select the Data Class

To specify which data class your comment addresses:

  1. In the "Data Class" drop-down menu, select the appropriate data class you want to comment on.
  2. If you are providing a general comment that is not specific to a data element, select "General" from the options. Comments with this designation will be displayed on the USCDI landing page.
  3. Note that the Data Class field will automatically populate based on your current location in the platform:
    1. If you are on a data class page, the field will be set to that specific data class
    2. If you are on a data element page, the corresponding data class will be pre-selected
       

3. Select the Data Element

To specify which data element your comment addresses:

  1. In the "Data Element" drop-down menu, select the specific data element you want to comment on.
  2. The drop-down menu will display only the elements available under the data class you selected in the previous step.
  3. You can use the search function within the drop-down to quickly locate a specific data element.
  4. If you are commenting on the data class itself rather than a specific element, you may leave this field blank.

Note: Comments on a specific data element will appear on the respective data element page, while comments on a data class (without a specific element selected) will appear on the landing page for that data class.
 

Data Class and Data Element

Fig 1 The "Data Class" and "Data Element" dropdown menus allow users to specify the exact content they wish to comment on.

4. Optional: Propose New Data Class or Element

If you cannot find the appropriate data class or element for your comment:

  1. Instead of clicking the "Comment On An Existing Data Class Or Element" button, click the adjacent button labeled "Propose a New Data Class or Data Element."
  2. This will redirect you to the ONDEC (ONC New Data Element and Class) Submission System.
  3. In the ONDEC system, follow the provided instructions to submit your proposal for a new data class or element.
  4. Once your proposal is submitted through ONDEC, it will be reviewed separately from the commenting process.
Propose New Data Class or Element

Fig 2 The "Propose a New Data Class or Data Element" button redirects users to the ONDEC Submission System for proposing new data elements not currently available in the system.

5. Complete the Comment Form

Fill out the required fields in the comment form:

Subject: Enter a brief, descriptive title that summarizes your comment. This helps reviewers quickly understand the nature of your feedback.

Comment: In this field, provide the full details of your comment or feedback. Be as clear and specific as possible about your suggestions, concerns, or observations. Include any relevant details that support your position.

6. Optional: Add Additional Comments

If you need to comment on multiple data classes or elements:

  1. After completing your first comment, click the link labeled "Comment on another data element" at the bottom of the form.
  2. A new comment section will appear, allowing you to enter details for your additional comment.
  3. For each additional comment, you must select the appropriate data class and data element from the drop-down menus.
  4. Complete the Subject and Comment fields for your additional comment.
  5. Repeat this process for each additional comment you wish to submit.

Fig 3 The "Comment on another data element" link enables users to create multiple comments addressing different elements within a single submission.

7. Optional: Upload Supporting Files

The platform allows you to upload supporting documentation to enhance your comment:

  • Locate the "File Upload" section at the bottom of the comment form.
  • Click to upload any files (such as PDFs or documents) that provide additional context, evidence, or clarification for your comment.

Important: If you have already entered your comments using the form fields, there is no need to upload duplicate content in PDF format. The file upload feature is intended for supplementary materials only. Please avoid uploading files that contain the same information already provided in your comment text.

Upload Supporting Files

Fig 4 The "File Upload" section permits users to attach supporting documentation that supplements their written comments.

8. Optional: Save and Exit

If you need to pause your work and return to complete your comment later:

  1. Click the "Save and Exit" button at the bottom of the form.
  2. Your comment will be saved as a draft that you can access and complete later.
  3. When you return to the platform, you will see a red triangle with an exclamation mark next to the “Return to saved Comment” button, indicating that you have saved comments in draft status.
  4. Click this button to continue working on your draft.
  5. You will be taken to a review page where you can:
    1. Select "Submit Comment" to officially submit your feedback.
    2. Click "Edit" to return to the comment form and make changes
    3. Select "Discard Draft" to delete the saved draft and start fresh

Fig 5 A red triangle with exclamation mark indicator appears next to the “Return to saved Comment” button when draft comments are saved in the system.

9. Review and Submit

Once you have completed your comment:

  1. Click the "Review and Submit" button at the bottom of the form.
  2. This will take you to a review screen displaying your comment(s) in full.
  3. Review all information for accuracy and completeness.
  4. On this review screen, you have three options: 
    1. Click "Submit Comment" to officially submit your feedback
    2. Click "Edit" to return to the comment form and make changes
    3. Click "Discard Draft" to delete the comment and start fresh
  5. The review screen also includes a "Print" button that allows you to create a printed copy of your comments for your records. 
  6. If you choose to submit, your comment will be recorded in the system and made available for review by the appropriate stakeholders.
Review and Submit

Fig 6 The review screen allows users to verify comment content and make any necessary modifications before final submission.

USCDI Comments

Close

Add a New Comment

Review comment and Submit

Edit
Comment #1
PDF, Doc, Docx
Max Size : 10 MB