Record of vaccine administration.

Data Element

Information from the submission form
Immunization Code
Description
The code for the vaccine that was administered or was to be administered.
Submitted By: Maria Michaels / CDC
Data Element Information
Rationale for Separate Consideration The current element of immunizations does not specifically state that this is used to capture the code or name of the immunization administered. Suggest renaming the current element of "Immunizations" to "Immunization Code".
Use Case Description(s)
Use Case Description Actively monitoring diseases, making decisions about public health threats, identifying trends in healthcare services utilization and other public health matters depend on accessible and accurate data. EHRs are a data source that can provide timely and relevant data beyond its use by health care providers. EHR data, if made more available for public health professionals and researchers, can lead to more rapid disease detection, tracking, and treatment and innovation in healthcare delivery.

Immunization information, including the coded identification of the vaccine administered, date the immunization is administered, immunization status and the reason why an immunization was not performed are important to multiple public health reporting and research use cases to track and analyze information about treatment for various health conditions.

The Making EHR Data More Available for Research and Public Health (MedMorph) project has the goal to create a reliable, scalable, and interoperable method to get electronic health record data for multiple public health and research scenarios (use cases). MedMorph has identified Healthcare Surveys, Electronic Case Reporting (eCR), Research (PCORnet), and Multiple Chronic Conditions (MCC) eCare Plan (for Immunization Code only) use cases that support the adoption of these data elements. These specific use cases are described in more depth on their respective web pages.
Estimated number of stakeholders capturing, accessing using or exchanging All 50 states participate in one or more of the public health use cases that exchange these data elements. Up to 14 territorial or city jurisdictions also participate in one of these public health use cases and use these data elements.

Supporting Links:
MedMorph Project Page: https://www.cdc.gov/csels/phio/making-ehr-data-more-available.html

Hepatitis C Case Report Form: https://www.cdc.gov/hepatitis/pdfs/HepatitisCaseRprtForm.pdf

PCORnet: https://pcornet.org/

MCC eCare Plan: https://confluence.hl7.org/display/PC/Multiple+Chronic+Conditions+%28MCC%29+eCare+Plan
Link to use case project page https://www.cdc.gov/csels/phio/making-ehr-data-more-available.html; https://www.cdc.gov/hepatitis/pdfs/HepatitisCaseRprtForm.pdf; https://pcornet.org/; MCC eCare Plan: https://confluence.hl7.org/display/PC/Multiple+Chronic+Conditions+%28MCC%29+eCare+Plan
Use Case Description A foundational goal of MedMorph is generalizability beyond the 10 use cases that are actively informing the MedMorph project, in order to support many more public health and research use cases. Therefore, other public health and research use cases that use the MedMorph architecture will also benefit from the adoption of these data elements.
Estimated number of stakeholders capturing, accessing using or exchanging All 50 states participate in one or more of the public health use cases that exchange these data elements. Up to 14 territorial or city jurisdictions also participate in one of these public health use cases and use these data elements.
Supporting Attachments MedMorph-ChronicHepatitisCSurveillanceUseCase-DRAFT.pdf
Healthcare Aims
  • Improving the health of populations
Maturity of Use and Technical Specifications for Data Element
Applicable Standard(s) Immunization Code: CVX: Vaccines Administered 2.16.840.1.113762.1.4.1010.6: https://vsac.nlm.nih.gov/valueset/2.16.840.1.113762.1.4.1010.6/expansion

Immunization Code: National Drug Codes (NDC): http://www2a.cdc.gov/vaccines/iis/iisstandards/ndc_tableaccess.asp

Immunization Status: FHIR Immunization Status Codes: http://hl7.org/fhir/ValueSet/immunization-status

Immunization Administered Date: FHIR datatypes: dateTime, String: https://www.hl7.org/fhir/us/core/StructureDefinition-us-core-immunization-definitions.html#Immunization.occurrence[x]

Reason Immunization Not Performed: FHIR Immunization Status Reason Codes: http://hl7.org/fhir/R4/valueset-immunization-status-reason.html
https://vsac.nlm.nih.gov/valueset/2.16.840.1.113762.1.4.1010.6/expansion; http://www2a.cdc.gov/vaccines/iis/iisstandards/ndc_tableaccess.asp; http://hl7.org/fhir/ValueSet/immunization-status
Additional Specifications HL7 FHIR US Core Implementation Guide v3.1.1: https://www.hl7.org/fhir/us/core/index.html

HL7 FHIR US Core Immunization: http://hl7.org/fhir/us/core/StructureDefinition-us-core-immunization.html. MustSupport for the following elements: Immunization Code, Immunization Status, Immunization Administered Date, Reason Immunization Not Performed

HL7 CDA® R2 Implementation Guide: Consolidated CDA Templates for Clinical Notes - US Realm): http://www.hl7.org/implement/standards/product_brief.cfm?product_id=492. SHALL for the following elements: Immunization Code, Immunization Administered Date, Reason Immunization Not Performed

HL7 CDA® R2 Implementation Guide: National Health Care Surveys (NHCS), R1 STU Release 3 - US Realm: https://www.hl7.org/implement/standards/product_brief.cfm?product_id=385

HL7 FHIR® Implementation Guide: Common Data Models Harmonization FHIR Implementation Guide (Release 0.1.0): http://hl7.org/fhir/us/cdmh/2019May/

HL7 FHIR® Implementation Guide: Electronic Case Reporting (eCR) - US Realm: http://hl7.org/fhir/us/ecr/STU1/

HL7 CDA® R2 Implementation Guide: Public Health Case Report, Release 2 - US Realm - the Electronic Initial Case Report (eICR): https://www.hl7.org/implement/standards/product_brief.cfm?product_id=436
Current Use Extensively used in production environments
Supporting Artifacts Level 2 – at scale, or in more widespread production use (routinely collected already) on several different EHR/HIT systems.

Widely available in EHR systems.

These data elements exist in FHIR with a FHIR Maturity level of 3 for the Immunization Resource. FHIR Immunization: http://hl7.org/fhir/immunization.html.

The Clinical Vaccines Administered (CVX) and National Drug Code (NDC) standards are included in the ISA with an adoption level of 5 in production implementations. Immunizations in ISA: https://www.healthit.gov/isa/representing-immunizations-administered.

ONC Interoperability Standards Advisory - Sending Health Care Survey Information to Public Health Agencies. Sending Health Care Surveys in ISA: https://www.healthit.gov/isa/sending-health-care-survey-information-public-health-agencies.

Part of Core EHR Certification since at least 2014.

IHE Connectathons 2019-2020 (CDA; as part of National Health Care Surveys IGs).   

HL7 Version 2.5.1 Implementation Guide: Immunization Messaging (Release 1.5) 3/1/2014Page 1 HL7 Version 2.5.1 Implementation Guide for Immunization Messaging: HL7 v2.5.1: https://www.cdc.gov/vaccines/programs/iis/technical-guidance/downloads/hl7guide-1-5-2014-11.pdf.  

Supporting Links:
IHE Connectathons:
https://fhir.epic.com/Specifications?api=21
https://developer.allscripts.com/FHIR?PageTitle=Resources
https://www.healthit.gov/sites/default/files/2014_test_methods/2014_edition_test_methods_archived.zip
http://hl7.org/fhir/immunization.html; https://www.healthit.gov/isa/representing-immunizations-administered; https://www.healthit.gov/isa/sending-health-care-survey-information-public-health-agencies
Number of organizations/individuals with which this data element has been electronically exchanged 5 or more. This data element has been tested at scale between multiple different production environments to support the majority of anticipated stakeholders.
Supporting Artifacts Level 2 – exchanged between 4 or more different EHR/HIT systems. More routinely exchanged between multiple different systems can justify adding to the next draft version.

HL7 CDA® R2 Implementation Guide: Public Health Case Report, Release 2 - US Realm - the Electronic Initial Case Report (eICR) is currently implemented in 5,400+ reporting sites nationally and exchanges Immunization information including: Immunization Code, Immunization Administered Date, Immunization Status, and Reason Immunization Not Performed. HL7 CDA® R2 Implementation Guide: Public Health Case Report, Release 2 - US Realm - the Electronic Initial Case Report (eICR): https://www.hl7.org/implement/standards/product_brief.cfm?product_id=436.

As part of National Health Care Surveys CDA IGs: IHE Connectathons 2019-2020. IHE Connectathon: Found in 'New Search', filter by 'Select an integration profile = Immunization Content'.

Care Connect API, INTEROPen, NHS Digital: https://nhsconnect.github.io/CareConnectAPI/api_medication_immunization.html.

Supporting Link:
HL7 CDA® R2 Implementation Guide: Public Health Case Report, Release 2 - US Realm - the Electronic Initial Case Report (eICR): https://www.hl7.org/implement/standards/product_brief.cfm?product_id=436.

IHE Connectathon: Found in 'New Search', filter by 'Select an integration profile = Immunization Content'.

Care Connect API, INTEROPen, NHS Digital: https://nhsconnect.github.io/CareConnectAPI/api_medication_immunization.html.
https://www.hl7.org/implement/standards/product_brief.cfm?product_id=436
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 Low.

Providers capture immunization information as a basic component of patient care.

Several existing IGs, as listed, require the exchange of this data element.

The Promoting Interoperability Programs Objective 8 - Public Health and Clinical Data Registry Reporting, Measures 1: Immunization Registry Reporting, 2: Syndromic Surveillance Reporting, 3 -: Electronic Case Reporting and 4: Public Health Registry Reporting all require these data elements.

This information is routinely communicated in HL7 CDA Documents, HL7 v2 and some FHIR API transactions.
Other Implementation Challenges None

Comment

Submitted by nedragarrett_CDC on 2021-09-29

Unified Comment from CDC

  • Rename element  to Vaccine Code to align with US Core and with the other elements in the Immunizations Class.  
  • Suggest replacing the V2 element of Immunizations with this Vaccine Code element that  includes a definition and descriptive name (keep the associated terminology).  
  • Additional Use Case: Immunization elements are a major piece of public health control and mitigation. When combined with case reports to a jurisdiction or notification to CDC, it allows the jurisdiction or CDC to see where immunizations may be lacking. Immunization information may not directly provide disparity information, but it is needed together with other disparity-related data (e.g., race, ethnicity, location) to identify vaccine breakthroughs or problems with vaccination access/coverage which may also speak to broader health disparities related to general access to medical care and services. Immunization information including date of administration is collected as part of case based surveillance for Hepatitis A, Acute Hepatitis B and Perinatal Hepatitis B to understand hepatitis transmission patterns and ensure appropriate interventions are prioritized within impacted communities.  
  • Number of stakeholders who capture, access, use or exchange this data element:  All US States and DC are funded through CDC’s Division of Viral Hepatitis flagship Notice of Funding Actions to perform surveillance activities, including collection of these data for surveillance purposes.  
  • Support for healthcare aims:  Improving patient experience of care, Improving health of populations, Reducing cost of care, Improving provider experience of care  
  • Use of data element:  Extensively used in production environments  
  • Exchange of data element: CDC Message Mapping Guides (MMG) (e.g., COVID-19);
  • The Multiple Chronic Conditions eCare Plan project successfully tested this element at the Sep 2020 and Jan 2021 FHIR connectathons and has implemented it at the OHSU testing site.
  • This element is used by CMS Quality Reporting and is marked Required or MustSupport in the FHIR QI Core IG  
  • CSTE supports inclusion of this measure into USCDI v3: supports information being shared with IIS across the country – should be captured for all IZ, not just children.

Submitted by maria.michaels… on 2021-04-09

Suggest renaming to Vaccine Code

The MedMorph project recommends renaming this element to Vaccine Code which aligns with the FHIR US Core element Immunization.vaccineCode. Also, will this element replace the V1 element of Immunizations?

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