Record of vaccine administration.

Data Element
Reason Immunization Not Performed
Description

Indicates the reason the immunization event was not performed.
Submitted By: Maria Michaels / CDC
Data Element Information
Data Element Description Indicates the reason the immunization event was not performed.
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.
Estimate the breadth of applicability of the use case(s) for this data element 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.
Estimate the breadth of applicability of the use case(s) for this data element 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
Use Case Description Immunizations HPV: HPV is estimated to cause 70% of oropharyngeal cancers in the United States, although it is unclear if having HPV alone is enough to cause oropharyngeal cancers, or if other factors interact with HPV to cause these cancers. Because the HPV vaccine protects against the types of HPV that can cause oropharyngeal cancers, it may also prevent oropharyngeal cancers. The United States is struggling to achieve HPV vaccination goals because HPV vaccination policies vary greatly nationwide, making it hard to implement sustainable programs. Surveillance of HPV vaccination and risk factors can help to establish associations, identify at-risk populations, and better inform clinical decision-making guidelines and interventions. These activities can increase vaccination acceptance rates and may lower HPV-associated oropharyngeal cancer prevalence and incidence.
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
Extent of exchange 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
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 0 - Use cases apply to a limited number of care settings or specialties, or data element represents a specialization of other, more general data elements.
Evaluation Comment This data element represents a specific type of the broader concept of Reason Not Performed.

Comment

Submitted by rdillaire on

CMS-CCSQ - Clarification on Reason Immunization Not Performed

Recommendation:  CMS CCSQ has difficulty understanding why all the value sets associated with Reason Immunization Not Performed are included for this data element. CCSQ recommends streamlining the value sets for this data element. For example, consider retaining the "Reason Immunization Not Performed: FHIR Immunization Status Reason Codes: http://hl7.org/fhir/R4/valueset-immunization-status-reason.html" value set as an Applicable Standard and consider the "NegationReasonCodes value set (http://hl7.org/fhir/R4/valueset-immunization-status-reason)" as an applicable standard.

Rationale:  The Reason Immunization Not Performed data element will allow for greater flexibility in reporting and assessing why immunizations did not occur, including patient refusal, which may allow for better understanding how this information could be included in future vaccination measures. Streamlining the value sets supported under interoperability definitions reduces the burden of the adoption of interoperability by healthcare providers, while reducing the risk for misalignment between systems as patient data are being coordinated.  Finally, incorporating this value set will provide programs greater flexibility in capturing reasons why vaccines are not delivered during a given patient interaction. 

Submitted by nedragarrett_CDC on

CDC's Consolidated Comment for USCDI v5

** ADD THIS USE CASE TO SUBMISSION **

  • "Immunizations HPV": HPV is estimated to cause 70% of oropharyngeal cancers in the United States, although it is unclear if having HPV alone is enough to cause oropharyngeal cancers, or if other factors interact with HPV to cause these cancers. Because the HPV vaccine protects against the types of HPV that can cause oropharyngeal cancers, it may also prevent oropharyngeal cancers. The United States is struggling to achieve HPV vaccination goals because HPV vaccination policies vary greatly nationwide, making it hard to implement sustainable programs. Surveillance of HPV vaccination and risk factors can help to establish associations, identify at-risk populations, and better inform clinical decision-making guidelines and interventions. These activities can increase vaccination acceptance rates and may lower HPV-associated oropharyngeal cancer prevalence and incidence.

NACCHO supports CDC's recommendation.

Submitted by nedragarrett_CDC on

Unified Comment from CDC

  • 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. Reasons for not being vaccinated help with discerning limited access versus the need for better health education.
     
  • 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. 
     
  • 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

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