Record of vaccine administration.

Data Element
Patient Assertion of Vaccine Credentials
Description

Whether or not the patient asserts they have verifiable vaccine credentials.
Submitted By: Nedra Garrett / 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 Need use case description from DGMQ or NCIRD
Estimate the breadth of applicability of the use case(s) for this data element This data is exchanged as part of the extensive implementation of electronic case reporting in the US. Target is nationwide, currently 5400+ sites are reporting. There are between 56 and 2400 public health agencies using this data. Electronic case reporting is also cited in the Cares Act regulations.
Link to use case project page https://www.cdc.gov/ecr/index.html
Healthcare Aims
  • Improving patient experience of care (quality and/or satisfaction)
  • Improving the health of populations
  • Improving provider experience of care
Maturity of Use and Technical Specifications for Data Element
Applicable Standard(s) HL7 FHIR: Vaccine Credential Patient Assertion Observation profile

HL7 CDA: Vaccine Credential Patient Assertion Observation

LOINC: 11370-4 "Immunization status - Reported"
https://www.hl7.org/implement/standards/product_brief.cfm?product_id=519 https://www.hl7.org/implement/standards/product_brief.cfm?product_id=436 https://loinc.org/11370-4/
Additional Specifications HL7 FHIR® Implementation Guide: Electronic Case Reporting (eCR) based on FHIR R4

HL7 CDA® R2 Implementation Guide: Public Health Case Report - the Electronic Initial Case Report (eICR)

HL7 FHIR: Vaccine Credential Patient Assertion Observation profile

HL7 CDA: Vaccine Credential Patient Assertion Observation


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 In limited use in test environments only
Supporting Artifacts NEED DGMQ or NCIRD/IIS to identify if captured elsewhere

Soon to be published: HL7 FHIR® Implementation Guide: Electronic Case Reporting (eCR) STU Release 2

Soon to be published: HL7 CDA® R2 Implementation Guide: Public Health Case Report - the Electronic Initial Case Report (eICR) Release 1, STU Release 3.0
https://www.hl7.org/implement/standards/product_brief.cfm?product_id=519 https://www.hl7.org/implement/standards/product_brief.cfm?product_id=436
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.
Potential Challenges
Restrictions on Standardization (e.g. proprietary code) These data elements are straightforward in nature and should not present a large burden to implement provided the EHR system is capturing the data.
Restrictions on Use (e.g. licensing, user fees) These data elements are straightforward in nature and should not present a large burden to implement provided the EHR system is capturing the data.
Privacy and Security Concerns These data elements are straightforward in nature and should not present a large burden to implement provided the EHR system is capturing the data.
Estimate of Overall Burden These data elements are straightforward in nature and should not present a large burden to implement provided the EHR system is capturing the data.
ONC 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 0 - Data element is not represented by a terminology standard or SDO-balloted technical specification or implementation guide.
Criterion #2
Maturity - Current Use 		Level 0 - Data element is captured, stored, or accessed in limited settings such as a pilot or proof of concept demonstration.
Criterion #3
Maturity - Current Exchange		 Level 0 - Data element is electronically exchanged in limited environments, such as connectathons or pilots.
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 "Patient-supplied" may be unnecessary, and could overly constrain this data element. Some vaccine credentials *contain* source of information (e.g. immunization information system), which would be important to capture, regardless of who actually provided the information (e.g. patient). Suggest not restricting this data element to LOINC 11370-4 "Immunization status - Reported".

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