| Submitted By: Nedra Garrett / CDC | |
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| 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 |
| Estimated number of stakeholders capturing, accessing using or exchanging | 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 |
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| 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 |
| 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. |
| 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 4 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 |
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| Maturity – Standards/Technical Specifications | Comment Level - May be represented by a vocabulary standard or an element of a published technical specification. |
| Maturity - Current Use | Comment Level - Used in limited test environments or pilots |
| Maturity - Current Exchange | Comment Level - Demonstrates limited exchange with external organizations, on same or different EHR/HIT systems |
| Breadth of Applicability - # Stakeholders Impacted | Comment Level - Used by few stakeholders, or for narrowly defined conditions or events |
| 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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