Core Data Elements for Functional Standards

Introduction

The CDC Core Data Elements (CDE) for Functional Standards is designed to serve as a resource for Immunization Information System (IIS) managers and staff, as well as others in the IIS community. While the primary audience of this document are IIS staff, this document may also provide valuable insights to stakeholders, such as Electronic Health Record (EHR) vendors.

Building upon the IIS Functional Guide, Volume 2: CDC Endorsed Data Elements, this resource provides comprehensive information on all CDC CDEs. It expands on the context and detailed descriptions to help the IIS community understand the role and significance of these elements in IIS operations and interoperability. IIS can use this information to ensure all CDEs are integrated into their systems, while IIS's data exchange partners can understand the baseline data elements available in IIS. This document does not provide detailed guidance on managing CDEs; for specific implementation guidance, refer to resources such as AIRA guidance documents or the Health Level Seven (HL7) v2.5.1 Implementation Guide for Immunization Messaging.

Core Data Elements are essential to the functionality of IIS as they ensure the completeness of patient and vaccination records for each vaccination event. Each CDE must be supported by several key functions. The IIS must manage each CDE by facilitating input, processing, validation, updates, and deletion to maintain data accuracy and consistency throughout its lifecycle. Additionally, CDE data must be securely stored to guarantee accessibility and preservation for future use. The IIS may also need to generate or transform CDEs, such as creating unique identifiers or combining data. Finally, the system must be capable of delivering CDEs in formats that are ready for use and submitting them seamlessly to other systems to promote interoperability and collaboration.

While the CDEs are fundamental to the functionality of IIS, it is important to recognize that they are not the only data elements that an IIS may want to include. The CDEs serve as a baseline of essential data elements that should be incorporated into an IIS. They represent the basic structure of data to be contained within the system but are not prescriptive regarding naming conventions, the frequency of data element repetition, how the data is used, or other specific attributes.

To align the CDEs with national standards, they are organized in a hierarchical structure that groups data elements into classes, such as "Medications" and "Encounter Information," to highlight their interconnections. The CDEs represent the final level of this hierarchy and are presented in bold, uppercase font for emphasis. Each CDE includes key details, such as its name, definition, data type, and examples, ensuring clarity and consistency.

• Description: Definition of each CDE
• Rationale for Inclusion: This section explains the basis for each data element's classification as a CDE, derived from the IIS Functional Standards. It outlines the specific reasons that support the necessity and relevance of each data element within the context of IIS.
• Functional Standards: The functional standard(s) associated with each CDE
• Repeat: Specifies whether the data element itself can repeat. If a data element is marked as "Yes," it can appear multiple times independently within the record or message. For instance, the "Patient Name" data element may repeat to accommodate various name types, while a "Date of Birth" data element would not repeat as it is typically unique per patient.
• Data Source: An indication of where the data typically originates (e.g., Vital Records, EHRs or the IIS).
• Standards Mapping: Each CDE is mapped to corresponding data elements in the HL7 v2.5.1 Implementation Guide for Immunization Messaging and the United States Core Data for Interoperability (USCDI), demonstrating alignment with immunization and national interoperability standards.
  

For each CDE, a table shows the standard, data element name used by the standard, and, if applicable, usage specifications for the associated field, component, or resource in the standard. This mapping supports compliance requirements such as the Assistant Secretary for Technology Policy (ASTP)/Office of the National Coordinator (ONC) for Health Information Technology (IT) Certification Program, which requires EHRs to demonstrate USCDI conformance.

This resource is designed to guide the IIS community in confidently designing, implementing, and evaluating systems. It introduces a common data model that supports key operations, such as creating user interfaces for managing patient, vaccination, and vaccine lot information, and establishing HL7 and interoperability standards for data exchange. IIS staff can use this guide to identify gaps in current implementations, ensure conformance to functional standards, and align their work with broader data interoperability initiatives.