Canadian Immunization Registry Functional Standards (IRFS) 2020-2024 - Recommendations from the Canadian Immunization Registry and Coverage Network (CIRC)

Contents

Requests for information on the Immunization Registry Functional Standards (IRFS) should be directed to: Canadian Immunization Registry and Coverage Network (CIRC): phac.circ-crcv.aspc@canada.ca

Glossary

Abbreviations:

AEFI
Adverse Events Following Immunization
IIS
Immunization Information System
IRFS
Immunization Registry Functional Standards
NIDE
National Immunization Data Elements
POS
Point of service

Background

The purpose of this document is to define Canadian Immunization Registry Functional Standards (IRFS) to support a network of interconnected Immunization Registries in CanadaThe IRFS describe the minimum standards needed by immunization registries to support immunization providers, immunization programs, Canadian consumers and other immunization stakeholders.

In order to fully support program and stakeholder immunization-related goals, the IRFS are written to reflect the functional capabilities that immunization registries should attain.

The foundational goal of immunization registry functionality is to facilitate standards-based complete, accurate, and timely capture of immunization records regardless of where a person is immunized. 

The Canadian immunization program delivery model includes multiple immunization providers and therefore multiple point of service (POS) applications.  Adoption of Immunization Registry Functional Standards and other standards-based tools (Appendix A & B), will help ensure that immunization records (captured inside or outside of registries) are complete and accurate. Clear data submission standards will also reduce the efforts required to consolidate records from multiple sources within the immunization registry.

To be successful, the IRFS must support the capture of immunization information at the point of service and have the ability to share this information with other electronic immunization record systems. The goal of the IRFS is to support accurate, complete immunization record collection, regardless of immunization service provider (e.g., pharmacist, primary care physician, emergency room, public health nurse) shared within and between provincial / territorial / other registries, to the extent permitted by provincial or territorial law.  This will support the following actions:

  1. Real-time access to clients’ comprehensive immunization history, regardless of where the client presents for service in Canada. This includes reason for non-immunization, where applicable (e.g., refusals, contraindications, etc.).
  2. Forecasting of routine vaccines for specific and grouped individuals, including for school-based and mass immunization clinic planning and delivery, and for the purpose of recalls and reminders, generation of consents, and related activities.
  3. Generation of immunization coverage reports, including through data exports for external analysis.
  4. The investigation of adverse events following immunization (AEFI).
  5. Client(s) access to their own records.

Overarching Principles Related to the Immunization Registry Functional Standards

Use of the Term Immunization Registry
The term “Immunization Registry” is intended to represent the immunization information system digital assets and interfaces utilized by a jurisdiction for the management and delivery of immunization program services. These assets could include interoperable source systems that may feed standardized data directly to a single database of vaccination events. This is commonly referred to as an Immunization Information System (IIS) internationally.   

Data Quality and Integrity
Standardized data submission is imperative to maintain the integrity and functionality of the Immunization Registry. As an Immunization Registry matures, the importance of maintaining data quality is paramount as the ability for the Registry to produce data for program analytics relies on complete and accurate data. 

Regulatory Framework
All immunization registry functionality must comply with federal, provincial / territorial, and local legislation, policies, and restrictions applicable to the jurisdiction(s).  An immunization registry must include appropriate measures to restrict access, manage/prevent loss and theft, and maintain the privacy of client’s personal health information.

Population level denominator data
The immunization registry utilizes appropriate sources of denominator data to support immunization service delivery and immunization coverage assessment. Appropriate sources for the population served by immunization programs may include vital statistics data (i.e., records of births and deaths), daycare/nursery & school enrollment lists, provincial/territorial health insurance plan, or alternative stakeholder registries.

Scope
While immunization programs require information system functionality for activities such as AEFI reporting and vaccine inventory management, these need not be core functionalities of an immunization registry.  Regardless, the IRFS adoption will support AEFI and vaccine inventory management by facilitating or supporting standards-based, complete and accurate immunization record keeping at the point of service. 

Interoperability
Common data standards must be utilized across immunization registries to support data exchange of vaccination records. Provinces and Territories should work together to agree upon specific sets of standards for data storage and transfer between jurisdictions. The National Immunization Data Elements (NIDE, see Appendix A) describes what variables should be collected, at minimum, when inputting a vaccination record in a registry. In September 2018, the Canadian Immunization Committee members agreed in principle to the need and recommended use of the National Immunization Data Elements.

Immunization Registry Functional Standards (IRFS)

Immunization Registry Goal #1

The Immunization Registry supports the capture of immunization records and the delivery of immunization services, regardless of the care setting.

Functional Standards:

Immunization Registry Goal #2

The Immunization Registry maintains standards-based complete, accurate and timely data on all clients and immunization services delivered.

Functional Standards:

Immunization Registry Goal #3

The Immunization Registry provides reliable digital access and exchange of electronic immunization information across all health providers with other jurisdictions (including federal), consistent with current legislative and interoperability requirements.

Functional Standards:

Immunization Registry Goal #4

The Immunization Registry supports timely and accurate Adverse Event Following Immunization (AEFI) reporting.

Functional Standards:

Appendix A: National Immunization Data Elements (NIDE) 2018

The pan-Canadian National Immunization Data Elements (NIDE) are the minimum fields an Immunization Registry must store and/or produce to support interoperability.  Fourteen data elements and their associated terminology subsets were defined in 2016; the 2018 update includes an additional four data elements and terminology subsets, plus updates to the content created in 2016. The minimum data elements an immunization registry should capture can be found below in Appendix B.

The NIDE are not intended to be a comprehensive list of all data elements that immunization registries and other information systems will need for optimal functionality.  The Immunization registry may infer / extract or auto populate distinct values or data elements; actual architectural implementations will differ among systems.

The pan-Canadian NIDE includes a guidance document for message content, format and transport to support real-time system interoperability, regardless of the system(s) in use (e.g., applicable for Panorama and other solutions). The guidance document is available here: NIDE 2018

The Canadian Vaccine Catalogue provides a downloadable database, updated monthly, containing the vaccine terminology subsets and variable product information that can be used to populate fields as prescribed by the NIDE.

Appendix B: The Mandatory (or core / minimum) Immunization Data Elements

Client and provider data elements are included, as applicable, as part of the conformance specifications.  However, the messaging / terminology standards for client and provider data elements are managed by jurisdictional client and provider registry requirements.

Two key use cases are provided below, with the corresponding mandatory data elements.  These data elements must be present for the record to be created.

Use Case #1:  Vaccine Administered.  Clinician has the "vial in hand" and therefore can provide specific details on the event including the product, client, and clinician details.
Data Element Recommended Usage
Administrable Immunizing Agent (Trade Name) Mandatory
Immunization Lot Number Mandatory
Immunization Expiry Date Mandatory
Date of Immunization Administration Mandatory
Client Unique Identifier Mandatory
Client Date of Birth Mandatory
Use Case #2:  Reported Immunization Record.  Clinician / client / parent is reporting a vaccine that was previously administered.
Data Element Recommended Usage
Immunizing Agent (Generic) OR
Administrable Immunizing Agent (Trade Name)
Mandatory
Immunization Reporting Source Mandatory
Date of Immunization Administration Mandatory
Client Unique Identifier Mandatory
Client Date of Birth Mandatory
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