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

Contents

• Glossary
• Background
• Overarching Principles Related to the Immunization Registry Functional Standards.
• Immunization Registry Functional Standards (IRFS)
  • Immunization Registry Goal #1
    • The Immunization Registry supports the delivery and capture of immunization services at the point of service delivery, regardless of the care setting.
  • Immunization Registry Goal #2
    • The Immunization Registry maintains standards-based complete, accurate and timely data on all clients and immunization services delivered.
  • Immunization Registry Goal #3
    • The Immunization Registry provides reliable digital access and exchange of electronic immunization information across all health provider types with other jurisdictions (including federal), consistent with current legislative and interoperability standards requirements.
  • Immunization Registry Goal #4
    • The Immunization Registry supports timely and accurate Adverse Event Following Immunization (AEFI) reporting.
• Appendix A: National Immunization Data Elements (NIDE) 2018
• Appendix B:  The Mandatory (or core / minimum) Immunization Data Elements

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

• Adverse Event Following Immunization (AEFI):
  Any untoward medical occurrence which follows vaccination and which does not necessarily have a causal relationship with the usage of the vaccine. The adverse event may be any unfavourable or unintended sign, abnormal laboratory finding, symptom or disease.
• Eligible (dose):
  The person has met the minimum age and minimum interval criteria for receipt of a valid dose of a specific vaccine, but has not yet reached the recommended age and or interval for that dose. The minimum age/interval is not recommended for routine forecasting, but once these criteria are met, vaccine doses received are considered valid doses.
• Due (dose):
  The person has reached the recommended interval and recommended age for receipt of the vaccine as per jurisdictional schedule, but is not yet considered to be behind schedule.
• Immunization Registry:
  A confidential, population-based, computerized information system that attempts to collect vaccination data about all persons within a geographic area.
• Immunization Registry User:
  Any person(s) interacting with patient data contained within an immunization registry.
• Interoperability:
  Interoperability is the ability of different information systems to connect within and across organizational/jurisdictional boundaries to access and exchange data.
• Invalid (dose):
  A dose of vaccine:
  - given before the minimum age or interval;
  or
  - did not meet other criteria to be considered a protective dose (e.g., a vaccination error such as incorrect route or dose, expired product, or without due attention to coadministered vaccines or recommended intervals to other vaccines such as sequential doses of live vaccines).
• Overdue (dose):
  The person is considered to be behind schedule for receipt of a vaccine dose generally one month (for infants) after the jurisdictional schedule. If the vaccine is part of the school-age program, it is recommended that a person is considered overdue once the school year has ended.   The overdue concept is administratively useful for specific actions that may be warranted to follow-up on unvaccinated/undocumented children e.g., additional reminder/recall or suspension for failure to comply with legislation/regulations.
• Providers:
  A health care professional who has authority to administer a vaccine product within a given jurisdiction.
• Reminder/Recall:
  A method to notify clients (and/or guardians) who are due for a vaccination (reminder) or past due (recall).
• Timely:  
  Available as soon as possible, with no administrative delays.
• Valid Dose:
  A dose of vaccine that is administered on or after the minimum age for receipt, or  minimum interval from (the) previous dose(s) of this antigen and which meets all criteria to be considered protective (e.g., no errors of route or dosing).
• Vaccination Event:
  Administration of a vaccine (active immunizing agent) product.

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 Canada.  The 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:

• 1.1.  The Immunization Registry provides complete and accurate individual immunization records for persons of all ages accessible to authorized users before and at the point and time where immunization services are being delivered.
• 1.2.  The Immunization Registry has the ability to capture both historical and current immunization services.
• 1.3.  The Immunization Registry has an automated function that determines vaccines eligible, due, or overdue (“vaccine forecast”) in a manner consistent with current jurisdictional immunization schedules or national guidelines; results of the forecaster are displayed to the authorized user each time a client’s record is viewed and can enable the production of reminder/recall notifications.

Immunization Registry Goal #2

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

Functional Standards:

• 2.1.  The jurisdiction has policies and/or legislation in place regarding the requirement of all immunization providers, regardless of setting, to submit standards-based complete, accurate and timely records for all immunization services delivered.
• 2.2.  The Immunization Registry captures and exchanges consolidated immunization records from all source databases for persons of all ages within the jurisdiction.
• 2.3.  The Immunization Registry has rules in place that will automatically identify, prevent, and resolve duplicate client records and / or vaccination events, and flag invalid doses and unsuccessful exchanges of information.
• 2.4.  The Immunization Registry, at minimum, can capture and exchange client-specific data for all Immunization Registry National Immunization Data Elements (see Appendix A), to the extent permitted by provincial or territorial law.
• 2.5.  The Immunization Registry captures and exchanges immunization and/or demographic information with authorized systems and users to facilitate tracking and sharing of vaccination events, regardless of provider. The process by which immunization records are updated/exchanged should be timely.
• 2.6. The immunization registry provides authorized users with an accurate numerator for the estimation of coverage at the population level to support and inform both the control and management of vaccine-preventable disease outbreaks and efforts to improve coverage of immunization rates. Denominator data will ideally be sourced from within the registry, however linkages to jurisdictional record-level population databases are also acceptable.

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:

• 3.1. The Immunization Registry has documented authorization (e.g., memoranda of understanding, interagency agreements, data sharing agreements) to request and receive immunization information from other Immunization Registries to the extent permitted by provincial or territorial law.
  • 3.1.1 In jurisdictions where privacy laws prevent data sharing between registries without patient, parental or caregiver consent, but allow registries to share data to a third party with patient, parental or caregiver consent, processes will be developed to seek such consent. In such cases, once consent is granted, the information will be transferred directly from one registry to the other without further patient/parent intervention.
• 3.2. The Immunization Registry can query another Immunization Registry for an immunization history, to the extent permitted by provincial or territorial law.
• 3.3. The Immunization Registry can provide client demographic and immunization records to Immunization Registries in other jurisdictions for clients who reside in those jurisdictions, to the extent permitted by provincial or territorial law.
• 3.4. When the Immunization Registry receives queries or submissions from other health information systems, it can generate an automatic response in accordance with jurisdictionally agreed immunization interoperability standards for message content/format and transport.
• 3.5. The Immunization Registry can provide access for individuals to their personal records.

Immunization Registry Goal #4

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

Functional Standards:

• 4.1. The Immunization Registry provides the necessary reports and/or functionality to facilitate investigations of AEFIs and vaccine recalls, when necessary, including the identification of recipients by vaccine product, lot, manufacturer, provider, and/or time frame.

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