Canadian Consensus Conference on a National Immunization Records System

March 2-3, 1998
Ottawa, Ontario

Abridged Report

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INTRODUCTION

The Canadian Consensus Conference on a National Immunization Records System was sponsored by Health Canada and held in Ottawa on March 2-3, 1998. It was attended by 60 invited participants representing the key stakeholder groups, including consumers, health care providers, privacy experts and federal, provincial and local public health officials. This Report was prepared by the Conference Chair, Dr. Richard Schabas, under the direction of the Steering Committee.

The Consensus Conference was intended to follow-up on the recommendations of the 1996 Canadian National Immunization Conference which recommended that:

An immunization tracking system is urgently needed in Canada to identify children due or overdue for immunization, to notify parents, to make appointments, to provide a database for health-care providers to monitor the immunization of patients at each encounter regardless of where the vaccine was administered, to assist in planning and identifying populations at risk for delayed immunization, to target interventions appropriately, and to evaluate the success of the program. In provinces where physicians deliver the bulk of immunizations, tracking systems adapted for practice, as well as for public health needs, must be developed. The positive exchange of ideas between conference participants suggests that the time has arrived for a national program to be administered provincially, thus ensuring compatibility between provinces so that this health-care information can be accessed when needed. A clearinghouse of current provincial, territorial, and local projects related to the issue and a consensus conference is needed to decide on standards and core information to be collected, and to ensure further compatibility of systems.

Dr. Donna Reynolds presented an overview of the current status of provincial/territorial immunization records systems in Canada. Dr. Edwin M. Kilbourne, Director of the Data Management Division of the National Immunization Program of the Centres for Disease Control and Prevention in Atlanta, provided an overview of the American experience with state and local immunization registries. Thomas Riley provided an overview of privacy and confidentiality issues.

GROUP DISCUSSIONS

The next stage of the Consensus Conference was built around a series of eight small group discussions on key issues. The work of these groups was supported by Issue Papers that were developed in advance of the Conference. The four small groups on the first day (Objectives, Barriers, Confidentiality, and Success Factors) dealt with general issues. The four small groups on the second day (General Systems Issues, Data Elements, Confidentiality and Reporting Functions) dealt with systems issues. Each small group brought a report back to plenary sessions where consensus was achieved. This consensus represents the recommendations of the Consensus Conference.

1. Objectives

To begin, an overall goal for the immunization registry was developed and agreed upon.

Goal An immunization registry will facilitate the control and elimination of Vaccine-Preventable diseases in Canada by ensuring the provision of information and knowledge necessary to achieve the best possible immunization coverage for Canadians.

a) General Objectives

1. Canada will establish an integrated and comprehensive immunization records system in all provinces and territories in Canada within five years of The Consensus Conference.

2. A common set of data elements and standards for all Canadian registries will be agreed upon within one year of the Consensus Conference.

b) Patient Care/Individual Level Objectives

1. The registries will provide current immunization status information to each individual and/or health care provider as necessary.

2. The registries will identify children due or overdue for immunization. They will notify parents/guardians and supply providers with information necessary to support follow-up.

3. The registries will provide information to parents/guardians and providers to avoid inappropriate immunization.

4. The registries will provide information to assist providers in determining the relationship between immunization and adverse events and follow individual patients if necessary.

c) Public Health/Surveillance Level Objectives

1. The registries will provide information on vaccine coverage to program planners and providers and assist in identifying poorly immunized populations and groups, targeting interventions and evaluating program efforts.

2. The registries will provide information to assist in the control of outbreaks of Vaccine-Preventable diseases.

3. The registries will measure progress towards F/P/T objectives for vaccine coverage and disease control.

4. The registries will minimize costs to the health care system (including private providers), public health and the school system by providing efficient records management.

5. The registries will provide information that will assist in assuring accountability for effective vaccine use.

2. Barriers

Overcoming barriers to the establishment and operation of immunization registries will be critical. The registries must have a sound legislative basis, in public health legislation and/or privacy legislation, and be supported by effective operational measures. Successful registries must be simple to use and flexible in application.

Provider barriers will be important. There must be meaningful incentives for providers to participate. One single technological solution may not be possible. There will almost certainly need to be more than one solution for data entry. All functional technological solutions should be considered, from bar codes and swipe cards to, in some cases, paper records.

Jurisdictional issues should not represent a barrier provided that there is agreement on a minimum data set and national standards and immunization schedules are not too rigid. To achieve this, there is a need for strong leadership at an F/P/T level.

Funding is potentially the most important barrier. This is compounded by the lack of public, political and media pressure for registries. It will be necessary to craft strong economic arguments for medium and long-term savings. Public/private and public/NGO partnerships should be actively developed. The American experience where an NGO provided substantial funding to support community registries should be a model. Funding to develop and start-up systems will be necessary. The example of federal funding of this kind in the United States is an example that Health Canada should follow. Pro-rated to the Canadian situation this would represent funding of at least $25 million annually during the years of registry development and implementation.

Establishing effective follow-up and recall procedures are barriers that must also be overcome. In provinces where immunization is based on private providers, the role of public health in follow-up should be clearly defined and linked to the registry. In provinces with mixed providers, the linkage should be to the last provider. The recall function must be adapted to the local/provincial conditions. The experience with some cancer screening programs, with centrally generated recall letters printed on private physicians' letterhead, provides worthwhile examples.

3. Confidentiality

a) General Issues

Effective management of privacy and confidentiality issues will be critical to the success of immunization registries in Canada. The need for confidentiality (i.e. security from inappropriate disclosure) in any immunization registry is a fundamental prerequisite. The issue of privacy (i.e. autonomous individual control over personal information) is more complex because it is inherently compromised by a well-functioning registry unless there is explicit consent at each stage. There was general agreement that immunization information is not highly sensitive in comparison to many other elements of personal health information and that the benefits of registries are substantial.

Consent is implicit for the collection and use of data elements by the health care provider giving the immunization. Consent becomes a more substantive issue in the context of disclosure (i.e. consent to put personal data elements into an immunization registry).

b) Privacy Recommendations

1. There should be a legislative foundation to support immunization registries. Ideally, this should take the form of mandatory reporting under public health legislation, similar to infectious disease reporting. This legislation would supersede privacy legislation. If this proved impractical, then providing registries with the authority to collect this information and an exemption from consent requirements under provincial privacy legislation is an alternative.

It will be necessary for each province/territory to review its privacy and public health legislation and develop plans for enhancement or revision. A national clearinghouse function would greatly assist this process.

2. This legislative approach requires a clear description of what data elements are included in registries, when this is be individually identifiable data and when it is only be aggregate data. It would require a clear statement of who has access to the data, including the data subject or parent/guardian, the current health care provider and the public health agency. The authority for any additional specific provincial requirements for other uses of data, for example for research, should be clearly spelled out.

3. There should be a clear statement of risks and benefits available for data subjects and providers. The risks would include wider disclosure of personal health information.

4. A well-functioning registry is essential to protect confidentiality. Any inappropriate disclosures would compromise confidentiality and stimulate increased concerns about privacy.

5. The registry reports should not stigmatize communities or providers.

6. There should be a clear accountability framework established in legislation. This should promote a culture of accountability within the registries and include substantial penalties for willful inappropriate disclosure.

c) Other Considerations

If a legislative basis for mandatory reporting cannot be established, it will be necessary to develop practical means of obtaining informed consent. This will include:

1. Establishing the information about collection and use required by a reasonable person, deciding if the consent must be written and developing supporting educational materials based on risk/benefit information.

2. Efforts to determine public opinion and involve consumer participation in this process. This should include the general public and at-risk groups. It should deal particularly with issues of perception of risk and benefits and accountability.

3. A communications plan, properly resourced, to inform the public, health care providers and policy makers about the information required and the functions of the registries.

4. Clear national reporting standards.

4. Success Factors

The Issue Paper on Success Factors addressed means of measuring success. The small group discussion accepted this analysis and focused instead on those measures necessary to accomplish success.

The elements necessary for success at a national level include:

1. Commitment at a senior level (i.e. Conference of Ministers and Conference of Deputy Ministers) to the concept of registries, the need for a legislative foundation for registries and the need to exchange immunization information.

2. Health Canada needs to accept that immunization registries are a priority and provide support in terms of standards development, a clearinghouse function, funding for development and start-up, integration with the National Health Surveillance System, economic analysis of the costs/benefits of registries and the promotion of research to improve registry function.

3. Provincial/territorial governments should commit to developing and supporting registries at a provincial or regional level, including the provision of adequate on-going operating funds. They should ensure that there is compatibility of registries within their province/territory and compatibility with other provinces/territories by adherence to national standards. Provincial/territorial governments should make the computerization of local public health departments and health care practice a priority. Provincial/territorial governments must provide a legislative foundation for immunization registries within provincial public health and privacy legislation.

4. The National Advisory Committee on Immunization (NACI) should review its immunization guidelines to make them more "programmer-friendly".

5. Public support must be achieved and maintained by ensuring the individual's ability to access their own records, by the provision of tangible evidence of benefit through notifications about due and overdue immunizations. Data subjects should only have to give information once. Preserving the confidentiality of information is absolutely essential to maintain public confidence. There should be clear guidelines about the acceptable uses of the data and how they may be used.

6. Provider support and participation are critical. This will require providing incentive to providers and partnership with provincial/territorial medical associations. Providers should be given aggregate reports and should be able to access their own practice data. Operation should be simple, efficient and user-friendly. There should be relief from client requests for immunization records.

7. Immunization registries should be developed as a model audit tool for quality improvement and used for health care provider education.

8. Registry operators should support the system by regular reporting to policy makers about progress towards coverage targets and by identifying cost savings.

5. General Systems Issues

The discussion about General Systems Issues was based on the assumption that the Canadian registries would have to accommodate multiple sources of information and multiple technical systems. The Consensus Conference recommends that the system would function best through single systems in each province. These must be compatible interprovincial and also compatible with Medical Services Branch immunization registry for First Nations.

Identification data should be based on a unique identifier (i.e. the provincial health care number). Enrollment would be within one month of birth through the birth registration process or through health insurance enrollment. There should be a reciprocal agreement to transfer records within three months of interprovincial migration. New immigrants should be enrolled within three months. Refugees should be enrolled through data transfer from Health Canada. There should be a process for de-enrollment based on mortality. This would require access to multiple sources of information because vital statistical reporting is slow. Addresses should be updated by information received from providers, school boards and health insurance plans.

Prospective data collection should be given priority. Ideally this should be done through direct electronic data entry by all providers at the time of immunization. This will require the accommodation of multiple entry systems. Bar code systems seem particularly attractive. There should also be an alternative paper reporting form, with standard data elements, for use when direct electronic entry is not practical. Electronic data entry from paper forms should be within 28 days of immunization. Each provider should be able to access the registry. This may require supplying providers with system equipment. There should be discussion with provincial billing agencies and medical associations to include more specific and detailed immunization information in medical insurance claims. Discussions with medical associations will be important in the development and marketing of the system.

Entry of retrospective data is a lower priority than entry of prospective data but is still necessary for an optimal system. The logistics of retrospective data entry should not be an excuse for not starting a system. Retrospective data should be detailed. Dummy dates should not be used and there should be an override capacity to allow a child to be entered as fully immunized even when immunization information is missing.

Interprovincial exchange of information is necessary. This will require adoption of common core data elements and electronic formats. The technical issues in this regard are of secondary importance to the political agreement to exchange data. The real priority is for provinces to get on with developing and implementing their registries.

6. Data Elements

As a general principle, data should only be entered once but should accessible to any legitimate user at any time.

Core data elements should include:

• a unique identifier (i.e. provincial health care number)
• name
• date of birth
• sex
• vaccine (antigen)
• dose number
• indication code for use when vaccine is limited to specific populations (unlinked from personal identifier in data base and will require discussion with provider and consumer groups to determine acceptance)
• indication code for exemption from immunization (with similar confidentiality considerations as above)
• date of immunization
• vaccine lot number
• chart initiation date
• date of issue of report(s) and to whom issued
• source of immunization information (e.g. parent recall, record, etc.)
• exemptions (i.e. laboratory evidence of immunity, contraindications, allergies, philosophical)
• adverse events
• history of Vaccine-Preventable diseases
• immunization schedule(s)
• parent/guardian name
• address
• phone number (home and office)
• date of notification of need for immunization
• provider access number
• public health unit/region
• Aboriginal status (requires validation)
• school attendance (Y/N)
• school identifier
• student number
• day nursery attendance (Y/N)
• day nursery identifier
• facility code for site of immunization (e.g. school or day nursery)
• "blank space" for notes and to accommodate new data elements in the future.

Outstanding issues include decisions about what data elements should be sent from one level to another level. The choice of a unique identifier will be important depending on the availability of the provincial health care number and its quality. Consideration will need to be given to protocols to estimate previous immunization history. There are issues about how Vaccine-Preventable diseases should be documented and there is need for consistent data definitions. There are questions about how far follow-up should be taken. There will be trade-offs between the need for quality assurance and the limits of data collection (e.g. collection of information about anatomical site of injection.)

Possible additional data elements could include country of birth and date of arrival in Canada which could be used to assess immunization levels in immigrants. Geocodes could be useful for assessing local rates. Institutional residence would assist with outbreak control.

7. Confidentiality

a) Systems Issues

A series of principles were developed in reference to system security, confidentiality and consent.

1. The immunization registry should be placed within a legislative framework. The system must adopt to the privacy climate of its province, which can vary markedly. There should be consultation with privacy bodies to avoid legislative gaps. It should allow the collection of nominal data at a regional level, at least. The legislation must allow parents, the current health care provider and the local public health authorities access to the child's record.

2. The system should be based on a security model. Only data necessary for the functioning of the system should be collected into the database. This is necessary to minimize the harm from an unintentional inappropriate disclosure. For example, if information about medical contraindications is collected it should be accessible to the practitioner only. In this context, usual means of security, like passwords and a user log, should be sufficient.

3. There should be a security architecture. There should be appropriate training for a limited number of key personnel. Staff with access should sign confidentiality oaths. Data should be encrypted for transmission. The organization responsible for operating the registry should develop a culture of confidentiality and should identify a person responsible for security.

4. There must be clarity on the handling of consent. If this system operates within a mandatory legal framework then consent is not an issue and opting out is not possible. If consent is required it should be sought at the earliest possible encounter not encumbered by more pressing parental concerns (e.g. childbirth). This raises particular issues with a system that depends on birth notices for enrollment. It may, in fact, be possible in this type of system to enroll without consent provided consent is obtained before immunization information is entered. Regardless of the need for consent, full and accurate information to parents about the registry is essential.

8. Reporting Functions

Reporting functions should be based on the principle that every report should result in an action.

Providers should have access to records on a real-time basis. This should be based on access to records of their own patients as defined by security provisions (i.e. last provider or ever provider of services). Providers should be able to obtain reports on the records of their own patients, including new patients. These records should be available on a "bring forward" or clinic basis. Providers should be able to access aggregate statistical reports on their practices and regular regional coverage reports for comparative purposes.

The local public health agency should have access to records of its residents, identified on a geocode or postal code basis. It should be able to generate local coverage reports. Each public health agency should have the capacity to query the records in any jurisdiction within the system. This will be necessary to collect information on people newly transferred into its jurisdiction and to assist with outbreaks, particularly in colleges and universities.

Other stakeholders, like consumers, manufacturers and NGOs, will want reports from immunization registries. There should be an annual report to the public on the state of the immunization program, including information about doses of vaccine distributed, doses of vaccine administered and coverage rates. The system should have the capacity to provide additional aggregate reports on a request basis. These should be run on a cost-recovery basis. These other stakeholders should not have direct access to the registry database.

Access to the database for research purposes should be encouraged, subject to ethical and confidentiality considerations. It will be important to distinguish between program evaluation and research. The appropriate use of the registry for research should be determined on a case-by-case basis and not predetermined. There need to be mechanisms for reviewing research proposals to their value, validity and ethics. This review should be conducted by an external body, (i.e. not by the operator of the registry). Data provision for research should be on a cost-recovery basis.

The specific types of reports regularly produced will be determined by each jurisdiction based on their own needs. In general, though, these will include:

1. Individual Immunization Records will include the full immunization record itself. In addition, it should provide personalized correspondence to provide reminders and recalls for immunization as well as encourage consent. It should be done on a "push" basis, similar to the Manitoba reminders at age 1, 2 and 5 years of age. The reminders should be issued before the scheduled immunization date for infants and high risk populations. In groups with low overdue rates, it may be more reasonable to withhold the reminder until after the immunization is overdue. The system should be able to produce lists of eligible children attending a clinic.

Access should ideally be interactive and on-line. Dial-up/fax back systems are a useful alternative. Correspondence should be addressed to either the health care provider or the parent/guardian.

2. Program Management reports should include lists of records missing personal identifiers, lists of providers, alphabetical lists of children by school or day nursery and number of doses of vaccine distributed and administered by time interval, vaccine and provider

3. Coverage reports should be based on residents in the area, based on postal code of residence regardless of provider. The data base should have enrollment from birth records and adjust for in and out migration. The registry should be able to provide an "up-to-date for age" report using standardized immunization logic. It should also allow for interjurisdictional differences in schedules, like timing of first and second dose MMR, presence or absence of an adolescent hepatitis B program, or use of Inactivated Polio Vaccine or Oral Polio Vaccine

There should be flexibility in running reports on population subgroups, populations served by specific health care providers or coverage as of specific dates or at specific ages.

SUMMARY

The process of the Consensus Conference was marked by strong and speedy consensus. There was support from all sectors for the utility and feasibility of this strategy. The following were identified as key features of an effective national immunization registry.

• Universal enrollment of the entire target population and all immunization providers. Canadian immunization registries should include all children in Canada. As a minimum start-up, they should include all children from birth to age seven years. They should be expanded in short order to include all school-age children. These registries should have the capacity to include other target populations, like travelers, candidates for influenza and pneumococcal immunization and residents of long-term care facilities. There should be lifelong retention of information.
• Record of all immunization events with ability to identify children due for immunization and have the capability to link to information about adverse vaccine reactions and incidence of Vaccine-Preventable diseases. Provider support is critical, particularly in those provinces with private or mixed immunization delivery systems, and should be based on incentives to participate. Likewise, the information held in the registry must be readily attainable to those authorized to access it. Finally, the system must be able to provide information on vaccine coverage.
• Integrate existing provincial/territorial immunization systems. The operation of the registries should be locally-based, where data entry should occur and the capacity for report generation exist. Therefore, P/T ministries of health must commit to providing sufficient on-going operating funding.
• Consistent common elements ( i.e. consistent within provincial/territorial registries and consistent between provincial/territorial systems). Health Canada has a key role in promoting the development of national standards, providing a national clearinghouse function and in providing developmental funding.
• The registries must be flexible in design and, in particular, be able to accommodate data entry from multiple sources such as birth records, provincial/territorial health insurance enrollment records, school and day nursery enrollment records and immigration notifications. The system must also be able to interact with other health information systems including those dealing with disease surveillance, adverse vaccine reactions and the immunization registry of Medical Services Branch of Health Canada..
• The registry must have a legislative foundation. Provincial/Territorial governments must provide a solid foundation for the registry within public health and privacy legislation.

NEXT STEPS

1. Health Canada should establish a National Working Group on Immunization Registries to further the agenda laid out in this Report. It should have representation from provinces and territories, provider groups, consumers, privacy interests and immunization advisory groups (e.g. NACI). Priority should be given to establishing data elements and technical standards and creating a national clearinghouse function.

2. Each province and territory should establish an Immunization Registry Working Group to actively plan and implement a registry. Membership should include public health authorities, providers, consumers and privacy interests. Several provinces already have committees of this kind.

3. Tangible support should be available to assist provinces in the development of registries on condition that they conform to national standards and data elements. Based on the contribution from the American federal government in support of a similar initiative, Canada requires a dedicated $25 million for each of the first two years of its registry development and a lesser amount thereafter.