In spite of record high immunization levels and the virtual absence of many vaccine-preventable diseases in the United States, reaching and sustaining the Year 2000 objective of 90% of 2-year-old children being up-to-date for all recommended immunizations is not guaranteed.1 1996 data from the National Immunization Survey showed that only 78% of 2year-old children had received a complete 4:3:1 basic immunization series (ie, four doses of DTP vaccine, three doses of poliovirus vaccine, and one dose of MMR vaccine), suggesting that about one million 2year-old children had not received all their immunizations.2
Research suggests that lack of information may be a major cause of underimmunization. Providers often overestimate the percentage of their patients who are fully immunized3'5; parents often do not know their children's immunization status6; and most providers do not remind their patients when an immunization appointment is due or missed.7'10 Missed immunization opportunities are common and may be increasing due to parental and provider confusion about new vaccine recommendations. Already 12 to 16 immunizations are recommended by 2 years of age." Ensuring that children are up-to-date is going to become increasingly complex as more vaccines are recommended for use.
Registries provide the information needed to sustain high immunization coverage by:
* maintaining databases that enroll all children at birth and storing information on each immunization encounter;
* consolidating scattered immunization records, thus enabling a valid assessment based on complete and accurate data of whether a patient needs an immunization;
* promoting automated and aggressive recall of children who need immunizations; and
* providing practice- and community-based coverage estimates to encourage immunization at every opportunity and to target public health interventions at populations at high risk for underimmunization.
Added benefits of registries could include assisting providers with implementing new vaccine recommendations; reporting adverse events following immunizations; tracking adolescent and adult immunizations; recording vaccine contraindications and exemptions; managing vaccine inventories; and evaluating the cost benefit of specific immunizations. Immunization registries can also integrate with other public health tracking and reporting programs, including the Special Supplemental Nutrition Program for Women, Infants, and Children (WIC), for clinic immunization assessment and referral; epidemiology and laboratory programs for disease reporting and laboratory surveillance; and maternal and child health programs for tracking children at high risk of adverse health outcomes, as identified by growth and nutrition monitoring, genetic testing, and hearing screening.
THE CENTERS FOR DISEASE CONTROL AND PREVENTION'S VISION AND COMMITMENT TO IMMUNIZATION REGISTRIES
The National Immunization Program (NlP) of the Centers for Disease Control and Prevention (CDC) advocates state- and community-based immunization registries as a key strategy to meet the Year 2000 immunization objective and sustain it into the 21st century. NIP also supports the ultimate goal of enrollment of all US preschool children in a state- or community-based immunization registry that is able to exchange information with other registries, integrate with the health care delivery system, and support essential public health functions.
NIP funds used to support immunization registry development are awarded through the 317 grant process to states and territories. There is no specific line item or funding category for registries, so each project has the discretion to spend what it considers necessary to promote registry development. At least $42.5 million awarded to the 64 immunization grantees by NIP was obligated for registry support in 1996, with $1 million obligated to support the linkage of WIC information systems to immunization projects in nine project areas. In 1997, at least $35 million was obligated to NIP's immunization grantees for registry support. In addition, $1.3 million was awarded for registry research and evaluation projects. Preliminary figures for 1998 indicate that, due to Congressional budget reductions, about $12.8 million will be obligated for registry support in the 317 grant process. In addition to 317 funds in 1998, approximately $43 million will be awarded for each of 3 years to approximately 10 projects to promote the integration of immunization registries with other health information systems.
CURRENT IMMUNIZATION REGISTRY STATUS
From June through September, 1997, immunization registry personnel from NIP's 64 immunization project grantees (50 states, eight territories, Washington, EXZ!, and five cities) were targeted for telephone interviews to create a "registry of registries." Information was collected on registry developmental status, attributes and linkages, and implementation barriers. By updating these data regularly and making up-to-date information available on the Internet, registry developers can learn from the successes and failures of their peers.
Preliminary data analysis suggests that 36 projects (56%) have operational registries, that is, registries that are beyond pilot testing with one or more sites routinely providing data to a central database (Figure). Seven additional projects (11%) reported registries that are pilot testing, 17 projects (27%) reported registries that are developing (ie, action is being taken on a registry plan, but the registry has yet to reach the pilot-testing or operational stage), planning (ie, the registry plan is being written, but action has yet to be taken on the plan), or assessing (ie, the registry needs have been or are being evaluated, but a registry plan has yet to be written). The four remaining projects (6%) were not interviewed (American Samoa, Marshall Islands, Micronesia, and Northern Mariana Islands) because their NIP program representative reported them to have no current registry activity.
It should be noted that the majority of sites that classified themselves as "operational" are in the early stages of operation. Few, if any, sites have "fully operational" registries; that is, where all public and private providers routinely provide data to the registry, and all targeted children have complete records available in the registry. In addition, the survey reflects only centrally-run registries. It does not take into account additional immunization registries operating in projects' catchment areas that were developed independently. Of the 60 projects surveyed, 25 (42%) reported an additional 255 immunization registries in their catchment areas.
In 1991, the Robert Wood Johnson Foundation (RWJ) initiated the All Kids Count Project (AKC) to develop vaccine tracking and monitoring systems for preschool children. Other private foundations joined this effort, resulting in 24 funded projects. Data from the ten AKC sites that did not receive 317 funds currently are being collected by CDC. In early 1998, RWJ launched phase two of the All Kids Count Project: 16 "mature" sites were funded with the expectation that they will achieve fully operational status by the year 2000. Twelve of these 16 sites receive 317 funds. The NIP and AKC are currently conducting joint visits to these sites to promote Project success.
BARRIERS TO FURTHER REGISTRY DEVELOPMENT
Although much progress has been made, enormous technical and nontechnical challenges must be overcome before reaching the vision of a network of intercommunicating community- and state-based immunization registries. Four of the most significant barriers are outlined below.
Health care provider/stakeholder participation
Private sector involvement is critical to the development of a nationwide network of immunization registries. Approximately 68% of children receive their immunizations in the private sector, according to a 1996 study.12 This percentage will grow as Medicaid-funded vaccines are increasingly given in managed care settings. Having access to private sector immunization records is essential to ensure that assessments of immunization needs are based on complete data and the proper immunizations are given on time.
Private sector benefits of registry participation include time savings by having consolidated immunization records; decreased workload in documenting immunizations for schools, camps, and daycare; reduced patient no-show rates; automated Health Employer Data Information Set (HEDIS) calculations for managed care organizations13; and managed care reimbursement fot immunizing out-of-plan children. To identify additional private sector incentives, NIP is currently funding three projects to identify effective ways to secure and maintain private provider participation.
One obvious disincentive to registry participation by private providers is duplicate entry of immunization encounters into both immunization registries and billing software. Two research projects are currently being funded by NIP to assess the feasibility of adapting existing billing and patient management systems to provide accurate and complete immunization information to a registry. NlP has also proposed modifications to the American Medical Association's Current Procedural Terminology (CPT) codes to increase their vaccine specificity and consequent usefulness to registries.
"Registry-friendly" state legislation has also been enacted that should promote private sector involvement in registries. Analysis of data collected by NIP from late 1997 through early 1998 of all states and Washington, DC, suggests that the following provisions in laws authorizing the establishment and maintenance of immunization registries support provider participation:
* provisions requiring or permitting providers to report to immunization registries;
* provisions providing immunities from civil and/or criminal liability for providers who make good faith disclosures to immunization registries or rely on information in immunization registries;
* penalties for improper disclosure of information; and
* provisions defining with whom immunization information may be shared.
State legislation that addresses the sharing of immunization information but does not specifically authorize immunization registries may also facilitate provider participation.
Privacy, Confidentiality, and Security
A major challenge in developing a nationwide registry network is balancing the need to gather and share public health information with the need to protect the privacy of patients and providers. NIP has worked with AKC to develop a manual on community immunization registries. One chapter, co-authored by the National Vaccine Advisory Committee, is dedicated to privacy and confidentiality issues.14 It recommends that each registry have a written policy on privacy and confidentiality in place at the time of registry development and provides recommended guidelines for development of these policies.
The Health Insurance Portability and Accountability Act of 1996 (Public Law 104-191) will have a positive impact on the security and confidentiality of data maintained by immunization registries. This Act requires the adoption of standards for electronic health information transactions and a unique health identifier for each individual, employer, health plan, and health care provider. Privacy standards for individually identifiable health information must also be adopted and must address individual rights, procedures to exercise these rights, and authorizations or requirements to disclose this information.
Technological and Operational Barriers
The NlP has purposely encouraged the local development of immunization registries that best meet the needs of states and communities. However, this has resulted in a wide range of implementations that cover different jurisdictions (ie, states, cities, counties, regions, provider groups, health plans), operate on different computer platforms, use different software packages, and have different core functions. Such variation makes communication and information exchange between systems increasingly challenging. It also makes assessing registry development and guiding registry efforts difficult. Consequently, NIP is now renewing its efforts to provide technical guidance and standards development for registries.
It is imperative that locally-developed registries be able to communicate with one another, on an asneeded basis (ie, when a child sees a new provider or moves to another state). To that end, NIP and the National Vaccine Advisory Committee have recommended the collection and exchange of a set of core data elements. NIP also supports the use of Health Level 7 (HL7) as the standard for data transmission between registries and has developed specific HL7 immunization messages. The adoption of these standards by immunization registries and private software vendors is critical.
Although there is a great deal of variation in the way registries are implemented, they also exhibit many commonalities. In October 1997, NIP surveyed 67 immunization program managers and registry developers on essential registry capacities (Table). Core functions identified (ie, registry functions considered essential by >75% of persons) will be used by NIP during on-site registry evaluations in 1998 to stage registry development and prioritize future efforts. NIP plans to foster evidence-based enhancements of registries through such evaluations.
Recognizing that immunization registries have common functions, NlP is now developing public domain computer code that can be easily integrated into existing registry software ("objects"). This will allow registries to add new functionality without duplicating programming efforts. Automated immunization needs assessment, vaccine ordering, and vaccine-associated adverse event reporting are some of the functions for which objects will be available.
NIP is also addressing other technical challenges of registries. The organization has funded two research projects to identify efficient methods for ensuring that each child has only one immunization record in a registry. NIP is also working with the Advisory Committee on Immunization Practices to ensure that immunization recommendations are "registry-friendly," enabling computerized algorithms to accurately assess immunizations needs. Continuing to identify commonalities and sharing effective technical solutions among registries will help to further increase developmental efficiency.
Resource Requirements and Funding
Registry functions: results from Immunization Program Managers Meeting Survey, 1997*
Significant investments for immunization registry development have already been made by state and local governments, foundations, the medical community, and other private partners. However, increased bearing of registry costs will be necessary by these groups, because Federal registry dollars are shrinking. New, innovative funding schemes will be necessary to ensure long-term sustainability. For example, at least three states (Washington, Oregon, and Maine) have established agreements for managed care organizations to pay a proportion of operating costs. In-kind support is also important. Examples of in-kind contributions include distributing software, purchasing computers, providing telecommunication services, and sharing training, consulting, and marketing skills.
To better assess the costs of developing and implementing immunization registries, NIP has funded three projects to identify the direct and indirect costs of maintaining a fully developed community-based immunization registry. NIP is also embarking on an assessment of overall immunization program costs for each of its 64 projects to determine the financial resources required to support "core immunization functions." Part of this process will involve an evaluation of per project costs of registry development and implementation. The results from these activities will be important in soliciting continued support for registries.
FUTURE DIRECTIONS: THE 1998 IMMUNIZATION REGISTRY INITIATIVE
On July 23, 1997, President Clinton directed Donna Shalala, Secretary of the Department of Health and Human Services, to work with the states on integrated immunization registries. As a result, the National Vaccine Advisory Committee has created a Workgroup on Immunization Registries. During 1998, this workgroup, in collaboration with NIP, will coordinate a series of meetings with registry partners and subsequently develop a National Immunization Registry Plan.
A four-step process for this Immunization Registry Initiative is being followed:
Step one was the launching of the Immunization Registry Initiative at a meeting on March 13, 1998. This kick-off meeting identified key workgroup members to guide the process and set a deadline for the completion of the National Immunization Registry Plan.
Step two is to convene a series of public meetings on registry challenges, including:
* health care provider/stakeholder participation;
* privacy, confidentiality, and security;
* technological and operational barriers; and
* resource requirements and funding.
These meetings will provide an opportunity for input from all stakeholders and will establish broadbased consensus among registry partners, including state and local public health agencies, professional organizations of private health agencies, managed care organizations, employer-funded healthcare plans, vaccine manufacturers, vendors and developers of medical information systems, information standards development organizations, parents, legislators, and other representatives of the public at large.
Step three is that, based on the discussions from the meetings, the Workgroup will develop recommendations, including the establishment of a target date to achieve the goal of having immunization registries in every community in the nation. The recommendations will be consolidated into a National Immunization Registry Plan and reviewed by the full National Vaccine Advisory Committee.
Step four is for the Secretary to launch the National Immunization Registry Plan and issue a callto-action at a national summit to be held in late 1998.
Although it is possible that these proposed steps will be modified by the workgroup, the 1998 Immunization Registry Initiative should be a major force in ensuring the creation of an integrated network of community- and state-based immunization registries.
Immunization registries are an important tool for helping to sustain and monitor current high immunization coverage rates. In fact, immunization registries "institutionalize" NIP's three main strategies for maintaining immunization coverage: 1) reminder/recall of due or delinquent children; 2) AFIX (coverage assessment of providers, feedback to providers, incentives for providers, and exchange of information between providers); and 3) linkage with WIC clinic immunization assessment and referral. However, significant barriers to registry implementation remain, including sustaining health care provider/stakeholder participation; privacy, confidentiality, and security concerns; technological and operational challenges; and ensuring the availability of adequate resources and funding. NIP is committed to the nationwide implementation of community- and state-based registries and will continue to provide leadership and technical assistance toward that end.
Further information can be obtained at: http://www.cdc.gov/nip/registry.
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Registry functions: results from Immunization Program Managers Meeting Survey, 1997*