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Reports from states indicate that confidentiality policies are being developed or modified to be consistent with these specifications.

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CDC continues to provide technical assistance to states regarding these specifications. Additionally, CDC will assess how well the minimum specifications apply to more substantial, integrated information systems and to data sharing between managed care organizations and registries. CDC and its partners will also explore other privacy concerns, including whether persons reaching age 18 years should be notified that they are in the registry or that their information is being archived.

As registries mature, interstate exchange of immunization information will become more critical. Presently, inconsistent state laws control interstate information sharing. States with stringent legal protections might not allow disclosure to states with less protective laws. Therefore, CDC is facilitating guidelines development for the interstate exchange of information. NVAC Recommendations Providers and interested community groups should be involved throughout registry development and implementation, beginning with the initial planning stages.

Registries should be simple to use and designed to minimize the administrative burden on vaccination providers. When possible, registries should capitalize on data that providers already collect for billing or other purposes, thereby avoiding duplicate data entry. This can be done by using billing or encounter information systems, although modifications might be necessary to ensure data completeness and quality.

Initial and subsequent training should be provided to assist with the technical and administrative challenges associated with seamlessly integrating registry functions into office environments.

Registries should include reminder or recall functions to improve adherence to recommended vaccination schedules. Data in immunization registries should be used to improve vaccination services and coverage; these data should not be used to punish providers whose vaccination coverage is below average. CDC Activities. In , to increase registry participation, CDC funded research projects to a identify strategies to encourage provider participation; b improve registry data quality by developing generalizable algorithms that ensure only one record per child in a database; and c assess the feasibility of avoiding duplicate data entry in provider offices by enabling preexisting billing or patient management systems to report vaccinations directly to an immunization registry.

Among the lessons learned from these projects is that provider participation depends, in part, on high quality registry data. Registries must be able to detect whether incoming information is already in the registry or is new. The majority of registries have developed processes for detecting when a registry contains multiple records for one child. Although no national criteria exist for evaluating the effectiveness of registry duplication-reduction algorithms, efforts are on-going to develop suitable evaluation criteria for these algorithms.

CDC is also developing a computerized tool that can examine registry data accuracy and completeness by comparing registry records with vaccination provider records. Furthermore, CDC is evaluating the feasibility of comparing coverage estimates generated from the National Immunization Survey NIS , which is a nationwide, random-digit--dial survey of children's vaccination coverage in the United States, with estimates based on registry databases. Concordance rates between registry estimates and established standard estimates should reflect the completeness and accuracy of immunization histories recorded in a registry's database.

Increased concordance rates should persuade providers and parents that registry data are of high quality. CDC has also identified registries that collect timely and complete immunization information for a substantial proportion of their target population or a subgroup of their population.

Vaccination coverage estimates from these sentinel sites are reported quarterly to CDC and compared with NIS estimates. These sites have been used to monitor new vaccination recommendation implementation and to demonstrate registry data usefulness in focusing public health interventions. Even when immunization records are of high quality, making appropriate vaccination decisions is difficult because of the complexity of vaccination schedules.

In , CDC released its Programmer's Guide to the Automated Immunization Evaluation Process , which offered assistance in developing automated decision support algorithms that assess a child's immunization history and determine which vaccinations are needed Subsequently, algorithms were created and incorporated into registries. To evaluate those algorithms, test cases were developed, and a public domain algorithm program that can function on multiple computer platforms is available. CDC is establishing the Provider Participation Team and Work Group to identify concerns and implement solutions to ensure participation of vaccination providers and recipients in immunization registries.

Initially, a national survey of pediatricians will be conducted to understand what they think about immunization registries and what would ensure their participation. Then, state vaccination projects will be surveyed to identify current activities to recruit providers and determine best practices. NVAC Recommendations CDC, in cooperation with state and local health agencies, provider groups, software and hardware vendors, and national standard-setting organizations, should lead the development, implementation, and maintenance of standards pertaining to immunization registries, including defining essential registry system functions and attributes; defining core data elements; certifying clinical decision-support functions; certifying the registry's ability to consolidate multiple records of the same person; enabling intra- and interregistry record exchange with standard messages; adopting system security standards to address technical and administrative problems and to ensure that access is limited to authorized persons; and certifying registry functions.

In , before these recommendations were made, CDC distributed the first comprehensive description of the general structure and function of an electronic immunization registry. At approximately the same time, CDC, in consultation with immunization grantees and NVAC, also developed essential data elements to identify a person and describe a vaccination event for record exchange.

Core data elements include a patient name first, middle, and last ; b patient birth date; c patient sex; d patient birth state or country; e mother's name first, middle, last, and maiden ; f vaccine type; g vaccine manufacturer; h vaccination or immunization date; and i vaccine lot number. In , at the recommendation of NVAC, a technical working group TWG , which included external registry stakeholders and information technology specialists, was formed.

The purpose of the group was to a reach agreement on standard vocabularies and protocols for data transfer; b serve as consultants to CDC and recommend registry functional standards; c assist in determining a registry accreditation or certification method and provide ongoing quality assurance monitoring; and d indicate ways to facilitate the integration of registry functions into existing information systems. Initial TWG accomplishments were their review and agreement with the proposed functional standards, their development of detailed definitions for these standards, and their identification of a method to certify registries on the basis of these standards.

Progress has also been made in enabling registries to exchange data by using standard coding and transmission rules defined by the HL7 standard 21, In , CDC began developing the standard HL7 immunization messages and an implementation guide for immunization record transactions. These messages became a part of the final, balloted HL7 standard in Plans include placing this application in the public domain so that each registry developer does not have to develop an application independently. The technical focus of CDC's registry activities is related to identifying methods to ensure reaching the health objective.

CDC is reviewing measurable criteria that have been proposed for each of the 12 functional standards. Standardized site visit protocols addressing these elements were developed to monitor registry progress in achieving the health objective relating to registries. NVAC Recommendations CDC should further study registry start-up and maintenance costs and compare these costs with those of alternative systems. Prospects for state and local health agencies securing funds to support their immunization registries should also be evaluated. NVPO should coordinate discussions regarding recommendations for long-term registry funding mechanisms.

A short-term e. This funding would provide time to establish a mechanism for long-term funding. Limited information is available regarding immunization registry costs. Registries offer potential cost savings. Registries might also reduce or offset costs by reducing vaccine-preventable disease morbidity and mortality through improved coverage, providing a means for assessing coverage at the local level, and decreasing the incidence of vaccine adverse events through the identification of children who have vaccine contraindications.

Involvement of all stakeholders in considering funding sources for registries will be critical Box 2. Although certain states have taken this funding opportunity, other sources need to be identified for a long-term funding solution. Despite potential benefits of registries to vaccination coverage, program operations, cost-savings, and parental support, immunization registries have critics and opponents. In , a congressional initiative to establish population-based immunization registries throughout the country was proposed. Opponents successfully argued against establishing a national immunization information database.

Consequently, efforts to establish state- and community-based immunization registries were begun and have since resulted in the development of state and local registries with different capabilities, legal authority, and success. Concerns regarding immunization registries and their recommended uses remain, including ensuring registry participation by all or approximately all vaccination providers; changing vaccination provider practices to rely on registry information for coverage and programmatic data for improving vaccination services among a population; developing and applying a standard evaluation protocol to document that each registry meets operational standards; facilitating data flow from provider settings and local population-based registries into and between state-based systems via the implementation of nationally recognized data standards; the implications of including data regarding a child's vaccine-associated adverse events or contraindications to specific vaccines in a registry's database; and appropriateness of integrating immunization data with other childhood preventive health service information systems e.

Population-based immunization registries, which collect information regarding children within a specified geographic area, can be an effective means for ensuring that children remain current with recommended vaccination schedules. Additionally, registries allow programs to rapidly and completely assess vaccination coverage in defined areas or among specific groups of children.

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D.C. Vital Records

In , NVAC held public hearings that produced four recommendations for immunization registries: a ensure each person's privacy and the confidentially of the information collected; b ensure participation by all vaccination providers and recipients; c ensure functionality; and d ensure sustainable funding.

CDC has worked on each of these recommendations with its partners. Minimum specifications to protect privacy and confidentiality have been developed and approved by NVAC. A set of 12 minimum operational standards have been established for population-based immunization registries, and standardized evaluation criteria to monitor registry progress are being developed.

The Centers for Medicare and Medicaid Services plans to share the financial burden of state registries. Although these actions do not guarantee that state and local vaccination programs can develop and implement fully operational registries, this national approach to standardization and shared allocation of substantial resources will facilitate this process. Ensuring participation by all providers and recipients has been more difficult and is not yet close to achievement.

Although certain national organizations have formally supported the concept of immunization registries, practitioners still find routine participation difficult to implement. Overcoming barriers to full participation remains the greatest challenge to population-based immunization registries. Public health considerationsCUnited States [Chapter 42]. Philadelphia, PA: W. Saunders Co. Impact of anti-vaccine movements on pertussis control: the untold story. Lancet ; Improving immunization coverage rates: an evidence-based review of the literature.

Epidemiol Rev ; Recommended childhood immunization scheduleCUnited States, MMWR ; Building, monitoring, and sustaining immunization capacity [Chapter 4]. In: Calling the shots: immunization finance policies and practices. Inappropriately timed immunizations: types, causes, and their relationship to record keeping. Am J Public Health ; Comparing a computer-based childhood vaccination registry with parental vaccination cards: a population-based study of Delaware children.

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