**Chapter 3. Immunization Information Systems**

**Overview**

The program goal is to increase to 95% the proportion of children under
age 6 enrolled in a fully operational immunization registry or
immunization information system (IIS) by the year 2010. In 1993, the
Centers for Disease Control (CDC) Immunization Services Division (ISD)
began awarding planning grants to develop IIS in every state. Since
then, federal funds have been awarded to promote and support the
development of IIS throughout the U.S. as a key data resource to provide
the information needed to improve and sustain high levels of coverage.

IIS are population-based computerized information systems that have been
implemented at the state or local levels and are an important tool for
tracking immunization records of an ever-increasing mobile population.
IIS consolidate vaccination records for persons with multiple providers,
provide vaccination needs assessments, generate reminder/recall notices,
produce official vaccination records, and provide practice- and
population-based vaccination coverage assessments.

**References**

*Some key documents are listed below and all are available on the
CDC/NCIRD Immunization Information System website at:
[www.cdc.gov/nip/registry](http://www.cdc.gov/nip/registry). A complete
bibliography of peer-reviewed publications maybe seen at:
<http://www.cdc.gov/nip/registry/pubs/pubs_2000-2006.htm>.*

-   Development of Community- and State-Based Immunization Registries
    (NVAC)

-   Community Immunization Registries Manual, Chapter II:
    Confidentiality (CDC/AKC)

-   Implementation Guide for Immunization Data Transactions using
    Version 2.3.1 of the Health Level Seven (HL7) Standard
    Protocol (CDC) (Implementation Guide Version 2.1, September 2002)

-   Recommended Core Data Set for State Immunization Information Systems
    (CDC)

-   Technical Development Guidance (revised Programmers Evaluation
    Guide) (CDC)

-   Progress in Development of Immunization Registries - United States
    2005 (MMWR December 15, 2006)

-   Registry Standards of Excellence in Support of an Immunization
    Program (American Immunization Registry Association's Programmatic
    Registry Operations Workgroup, October 15, 2002)

-   2007 Vaccines for Children Program Operations Guide:
    <http://www.cdc.gov/nip/home-partners.htm#progmgrs>

-   All other chapters of 2008-2012 Immunization Program Operations
    Manual (IPOM)

**Program Requirements**

**3.1 Strive to achieve the program goal of enrolling at least 95
percent of children under six years of age in a fully operational IIS.**

> [Required activities]{.underline}
>
> 3.1a. Annually increase the percentage of children participating in
> the IIS to achieve the program goal of enrolling at least 95 percent
> of children under six years of age in a fully operational IIS.
>
> *Performance measure:* Percentage (increase) of children \<6 years of
> age in the IIS catchment area who are participating in the IIS.
> Progress made will be evaluated using the Immunization Information
> System Annual Report and other methods.
>
> *Target:* Progress toward 95% set by individual programs
>
> [Recommended activities]{.underline}
>
> 3.1b. Promote activities and other strategies designed to facilitate
> IIS participation. Develop a plan for increasing participation of
> children \<18 years of age in an IIS using strategies such as linking
> with other public health programs, (e.g. WIC, Medicaid, lead, STD
> clinics, newborn metabolic screening, newborn hearing, as well as
> schools, military, and Indian Health Services).
>
> *Performance Measure*: Percentage (increase) of children ≤18 years of
> age in the IIS catchment area who are participating in the IIS.
> Progress made will be evaluated in the Immunization Information System
> Annual Report.
>
> 3.1c. If applicable, develop a plan for increasing adult participation
> in IIS using strategies such as linking with other public health
> programs, hospitals, and nursing homes and long term care facilities.
>
> *Performance Measure*: Percentage (increase) of adults \>18 years of
> age in the IIS catchment area who are participating in the IIS.
> Progress made will be evaluated in the Immunization Information System
> Annual Report.

**3.2 Produce an annual detailed report that documents how each
immunization program component demonstrates IIS data use to support
immunization program activities. At a minimum, the report should
describe the use of IIS data to identify areas where immunization
coverage is low, assess immunization practices and coverage status,
document IIS vaccination histories used to assist with the investigation
of vaccine-preventable disease, describe IIS data caveats such as
participation rate limitations, document number of children one dose
away from being up to date, use of vaccine inventory and control data,
and number of AFIX assessments done with IIS data.**

> [Required activities]{.underline}
>
> 3.2a. Use IIS data to assess the immunization coverage by provider
> practice and geographic area (e.g., counties).
>
> *Performance Measure*: Percentage (increase) of immunization coverage
> for children 19-35 months of age and children \<6 years of age in the
> IIS catchment area who are participating in the IIS. Progress made
> will be evaluated using the Immunization Information System Annual
> Report and other methods.
>
> 3.2b. Use IIS data to assess the percentage of public and private
> provider sites participating in the IIS and then collaborate with
> provider organizations and other stakeholders in the IIS catchment
> area to assist with provider recruitment, planning, and
> implementation.
>
> *Performance Measure*: Percentage of public provider sites that
> routinely submit immunization events to the IIS on children \<6 years
> of age
>
> *Target*: Progress toward 100% set by individual programs
>
> *Performance Measure*: Number and percentage of private provider sites
> submitting immunization events to the IIS on children \<6 years of age
>
> *Target*: Progress toward 95% set by individual programs
>
> 3.2c. Evaluate IIS data to measure progress in (1) provider recruiting
> and training efforts at the regional, health district, or county
> level, (2) frequency of provider submissions of data, (3) completeness
> of provider submissions, and (4) provider use of specific IIS
> features.
>
> *Performance Measure*: Percentage of immunization records received and
> processed by the IIS within 30 days, percentage of provider patients
> with data in the IIS since enrollment, percentage of provider
> immunization histories in the IIS that are complete
>
> *Target*: 90% of records received and processed within 30 days, 80% of
> provider patients in the IIS, and 90% immunization record completeness
> in the IIS.
>
> [Recommended activities]{.underline}
>
> 3.2d. Use IIS data to generate grantee management reports such as:

-   User frequency statistics

-   System operations data

-   Number of reports generated per provider practice

**3.3 Conduct an evaluation of the IIS operations and subject data to an
independent objective analysis (e.g., review of IIS operations and data
by third party assessments to certify readiness, evaluate selected
measures of data quality, or use of the data in a regional or national
analysis.)**

> [Required activities]{.underline}
>
> 3.3a. Participate in CDC national IIS data queries such as new vaccine
> uptake, data quality measures, etc.
>
> [Recommended activities]{.underline}
>
> 3.3b. Conduct an evaluation of IIS data generated by a pandemic
> influenza exercise or a public health emergency such as Hurricane
> Katrina.

**3.4 Update and implement a business plan for the IIS.**

> [Required activities]{.underline}
>
> 3.4a. Develop an ISD-approved two-year business plan to ensure
> reaching the IIS program goal. The plan should include: a vision
> statement; goals; objectives; a needs assessment; a management and
> staffing plan; an implementation plan; timelines with action steps and
> key milestones as well as assigned responsibilities; a project
> monitoring and evaluation plan; and a two-year budget. The plan must
> also specifically address: 1) Achievement and maintenance of the
> twelve National Vaccine Advisory Committee (NVAC)-approved Functional
> Standards for immunization registries; 2) A continued increase in the
> proportion of children from birth through five years of age enrolled
> in the registry and with two or more immunizations recorded in the
> registry; and 3) A continued increase in the proportion of active
> immunization provider sites using registries (i.e., public and private
> provider sites both enrolled and submitting immunization data). The
> plan should be updated at least annually.
>
> 3.4b. A previously submitted and approved business plan must be
> referenced and updated. The updated business plan must reference the
> need for the project or activity; a description of the project or
> intervention; a management and evaluation plan; a timeline with action
> steps and assigned responsibilities; the benefit to the IIS; a budget
> and budget justification; and a description of how the project or
> intervention will benefit or support the immunization program in
> addressing program priorities and policies, pandemic influenza
> preparedness, adult immunization, vaccine ordering and management, and
> adverse events reporting.

**3.5 Implement and maintain IIS in accordance with the National Vaccine
Advisory Committee functional recommendation/standards of operation.**

> [Required activities]{.underline}
>
> 3.5a. Evaluate IIS data to assess progress with meeting the 12
> functional standards of operations. See functional standards.
>
> *Performance measure:* Percentage of functional standards attained.
> Progress made will be evaluated in the Immunization Information System
> Annual Report.
>
> *Target:* Annual progress toward meeting all 12 functional standards

**Functional Standards for IIS**

-   Electronically stores data on all NVAC-approved core data elements

-   Establishes an IIS record within six weeks of birth for each newborn
    child born in the catchments area

-   Enables access to and retrieval of immunization information in the
    IIS at the time of the encounter

-   Receives and processes immunization information within one month of
    vaccine administration

-   Protects the confidentiality of medical information

-   Ensures the security of medical information

-   Exchanges immunization records using Health Level Seven (HL7)
    standards

-   Automatically determines the routine childhood immunization(s)
    needed, in compliance with current recommendations of the ACIP, when
    an individual presents for a scheduled immunization

-   Automatically identifies individuals due/late for immunization(s) to
    enable the production of reminder/recall notifications

-   Automatically produces immunization coverage reports by providers,
    age groups, and geographic areas

-   Produces official immunization records

-   Promotes accuracy and completeness of IIS data

**3.6 Additional Activities**

> [Recommended activities]{.underline}
>
> 3.6a. IIS funded through ISD, like all systems funded through CDC
> grants, contract and cooperative agreements, must comply with the
> Public Health Information Network (PHIN) standards and specifications.