IIS Functional Standards

At a glance

This sets forth the current IIS Functional Standards and the accompanying IIS programmatic goals, guidance statements, and supporting resources that guide the direction and progress of IISs.

Overview

The IIS Functional Standards documentation communicates the IIS program goal, followed by the relevant functional standards and the supporting guidance statements with specific activities. Supporting resources to meet the applicable standards are also listed.

  • Program goals describe how the IIS should meet the business needs of the jurisdiction it serves.
    • Program goals are ordered to mirror the processes required to establish and maintain a high-functioning IIS. The goals begin with setting the foundation of establishing a safe and secure platform that has the capability to collect and store data within that platform. Next, the goals describe sharing high-quality data with key partners and cover accessibility of data within the IIS for providers and the public. The final goals cover preparing the IIS for public health emergencies and engaging in emerging technologies.
  • Functional Standards reflect the expected functionality an IIS should strive to attain to meet program goals. Note: in this update, some Functional Standards apply to multiple program goals and may fall into multiple categories.
  • Guidance statements offer detailed direction that immunization program staff can use when developing systems, processes, and policies to achieve the program goals.
  • Supporting resources include various tools and sources of information IIS staff can use to carry out the processes described in the guidance statements. Some guidance statements may not have supporting resources because the resources have yet to be developed. Moreover, resources may be updated at intervals that differ from the IIS Functional Standards review cadence.

IIS Functional Standards Matrix

Goal A. Establish and maintain a secure, confidential Immunization Information System.

Guidance Statements

1.1 The IIS establishes, documents, and updates policies and procedures to manage the collective functions, capabilities, and attributes of an IIS.

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1.2 The IIS establishes and maintains the technical infrastructure to securely capture, store, and process patient demographic and vaccination data consistent with established policies and procedures.

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1.3 The IIS provides ongoing training to ensure awareness of and to promote adherence to policies and procedures.

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Guidance Statements

3.1 The IIS implements service-level agreements between the program and the entities providing information technology and support.

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3.2 The IIS implements and maintains the infrastructure to fulfill service-level agreements.

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Goal B. Continuously improve IIS data quality.

Guidance Statements

4.1 The IIS supports the identification, prevention, and resolution of duplicate and fragmented patient demographic and vaccination data in accordance with policies and procedures.

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4.2 The IIS monitors data quality within the IIS in accordance with policies and procedures.

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4.3 The IIS uses electronic tools to standardize and/or validate addresses in the IIS.

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4.4 The IIS delivers feedback and training to IIS partners and providers to ensure complete, timely, and accurate patient demographic and vaccination records.

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4.5 The IIS meets federal and jurisdictional data quality metrics.

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Goal C. Promote electronic data exchange between the IIS and its partners and providers.

Guidance Statements

5.1 The IIS exchanges data in accordance with current interoperability standards endorsed by CDC for message content, format, and transport.

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5.2 The IIS actively recruits, enrolls, and onboards IIS partners and providers for electronic data exchange.

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5.3 The IIS actively monitors and evaluates data submitted via electronic data exchange.

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5.4 The IIS investigates and resolves electronic data exchange errors and anomalies with IIS partners and providers.

Goal D. Ensure the delivery of immunization services reflects current ACIP recommendations.

Goal E. Ensure appropriate user access to data.

Guidance Statements

7.1 The IIS implements confidentiality policies that protect the privacy of individuals whose data are contained in the system.

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7.2 The IIS implements comprehensive account management policies consistent with industry security standards.

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7.3 The IIS supports technical attributes for the set up and access of user roles and permissions.

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7.4 The IIS provides user access in accordance with policies and procedures.

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7.5 The IIS supports authorized IIS partners' and providers' appropriate access to data in the IIS for public and population health purposes (e.g. childcare, schools, college, health plans, clinics).

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7.6 The IIS provides training that covers accessing patient demographic and vaccination data.

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7.7 The IIS identifies and inactivates user and site accounts when they are no longer active or no longer authorized to access the system.

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Guidance Statements

8.1 The IIS provides consumers with direct access to immunization records in accordance with policies and procedures.

Goal F. Support the generation and use of IIS data through various channels and formats.

Guidance Statements

10.1 The IIS supports direct access for internal authorized users to IIS databases for data extracts and queries in accordance with policies and procedures.

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10.2 The IIS supports access to data for data visualization, presentation, and analysis.

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Guidance Statements

11.1 The IIS supports vaccine adverse event investigation.

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11.2 The IIS refers users to appropriate resources to support adverse event documentation.

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Goal G. Support federal and jurisdictional vaccine program requirements.

Guidance Statements

14.1 The IIS establishes vaccine program procedures in accordance to federal and jurisdictional policies.

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14.2 The IIS supports the tracking of eligibility at the dose level for publicly purchased vaccine.

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14.3 The IIS generates a report listing patients that received a non-viable vaccine.

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14.4 The IIS generates a report listing provider sites that received vaccine lots recalled by the manufacturer.

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Guidance Statements

15.1 The IIS supports vaccine inventory management, tracking, and reconciliation at the IIS jurisdiction and provider site levels.

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15.2 The IIS supports creating vaccine orders and monitoring order status.

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15.3 The IIS supports reporting vaccine returns and wastage.

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15.4 The IIS automatically decrements administered doses (not historical doses) from active inventory.

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Guidance Statements

16.1 The IIS establishes data exchange with VTrckS in accordance with ExIS (External Information System) specifications.

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16.2 The IIS completes updates to ExIS functionality following publication of specifications.

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16.3 The IIS establishes automated data exchange with VTrckS.

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Goal H. Support response efforts for vaccine-preventable disease outbreaks and other public health emergencies.

Guidance Statements

17.1 The IIS establishes, coordinates, and executes emergency preparedness plans and procedures in accordance with federal and jurisdictional policies.

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17.2 The IIS supports expedited communication and onboarding with partners to capture patient demographic and vaccination data in an emergency.

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17.3 The IIS provides training to onboarded partners.

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17.4 The IIS supports vaccine administration functionality to include offline documentation of vaccine administration.

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17.5 The IIS supports integration with tools for vaccination appointment scheduling.

17.6 The IIS supports public health immunization reporting to federal and jurisdictional authorities.

Goal I. Participate in and prioritize emerging technologies and standards.

Guidance Statements

18.1 The IIS coordinates modernization efforts.

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18.2 The IIS plans and executes efforts that align IIS initiatives with modernization priorities.

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18.3 The IIS participates in initiatives to develop standards and/or capabilities.

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