Functional Standards (v5.0): Introduction

Background

The Immunization Information System (IIS) Functional Standards describe the operations, data quality, and technology needed by IISs to effectively support immunization programs, vaccination providers, and other partners and their immunization-related goals. The Informatics and Data Analytics Branch (IDAB), formerly known as Immunization Information Systems Support Branch (IISSB), issued the first IIS Functional Standards in 1997 in collaboration with immunization program managers. Over the years, the standards have been reviewed and revised, setting the course for future development of IISs. To remain current with expanding IIS functionalities and the evolving health Information Technology (IT) environment, IDAB and IIS partners periodically collaborate to update the IIS Functional Standards. The IIS Functional Standards reflect the future-state functionality an IIS should strive to attain to effectively support program and partner immunization-related goals.

Overview

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.

The IIS program goals outline what is necessary to manage and safeguard public health through use of IISs. It is essential to establish and maintain a secure, confidential IIS that prioritizes continuous improvement of data quality and actively promotes electronic data exchange between the IIS and its partners and providers. Moreover, it is crucial to ensure that the delivery of immunization services align with the latest Advisory Committee on Immunization Practices (ACIP) recommendations and that users are provided proper access to data. The IIS should be a robust system that supports the generation and utilization of data through various channels and formats, aligns with federal and jurisdictional vaccine program requirements, and strengthens response efforts for vaccine-preventable disease outbreaks and other public health emergencies. These measures will enhance the effectiveness of immunization programs and protect community health.

The Requirements Traceability Matrix (RTM) is an IIS resource, updated in 2022, intended to clarify minimum expectations of IIS technology. The baseline functional and non-functional requirements included in the RTM describe the intended behaviors of an IIS and how the IIS must operate to support the IIS Functional Standards. The RTM is referenced as a resource throughout the IIS Functional Standards and should be utilized to identify and address gaps in IIS functions, capabilities, and technical qualities that are not specifically outlined in the IIS Functional Standards.

The Functional Standards Diagram depicts the relationship between the components of the IIS Functional Standards to illustrate how the different resources may provide ongoing guidance to jurisdictional staff maintaining and operating an IIS. The IIS Functional Standards and the IIS Functional Standards Diagram lay out components that help assure that IISs attain a level of uniformity and consistency in supporting common clinical, programmatic, and public health immunization goals. The Functional Standards represent a baseline set of goals that an immunization program will strive to achieve throughout the term of a cooperative agreement.

Intended audience

The primary audiences for the IIS Functional Standards are jurisdictional immunization program managers, IIS managers, and staff responsible for implementing and supporting IIS operations, data quality, and IIS technology. Additional audiences include staff that use the IIS for business operations and technology vendors that support the IIS. Diverse audiences and partners access and utilize the IIS Functional Standards; to effectively provide each of these diverse audiences with their own tailored guidance and relevant information, the IIS Functional Standards are organized by program goals with the aligned functional standards, guidance statements, and the supporting resources that provide progressively detailed information to guide those who carry out the functions.

Overarching principles

Use of the term IIS

Each of the IIS Functional Standards and guidance statements in the document begins with the language, "the IIS." The use of this term can represent the information system, the program, the people, and the processes associated with an IIS.

Regulatory framework

All IIS functionality, technology, and operations must meet federal and jurisdictional laws as well as applicable restrictions. Although this is not explicitly stated throughout the document, the regulatory context should be considered for each IIS Functional Standard.

Technology and data standards

Industry standards are foundational in ensuring immunization programs and information systems meet current and future programmatic goals. The Functional Standards provide guidance based on established industry standards relative to public health technology and data collection.

Metrics and measures

Established metrics and measures, developed by public health experts, with broad community input help ensure the IISs align with standards as measured through evaluation and validation. IIS assessments measure and validate IIS functionality and data. Through testing, discovery, IIS assessments, and data validation, IISs can measure and demonstrate functionality and system capability.

Data quality

As the volume of data in an IIS grows over time, it is essential to monitor and consistently improve upon the quality of these data. Accurate data in the IIS is the cornerstone of achieving all immunization-related goals. Data quality is woven into the program goals, Functional Standards, guidance statements, and supporting resources to underscore the importance of incorporating the data quality attributes of availability, completion, timeliness, and validity.

Policies and procedures

Policies and procedures impact the implementation of functional standards in a particular jurisdiction. Meeting some of the functional standards may necessitate the development and documentation of policies and standard operating procedures (SOP).

Organization of the document

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.

Functional Standards Diagram

The IIS Functional Standards Diagram identifies components of the Functional Standards package, to include:

• Program Goals
• Functional Standards
• Guidance Statements
• Supporting Resources
• IPOM

These components either individually or in tandem with each other, influence, drive, direct, and/or inform the IIS.

Technology and Data Standards ensure consistency of the IIS technology. Metrics and Measures enable an IIS to evaluate and assess its progress and status in meeting the Functional Standards. These two foundational elements, in conjunction with the Functional Standards components, promote an efficient, effective and scalable IIS.

Technology and Data Standards

• HL7 Standards and IG
• CDC Endorsed Data Elements
• CDSi Specifications
• Security Standards
• USCDI and ISA (Interoperability Standards Advisory)
• IIS Transport (SOAP)

Metrics and Measures

• M&I Program
• IIS Dashboard
• Jurisdictional Metrics
• DQ Report
• IISAR

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Acronyms

Terms in order of appearance (top to bottom, left to right)