At a glance
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.
- 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.
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.
Supporting resources:
- IIS Policy and Legislation
- Confidentiality and Privacy Considerations for IIS
- Security Guidance Considerations for Immunization Information Systems
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.
Supporting resources:
- IT Enterprise Performance Life Cycle Framework
- Requirements Traceability Matrix - Nonfunctional
- Performance
- Usability
- Reliability
- Security
- Maintainability
- Portability
- Performance
1.3 The IIS provides ongoing training to ensure awareness of and to promote adherence to policies and procedures.
Supporting resource:
Guidance Statements
2.1 The IIS establishes and maintains the infrastructure needed for disaster avoidance.
Supporting resources:
- Security Guidance Considerations for Immunization Information Systems
- Requirements Traceability Matrix - Non-Functional: Reliability
- Requirements Traceability Matrix - Non-Functional: Security
2.2 The IIS establishes and tests recovery plans to mitigate system downtime.
Supporting resources:
Guidance Statements
3.1 The IIS implements service-level agreements between the program and the entities providing information technology and support.
Supporting resource:
3.2 The IIS implements and maintains the infrastructure to fulfill service-level agreements.
Supporting resource:
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.
Supporting resources:
- Fundamentals of IIS: Data Quality
- Requirements Traceability Matrix - Data Quality: Patient Matching & DeDuplication
- Requirements Traceability Matrix - Data Quality: Vaccination Event
- Consolidating Demographic Records and Vaccination Event Records - Mini Guide
- Consolidating Demographic Records and Vaccination Event Records - Full Guide
- Immunization Information Systems Patient-Level De-Duplication Best Practices
- The Unique Records Portfolio
- Vaccination Level Deduplication in Immunization Information Systems - Mini Guide
- Vaccination Level Deduplication in Immunization Information Systems - Full Guide
- IIS Data Quality Blueprint
4.2 The IIS monitors data quality within the IIS in accordance with policies and procedures.
Supporting resources:
- Data Quality Assurance in Immunization Information Systems - Mini Guide
- Data Quality Assurance in Immunization Information Systems - Full Guide
- IIS Data Quality Blueprint
- IIS Recommended Core Data Elements
- IIS Functional Guide - CDC Endorsed Data Elements, Volume 2
- Data at Rest (DAR) Technical Resources
4.3 The IIS uses electronic tools to standardize and/or validate addresses in the IIS.
Supporting resources:
4.4 The IIS delivers feedback and training to IIS partners and providers to ensure complete, timely, and accurate patient demographic and vaccination records.
Supporting resources:
4.5 The IIS meets federal and jurisdictional data quality metrics.
Supporting resources:
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.
Supporting resources:
- Advanced HL7 for IIS: Course and Quick Reference Guides - eLearning
- Fundamentals of IIS: HL7 Basics
- Fundamentals of IIS: Interoperability
- Aggregate Analysis Reporting Tool (AART)
- Guidance for HL7 RSP Messages to Support Interoperability
- EHR-IIS Interoperability Enhancement Project Transport Layer Protocol Recommendation Formal Specification
- Foundational Guidance for Minimum Functionality to Improve Visibility and Access to Information from Acknowledgement Messages
- Guidance for HL7 ACK Messages to Support Interoperability
- HL7 Version 2.5.1 Implementation Guide for Immunization Messaging, Release 1.5
- HL7 Version 2.5.1 Implementation Guide for Immunization Messaging, Release 1.5 - Addendum
- Implementation Guide Authoring and Management Tool (IGAMT) (nist.gov)
- IIS Functional Guide - Query and Response, Volume 1
- IIS-IIS Companion Guide (Requires login to CDC SharePoint)
- IIS Transport (SOAP)
- IZ Gateway Information Sheet
- IZ Gateway HL7 Implementation Guide v1.1
- Public Health IIS Interjurisdictional Memorandum of Understanding - Fillable Form
- Requirements Traceability Matrix - Support Interoperability: Data Exchange
- Requirements Traceability Matrix - Support Interoperability: Interfaces
- IIS Assessment Aggregate Status Report - Message Submission and Acknowledgement
- IIS Assessment Aggregate Status Report - Query and Response
- IIS Assessment Aggregate Status Report - Transport
5.2 The IIS actively recruits, enrolls, and onboards IIS partners and providers for electronic data exchange.
Supporting resources:
- Data Validation Guide for the IIS Onboarding Process
- Onboarding Consensus-Based Recommendations
- AIRA Provider Onboarding Templates
- Improving Immunization Information Sharing through Unified Adoption of a Transport Standard
- National Institute of Standards and Technology (NIST) Immunization Test Suite
- Importing Legacy Data to Improve IIS Saturation
- IIS Orientation to Provider Onboarding: Resource Checklist
- Presentations on Provider IIS Participation
- Requirements Traceability Matrix - Non-Functional Performance
- Requirements Traceability Matrix - Support Interoperability
- Data Exchange
- Interfaces
- Onboarding
- Data Exchange
5.3 The IIS actively monitors and evaluates data submitted via electronic data exchange.
Supporting resources:
- IIS Data Quality Practices - Monitoring and Evaluating Data Submissions
- Data Quality Assurance in Immunization Information Systems - Mini Guide
- Data Quality Assurance in Immunization Information Systems - Full Guide
- Data Quality Incoming/Outgoing Validation: Basic Level
- Data Quality Incoming/Outgoing Validation: Complete Level
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.
Guidance Statements
6.1 The IIS establishes and maintains Clinical Decision Support (CDS) functionality consistent with ACIP recommendations.
Supporting resources:
- IIS: Clinical Decision Support - Logic Specification, Supporting Data, Test Cases
- CDSi Training Material
- Requirements Traceability Matrix - Evaluate and Forecast: Clinical Decision Support
- Clinical Decision Support for Immunization (CDSi) - Mini Guide
- Introduction to the CDSi Project - Video
6.2 The IIS establishes and maintains Clinical Decision Support functionality in alignment with CDSi resources published on the CDC website.
Supporting resources:
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.
Supporting resources:
- Confidentiality and Privacy Considerations for IIS
- Requirements Traceability Matrix - Non-Functional: Security
7.2 The IIS implements comprehensive account management policies consistent with industry security standards.
Supporting resources:
- Security Guidance Considerations for Immunization Information Systems
- Requirements Traceability Matrix - Non-Functional: Security
7.3 The IIS supports technical attributes for the set up and access of user roles and permissions.
Supporting resources:
- Requirements Traceability Matrix - Administer System:
- Hierarchy Configuration
- System Configuration
- User Roles and Permissions
- System Alerts
- Hierarchy Configuration
- Requirements Traceability Matrix - Manage Organizations & Facilities:
- Organization/Facility
- Add, Edit, Inactivate
- VFC/Vaccine Program
- Organization/Facility
- Organization/Facility
- Requirements Traceability Matrix - Manage Users:
- User Search
- Add, Edit, Inactivate User
- Authentication & Authorization
- Password Management
- User Search
7.4 The IIS provides user access in accordance with policies and procedures.
Supporting resources:
- Security Guidance Considerations for Immunization Information Systems
- Presentations on Provider IIS Participation
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).
Supporting resources:
- Presentations on Provider IIS Participation
- Presentations on IIS and Pharmacies
- Presentations on IIS and Health Plans
- Presentations on IIS and Schools
- Presentations on IIS and Childcare
7.6 The IIS provides training that covers accessing patient demographic and vaccination data.
Supporting resources:
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.
Supporting resources:
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
9.1 The IIS provides standard and ad hoc reports to meet federal and jurisdictional reporting requirements.
Supporting resources:
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.
Supporting resources:
10.2 The IIS supports access to data for data visualization, presentation, and analysis.
Supporting resources:
Guidance Statements
11.1 The IIS supports vaccine adverse event investigation.
Supporting resources:
11.2 The IIS refers users to appropriate resources to support adverse event documentation.
Supporting resources:
12.1 The IIS provides access to data to assess vaccination coverage and identify vulnerable populations.
Supporting resources:
- Immunization Quality Improvement Providers (IQIPs)
- Analytic Guide for Assessing Vaccination Coverage Using an IIS
- Practical Examples of IIS Population-Based Coverage Assessments
- Requirements Traceability Matrix - Data Access: Standard Reports
- Comparing and Communicating Vaccination Coverage Estimates from Immunization Information Systems, the National Survey, and Related Assessments
12.2 The IIS manages patient status at provider site and jurisdiction levels.
Supporting resources:
12.3 The IIS provides IIS-related training on accessing, generating, and interpreting reports.
Supporting resources:
12.4 The IIS supports compliance with immunization requirements in childcare, school, and college settings.
Supporting resources:
13.1 The IIS supports conducting reminder/recall activities without assistance from IIS staff.
Supporting resources:
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.
Supporting resources:
- Presentations on IIS Support for Various VFC, State and Local Vaccine Programs
- IIS Collaboration with VFC and Grantee Immunization Programs - Mini Guide
- IIS Collaboration with VFC and Grantee Immunization Programs - Full Guide
14.2 The IIS supports the tracking of eligibility at the dose level for publicly purchased vaccine.
Supporting resources:
14.3 The IIS generates a report listing patients that received a non-viable vaccine.
Supporting resources:
- IIS Collaboration with VFC and Grantee Immunization Programs - Mini Guide
- IIS Collaboration with VFC and Grantee Immunization Programs - Full Guide
14.4 The IIS generates a report listing provider sites that received vaccine lots recalled by the manufacturer.
Supporting resources:
Guidance Statements
15.1 The IIS supports vaccine inventory management, tracking, and reconciliation at the IIS jurisdiction and provider site levels.
Supporting resources:
15.2 The IIS supports creating vaccine orders and monitoring order status.
Supporting resources:
15.3 The IIS supports reporting vaccine returns and wastage.
Supporting resources:
15.4 The IIS automatically decrements administered doses (not historical doses) from active inventory.
Supporting resources:
Guidance Statements
16.1 The IIS establishes data exchange with VTrckS in accordance with ExIS (External Information System) specifications.
Supporting resources:
16.2 The IIS completes updates to ExIS functionality following publication of specifications.
Supporting resources:
16.3 The IIS establishes automated data exchange with VTrckS.
Supporting resources:
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.
Supporting resources:
17.2 The IIS supports expedited communication and onboarding with partners to capture patient demographic and vaccination data in an emergency.
Supporting resources:
17.3 The IIS provides training to onboarded partners.
Supporting resources:
17.4 The IIS supports vaccine administration functionality to include offline documentation of vaccine administration.
Supporting resources:
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.
Supporting resources:
- Data Modernization for IIS - One Page Guide
- CDC Data Modernization Initiative
- Data Modernization Implementation Support
18.2 The IIS plans and executes efforts that align IIS initiatives with modernization priorities.
Supporting resources:
18.3 The IIS participates in initiatives to develop standards and/or capabilities.
Supporting resources: