Attachment B_IIS Baseline Requirements RTM .xlsx
XLSX spreadsheet 499 KB Posted
- Attached to
- IMMUNIZATION INFORMATION SYSTEM (IIS)
- Solicitation number
- CRFP 0506 MIS2700000001 1
- Issued by
- Kanawha County, West Virginia
About this file
This is an Immunization Information System (IIS) Baseline Requirements Traceability Matrix (RTM) developed by the Public Health Informatics Institute in partnership with the Association of Immunization Managers (AIRA) and the Centers for Disease Control and Prevention (CDC), with financial support from CDC under Cooperative Agreement number 6 NH23IP922664-01. The RTM serves as a comprehensive procurement planning document for West Virginia and other immunization programs seeking to procure, enhance, or assess IIS platforms, modules, or specific functionalities. The document outlines 674 baseline functional and non-functional requirements organized across eleven functional areas: Administer System (61 requirements), Manage Organizations and Facilities (83 requirements), Manage Users (35 requirements), Support Interoperability (65 requirements), Ensure Data Quality (32 requirements), Evaluate and Forecast (64 requirements), Manage Patient and Immunization Records (83 requirements), Manage Vaccine Inventory (87 requirements), Provide Data Access (65 requirements), and nine non-functional technical attributes including Performance, Usability, Reliability, Security, Maintainability, and Portability (99 requirements). Each requirement is designated as either Essential (E) or Optional (O) and includes columns for vendor responses, comments, and implementation timelines with cost estimates for customizations.
The RTM is intended for use throughout the system development life cycle (SDLC) and provides step-by-step guidance for immunization programs to identify procurement scope, validate requirements with stakeholders, incorporate findings into solicitations, and conduct user acceptance testing. The document emphasizes maintaining the RTM throughout design, build, test, and release phases and recommends establishing unique requirement identifiers, adding jurisdiction-specific requirements, and using additional priority designations for legally mandated requirements. Jurisdictions are advised to review requirements based on current operational challenges, define jurisdiction-specific needs regarding user-defined parameters and policies, and engage procurement offices early to understand timelines and approval processes. The RTM includes an embedded IIS Functional Model with visual depictions of core functions and capabilities, a glossary of terms, and a crosswalk comparing the Functional Model to existing IIS Functional Standards, making it a foundational tool for procurement decisions and gap analysis in immunization information system capabilities.
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Cover page
| Immunization Information System (IIS) Baseline Requirements Traceability Matrix (RTM) |
| Update Released July 2025 |
| This requirements traceability matrix (RTM) contains draft baseline functional and non-functional requirements for an immunization information system (IIS). The requirements clarify minimum expectations for what IIS technology must do and how it must operate to support IIS Functional Standards and programmatic and immunization stakeholder needs. The functional requirements describe intended behaviors of an IIS to support business processes and tasks, by function and capability. The non-functional requirements convey technical requirements related to how a system must operate, by attribute and sub-characteristic. An embedded IIS Functional Model presents a visual depiction of the core functions, capabilities and attributes of IIS and serves as a companion to the requirements. |
This RTM is intended to be used by immunization programs as a starting point for the procurement of an IIS platform, module or enhancement. The RTM should be used throughout the system development life cycle (SDLC) to ensure requirements are met in a final product or system. Immunization programs and IIS may also use the IIS Functional Model and the requirements within this RTM to help assess and identify gaps in current IIS functions, capabilities and technical quality and provide a roadmap for future development within or across jurisdictions.
| Contents | |
| Guidance: Using the RTM | Step-by-step guidance and helpful hints/notes for using the RTM as part of a procurement process. |
| Functional Model | Draft IIS Functional Model (FM), a visual depiction of IIS functions and capabilities and attributes. |
| FM Descriptions | Descriptions of the IIS Functional Model functions and capabilities and attributes; also provides an indication of total requirements by function/category. |
| RTM Format | Description of how the RTM is structured for presentation of the requirements. |
| Requirements by Function/Grouping: | |
| Admin System | Requirements related to the function: Administer System |
| Manage Orgs | Requirements related to the function: Manage Organizations and Facilities |
| Manage Users | Requirements related to the function: Manage Users |
| Interop | Requirements related to the function: Support Interoperability |
| Data Quality | Requirements related to the function: Ensure Data Quality |
| Eval Forecast | Requirements related to the function: Evaluate & Forecast |
| Manage Pt Iz Record | Requirements related to the function: Manage Patient & Immunization Records |
| Manage Vaccine Inventory | Requirements related to the function: Manage Vaccine Inventory |
| Data Access | Requirements related to the function: Provide Data Access |
| Non-functional | Technical requirements across key attributes |
| Glossary | List of terms used in requirements and their definitions |
| Crosswalk to FS | Compare the Functional Model to the IIS Functional Standards (FS) |
This RTM was developed by the Public Health Informatics Institute, in partnership with AIRA and CDC and with financial support from CDC under Cooperative Agreement number 6 NH23IP922664-01. Questions, comments and suggestions are welcomed at iis@phii.org.
Attachment B_IIS Baseline Requirements RTM_Cover Page mailto:iis@phii.org Guidance using the RTM
| Guidance for leveraging the RTM workbook in a procurement | Return to Cover Page |
| Suggested steps and helpful hints for immunization programs and IIS when using the IIS Functional Model and requirements within this RTM as part of a procurement and system development life cycle. |
1. Identify the scope of the procurement -- Are you looking to procure an IIS platform or a specific module or enhancement?
-- Identify which functions and capabilities within the IIS Functional Model may relate to your project scope.
-- What technologies/systems do you have access to within your jurisdiction that will fulfill certain functions/capabilities/requirements?
-- What technologies/systems will need to be integrated with the procured solution?
-- Use the RTM to identify the requirements in scope.
2. Identify stakeholders/representatives to be included in the requirements review and validation process (and will be included in user acceptance testing) -- Include people that do the work, i.e., staff from across the IIS and immunization program who will be using the system/module/enhancement being procured.
-- Include representatives from IT, as appropriate, e.g., a jurisdictional IT security officer.
-- Consider validating requirements with end users to ensure completeness and accuracy and to inform prioritization.
-- Engage with the procurement office early in the process to fully understand jurisdictional requirements, policies, templates, approval processes, and timelines.
3. Gather existing business process documentation for reference -- Gather standard operating procedures, documented workflows, business process analysis documents, help desk and tickets.
-- These materials will assist in the review and validation of the requirements within the RTM.
4. Kickoff the requirements review and validation process -- Identify reviewers for the functions and requirements within scope, considering individuals' subject matter expertise.
-- Schedule and conduct a meeting with all stakeholders/representatives to discuss the requirement review and validation plan.
-- Introduce the Functional Model functions, capabilities and/or attributes in scope.
-- Orient the group to the RTM format and contents, including the glossary of terms.
-- Review the project schedule and individual responsibilities.
5. Review and validate requirements -- Review the requirements by tab with the appropriate program staff and/or impacted stakeholders (consider daily facilitated review sessions). Review the requirements based on current issues, concerns, challenges to ensure/mitigate current issues, concerns, etc. (using documentation gathered in step 3).
-- Discuss and define jurisdiction-specific needs and requirements. In particular, consider requirements that include 'as per jurisdictional policy,' those indicating 'user-defined parameters,' and non-functional requirements where jurisdiction-specific values should be entered.
-- Validate the requirements in terms of their:
* Completeness and accuracy: add jurisdiction-specific requirements in a separate tab (included in the RTM workbook) or as additional rows in the appropriate existing tab.
* Clarity: offer clarifications as comments in the "Comments" column. CDC strongly recommends not altering the wording of the requirements in the RTM.
* Priority: CDC strongly recommends that values listed in the "Priority: E, O (essential, optional)" column remain as is unless jurisdictional law/policy says otherwise.
6. Approve the final set of requirements -- Gain approval of the final requirements from program and jurisdictional IT leadership, as appropriate.
-- Use the "Req. #" column on each tab to assign a unique identifier, which will facilitate traceability throughout the development lifecycle.
7. Include the requirements in the solicitation to inform vendor selection.
-- Conduct a final re-validation of the requirements: what has changed? Are the requirements still accurate and relevant? Have any priorities changed?
-- Work with your procurement office to ensure your requirements are incorporated into your solicitation. Attach or otherwise incorporate the RTM or requirements listing based on jurisdictional policy.
-- Provide instructions for solicitation respondents to comment on each requirement, using the "Vendor Response" and "Vendor Comments" columns.
-- Review responses and conduct due diligence to determine a solution/vendor that best meets your needs.
8. Work with the selected vendor on configuration and specifications, as needed.
-- Ensure that your essential requirements are met.
-- Review vendor system documentation to determine potential gaps for future consideration.
9. Test the delivered solution to ensure requirements are met.
-- Refer to the vendor documentation to control the quality and completeness of the procured solution in meeting the requirements within the RTM.
-- Add columns to the RTM for further traceability of the requirements through the SDLC. For example, 'Script #' and 'Tester' columns can be included to ensure each requirement has a corresponding test and tester during user acceptance testing.
-- Identify individuals who will be involved in user acceptance testing; ensure these staff are prepared for the testing process and know how to document testing results.
10. Update business processes & documentation, as needed -- Update standard operating procedures to reflect and refine staff interaction with the new technology.
11. Use the requirements, testing process, and business process documentation to develop training -- Be sure to train internal staff as well as external end-users.
| Helpful Hints and Notes |
| -- The RTM can be used in conjunction with requirements definition tools, such as task flow diagrams. (For more information on PHII's Collaborative Requirements Development Methodology visit: https://www.phii.org/crdm) |
| -- On each tab, high-level requirements are shaded in blue; rows beneath each high level requirement provide further detail. |
| -- Each requirement should have a unique ID number. Do not change the ID number for requirements provided in this sheet. When adding new requirements, label with jurisdiction name. |
| -- Tabs can be added to the RTM to encompass business processes or business rules within the workbook. |
| -- Columns can be added to the RTM for further traceability of the requirements through the design, build, test and release activities. For example, a 'Script #' column can be included to ensure each requirement has a corresponding test during user acceptance testing. |
| -- To be most effective in tracking a solution that meets program requirements, the RTM must be maintained throughout the system development life cycle. |
| -- Requirements must be prioritized to ensure that the most critical ones are initially addressed with available funding. Subsequent prioritization of needs may be warranted to differentiate those required for Day 1 and those that could be delivered in future releases. |
| -- Consider using an additional priority designation of 'R' for 'Required by Law' to indicate requirements that stem from jurisdictional laws/administrative rules. Provide a reference to the statute/rule. |
Attachment B_IIS Baseline Requirements RTM_Guidance https://www.phii.org/crdm) Functional Model Return to Cover Page
Attachment B_IIS Baseline Requirements RTM_Functional Model
FM descriptions IIS Functional Model descriptions Return to Cover Page
| Tab Name | # of Reqs | Function | Function Description | Capability | Capability Description |
| Admin System | 61 | Administer System | Management of global system settings and alerts, including set up of user roles and permissions. | Hierarchy Configuration | -- ability to create hierarchy that informs the association between geographical levels within the jurisdiction and among organizations, facilities, providers and users |
| System Configuration | -- ability to define system-wide settings, such as management of code tables | ||||
| User Roles and Permissions | -- ability to define and manage user roles and use role permissions to perform a function, activity or task | ||||
| System Alerts | -- ability to broadcast communication to IIS users viewable upon logging into the system | ||||
| Manage Orgs | 83 | Manage Organizations and Facilities | Management of organizations and facility accounts. | Organization/Facility Search | -- ability to look up and retrieve an organization or facility account |
| Add, Edit, Inactivate Organization/Facility | -- ability to add, edit or inactivate an organization or facility; ability for an organization to initiate enrollment and re-enrollment in the IIS | ||||
| VFC/Vaccine Program Enrollment | -- ability to enroll and re-enroll a provider organization in VFC and/or other vaccine program(s) | ||||
| Organization/Facility Outreach | -- ability to communicate with organization/facility representatives | ||||
| Manage Users | 35 | Manage Users | Management of user accounts. | User Search | -- ability to define parameters to look up and retrieve a user account |
| Add, Edit, Inactivate User | -- ability to add, edit or inactivate a user account | ||||
| Authentication and Authorization | -- ability to validate a user's identity, entity and system permissions | ||||
| Password Management | -- ability to administer, change and reset user passwords | ||||
| Interop | 65 | Support Interoperability | Manage interfaces to exchange data between the IIS and other systems. | Onboarding | -- ability to establish/re-establish/modify an interface with another information system for the electronic exchange of demographic and/or immunization data |
| Interfaces | -- ability to facilitate electronic data exchange with other information systems, including EHRs, VTrckS, jurisdictional vital records, and the IZ Gateway | ||||
| Data Exchange | -- ability to exchange data electronically and monitor and troubleshoot data exchange | ||||
| Data Quality | 32 | Ensure Data Quality | Deduplication and consolidation of records. | Patient Matching and Deduplication | -- ability to identify and manage duplicate and potential duplicate patient records |
| Vaccination Event Matching and Deduplication | -- ability to identify and manage duplicate and potential duplicate vaccination entries | ||||
| Eval Forecast | 64 | Evaluate and Forecast | Determine the validity of past immunizations administered as a basis for determining immunizations due. | Clinical Decision Support | -- ability to evaluate and forecast immunizations for a patient per ACIP guidelines and in alignment with CDSi specifications |
| Reminder/Recall | -- ability to identify and notify patients who are due for upcoming immunizations (reminder) and/or are past due (recall) | ||||
| Coverage Reports | -- ability to create reports to support immunization coverage assessment at the provider and geographic levels including reports for the CDC's VFC provider-level immunization quality improvement program (IQIP) | ||||
| Manage Pt Iz Record | 83 | Manage Patient and Immunization Records | Manage patient demographics and patient immunization record. | Patient Search | -- ability to look up and retrieve a patient record |
| Add, Edit Patient Demographics | -- ability to add, edit or inactivate a patient record | ||||
| Patient Status | -- ability to manage the assignment of a specific patient to a provider organization or jurisdiction | ||||
| Patient Consent | -- ability to manage patient agreement to participate in the IIS in accordance with jurisdictional policy | ||||
| Add, Edit Patient Immunization | -- ability to add, edit an immunization record | ||||
| Print/Export Report | -- ability to print or export either a patient or immunization record | ||||
| Mass Vaccination | -- ability to capture a large volume of demographic and immunization data in emergency situations | ||||
| Manage Vaccine Inv | 87 | Manage Vaccine Inventory | Order publicly-purchased vaccine and manage vaccine inventory. | Vaccine Inventory Search | -- ability to look up and retrieve vaccine doses in inventory |
| Add, Edit Vaccine Inventory | -- ability to manage vaccine inventory, including ordering, storing and handling, and reconciliation of vaccine doses | ||||
| Vaccine Ordering | -- ability to order publicly funded vaccines as authorized | ||||
| Review/Approve Order | -- ability to review, edit, and authorize an organization's vaccine order for approval, submission and fulfillment | ||||
| Vaccine Dose Decrementing | -- ability to automatically decrement vaccine doses from inventory when matched vaccine doses are reported as administered | ||||
| Vaccine Inventory Reconciliation | -- ability to maintain an accurate count of vaccine doses available based on doses administered, wasted, transferred, and expired | ||||
| Vaccine Transfer | -- ability to transfer vaccine from one VFC provider organization to another in certain situations | ||||
| Vaccine Wastage | -- ability to manage nonviable vaccine reporting | ||||
| Vaccine Expiration | -- ability for notification and management of vaccine inventory expired and due to expire | ||||
| Data Access | 65 | Provide Data Access | Provision of access to data and information. | Standard Reports | -- ability to generate pre-configured reports available and accessible in the IIS |
| Ad Hoc Queries and Reports | -- ability to create, save and schedule data queries and customized reports on demand | ||||
| Print/Export Report | -- ability to generate data to print or use in other systems | ||||
| Consumer Access | -- ability for authorized consumers to directly access IIS data for which they are authorized | ||||
| Tab Name | # of Reqs | Attribute | Description | Sub-Characteristic | Description |
| Non-functional | 99 | Performance | Performance efficiency relative to the amount of resources used under stated conditions. | Time behavior | -- degree to which the response and processing times and throughput rates of a product or system, when performing its functions, meet requirements |
| Resource utilization | -- degree to which the amounts and types of resources used by a product or system, when performing its functions, meet requirements | ||||
| Capacity | -- degree to which the maximum limits of a product or system parameter meet requirements | ||||
| Usability | Degree to which a product or system can be used by specified users to achieve specified goals with effectiveness, efficiency and satisfaction in a specified context of use. | Operability | -- degree to which a product or system has attributes that make it easy to operate and control | ||
| User error protection | -- degree to which a system protects users against making errors | ||||
| Accessibility | -- degree to which a product or system can be used by people with the widest range of characteristics and capabilities to achieve a specified goal in a specified context of use | ||||
| Reliability | Degree to which a system, product or component performs specified functions under specified conditions for a specified period of time. | Availability | -- degree to which a system, product or component is operational and accessible when required for use | ||
| Fault tolerance | -- degree to which a system, product or component operates as intended despite the presence of hardware or software faults | ||||
| Recoverability | -- degree to which, in the event of an interruption or a failure, a product or system can recover the data directly affected and re-establish the desired state of the system | ||||
| Security | Degree to which a product or system protects information and data so that persons or other products or systems have the degree of data access appropriate to their types and levels of authorization. | Confidentiality | -- degree to which a product or system ensures that data are accessible only to those authorized to have access | ||
| Non-repudiation | -- degree to which actions or events can be proven to have taken place so that the events or actions cannot be repudiated later | ||||
| Accountability | -- degree to which the actions of an entity can be traced uniquely to the entity | ||||
| Authenticity | -- degree to which the identity of a subject or resource can be proved to be the one claimed | ||||
| Maintainability | Degree of effectiveness and efficiency with which a product or system can be modified to improve it, correct it or adapt it to changes in environment, and in requirements. | Analyzability | -- degree of effectiveness and efficiency with which it is possible to assess the impact on a product or system of an intended change to one or more of its parts, or to diagnose a product for deficiencies or causes of failures, or to identify parts to be modified | ||
| Portability | Degree of effectiveness and efficiency with which a system, product or component can be transferred from one hardware, software or other operational or usage environment to another. | Adaptability | -- degree to which a product or system can effectively and efficiently be adapted for different or evolving hardware, software or other operational or usage environments | ||
| Installability | -- degree of effectiveness and efficiency with which a product or system can be successfully installed and/or uninstalled in a specified environment | ||||
| 674 |
Attachment B_IIS Baseline Requirements RTM_FM Descriptions
RTM format RTM Format Return to Cover Page
| Status | Req. #* | Capability/Attribute | ***Requirement: The IIS must/should have… | Comments | Reviewer notes | Priority: E, O | |
| (essential, optional)** | Vendor response: Yes, Yes with customization*, No | ||||||
| *Comment required | Vendor comment(s) |
If Yes with customization: Indicate the anticipated cost and timeline for development and release.
| Updated from the previous version of the RTM or newly added. | [Req. ID] | [Capability/attribute name, e.g., "System Configuration"] | [high-level requirement] | --Suggested recommendations for the requirement. | |
| --Indication of relationship to a priority cross-functional need such as mass vaccination or school reports. | [Reviewer notes related to: |
-- Organization of the requirement (in terms of its associated capability and/or function) -- Wording of the requirement
| -- Misc thoughts] | [Draft priority designation, e.g. "E"] | ||||
| Updated from the previous version of the RTM or newly added. | [Req. ID] | [Capability/attribute name, e.g., 'System Configuration'] | [detailed requirement] | --Suggested recommendations for the requirement. | |
| --Indication of relationship to a priority cross-functional need such as mass vaccination or school reports. | [Reviewer notes related to: |
-- Organization of the requirement (in terms of its associated capability and/or function) -- Wording of the requirement -- Misc thoughts] [Draft priority designation, e.g. "E"]
*Numbering/identification of individual requirements will occur at the very end of the review and revision process, once requirements are final.
| **Priority designations: |
| E: Essential: Baseline, critical requirement reflective of core functionality/attribute for a viable IIS as defined by CDC. |
| O: Optional: Not essential for all IIS as defined by CDC. |
*** Rows highlighted in blue indicate a high-level requirement
Attachment B_IIS Baseline Requirements RTM_RTM Format
Admin system Function: Administer System Return to Cover Page
| Capability | Requirement: The IIS must/should... | Priority: E, O | |
| (essential, optional) | Vendor response: Yes, Yes with customization*, No | ||
| *Comment required | Vendor comment(s) |
If Yes with customization: Indicate the anticipated cost and timeline for development and release.
| Hierarchy Configuration | ability to establish the IIS hierarchy to associate and manage relationships between entities | E |
| Hierarchy Configuration | ability to associate user(s) to a facility | E |
| Hierarchy Configuration | ability to associate clinician(s) to a facility | E |
| Hierarchy Configuration | ability to associate facility/facilities to an organization | E |
| Hierarchy Configuration | ability to establish geographic jurisdictional hierarchy | E |
| Hierarchy Configuration | ability to aggregate data across user-defined hierarchies | E |
| System Configuration | ability to maintain inventory availability in IIS visible to authorized users | E |
| System Configuration | ability for jurisdictional admin to maintain separate VFC supplied inventory in the IIS | E |
| System Configuration | ability for jurisdictional admin to maintain separate jurisdiction supplied inventory | E |
| System Configuration | ability for jurisdictional admin to maintain separate private stock inventory | E |
| System Configuration | ability for jurisdictional admin to manage code sets | E |
| System Configuration | ability for jurisdictional admin to update NDC codes | E |
| System Configuration | ability for jurisdictional admin to update CVX codes | E |
| System Configuration | ability for jurisdictional admin to update MVX codes | E |
| System Configuration | ability to configure default values to minimize data input | E |
| System Configuration | ability to display an error message in the user interface when minimum information required is not complete | E |
| System Configuration | ability to standardize addresses per US Postal conventions and codes | E |
| System Configuration | ability to verify validity of addresses (as valid USPS addresses) in the IIS through electronic means (e.g., SmartyStreets) | E |
| System Configuration | ability to geocode addresses | E |
| System Configuration | ability to validate accurate assignment of address to an individual through electronic means (e.g., LexisNexis) | O |
| System Configuration | ability for jurisdictional admin to modify facility types according to immunization program descriptions and CDC VFC Program descriptions | E |
| System Configuration | ability for jurisdictional admin to configure rules governing data validation of incoming HL7 messages | E |
| System Configuration | ability to configure an authorization agreement as per jurisdictional policy | O |
| System Configuration | ability to configure a user agreement as per jurisdictional policy | O |
| System Configuration | ability to display age in year/month/day format in all age display fields (e.g., 2 years, 4 months, 3 days) | E |
| System Configuration | ability to provide optional calendar to select a date in a web client | O |
| System Configuration | ability to add patient priority group indicators | E |
| System Configuration | ability to modify patient priority group indicators | E |
| System Configuration | ability for jurisdictional admin to manage business rules related to data quality | E |
| System Configuration | ability for jurisdictional admin to specify business rules for monitoring data quality | E |
| System Configuration | ability for jurisdictional admin to modify business rules for monitoring data quality | E |
| System Configuration | ability to configure the organization enrollment form | E |
| System Configuration | support rules-based logic to suggest approval or rejection of enrollment form based on review of completed fields | E |
| System Configuration | ability to manage rules-based logic for approval or rejection of enrollment form | E |
| System Configuration | ability for jurisdictional admin to create enrollment forms based on program requirements | E |
| System Configuration | ability for jurisdictional admin to modify an enrollment form | E |
| System Configuration | ability to auto-populate existing user information in the IIS with the information on the enrollment form when creating a new facility in the IIS | O |
| System Configuration | ability to auto-populate the organization information in the IIS with information on the enrollment form when creating a new organization in the IIS | O |
| System Configuration | ability for jurisdictional admin to configure vaccine forecasting business rules | E |
| System Configuration | ability to apply effective dates to vaccine rules | O |
| System Configuration | ability to incorporate new vaccines per ACIP into the forecasting algorithm | E |
| System Configuration | ability to support a record search algorithm to return "best matches" | E |
| System Configuration | ability for jurisdictional admin to configure the number of search results to be displayed per jurisdictional policy | E |
| System Configuration | ability for jurisdictional admin to modify required parameters for patient searches | E |
| System Configuration | ability to restrict certain data from being included in reports such as sensitive demographic information e.g., address, phone number, mother's maiden name, Medicaid ID | E |
| System Configuration | ability to open multiple screens simultaneously within the application | O |
| User Roles and Permissions | ability for jurisdictional admin to manage user roles and permissions by task per jurisdictional policy | E |
| User Roles and Permissions | ability for jurisdictional admin to add user roles with distinct permissions | E |
| User Roles and Permissions | ability for jurisdictional admin to modify user roles with distinct permissions | E |
| User Roles and Permissions | ability for jurisdictional admin to inactivate user roles | E |
| User Roles and Permissions | ability for jurisdictional admin to modify permissions to IIS processes and data for specific user roles | E |
| User Roles and Permissions | ability for jurisdictional admin to restrict system functionality by user role | E |
| User Roles and Permissions | ability for jurisdictional admin to restrict authorized user access to data based on user role | E |
| User Roles and Permissions | ability for jurisdictional admin to enable access to standard reports based on user role | E |
| User Roles and Permissions | ability to automatically update all users assigned to a role based on changes made to the "master" role attributes | E |
| System Alerts | ability for jurisdictional admin to manage system alerts | E |
| System Alerts | ability to view global messages upon logging into the application | E |
| System Alerts | ability for jurisdictional admin to add system alerts for specific IIS users to view when logging into application | O |
| System Alerts | ability for jurisdictional admin to add global messages | E |
| System Alerts | ability for jurisdictional admin to edit global messages | E |
| System Alerts | ability for jurisdictional admin to inactivate global messages | E |
Attachment B_IIS Baseline Requirements RTM_Admin System
Manage orgs Function: Manage Organizations and Facilities Return to Cover Page
| Capability | Requirement: The IIS must/should have… | Priority: E, O | |
| (essential, optional) | Vendor response: Yes, Yes with customization*, No | ||
| *Comment required | Vendor comment(s) |
If Yes with customization: Indicate the anticipated cost and timeline for development and release.
| Organization/Facility Search | ability to search organization/facility information stored in the IIS | E |
| Organization/Facility Search | ability for jurisdictional admin to search organizations/facilities by user-defined parameters | E |
| Organization/Facility Search | ability to clear and re-enter search criteria when searching for an organization/facility | E |
| Add, Edit, Inactivate Organization | ability for applicant from unauthorized (non-participating/enrolled) organization to enroll electronically for participation in the IIS | E |
| Add, Edit, Inactivate Organization | ability for applicant from unauthorized organization to add IIS enrollment information online | E |
| Add, Edit, Inactivate Organization | ability for applicant from unauthorized org to submit IIS enrollment information online | E |
| Add, Edit, Inactivate Organization | ability for applicant from unauthorized org to save partially complete IIS enrollment information | O |
| Add, Edit, Inactivate Organization | ability for applicant from unauthorized org to return to a partially complete IIS enrollment information | O |
| Add, Edit, Inactivate Organization | ability to prevent submission of incomplete IIS enrollment information when required field(s) are missing | E |
| Add, Edit, Inactivate Organization | ability to electronically notify the applicant of incomplete IIS enrollment information specifying the missing required fields | E |
| Add, Edit, Inactivate Organization | ability to electronically notify applicant that IIS enrollment information has been submitted | E |
| Add, Edit, Inactivate Organization | ability for applicant from unauthorized org to edit rejected IIS enrollment information | E |
| Add, Edit, Inactivate Organization | ability for applicant from unauthorized org to resubmit a rejected IIS enrollment | E |
| Add, Edit, Inactivate Organization | ability to capture electronic signature for enrollment, for an authorization agreement | O |
| Add, Edit, Inactivate Organization | ability for jurisdictional admin to manage organization/facility IIS enrollment | E |
| Add, Edit, Inactivate Organization | ability for jurisdictional admin to manage organization/facility IIS enrollment status | E |
| Add, Edit, Inactivate Organization | ability for jurisdictional admin to inactivate an organization | E |
| Add, Edit, Inactivate Organization | ability for jurisdictional admin to reactivate an organization | E |
| Add, Edit, Inactivate Organization | ability to store IIS enrollment status for an organization/facility | E |
| Add, Edit, Inactivate Organization | ability for jurisdictional admin to inactivate a facility | E |
| Add, Edit, Inactivate Organization | ability for jurisdictional admin to reactivate a facility | E |
| Add, Edit, Inactivate Organization | ability for jurisdictional admin to electronically approve IIS enrollment | E |
| Add, Edit, Inactivate Organization | ability to include reason for rejecting IIS enrollment of an organization | E |
| Add, Edit, Inactivate Organization | ability to electronically notify the organization that the submitted enrollment was rejected along with the reason | E |
| Add, Edit, Inactivate Organization | ability for jurisdictional admin to manage organization and facility records within the IIS | E |
| Add, Edit, Inactivate Organization | ability for jurisdictional admin to add an organization | E |
| Add, Edit, Inactivate Organization | ability for jurisdictional admin to modify an organization record | E |
| Add, Edit, Inactivate Organization | ability for jurisdictional admin to add a facility | E |
| Add, Edit, Inactivate Organization | ability for jurisdictional admin to modify a facility record | E |
| Add, Edit, Inactivate Organization | ability to automatically generate unique facility IIS ID | E |
| Add, Edit, Inactivate Organization | ability for jurisdictional admin to associate a facility to an organization | E |
| Add, Edit, Inactivate Organization | ability for jurisdictional admin to edit association between a facility an organization | E |
| Add, Edit, Inactivate Organization | ability to store multiple unique facility site IDs associated with a particular facility (to facilitate matching of facilities between the IIS and other data systems) | E |
| Add, Edit, Inactivate Organization | ability to capture a facility's mailing address | E |
| Add, Edit, Inactivate Organization | ability to capture a facility's shipping address | E |
| Add, Edit, Inactivate Organization | ability to enter contact information for the facility contact | E |
| Add, Edit, Inactivate Organization | ability to enter contact information for an optional contact | E |
| Add, Edit, Inactivate Organization | ability to indicate if an organization/facility is a site where immunizations are administered | E |
| Add, Edit, Inactivate Organization | ability to indicate if an organization/facility is a site where vaccines are stored for redistribution | O |
| Add, Edit, Inactivate Organization | ability to save documents (i.e., enrollment/onboarding documents, storage and handling, borrowing, temperature logs, wastage, etc.) to specific organization/facility file folder per policy | E |
| Add, Edit, Inactivate Organization | ability for jurisdictional admin to retrieve electronic files from provider file folder | E |
| Add, Edit, Inactivate Organization | ability for jurisdictional admin to record notes related to a organization/facility | E |
| Add, Edit, Inactivate Organization | ability to flag an organization as participating in VFC and/or other user-defined vaccine program(s) | E |
| Add, Edit, Inactivate Organization | ability to retrieve organization/facility information from scanned forms and automatically fill required data fields with retrieved information | O |
| VFC/Vaccine Program Enrollment | ability for an organization to submit vaccine program enrollment information electronically | E |
| VFC/Vaccine Program Enrollment | ability to capture electronic signature for vaccine program enrollment | E |
| VFC/Vaccine Program Enrollment | ability to access the vaccine program agreement in a separate window from the vaccine program enrollment | E |
| VFC/Vaccine Program Enrollment | ability to provide link to the blank formatted vaccine program enrollment form | E |
| VFC/Vaccine Program Enrollment | ability for the jurisdictional vaccine program admin to assign a VFC pin number to a newly enrolled VFC site | E |
| VFC/Vaccine Program Enrollment | ability to select the type of certified monitoring device being used to record temperatures | E |
| VFC/Vaccine Program Enrollment | ability for the jurisdictional vaccine program admin to document that a facility has a certificate of calibration for the temperature monitoring device | O |
| VFC/Vaccine Program Enrollment | ability for the jurisdictional vaccine program admin to approve a vaccine program enrollment | E |
| VFC/Vaccine Program Enrollment | ability for the jurisdictional vaccine program admin to enter an expiration date for a vaccine program enrollment | E |
| VFC/Vaccine Program Enrollment | ability for the jurisdictional vaccine program admin to document that the vaccine program facility has a routine and emergency vaccine management plan | E |
| VFC/Vaccine Program Enrollment | ability for the jurisdictional vaccine program admin to document that a facility participating in VFC has a VFC Coordinator annual training certificate | E |
| VFC/Vaccine Program Enrollment | ability for the jurisdictional vaccine program admin to document that a facility participating in VFC has a Backup Coordinator annual training certificate | E |
| VFC/Vaccine Program Enrollment | ability for the jurisdictional vaccine program admin to add comments during the vaccine program enrollment approval process | O |
| VFC/Vaccine Program Enrollment | ability to require the vaccine program facility to indicate the number of vaccine storage units being monitored | O |
| VFC/Vaccine Program Enrollment | ability to require the vaccine program facility to indicate the types of vaccine storage units being monitored | O |
| VFC/Vaccine Program Enrollment | ability to require the vaccine program facility to indicate whether they store Varicella and MMRV vaccine | E |
| VFC/Vaccine Program Enrollment | ability to enter contact information for the facility Primary Vaccine Coordinator | E |
| VFC/Vaccine Program Enrollment | ability to enter contact information for the facility Backup Vaccine Coordinator | E |
| VFC/Vaccine Program Enrollment | ability to enter contact information for the facility vaccine program Agreement Signatory | E |
| VFC/Vaccine Program Enrollment | ability to capture the day of the week that a vaccine program facility may receive vaccine shipments | E |
| VFC/Vaccine Program Enrollment | ability to capture the time that a vaccine program facility may receive vaccine shipments | E |
| VFC/Vaccine Program Enrollment | ability to automatically turn off vaccine ordering capabilities for a facility that does not have an up-to-date vaccine program enrollment | E |
| VFC/Vaccine Program Enrollment | ability to capture required information for VFC clinician: last name, first name, title, medical license number, NPI number, still active with facility, are they a signatory, specialty (FP, Peds) during the enrollment process | E |
| VFC/Vaccine Program Enrollment | ability to attach VFC documentation (in multiple formats) such as: VFC training certification, certificate of calibration, medical license, floor design diagram and other documents | E |
| VFC/Vaccine Program Enrollment | ability for IIS staff to retrieve electronic files from organization/facility file folder | O |
| VFC/Vaccine Program Enrollment | ability to automatically validate clinician license number against Professional Licensing Agency record database | O |
| VFC/Vaccine Program Enrollment | ability to submit vaccine program re-enrollment data electronically | E |
| VFC/Vaccine Program Enrollment | ability to electronically notify a facility VFC/vaccine program coordinator of an upcoming need for VFC/vaccine program re-enrollment | O |
| VFC/Vaccine Program Enrollment | ability for the jurisdictional vaccine program admin to modify the date for online renewal electronic notifications for each vaccine program facility | E |
| VFC/Vaccine Program Enrollment | ability to suspend ordering capabilities for a facility pending approval of vaccine program enrollment | E |
| VFC/Vaccine Program Enrollment | ability to re-activate ordering capabilities for a facility when a vaccine program enrollment is approved | E |
| Organization/Facility Outreach | ability to send electronic communications to organization/facility contacts | E |
| Organization/Facility Outreach | ability to send a final electronic notification reminder, re: renewal, to all VFC facilities that have not completed the renewal by their expiration date | E |
| Organization/Facility Outreach | ability to send electronic communications directly from the IIS | O |
| Organization/Facility Outreach | ability to send electronic communications directly from the IIS to multiple recipients | O |
| Organization/Facility Outreach | ability to notify more than one user at a participating vaccine program facility of any vaccine program notification | O |
| Organization/Facility Outreach | ability for the jurisdictional vaccine program admin to customize vaccine program enrollment alerts to participating vaccine program facilities when needed | O |
| Organization/Facility Outreach | ability for the jurisdictional vaccine program admin to modify the date for online renewal electronic notifications for each participating vaccine program facility | O |
| Organization/Facility Outreach | ability to electronically notify the jurisdictional vaccine program admin of vaccine program follow-up activities for a new vaccine program facility enrolled for 6 months | O |
Attachment B_IIS Baseline Requirements RTM_Manage Orgs
Manage users Function: Manage Users Return to Cover Page
| Capability | Requirement: The IIS must/should have… | Priority: E, O | |
| (essential, optional) | Vendor response: Yes, Yes with customization*, No | ||
| *Comment required | Vendor comment(s) |
If Yes with customization: Indicate the anticipated cost and timeline for development and release.
| User Search | ability for jurisdictional admin to search for user accounts by user-defined criteria | E |
| User Search | ability for jurisdictional admin to view all user accounts | E |
| User Search | ability for organization admin to search all user accounts associated with their organization | E |
| User Search | ability for organization admin to view all user accounts associated with their organization | E |
| User Search | ability to sort users by user defined-criteria | O |
| Add, Edit, Inactivate User | ability for admin to manage user accounts | E |
| Add, Edit, Inactivate User | ability to track the progress of a new user registration | O |
| Add, Edit, Inactivate User | ability for admin to add new users | E |
| Add, Edit, Inactivate User | ability for admin to modify user accounts | E |
| Add, Edit, Inactivate User | ability for admin to inactivate user accounts | E |
| Add, Edit, Inactivate User | ability for jurisdictional admin to inactivate multiple accounts in one transaction | O |
| Add, Edit, Inactivate User | ability for organization admin to inactivate user accounts associated with their organization | E |
| Add, Edit, Inactivate User | ability to store reason for inactivation of user account | E |
| Add, Edit, Inactivate User | ability for jurisdictional admin to reactivate an inactivated account | E |
| Add, Edit, Inactivate User | ability to electronically notify a user that their account is locked (inaccessible) as per jurisdictional security policy | O |
| Add, Edit, Inactivate User | ability to electronically notify a user that their account is inactive | O |
| Add, Edit, Inactivate User | capture clinician activity status (out of state, loss of certification, change of practice status, other) | O |
| Add, Edit, Inactivate User | ability for jurisdictional admin to assign a role to authorized users | E |
| Add, Edit, Inactivate User | ability for organization admin to assign a role to authorized users within their organization | E |
| Authentication & Authorization | ability to authenticate user | E |
| Authentication & Authorization | ability to access the system through an authorized username and password | E |
| Authentication & Authorization | ability to support access via single-sign in for jurisdictional users | O |
| Authentication & Authorization | ability to switch between multiple organizations | O |
| Authentication & Authorization | ability to view jurisdictional policy agreements | E |
| Authentication & Authorization | support multi-factor authentication per jurisdictional policy | O |
| Password Management | ability to generate electronic notification to authorized user of account credentials | E |
| Password Management | ability to electronically notify authorized users of their username | E |
| Password Management | ability to electronically notify authorized users of their temporary password in a separate notification | E |
| Password Management | ability to generate electronic notification at periodic intervals to authorized users of their pending account password expiration | E |
| Password Management | ability for jurisdictional admin to configure the periodic intervals for generation of notifications to authorized users of their pending account password expiration | O |
| Password Management | ability to support temporary password which will be required to change during initial log in | E |
| Password Management | ability to support temporary password which will expire in X number of days determined by policy | E |
| Password Management | ability for users to change their own passwords per program/jurisdiction security policy | E |
| Password Management | ability for users to reset their password per program/jurisdiction security policy | E |
| Password Management | ability to prompt users to change their password at time intervals per program/jurisdiction security policy | E |
Attachment B_IIS Baseline Requirements RTM_Manage Users
Interop Function: Support Interoperability Return to Cover Page
| Capability | Requirement: The IIS must/should have… | Priority: E, O | |
| (essential, optional) | Vendor response: Yes, Yes with customization*, No | ||
| *Comment required | Vendor comment(s) |
If Yes with customization: Indicate the anticipated cost and timeline for development and release.
| Onboarding | ability to onboard organizations/facilities to facilitate electronic data exchange | E | |
| Onboarding | ability to track an organization's/facility's progress through the onboarding process | O | |
| Onboarding | ability to capture EHR system specification details | E | |
| Onboarding | ability to create a unique username to assign to the organizations/facilities during the test phase | E | |
| Onboarding | ability to create a unique password to assign to the organizations/facilities during the test phase | E | |
| Onboarding | ability to electronically alert the vendor/organization when the certificate for transport is going to expire in X time period | E | |
| Onboarding | ability to store digital certificate information | E | |
| Onboarding | ability to validate that the transport layer between the test site and IIS is functional | E | |
| Onboarding | ability to validate system connectivity prior to the submission of test data | E | |
| Onboarding | ability to identify data formatting errors during testing | E | |
| Onboarding | ability to provide test message submission summary report to the EHR vendor | E | |
| Onboarding | ability for EHR vendor to view details regarding the processing of test data in terms of errors and warnings in the messages | E | |
| Onboarding | ability for IIS authorized staff to review and approve onboarding forms | E | |
| Onboarding | ability for IIS staff to review and reject onboarding forms | E | |
| Onboarding | ability for applicant to edit a rejected onboarding application | E | |
| Onboarding | ability for applicant to save a rejected onboarding application | E | |
| Onboarding | ability for applicant to resubmit a rejected onboarding application | E | |
| Onboarding | ability to compare onboarding application information to current records to determine most current data | E | |
| Interfaces | ability to interface with other systems to facilitate electronic data sharing/exchange per jurisdictional policy | E | |
| Interfaces | ability to interface with electronic health record systems | E | |
| Interfaces | ability to interface with the Immunization Gateway | E | |
| Interfaces | ability to interface with an application that facilitates patient scheduling | E | |
| Interfaces | ability to exchange data with CDC Vaccine Tracking System (VTrckS) based on most current CDC ExIS Specifications | E | |
| Interfaces | ability to order vaccine via electronic interface with VTrckS | E | |
| Interfaces | ability to receive vaccine inventory/shipping information | E | |
| Interfaces | ability to batch export vaccine inventory for submission to VTrckS | E | |
| Interfaces | ability to batch export vaccine ordering information for submission to VTrckS | E | |
| Interfaces | ability to batch export facility information | E | |
| Interfaces | ability to export vaccine return and wastage data to VTrckS | E | |
| Interfaces | ability to use the VTrckS-API for file exchange between the IIS and VTrckS based on CDC requirements and API file specifications | O | |
| Interfaces | ability to receive data through an interface with jurisdictional vital records system | E | |
| Interfaces | ability to update IIS data from Vital Records for birth events | E | |
| Interfaces | ability to update IIS data from Vital Records for death events | E | |
| Interfaces | ability to update IIS data from Vital Records for adoption events | E | |
| Interfaces | ability to update IIS data from Vital Records for name change events | E | |
| Interfaces | ability to detect if a newborn record is a potential duplicate in the IIS | E | |
| Interfaces | ability to use new Vital Record data for matched records to update patient demographic data | E | |
| Interfaces | ability to update the IIS with date of death from Vital Records data | E | |
| Interfaces | ability to prevent updates to IIS records | O | |
| Data Exchange | ability to support real-time data exchange per the CDC HL7 implementation guide | E | |
| Data Exchange | ability to process an HL7 message | E | |
| Data Exchange | ability to respond to an HL7 message | ||
| ability to respond to an HL7 message | E | ||
| Data Exchange | ability to create an HL7 message | E | |
| Data Exchange | ability to capture IIS Core Data Elements | E | |
| Data Exchange | ability to store IIS Core Data Elements | E | |
| Data Exchange | ability to accept last prior version of HL7 messages |
| E | ||
| Data Exchange | ability to manually correct a submitted record and resubmit for processing | O |
| Data Exchange | ability to support data exchange in non-HL7 format | E |
| Data Exchange | ability to import bulk patient demographic information into IIS | E |
| Data Exchange | ability to import bulk immunization information into IIS | E |
| Data Exchange | ability to export routine, seasonal, and emergency vaccination files (aggregate and de-identified) | E |
| Data Exchange | ability to export routine, seasonal, and emergency vaccination files (aggregate and de-identified) automatically via CDC approved system | O |
| Data Exchange | ability to monitor and troubleshoot data exchange | E |
| Data Exchange | ability to view VXU messages submitted by an organization | E |
| Data Exchange | ability to view HL7 messages for an organization within a defined date range per jurisdictional policy | E |
| Data Exchange | ability to view HL7 ACK messages generated for an organization | E |
| Data Exchange | ability to view incoming HL7 QBP messages submitted by an organization | E |
| Data Exchange | ability to view RSP messages generated for an organization | E |
| Data Exchange | ability to log acknowledgement messages indicating warnings and errors | E |
| Data Exchange | ability to retrieve error messages within a specified date range by organization | E |
| Data Exchange | ability to retrieve acknowledgment messages within a specified date range by organization | E |
| Data Exchange | ability to filter error messages | E |
| Data Exchange | ability to filter acknowledgement messages | E |
| Data Exchange | ability to sort error messages | E |
This is the start of the file's text. The full file is on GovTribe.
File details come from the government source that posted it. Updated .