CITI_PWSdraft.docx

PERFORMANCE WORK STATEMENT (PWS)

VA Research Education and Training – CITI Program Enterprise Subscription

1.0 BACKGROUND

1.1 The Office of Research & Development (ORD) requires coordinated, accessible, and compliant research education and training for personnel across the VA enterprise. The Research Education and Training (RET) unit within ORD is responsible for ensuring VA research personnel receive training aligned with VA and federal requirements, VHA research standards, and program goals related to human subjects protection, biosafety and biosecurity, animal research, privacy/security, and electronic health record (EHR) systems (see Appendix A).

1.2 The RET unit also oversees VA’s relationship with the Collaborative Institutional Training Initiative (CITI), as well as the development, implementation, and metrics-based evaluation of VA research educational programs and platforms.

1.3 ORD has collaborated with the CITI Program since 2006, formalized through a 2014 CRADA that allowed VA to use CITI courses and provided support to reduce VA-related help‑desk burden.

2.0 PURPOSE

2.1 VA requires an enterprise-wide training solution that ensures uninterrupted access to research education content for VA-affiliated learners across all research disciplines.

2.2 This contract will provide enterprise training continuity through a subscription covering all VA sites and learners.

3.0 SCOPE OF SERVICES

3.1 The contract will provide a subscription that includes

3.1.1 24/7 online access

3.1.2 Includes access for all VA and VA-affiliated researchers

3.1.2.1 Includes all currently configured 168 VA sites

3.1.2.2 Includes new post contract award, site to be added during the contract period at add at no additional cost

3.1.3 Courses include

3.1.3.1 Core Research Foundations series, including Human Subjects Research, Good Clinical Practice, Information Privacy and Security, Animal Care and Use, Responsible Conduct of Research, and Conflicts of Interest.

3.1.3.2 Additional courses and series currently used across the VA, including, by way of example, Biosafety and Biosecurity Comprehensive, Laboratory Chemical Safety, Animal Care and Use (Advanced), Clinical Research Coordinator Foundations and Advanced, IRB Administration Foundations, Disaster Planning and Response, and Webinar series access.

3.1.3.3 Provide flexibility for the VA to make use of CITI full course catalog and newer programming that may become relevant over time, such as artificial intelligence (AI)-related content. Examples include Essentials of Responsible AI, AI in Human Subjects Research, and webinars such as Generative Artificial Intelligence in Research Design, Generative AI and Science Communication, and Redefining Ethical Research Practice in the Age of AI. This list is not exhaustive and does not include other courses which may become available after the submission of procurement.

3.1.3.4 Existing custom courses used by some VA facilities will be grandfathered under the contract, and there will be no additional charge for their continued use.

3.1.3.5 New custom courses or revised existing custom courses (not grandfathered in) will be created when ordered on a funded task order and only at the direction of the designated POC/COR or CO.

3.1.3.5.1 Custom courses will be available on separate line item.

3.1.4 The services also include admin access for local research administrators, standard implementation, setup, configuration, and timely (updates or resolution within 2 weeks [14 calendar days] of request being received) help desk support.

3.2 TASKS AND DELIVERABLES

3.2.1 Task 1: Enterprise Subscription Access for users

3.2.1.1 The Contractor shall provide:

3.2.1.1.1 Uninterrupted 24/7 one site access for all VA-affiliated learners across all currently configured or newly, post contract award, configured VA sites.

3.2.1.1.1.1 Planned outages should not exceed 24 hours; notice to VA sites will be provided at least 2 business days prior to the planned outages.

3.2.1.1.1.1.1 Updates on any unplanned outages will be provided to VA sites daily until the outages are resolved.

3.2.1.1.2 Access maintained for approximately 16,900 current, unique learners throughout the time frame of the contract.

3.2.1.1.2.1 No additional costs for extra users will be charged.

3.2.1.1.3 Access for new users created within two weeks (fourteen calendar days) of request being received. and maintained for any new, post-contract award, unique users throughout the time frame of the contract.

3.2.1.1.3.1 No additional costs for extra users will be charged.

3.2.2 Task 2: Training Library Access

3.2.2.1 The Contractor shall provide :

3.2.2.1.1 Access to existing custom courses will continue to be grandfathered, with no additional fee for continued use unless edits, relaunches, or other staff-supported changes are requested.

3.2.2.1.2 Access to all included courses and newly published training, including peer-reviewed online educational courses and webinars in research regulations and emerging topics for various types of research, including human research, animal use/welfare, and research safety.

3.2.2.1.3 Content updates are aligned in a timely manner (within 60 calendar days or earlier if required by regulatory/federal mandates) with regulatory changes (e.g., OHRP releases).

3.2.2.1.4 Contractor’s training programs must offer a granularity, regulatory mapping, and enterprise‑wide compatibility required to meet VA’s complex research‑oversight needs.

3.2.2.1.4 Provide a fully customizable training architecture that enables VA to tailor course content, learning pathways, and module requirements to both national VA policy and site‑specific research office needs

3.2.2.1.5 The contractor shall create and/or revise custom courses as requested by VA sites.

3.2.2.1.5.1 The cost for each custom course addition and/or revision (for those not grandfathered in after the contract is awarded) will be managed as a separate line item of this contract.

3.2.2.1.6 All courses shall be are accessible through CITI Program Learning Management System (LMS) platform, not a third party platform.

3.2.3 Task 3: Technical Support

3.2.3.1 The Contractor shall :

3.2.3.1.1 Implement and setup for new and existing VA sites, basic changes to configurations, and timely (updates or resolution within 2 weeks of request being received) help desk support.

3.2.3.1.2 Requests to add/remove courses to the curriculum and to change local site administrators will be concurred on by either the Administrative Officer for Research (AO/R) or the Associate Chief of Staff for Research (ACOS/R) aka. Chief of Research of that facility.

3.2.3.1.2.1 Requests to add/remove courses to the curriculum of a VA Program Office under this subscription will be concurred on by the Director of Research Education & Training in ORD.

3.2.3.1.3 Continue to give (within 3 business days of request) and maintain the appropriate (facility-level) administrator access to each facility / site administrator at all participating VA sites.

3.2.3.1.4 Continue to give and maintain the appropriate (facility and enterprise-levels) administrator access to designated ORD ePROS Research Education & Training (RET) staff (and designated back-ups).

3.2.4 Task 4: Reporting

3.2.4.1 The Contractor Shall:

3.2.4.1.1 Provide Usage reports as requested, consistent with CITI’s reporting tools, reflecting course completion data across all VA sites.

3.2.4.1.1.1 CITI team will provide more detailed reports if available, upon specific requests by the local site administrators, as needed.

3.2.4.1.2 Provide seamless integration of CITI training report daily with project tracking platform used by VA (currently IRBNet).

3.2.4.1.2.1 Each VA site using Automated Downloads can use V1 and/or V2, including where V1 is needed for IRBNet integration.

3.2.4.1.3 Provide designated ORD ePROS Research Education & Training (RET) staff access to reporting dashboards (or equivalent report formats) for each and all VA facilities and Program Offices under this subscription contract.

3.2.4.1.3.1 Newly added/removed VA site will be reported to designated ORD ePROS Research Education & Training (RET) staff within two weeks (fourteen calendar days) of request being received.

3.2.4.1.4 Reports shall support ORD ePROS RET's metrics-based evaluation of VA research educational programs, with data accessible at both the individual facility and enterprise-wide level.

3.2.5 Task 5: Transition

3.2.5.1 The Contractor Shall:

3.2.5.1.1 Subject to funding, provide continuing, uninterrupted access to CITI Program courses as defined in 3.2.1 before and after implementation of the contract, with no gap between CRADA termination and contract start.

3.2.5.1.2 Provide a transition status report delivered to the COR within 30 days of contract award confirming all current 168 sites are active and accessible.

3.3 Additional requirements

3.3.1 The Government expects monthly project management and communication with COR.

3.3.1.1 If emergent major issue, communication is required or within 1 business day upon notification of issue.

3.3.2 Contractor shall attend performance review meetings between COR and CITI Program every six months after start of the contract and six months after the start of a new year until the end of the contract. Thus, a total of 2 review meetings for each year of the contract.

3.3.2.1 Meeting materials on performance data, including the number of VA sites, the course categories used, the number of unique learners, etc. will provided to the Government POCs at least 5 business days in advance of the meetings.

3.3.3 Accurate invoices submitted consistent with contract terms and reflecting services rendered.

4.0 CONTRACTOR QUALIFICATIONS

4.1 Have the ability to provide 24/7 access to the current 168 VA sites and upcoming ones (as needed) for courses listed in 3.1.3 above with specific emphasis on continuing to provide seamless access the custom courses listed in 3.1.3.4.

4.1.1 The ability to edit these established courses referenced in 3.1.3.4 based on new information and policy updates is also required.

4.2 Provide seamless, daily updated, integration of course completion certification for researchers and research committee members with the VA-enterprise research project tracking platform IRBNet (i.e., VA Innovation and Research Review System [VAIRRS]).

4.3 Contractor employees must have familiarity with VA Research Program structure in giving the appropriate (facility-level) administrator access to each facility / site administrator and giving the appropriate (enterprise and facility-level) administrator access to designated ORD staff.

4.4 Contractor employees must have subject-matter expertise necessary to design, develop, and update specialized research training courses, ensuring accuracy and alignment with required regulatory and scientific topics.

4.5 Must provide ability to map content directly to VA‑mandated regulatory frameworks, the flexibility to configure modules for highly variable local research office requirements, and the capacity to integrate custom VA‑authored modules at scale.

4.6 Contractor can deliver a complete set of required courses and have the ability to customize additional courses as required by 3.1.3.

4.7 Contractor can provide comprehensive reporting tools that integrate seamlessly with the VA research project submission and review system to support compliance tracking and record keeping.

4.7.1 These reporting tools provide real‑time visibility across national and local research offices, supporting VA’s obligation to maintain accurate training records for audits, accreditation reviews, and regulatory oversight.

4.8 Contractor’s systems must align reports directly with VA‑specific compliance categories, integrate seamlessly with existing VA workflows, or support nationwide uniformity across more than 100 VA research programs.

4.9 Contractor’s reporting infrastructure must be fully established, widely adopted across multiple federal agencies, and proven to support fast-moving, regulated research environments.

5.0 Other contract requirement/information

5.1 PERIOD OF PERFORMANCE:

Five-Year contract.

5.2 PLACE OF PERFORMANCE: Services performed remotely through CITI Program’s LMS platform.

5.3 SECURITY REQUIREMENTS

5.3.1 The contractor, its personnel, and any subcontractors shall comply with all applicable Federal laws, regulations, standards, and VA Directives and Handbooks pertaining to information and information system security. Certification and Accreditation (C&A) requirements do not apply to this contract. A Security Accreditation Package is not required.

5.4 GOVERNMENT-FURNISHED INFORMATION

· The Government will not furnish equipment (GFE) to the contractor.

· No contractor personnel shall have access to VA computer systems.

· No contractor personnel shall be granted access to VA facilities.

5.5 Records Management Language for Contracts

When Federal agencies acquire goods or services, they need to determine what Federal records management requirements should be included in the contract. Federal contractors often create, send, or receive Federal records. Federal contracts should provide clear legal obligations describing how the contract employees must handle Federal records.

Agency records officers, procurement counsel, and acquisitions officers must discuss how to integrate records management obligations into their existing procurement processes. NARA has developed the following language to be included as an agency-specific term and condition in Federal contracts for a variety of services and products. The majority of contracts should include language on records management obligations, but each contract should be evaluated individually. For example, the data-rights paragraph (Paragraph 10 below) may not be appropriate for all contracts. Instead, agencies may be better served by one of the established data-rights clauses in the Federal Acquisition Regulations.

This language should not replace specific records management requirements included within Federal information system contracts.

RECORDS MANAGEMENT OBLIGATIONS

A. Applicability This clause applies to all Contractors whose employees create, work with, or otherwise handle Federal records, as defined in Section B, regardless of the medium in which the record exists.

B. Definitions “Federal record” as defined in 44 U.S.C. § 3301, includes all recorded information, regardless of form or characteristics, made or received by a Federal agency under Federal law or in connection with the transaction of public business and preserved or appropriate for preservation by that agency or its legitimate successor as evidence of the organization, functions, policies, decisions, procedures, operations, or other activities of the United States Government or because of the informational value of data in them.

The term Federal record:

· includes VA Medical Center records.

· does not include personal materials.

· applies to records created, received, or maintained by Contractors pursuant to their VA Medical Center contract.

· may include deliverables and documentation associated with deliverables.

C. Requirements Contractor shall comply with all applicable records management laws and regulations, as well as National Archives and Records Administration (NARA) records policies, including but not limited to the Federal Records Act (44 U.S.C. chs. 21, 29, 31, 33), NARA regulations at 36 CFR Chapter XII Subchapter B, and those policies associated with the safeguarding of records covered by the Privacy Act of 1974 (5 U.S.C. 552a). These policies include the preservation of all records, regardless of form or characteristics, mode of transmission, or state of completion.

In accordance with 36 CFR 1222.32, all data created for Government use and delivered to, or falling under the legal control of, the Government are Federal records subject to the provisions of 44 U.S.C. chapters 21, 29, 31, and 33, the Freedom of Information Act (FOIA) (5 U.S.C. 552), as amended, and the Privacy Act of 1974 (5 U.S.C. 552a), as amended and must be managed and scheduled for disposition only as permitted by statute or regulation.

In accordance with 36 CFR 1222.32, Contractor shall maintain all records created for Government use or created in the course of performing the contract and/or delivered to, or under the legal control of the Government and must be managed in accordance with Federal law. Electronic records and associated metadata must be accompanied by sufficient technical documentation to permit understanding and use of the records and data.

VA Medical Center and its contractors are responsible for preventing the alienation or unauthorized destruction of records, including all forms of mutilation. Records may not be removed from the legal custody of the VA Medical Center or destroyed except for in accordance with the provisions of the agency records schedules and with the written concurrence of the Head of the Contracting Activity. Willful and unlawful destruction, damage or alienation of Federal records is subject to the fines and penalties imposed by 18 U.S.C. 2701. In the event of any unlawful or accidental removal, defacing, alteration, or destruction of records, Contractor must report to the VA Medical Center. The agency must report promptly to NARA in accordance with 36 CFR 1230.

The Contractor shall immediately notify the appropriate Contracting Officer upon discovery of any inadvertent or unauthorized disclosures of information, data, documentary materials, records or equipment. Disclosure of non-public information is limited to authorized personnel with a need-to-know as described in the obligation. The Contractor shall ensure that the appropriate personnel, administrative, technical, and physical safeguards are established to ensure the security and confidentiality of this information, data, documentary material, records and/or equipment is properly protected. The Contractor shall not remove material from Government facilities or systems, or facilities or systems operated or maintained on the Government’s behalf, without the express written permission of the Head of the Contracting Activity. When information, data, documentary material, records and/or equipment is no longer required, it shall be returned to VA Medical Center control or the Contractor must hold it until otherwise directed. Items returned to the Government shall be hand carried, mailed, emailed, or securely electronically transmitted to the Contracting Officer or address prescribed in the obligation. Destruction of records is EXPRESSLY PROHIBITED unless in accordance with Paragraph (4).

The Contractor is required to obtain the Contracting Officer's approval prior to engaging in any contractual relationship (sub-contractor) in support of this contract requiring the disclosure of information, documentary material and/or records generated under, or relating to, contracts. The Contractor (and any sub-contractor) is required to abide by Government and VA Medical Center guidance for protecting sensitive, proprietary information, classified, and controlled unclassified information.

The Contractor shall only use Government IT equipment for purposes specifically tied to or authorized by the contract and in accordance with VA Medical Center policy.

The Contractor shall not create or maintain any records containing any non-public VA Medical Center information that are not specifically tied to or authorized by the contract.

The Contractor shall not retain, use, sell, or disseminate copies of any deliverable that contains information covered by the Privacy Act of 1974 or that which is generally protected from public disclosure by an exemption to the Freedom of Information Act.

The VA Medical Center owns the rights to all data and records produced as part of this contract. All deliverables under the contract are the property of the U.S. Government for which VA Medical Center shall have unlimited rights to use, dispose of, or disclose such data contained therein as it determines to be in the public interest. Any Contractor rights in the data or deliverables must be identified as required by FAR 52.227-11 through FAR 52.227-20.

Training. All Contractor employees assigned to this contract who create, work with, or otherwise handle records are required to take VA Medical Center -provided records management training. The Contractor is responsible for confirming training has been completed according to agency policies, including initial training and any annual or refresher training.

6.0 Performance requirements summary

The contractor service requirements are summarized into performance objectives that relate directly to mission essential items. The performance threshold briefly describes the minimum acceptable levels of service required for each requirement. These thresholds are critical to mission success.

What: Access logs/incident reports; contractor-reported uptime data How: Review Frequency: Daily, during unplanned outages.

Who: COR Or Government POC

Positive/Negative CPARS Performance Rating

How: Review Frequency: Monthly Who: COR Or Government POC Positive/Negative CPARS Performance Rating

How: Review Frequency: Quarterly and/or Upon Regulatory Change.

Who: COR Or Government POC Positive/Negative CPARS Performance Rating

Implement and setup for new and existing VA sites, basic changes to configurations, and timely (updates or resolution within 2 weeks of request being received) help desk support.

How: Review Frequency: Monthly / Upon request Who: COR Or Government POC Positive/Negative CPARS Performance Rating

How: Review Frequency: As needed/upon request Who: COR Or Government POC Positive/Negative CPARS Performance Rating

How: Review Frequency: As needed/upon request Who: COR Or Government POC Positive/Negative CPARS Performance Rating

How: Review Frequency: At contract award and through Day 30; at renewal of each option year Who: COR Or Government POC Positive/Negative CPARS Performance Rating

Appendix A:

VA regulations on research training requirements include:

VHA Directive 1200.05(4), Jan 7, 2019, amended Apr 1, 2025: Requirements for the Protection of Human Subjects in Research.

VHA Directive 1200.08(1), Apr 24, 2019, amended Jan 8, 2021: Safety of Personnel and Security of Laboratories involved in VA Research.

VHA Directive 1200.07, May 23, 2023: VA Research with Animals.

VHA Directive 1605.01, July 24, 2023: Privacy and Release of Information.

VHA Directive 1907.01(1), Apr 5, 2021, amended Dec 11, 2023: VHA Health Information Management and Health Records.