P01 - Statement of Work Contracting.docx

PERFORMANCE WORK STATEMENT

Title: Web-Based Software for Sustained Attention Diagnostics in Veterans Objectives The Contractor shall provide web-based application support services for Dr. Esterman (and his collaborators) at VA Boston Healthcare System (VA BHS) Jamaica Plain (JP) campus to include additional testing, implementation, and data collection for the following studies and grants: “Cognitive and Neural Mechanisms of Inhibitory Control,” “Suicide Risk Interventions: A Comparison of Treatment Dose and Neural Markers of Treatment Outcome,” “Long-Term Psychological and Physical Health Outcomes Following Military Deployment: The Veterans After-Discharge Longitudinal Registry (Project VALOR),” and the Veterans Affairs Boston Healthcare System Research and Development IRB requirements.

Scope The Contractor shall provide ongoing web-based application services in support of the data and efforts from Dr. Esterman’s Sustained Attention Diagnostics in Veterans studies/projects as outlined below in Tasks and Deliverables. The associated tasks and deliverables are maintained and advanced for and will be visible and accessible to/by Dr. Esterman and his collaborators through the information technology services being provided by the Contractor.

Sustained Attention is a key cognitive operation that is crucial for daily life tasks such as, but not limited to: studying, driving, and communicating. Sustained Attention is amongst the most common deficient cognitive operations seen in Veterans (many in which suffer from Post Traumatic Stress Disorder (PTSD), Traumatic Brain Injury (TBI), pain, depression, sleep problems, and age-related cognitive decline). These projects aim to identify and diagnose sustained attention related cognitive operation and key cognitive processing deficits, leading to better diagnostic tools and providing better approaches to treating Veterans more reliably.

Background

From 2021, the Contractor’s information technology services have been utilized by VA BHS Jamaica Plain campus under Contract Number 36C24E21D0046. This contract will continue the services as outlined below in Tasks and Deliverables.

Previous research indicates that PTSD, TBI, pain, depression, sleep problems, pain, and age-related cognitive decline are associated with differential sustained attention deficits in Veterans. The projects being led have sought and continually seek to identify the particular dysfunctional mechanisms that underlie these deficits. The research compares the differences in sustained attention deficits when using either non-emotional (e.g., scenes of cities/mountains) or emotional stimuli (e.g., angry faces).

General Information The Contractor shall have prior experience and knowledge in the following areas:

· Developing JavaScript programs that run behavioral experiments on a web browser.

· Proficiency utilizing JavaScript, HTML, and CSS to display image stimuli in a sequence-like manner while dynamically changing opacities.

· Proficiency utilizing JavaScript's DOM event and Date objects to calculate user's response times to keyboard/mouse events.

· Collecting and storing user's experiment data to a MySQL database, including attributes such as a user's average response times, accuracy scores, and experiment parameters.

· Clinical software design of the gradCPT or comparable program.

· Web-based data collection that has been used for clinical trials.

· Web-based data collection that has led to published results in scientific journals, based on VA on NIH-funded trials.

Other Information

The Contractor understands that software developed cannot collect any data from participants that includes the 18 HIPAA identifiers, for this Contract.

Physical Security: The contractor shall be responsible for safeguarding all government equipment, information, and property.

Post Award Conference/Periodic Progress Meetings: The Contractor agrees to virtually attend post-award progress meetings as needed.

Tasks and Deliverables

Year One, Base Year (09/01/2024-08/31/2025):

1. Refining the development and programming of the web-based study application to ensure viable data is collected throughout the first year of the funded research projects.

2. Refining previously developed web-based application to deliver sustained attention diagnostic tests for the study.

3. Testing, implementing, and collecting data through the developed web-based application during the first year of the study.

Deliverable 1 – Web-based Raw Data (from up to 2000 Veteran participants) Deliverable 2 – Quality Control Metrics Deliverable 3 – Software Modifications (as needed) Deliverable 4 – Technical Support (as needed) Option Year 1, Year Two (09/01/2025-08/31/2026):

Refining the development and programming of the web-based study application to ensure viable data is collected throughout the first year of the funded research projects.

1. Refining previously developed web-based application to deliver sustained attention diagnostic tests for the study.

2. Testing, implementing, and collecting data through the developed web-based application during the first year of the study.

Deliverable 1 – Web-based Raw Data (from up to 2000 Veteran participants) Deliverable 2 – Quality Control Metrics Deliverable 3 – Software Modifications (as needed) Deliverable 4 – Technical Support (as needed) Option Year 2, Year Three (09/01/2026-08/31/2027):

Refining the development and programming of the web-based study application to ensure viable data is collected throughout the first year of the funded research projects.

1. Refining previously developed web-based application to deliver sustained attention diagnostic tests for the study.

2. Testing, implementing, and collecting data through the developed web-based application during the first year of the study.

Deliverable 1 – Web-based Raw Data (from up to 2000 Veteran participants) Deliverable 2 – Quality Control Metrics Deliverable 3 – Software Modifications (as needed) Deliverable 4 – Technical Support (as needed) Option Year 3, Year Four (09/01/2027-08/31/2028):

Refining the development and programming of the web-based study application to ensure viable data is collected throughout the first year of the funded research projects.

1. Refining previously developed web-based application to deliver sustained attention diagnostic tests for the study.

2. Testing, implementing, and collecting data through the developed web-based application during the first year of the study.

Deliverable 1 – Web-based Raw Data (from up to 2000 Veteran participants) Deliverable 2 – Quality Control Metrics Deliverable 3 – Software Modifications (as needed) Deliverable 4 – Technical Support (as needed) Option Year 4, Year Five (09/01/2028-08/31/2029):

Refining the development and programming of the web-based study application to ensure viable data is collected throughout the first year of the funded research projects.

1. Refining previously developed web-based application to deliver sustained attention diagnostic tests for the study.

2. Testing, implementing, and collecting data through the developed web-based application during the first year of the study.

Deliverable 1 – Web-based Raw Data (from up to 2000 Veteran participants) Deliverable 2 – Quality Control Metrics Deliverable 3 – Software Modifications (as needed) Deliverable 4 – Technical Support (as needed) 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:

1. includes VHA records.

2. does not include personal materials.

3. applies to records created, received, or maintained by Contractors pursuant to their VHA contract.

4. may include deliverables and documentation associated with deliverables.

C. Requirements

1. 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.

2. 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.

3. In accordance with 36 CFR 1222.32, the 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.

4. VHA 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 VHA or destroyed except 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, the Contractor must report to VHA. The agency must report promptly to NARA in accordance with 36 CFR 1230.

5. 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 [contract vehicle]. 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 VHA 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 [contract vehicle]. Destruction of records is EXPRESSLY PROHIBITED unless in accordance with Paragraph (4).

6. 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 VHA guidance for protecting sensitive, proprietary information, classified, and controlled unclassified information.

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

8. The Contractor shall not create or maintain any records containing any non-public VHA information that is not specifically tied to or authorized by the contract.

9. 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.

10. The VHA 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 VHA 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.

11. Training. All Contractor employees assigned to this contract who create, work with or otherwise handle records are required to take VHA-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.

** VHA training for contractors is available in Talent Management System (TMS):

Records Management for Records Officers and Liaisons, Item #3873736

D. Flow down of requirements to subcontractors

1. The Contractor shall incorporate the substance of this clause, its terms, and requirements including this paragraph, in all subcontracts under this [contract vehicle], and require written subcontractor acknowledgment of same.

2. Violation by a subcontractor of any provision set forth in this clause will be attributed to the Contractor.