36C24125Q0569.docx

Presolicitation Notice Presolicitation Notice

GENERAL INFORMATION

SET-ASIDE

VA BOSTON HEALTHCARE SYSTEM

150 Huntington Avenue

Boston MA 02130

POSTAL CODE

COUNTRY

CONTACT INFORMATION

VAMC Connecticut Network Contracting Office 1 950 Campbell Avenue West Haven CT 06516

POINT OF CONTACT*

Contract Specialist Ophelia Wilson Ophelia.Wilson@va.gov

ADDITIONAL INFORMATION

DESCRIPTION

NOTICE OF THE INTENT TO SOLE SOURCE TO TRUSTEES OF BOSTON UNIVERSITY/ BOSTON UNIVERSITY 80 E.CONCORD ST T3C BOSTON, MA 02218, United States. Response Due Date: June 30, 2025, by 09:00AM (EST) NOTICE OF THE INTENT TO SOLE SOURCE SYNOPSIS Network Contract Office 1, Procurement Office East on behalf of The Department of Veterans Affairs, Boston VA Medical Center intends to award a firm-fixed contract with four options to TRUSTEES OF BOSTON UNIVERSITY/ BOSTON UNIVERSITY to provide Installation, Programming, and Testing located at the Boston VAMC. The proposed procurement is for products/services for which the Government intends to solicit and negotiate with only one source under the authority of FAR 6.302-1 -- Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements. 41 U.S.C. 3304(a)(1). The North American Industry Classification System code (NAICS) for this requirement is 541715. All responsible sources that feel they should be considered qualified to provide the above-mentioned products may submit a response to this notice (by the response due date shown above) to Ophelia.Wilson@va.gov. The information provided shall include detailed (and relevant) documentation to allow the government to perform adequate market research and make a proper determination. A determination by the government not to compete this proposed requirement based upon responses to this notice is solely within the discretion of the Government. Information received will be considered solely for the purpose of determining whether to conduct a competitive procurement. THIS IS NOT A REQUEST FOR COMPETITIVE PROPOSALS. THERE IS NO SOLICITATION AVAILABLE AT THIS TIME. REQUESTS FOR A SOLICITATION WILL NOT RECEIVE A RESPONSE.

Statement of Work for Boston University (BU) Data Management Service Contract

A. GENERAL GUIDANCE

1. Title of Project: BU Data Management Contract Transaction Number: TBD

2. Scope of Work: The VA Biorepository Brain Bank (VABBB) requires maintenance and support for the REDCap system that VABBB personnel utilize for collecting, entering, tracking, reviewing, cleaning, and reporting project data for presentations, conferences, publications, etc. This service must include web-based training and booster training; implementation of SAS based data management and quality control procedures; participant-level data cleaning; analytic dataset creation including derived variables and appropriate documentation; development and maintenance of reports; statistical analyses.

The maintenance and support for the REDCap system and associated data analysis and management will require the combined effort of 3 project personnel- a senior data manager, a senior statistical programmer, and a statistical programmer.

3. Background: The REDCap system that is in use by the VABBB has been maintained by BU Biostatistics and Epidemiology Data Analytics Center (BEDAC) since 2018. The BEDAC team is made up of VA WOC employees who have developed and overseen this data system since its inception within the VABBB. The BEDAC team has cleaned, analyzed, and developed over 15 different datasets that the VABBB has used for various publications and presentations.

This contract will be a follow-on to contract 36C24120P0728 with BU, which expires 7/18/2025. The contract provides a highly specialized service to the VABBB that is unable to be completed by a VA FTE and will have direct implications on health outcomes for veterans if not continued.

4. Performance Period: The anticipated POP for this contract is July 19th, 2025-July 18th, 2030.

5. Type of Contract: This is a firm fixed price service contract.

B. CONTRACT AWARD MEETING

No “kick-off” meeting will be required as this will be a continuation of the existing contract.

C. GENERAL REQUIREMENTS

BEDAC will provide continued data management and analysis service to the VABBB.

D. SPECIFIC MANDATORY TASKS AND ASSOCIATED DELIVERABLES

Under the direction of the VA project principal investigator, BEDAC staff will coordinate all data management activities for the project and provide supervision for all data management staff; advise on and assist with data collection system design and development; oversee data collection form development; oversee design and construction of electronic data systems; oversee development of manuals for all data systems; assist in the development and implementation of web-based randomization where applicable; develop protocols for secure data transfer of any reasonable external data elements; oversee development of data management plans; act as liaison among statisticians, data management personnel, field personnel, and other investigators; participate in program meetings and individual project meetings; oversee development of SAS programming for data cleaning procedures, dataset creation, reporting, analysis and data sharing; participate in VA training as appropriate; develop specifications for receipt of external data, data harmonization and data cleaning of datasets; ensure that the statistical analyses performed are robust and follow the SAP; make interim decisions on analytic approach; develop analytic specifications; review SAS programming code, maintain web-based data collection and management systems using REDCap; train REDCap users; develop SAS programming for the creation of interim and final analytic datasets (including derived variables) and their accompanying documentation (data dictionaries); develop SAS programming for interim and final reporting of data completeness, enrollment, visit/form accrual, descriptive characteristics and ad-hoc reports; provide analytic support, and assist with the preparation of manuscripts, abstracts, and presentations. REDCap user permissions will be approved and managed by the VA principal investigator. BEDAC staff will remain in consistent communication with the VABBB team to resolve data discrepancies.

E. EVALUATED OPTIONAL FEATURES

N/A

F. SCHEDULE FOR DELIVERABLES

Data managements services will be performed in concurrence with the requirements and deadlines set by VABBB staff.

G. CHANGES TO THE STATEMENT OF WORK

Changes to the SOW must be approved by the VA principal investigator, the COR, and the Contracting Officer.

H. REPORTING REQUIREMENTS

N/A

I. TRAVEL

N/A

J. GOVERNMENT RESPONSIBILITIES

VABBB staff will continue to enter data into the REDCap system for analysis and management by the BEDAC team.

K. CONTRACTOR EXPERIENCE REQUIREMENTS

Qualifications of Key Personnel: Personnel must be experienced data managers and statistical programmers.

L. CONFIDENTIALITY AND NONDISCLOSURE

BU shall comply with all rules and regulations regarding the service provided.

CONTRACTOR PERSONNEL SECURITY REQUIREMENTS

BEDAC staff will maintain WOC status with the VA and complete all privacy, security, and technology trainings required of VA affiliates. The contract work requires BEDAC staff to clean and analyze deidentified sensitive information. BEDAC staff will not have access to or work with any PII/PHI. The VA sensitive information will remain on the VA network; there will be no transfer of VA sensitive information. Connection from contractor-owned IT devices to a VA internal network will not be required.

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):

5. 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.

Presolicitation Notice