SOW-Biomarker Generation7-14-2026accepted.docx

STATEMENT OF WORK

Contract Title: LIMBIC and TRACTs Biomarker Generation and Harmonization

Background: The PRECEDE Laboratory at Johns Hopkins University will analyze proteins, mRNA, and other fluid biomarkers needed for LIMBIC and TRACTs consortium research. These analyses will be performed using Olink and Quanterix platforms, which are uniquely available in this laboratory. Resulting biomarker data will be harmonized using established analytical pipelines to allow cross-cohort comparison.

Scope: . The samples are currently located at John Hopkins University as they were the site for the LIMBIC Biomarker Core and the basis for the samples being utilized for this project. Laboratory infrastructure including Olink, Quanterix, and Illumina sequencing will be used to generate proteomic and genetic data. Consumables and personnel support required for these analyses are to be included in the price and not separately billed. Services include execution of assays, data harmonization, and delivery of resulting datasets. Consumables will be shipped to the JHU laboratory. All assays and harmonization activities will occur within the PRECEDE Laboratory.

Functions to be Performed

· Biomarker assay execution: Perform high‑throughput proteomic and fluid biomarker assays using Olink Explorer (5,400 proteins per kit) and Quanterix (Simoa) platforms on consortium samples.

· Sequencing support: Conduct Illumina‑based sequencing associated with biomarker panels and data verification workflows.

· Data harmonization: Apply established analytical pipelines to normalize, QC, and harmonize resulting datasets to enable cross‑cohort comparability for LIMBIC and TRACTs research.

· Logistics & sample handling: Receive consumables; manage sample intake, chain‑of‑custody, and lab processing through the PRECEDE Laboratory; deliver final datasets to the Government.

· 2) Services or Performance Required

· Scope & volume: Analyze up to 3,000 samples (initial minimum 1,250 samples on Olink Explorer) contingent on funding; provide end‑to‑end assay execution, QC, and harmonization.

· Outcomes:

· Delivery of validated, harmonized biomarker datasets suitable for cross‑cohort analyses, consistent with consortium standards. Timely completion of assay runs and sequencing per task order schedules.

Essential Physical Characteristics

· Co‑located platforms: Access to and operation of both Olink and Quanterix platforms within the same laboratory are essential to maintain standardized protocols and ensure analytical comparability across cohorts; harmonization requires all assays to be run in one lab.

· Specific consumables & capacity: Availability of Olink Explorer kits (5,400 proteins scope), Illumina sequencing kits, and associated consumables; laboratory capacity to process 1,250+ samples in year one and scale up to 3,000 samples.

Validated pipelines & QC: Established data harmonization pipelines, platform‑specific calibration/QA procedures, and secure data delivery capabilities are required to meet consortium scientific integrity standards

Additional Information/Requirements:. Johns Hopkins University PRECEDE Laboratory is the only laboratory equipped with both Olink and Quanterix platforms required for the specified biomarker assays. No other vendor provides these combined capabilities. Analyses must be performed in the same lab to maintain harmonized protocols and ensure dataset comparability for reliability of research results.The vendor is the original developer of the harmonization analytical pipelines, offering proprietary methodologies that cannot be replicated without access to their internal infrastructure and expertise.

Contract Type:

Firm Fixed price

Period of Performance: The period of performance will be based off the time of award for one year. A minimum of 1,250 samples to be processed on the Olink Explorer (5,400 protein) platform. The required kits and sequencing runs for this workload must be completed within the performance year.

Place of Performance:

Security Requirements: The C&A requirements do not apply, and a Security Accreditation Package is not required.

VA RECORDS POLICY:

All records (administrative and/or health specific) created during the period of the contract belong to Salt Lake City VAMC. Said records must always be handled in accordance with National Archives and Records Administration (NARA) requirements as outlined in VA Directive 6300 Records and Information Management and its Handbook 6300.1 Records Management Procedures, VHA Records Control Schedule 10-1, and VA Handbook 6500.1 regarding Electronic Media Sanitization. Said records must also be returned to Salt Lake City VAMC at the end of the contract and/or destroyed in accordance with the VHA Record Control Schedule (RCS)10-1. For questions, please contact the Salt Lake City VAMC Records Officer.

RECORDS MANAGEMENT STATEMENT

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. chapters 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, 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. Salt Lake City VAMC 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 Salt Lake City VAMC 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 Salt Lake City VAMC. 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 Salt Lake City VAMC 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 subcontractor) is required to abide by Government and Salt Lake City VAMC 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 Salt Lake City VAMC policy.

8. The Contractor shall not create or maintain any records containing any nonpublic Salt Lake City VAMC information that are 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 Salt Lake City VAMC 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 Salt Lake City VAMC 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, Talent Management System (TMS) Item #3873736 Records Management for Records Officers and Liaisons. The Contractor is responsible for confirming training has been completed according to agency policies, including initial training and any annual or refresher training.