STATEMENT OF WORK.pdf

STATEMENT OF WORK (SOW)

A. GENERAL INFORMATION

a. Title of Project: AI-Guided Blood Proteomics for Treatment Optimization in Veterans with Metastatic Prostate Cancer

b. Background:

Advanced prostate cancer remains a leading cause of cancer morbidity and mortality among Veterans, yet validated circulating biomarkers that predict treatment response or early disease progression are lacking. Current clinical decision-making relies primarily on PSA kinetics and radiographic imaging, which have well-recognized limitations in sensitivity and lead time. High-plex proteomic profiling of serial plasma specimens offers the potential to identify novel protein signatures that reflect tumor biology in real time, enabling earlier detection of therapeutic resistance and more personalized treatment sequencing. The goal of this contracted work is to generate reproducible, high-quality proteomic data from the study’s longitudinal plasma specimens so that the VA study team can conduct exploratory analyses linking circulating proteomic changes to clinical outcomes, ultimately informing future biomarker validation studies and precision oncology strategies for Veterans with advanced prostate cancer.

The Washington DC VA Medical Center (DC VAMC) is conducting a prospective biospecimen collection and clinical data repository study enrolling Veterans with advanced prostate cancer, including metastatic hormone-sensitive prostate cancer (mHSPC) and metastatic castration-resistant prostate cancer (mCRPC), receiving standard-of-care systemic therapy with or without stereotactic body radiotherapy (SBRT). The study collects serial peripheral blood specimens at defined timepoints before, during, and after treatment to build a longitudinally annotated biospecimen repository. The current funded phase of this research requires high-plex circulating proteomic profiling of coded plasma specimens using the SomaScan assay platform to support the exploratory biomarker analyses described above. The VA requires a vendor with an established, analytically validated, CLIA-certified plasma proteomic assay platform capable of processing coded research specimens in defined study batches and returning standardized proteomic data output and quality documentation to the VA study team.

c. Period of Performance: The contract period of performance will be a base year with a one-year option period

d. Place of Performance: All work shall take place at the vendor’s facility.

e. Contract Type: The contract is a Firm Fixed Price Contract.

f. Specified Tasks: The vendor shall:

a. Receive the coded frozen plasma aliquots shipped by the VA. The VA is responsible for shipping specimens in accordance with the vendor’s current sample submission requirements, including frozen storage at -80°C and appropriate shipment.

b. Thaw and prepare plasma samples for SomaScan assay processing in accordance with the vendor’s standard operating procedures.

c. Perform SomaScan assay processing on all submitted samples, including standard assay-level quality control.

d. Return proteomic data output in standard ADAT file format, accompanying quality assurance documentation (PDF assay quality statement), and any unused sample material to the VA study team at the Washington DC VAMC.

e. Process samples in study batches as submitted by the VA (anticipated minimum batch size of approximately 40 samples per submission). The currently funded scope anticipates approximately 120 total plasma samples from approximately 24 participants, to be submitted across multiple batches over the period of performance.

E. CHANGES TO STATEMENT OF WORK

Any changes to this SOW shall be authorized and approved only through written correspondence from the Contracting Officer. Costs incurred by the contractor through the actions of parties other than the Contracting Officer shall be borne by the contractor.

F. CONTRACTOR PERSONNEL

The contractor shall be responsible for recruiting, selecting, hiring, and supervising all contractor personnel. The contractor's management responsibilities shall include all activities necessary to ensure the accomplishment of timely and effective support, performed in accordance with the requirements contained in the SOW.

G. CONFIDENTIALITY AND NONDISCLOSURE

1. The preliminary and final deliverables and all associated working papers and other materials deemed relevant by the VA which have been generated by the contractor in the performance of this contract are the exclusive property of the U.S. Government and shall be submitted to the Contracting Officer at the conclusion of the contract.

2. The Contracting Officer will be the sole authorized official to release verbally or in writing any data, the draft deliverables, the final deliverables, or any other written or printed materials pertaining to this contract. No information shall be released by the contractor.

Any request for information relating to this contract presented to the contractor shall be submitted in writing to the Contracting Officer for response.

3. Press releases, marketing material, or any other printed or electronic documentation related to this project shall not be publicized without the written approval of the Contracting Officer.

4. Bloos Sample Protein Measurement Analysis

5. The service, function, or activity is characterized as research as defined in the Common Rule or as in Title 38 Code of Federal Regulations (CFR) 16.102(g), or VHA Handbook 1200.05; or the PHI is being disclosed to a researcher. Therefore it is not required for the contractor to sign a National Business Associate Agreement with the VA.

H. RIGHTS IN DATA

1. Information made available to the contractor or subcontractor by VA for the performance or administration of this contract or information developed by the contractor/subcontractor in performance or administration of the contract shall be used only for those purposes and shall not be used in any other way without the prior written agreement of the VA. This clause expressly limits the contractor/subcontractor's rights to use data as described in Rights in Data- General, FAR 52.227-14(d) (1).

2. VA information should not be co-mingled, if possible, with any other data on the contractors/subcontractor’s information systems or media storage systems in order to ensure VA requirements related to data protection and media sanitization can be met. If co-mingling must be allowed to meet the requirements of the business need, the contractor must ensure that VA’s information is returned to the VA or destroyed in accordance with VA’s sanitization requirements. VA reserves the right to conduct on-site inspections of contractor and subcontractor IT resources to ensure data security controls, separation of data and job duties, and destruction/media sanitization procedures are in compliance with VA directive requirements.

3. Prior to termination or completion of this contract, contractor/subcontractor must not destroy information received from VA, or gathered/created by the contractor in the course of performing this contract without prior written approval by the VA. Any data destruction done on behalf of VA by a contractor/subcontractor must be done 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, applicable VA Records Control Schedules, and VA Handbook 6500.1, Electronic Media Sanitization. Self-certification by the contractor that the data destruction requirements above have been met must be sent to the VA Contracting Officer within 30 days of termination of the contract.

4. The contractor/subcontractor must receive, gather, store, back up, maintain, use, disclose and dispose of VA information only in compliance with the terms of the contract and applicable Federal and VA information confidentiality and security laws, regulations and policies. If Federal or VA information confidentiality and security laws, regulations and policies become applicable to the VA information or information systems after execution of the contract, or if NIST issues or updates applicable FIPS or Special Publications (SP) after execution of this contract, the parties agree to negotiate in good faith to implement the information confidentiality and security laws, regulations and policies in this contract.

5. The contractor/subcontractor shall not make copies of VA information except as authorized and necessary to perform the terms of the agreement or to preserve electronic information stored on contractor/subcontractor electronic storage media for restoration in case any electronic equipment or data used by the contractor/subcontractor needs to be restored to an operating state. If copies are made for restoration purposes, after the restoration is complete, the copies must be appropriately destroyed.

I. RECORDS MANAGEMENT

The following standard items relate to records generated in executing the contract and should be included in a typical Electronic Information Systems (EIS) procurement contract:

1. Citations to pertinent laws, codes and regulations such as 44 U.S.C chapters 21, 29, 31 and 33; Freedom of Information Act (5 U.S.C. 552); Privacy Act (5 U.S.C. 552a); 36 CFR Part 1222 and Part 1228.

2. Contractor shall treat all deliverables under the contract as the property of the U.S.

Government for which the Government Agency shall have unlimited rights to use, dispose of, or disclose such data contained therein as it determines to be in the public interest.

3. Contractor shall not create or maintain any records that are not specifically tied to or authorized by the contract using Government IT equipment and/or Government records.

4. 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 by the Freedom of Information Act.

5. Contractor shall not create or maintain any records containing any Government Agency records that are not specifically tied to or authorized by the contract.

6. The Government Agency owns the rights to all data/records produced as part of this contract.

7. The Government Agency owns the rights to all electronic information (electronic data, electronic information systems, electronic databases, etc.) and all supporting documentation created as part of this contract. Contractor must deliver sufficient technical documentation with all data deliverables to permit the agency to use the data.

8. Contractor agrees to comply with Federal and Agency records management policies, including those policies associated with the safeguarding of records covered by the Privacy Act of 1974. These policies include the preservation of all records created or received regardless of format [paper, electronic, etc.] or mode of transmission [e-mail, fax, etc.] or state of completion [draft, final, etc.].

9. No disposition of documents will be allowed without the prior written consent of the Contracting Officer. The Agency and its contractors are responsible for preventing the alienation or unauthorized destruction of records, including all forms of mutilation. Willful and unlawful destruction, damage or alienation of Federal records is subject to the fines and penalties imposed by 18 U.S.C. 2701. Records may not be removed from the legal custody of the Agency or destroyed without regard to the provisions of the agency records schedules.

10. 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, this contract. The Contractor (and any sub-contractor) is required to abide by Government and Agency guidance for protecting sensitive and proprietary information.