PerformanceWorkStatement final2-25-2026.docx

PERFORMANCE WORK STATEMENT

Metabolomics

1.0 Background/Scope/Qualifications

1.1 VA Overview of Research Effort: The VHA is one of the largest healthcare networks in the US that provides healthcare services for the nations’ Veteran population. One of the charges of the VHA is to promote research and development dedicated to improving the health and lives of Veterans. The Office of Research and Development (ORD) created the Genomic Medicine Program (GMP) in 2006 to support and lead VA as it moves into the venue of genomic or precision medicine. The field of genomics and other –omics analyses and personalized medicine is a rapidly evolving one. The VA stands at this cutting edge and needs resources to ensure that the Veterans receive the benefit of the latest technology and research.

1.2 This Performance Work Statement is to secure metabolomics analysis to support the objectives of the VA’s Million Veteran Program (MVP). MVP is a national research program begun in 2011 that is creating a resource of genetic information of at least one million consented Veteran volunteers linked with information from self-reported survey instruments and one of the richest electronic health records systems. There are currently 61 Veteran Affairs Medical Centers (VAMC) enrolling participants into MVP, and over 1,090,000 participants have fully consented to provide health data as well as an EDTA (calcium disodium ethylene-diaminetetraacetate) blood sample to the study. MVP is one of the world’s largest biomedical resources of its kind. The program is seeking to continue its current effort to perform multi-omics analysis of Veteran-provided biological samples, including metabolomics. Vendor must have

2.0 Scope

2.1 The VHA Million Veteran Program requires the services to provide metabolomics analysis for human samples derived from peripheral whole blood (and preserved in of a vendor for metabolomics analyses for human EDTA (calcium disodium ethylene-diaminetetraacetate) for the Department of Veterans Affairs (VA) Veterans Health Administration (VHA), Office of Research and Development’s Million Veteran Program (MVP).

2.2 The human plasma samples shall be sent by the Government to the contractor facility from the VA MVP biorepository at an expected rate of 10,000 to 20,000 samples per year.

2.3 Specific Tasks/Requirements.

2.3.1 The contractor shall provide a detailed Project Management Plan(PMP) within 5 days of contract award to address the following tasks necessary to complete the metabolomics work, and shall address the capabilities to provide specific requirements.

2.3.1.2 The contractor shall demonstrate that they are certified in Good Laboratory Practice (GLP) within 5 days after award.

2.3.1.3 The contractor shall be required to complete and submit a Contractor Security Control Assessment within 30 days of award of a contract in accordance with VA Handbook 6500.6.

2.3.2 Task 1: Provide a detailed VA Sample Security and Data Security Plan within 7 days after award:

2.3.2.1 All materials and samples utilized during the course of the contract are the property of the Department of Veterans Affairs and must be handled in a confidential and secure manner.

2.3.2.2 The contractor shall outline in their response: their planned lab Standard Operating Procedures (SOPs) methods for handling and securing of samples including paper and electronic documents, the methods, assurances and processes for destruction of samples and data, details of proposed shipping requirements like method/conditions for shipping, receipt & acknowledgement of shipments, encryption of hard drives (if that is the VA requested delivery method); documentation of security of electronic data delivery (if that is VA requested delivery method) as well as the contractors ability to perform in accordance with and subject to the following references:

2.3.2.2.1 VA Handbook 6500.1 - Electronic Media Sanitization,

2.3.2.2.2 VA Directive 6300 – Records and Information Management and its Handbook

2.3.2.2.3 6300.1 Records management Procedures,

2.3.2.2.4 National Archives and Records Administration(NARA),

2.3.2.2.5 FISMA,

2.3.2.2.6 HIPAA,

2.3.2.2.7 NIST,

2.3.2.2.8 Related VA security and privacy control requirements applicable with provisions and clauses within this requirement.

2.3.2.3 This plan shall address how the contractor will meet these requirements. Simply stating or acknowledging the references is unacceptable.

2.3.3 Task 2: Attend an initial contract kick-off meeting, and attend as needed meetings through the life of the contract.

2.3.3.1 A kick off meeting will be held virtually via teleconference between the vendor and the VA within 14 days after contract award and shall be attended by all staff on contract. The contract requesters (Million Veteran Program Co-Chair Office at VAPAHCS) will coordinate the meeting.

2.3.3.2 The contractor shall be required to communicate with Program staff on an as needed basis throughout the life of the contract via teleconference or videoconference.

2.3.4 Task 3: Receipt and temporary storage of VA samples for metabolomics analysis

2.3.4.1 The contractor shall provide receipt of delivery acceptance within 1 day after sample delivery.

2.3.4.2 The contractor shall include in the PMP the outer boundaries of needed plasma sample quality, quantity and shipping requirement which will then be discussed and finalized at the virtual Kick-off meeting.

2.3.4.3 VA will provide the contractor up to 20,000 coded human plasma samples. The samples shall be stored within 1 day of delivery by the contractor at -80 degrees Celsius in locked upright or chest freezers (with emergency back-up power) until the samples are processed.

2.3.4.3.1 Any unused samples are to be kept until the end of the contract, then returned to VA or destroyed at the request of the COR per specified VA policies.

2.3.4.4 Sample tracking and management process shall be in place to ensure security of VA samples.

2.3.5 Task 4: Metabolomics Analysis

2.3.5.1 The contractor shall have two separate panels for Metabolomics Analysis readily available to run the vendor provided samples. For the base year, the Global Discovery Panel will be used. The appropriate panel to be used during the option years will be determined at the time of order. A Global Discovery Panel is a relative concentrated profile of all structurally named small-molecule entities, which can include both endogenous compounds, xenobiotics, and their metabolites, extracted from the samples and detected by the contractor’s Global Metabolomics platform. A Complex Lipids Targeted Panel measures the concentration of up to 1.125 lipid species using single-point quantitation.

2.3.5.2 Contractor shall test plasma for quality sufficient to proceed with vendor procedures, and to confirm quality from VA reporting sent with samples, and to identity match samples before and after metabolomics measurements.

2.3.5.2.1 Contractor to conduct metabolomic analysis within 8-12 weeks of acceptance of initial delivery of 2,880 samples. Additional batches of 2,880 samples will be sent thereafter and the contractor shall conduct metabolomic analysis at a 4 week cadence.

2.3.5.3 Contractor shall provide the following services when a task order is issued:

2.3.5.3.1 Summary report that includes methods used and quality control statistics

2.3.5.3.2 Raw and scaled data for each biochemical detected

2.3.5.3.3 Measures of variability, including but not limited to inter and intra-plate, between days, and between equipment used for measurement.

2.3.5.3.4 Identity of each metabolite and validation of method used. Identified compounds should be labeled according to whether they have identities

2.3.5.3.4.1 validated by reference standard

2.3.5.3.4.2 matched to literature;

2.3.5.3.4.3 matched to public database;

2.4.5.3.4.4 by molecular formula;

2.4.5.3.4.5 are identified only by unique ion feature

2.3.5.3.5 Quantification of each metabolite

2.3.6 Task 5: Provide reports and required Data

2.3.6.1 Monthly Written Report:

2.3.6.1.1 This report shall be delivered electronically via email no later than 8-12 weeks after the initial acceptance of the first 2,880 samples. Monthly reports shall be delivered for each additional sample batch sent.

2.3.6.1.2 The report shall track parameters, including:

2.3.6.1.2.1 Number of samples completed to desired parameters as requested per the task order

2.3.6.1.2.2 Quality control measurements of data (including number of samples that did not meet QC measurement standards)

2.3.6.1.2.3 These reports will include any non-compliance issues, to include if and the number of samples that do not meet contractor’s QC standards and,

2.3.6.1.2.4 In accordance with the most current industry standards, any other data that may be deemed beneficial to VA by contractor.

2.3.6.2 Required Metabolomics Data

2.3.6.2.1 Contractor shall supply completed metabolomics analyses data for the VA samples including the data requirements in Task 4 within 8-12 weeks of the initial 2,880 sample batch delivered. Additional delivered sample batches of 2,880 that have been metabolomically analyzed will have their data sent monthly. Data must be generated in a secure manner in one or all of the requested formats below:

2.3.6.2.1.1 VA approved encrypted hard drives. Encryption shall be in accordance with VA security standards, VA Handbook 6500.6, by shipment of encrypted physical hard drives to VA location (provided by COR) by courier or overnight shipping, and including signature delivery confirmation. Currently the approved drive is 40TB (RAID 0) CSE-40TB4-SU3 (https://www.buslink.com/product.php?prod_id=442).

2.3.6.2.1.2 VA-approved cloud location encrypted in transit.

Electronic Data and/or physical hard drives shall be sent to the VA or to an approved federal partner location within one week upon completion of each task order unless a specific schedule is mentioned in the individual task order.

2.3.7 Task 6: Destruction of Unused sample and metabolomic data

2.3.7.1 The contractor shall return or destroy unused VA samples, in compliance with relevant sections of VA Handbook 6500.1 and per direction with written approval of the Contracting Officer’s Representative or Contracting Officer.

2.3.7.1.1 The acceptable method of destroying VA samples is by bleaching and certified to that effect.

2.3.7.2 The contractor shall destroy all data associated with VA sample as per direction and with approval of the VA COR/Contracting Officer and in full compliance of the VA Handbook 6500.1 specifically paragraphs 5 and 6.

2.3.7.2.1 Once the data is received, the VA COR will notify the vendor in writing of the same.

2.3.7.2.2 The data on the vendor’s end shall be destroyed by the vendor after documented completion of initial QC checks by the VA.

2.3.7.2.3 The vendor should be able to store the raw data for duration of the contract.

3.0 Contractor Qualifications: The contractor shall have the following qualifications, capabilities, and be able to document the following:

3.1 Laboratory facilities where work to be conducted in is located within the Continental United States.

3.1.1 No work shall be performed outside of the United States or in any locality outside of the jurisdiction of the laws of the United States.

3.2 Evidence that the technology to be used works under human plasma derived from whole blood using EDTA (calcium disodium ethylene-diaminetetraacetate) as anticoagulant

3.3 Data that the technology to be deployed covers major biological pathways as evident by bioinformatic reports to support this statement.

3.4 Evidence that provider has the option to recover further biomarker assays based on original readings

3.5 Platform to be deployed to include at least 1,000 unique biomarkers

3.6 Evidence, from publications, that platform to be deployed can identify individuals at high-risk on a wide range of medical entities (i.e., disease agnostic)

3.7 Provider must demonstrate evidence that have measured >50,000 human samples to date

3.8 Provider must demonstrate that the laboratory facilities where work will be conducted has the capacity for large-scale measurements in tens of thousands per-year

3.9 Capacity for storage of biospecimens in the tens of thousands until direction provided to destroy or return

3.10 Evidence of at least 100 scientific per-review publications using the technology to be deployed by the provider

3.11 An extensive chemical reference library (>4000) metabolites representing the following major metabolic pathways:

3.11.1 Carbohydrate

3.11.2 Vitamin

3.11.3 Energy

3.11.4 Nucleotide

3.11.5 Lipid

3.11.6 Drug metabolites

3.11.7 Microbiome

3.11.8 Amino acids

3.11.9 Xenobiotics

3.12 Final derived data must be reported as verified true biochemical entities rather than spectral features. This data must be compatible with data acquired in previous contract (36C24E21D0013) in terms of specificity and sensitivity THIS IS A CRITICAL REQUIREMENT.

3.13 Ability for Sample tracking and management utilizing bar coding to ensure security & traceability of VA samples.

3.14 Ability to produce documentation of sample handling and processing attributes/audit trail, etc. that would address sample mixing and sample error tracking.

3.15 Demonstrated prior experience working with partners in government, biotechnology, and academic industries

3.16 Extensive working experience with unique/unrecoverable patient plasma (EDTA-calcium disodium ethylene-diaminetetraacetate) samples

3.17 Highly desirable is expertise in statistical and pathway analysis

3.18 The contractor shall demonstrate that they are certified in Good Laboratory Practice (GLP)

3.19 Contractors shall be required to submit for a NACI low level background investigation and security clearance in accordance with the VA IT Security Clause and complete the required training and procedures to comply with these requirements.

4.0 PLACE OF PERFORMANCE

4.1 The performance of this work shall be at the contractors facility, which shall meet the qualifications listed in this PWS.

4.2 All certifications and assurances shall be provided to the COR prior to initiation of work.

4.3 The contractor will not be required to perform sample gathering at a government location, however the contractor will be required to demonstrate that the selected worksite meets all security requirements for the use of research coded samples.

4.3.1 This will include the use of encrypted computers and an established system of information management in accordance with all federal and VA-specific security standards established by Federal law and regulation and VA-specific policy.

4.4 The contractor shall be required to complete and submit a Contractor Security Control Assessment within 30 days of award of a contract in accordance with VA Handbook 6500.6.

4.5 No work shall be performed outside of the United States or in any locality outside of the jurisdiction of the laws of the United States.

5.0 TRAVEL

No contractor travel is required for this contract.

6.0 PERFORMANCE PERIOD

The performance period for these services shall be for five years with no options.

7.0 DELIVERABLES

7.1 Schedule for Deliverables:

7.1 If for any reason, any deliverable cannot be delivered within the time schedule indicated in the approved project schedule, the contractor shall provide a written explanation (within 5 business days prior the due date) to the Contracting Officer, with a copy to the COR.

7.1.1 This written transmittal shall include a firm commitment of when the work shall be completed.

7.1.2 This notice to the COR shall cite the reasons for the delay, and the impact on the overall project.

8.0 Confidentiality and Non-Disclosure

8.1 All samples and data provided by the Government and all data first produced or delivered during this contract is the sole property of the VA.

8.2 The contractor recognizes that in the performance of this contract it may receive or have access to sensitive or confidential information, including personal information of VA employees and information proprietary in nature by system contractors, equipment manufacturers and other private or public entities. The contractor shall restrict access to sensitive or confidential information to the minimum number of employees necessary for contract performance.

8.3 The contractor shall indoctrinate its employees and all subcontractor employees working on this contract on the laws, rules and regulations governing access to sensitive and/or confidential information.

8.4 All persons concerned shall understand that unauthorized access to or use of sensitive or confidential information related to this contract shall result in immediate termination of the individual or individuals from the contract and be subject to legal prosecution to the fullest extent of the law.

8.5 The contractor shall conduct an appropriate background investigation on all of its employees and subcontractor employees working on this contract and who require access to government computer systems.

9.0 Contract Administration

Notwithstanding the Contractor's responsibility for total management during the performance of this contract, the administration of the contract will require maximum coordination between the Government and the Contractor. The following individuals will be the Government's points of contact during the performance of this contract:

9.1 Contracting Officer’s Representative (COR):

The COR shall be designated on the authority of the Contracting Officer at the time of contract award to monitor all technical aspects of the contract. In no event is the COR empowered to change any of the terms and conditions of the contract. Changes in any section of this contract shall be made only by the Contracting Officer pursuant to a properly executed modification. The types of actions within the purview of the COR’s authority are to ensure that the Contractor performs the technical requirements of the contract, and to notify both the Contractor and the Contracting Officer of any deficiencies observed.

10.0 Security:

Security requirements apply. Based upon a review of the PWS/SOW as presented, the contractor will not have access to VA sensitive information or PII/PHI to fulfill the terms of the contract. A BAA will not be required.

11.0 PERFORMANCE REQUIREMENT 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.

Performance Objective

Incentive