36C24E20R0019-000.docx

Contract Opportunity Special Notice

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* = Required Field Contract Opportunity Special Notice Q301 MVP Genome BioStorage Intent to Sole Source Due to the inability to update the specifications on Special Notice 36C24E20R0010, this new notice has been issued with the updated information.

15212-5319 36C24E20R0019 N 541380 US Department of Veterans Affairs Veterans Health Administration Regional Procurement Office (RPO) East 323 North Shore Drive, Suite 500 Pittsburgh PA 15212-5319 Contracting Officer: Michael Haydo Email: michael.haydo@va.gov The Veteran’s Administration (VA) Office of Research and Development, Regional Procurement Office – East in Pittsburgh, PA intends to negotiate on a sole source basis with BioStorage Technologies, Inc., based in Indianapolis, Indiana. The Million Veteran Program (MVP) is a national research program initiated in 2011 that is creating a resource of genetic information of one million consented Veteran volunteers linked with information from self-reported survey instruments and their electronic health records. Currently, over 800,000 participants have fully consented and provided a blood sample to MVP.

The government’s requirement is to provide continued high throughput custom genotyping array, DNA methylation, and molecular analysis on custom genotyping single nucleotide polymorphisms (SNP) chips being used for the molecular analysis for the ongoing MVP research samples. The MVP study has already processed over 800,000 samples, including 700,000 genotyping samples, 42,000 methylation samples and 2,000 metabolite sample analyses. The resultant data is currently being analyzed by more than 31 research teams to investigate various diseases affecting Veterans including PTSD, Gulf War Syndrome, Cardiovascular disease, Age related eye disease, Tinnitus, Kidney disease, diabetics, multiple myeloma, Suicidality, Dementia, Schizophrenia, bipolar illness, and many others. The continued success of the MVP research study necessitates continuity in the custom processes and protocols to reduce batch variations. Current processes, procedures and assay conditions have resulted in batch variations of below 1% by customizing these assays, and this level of continuity needs to be maintained to prevent disruptions and to generate the required statistical prediction power for MVP data as a single cohort.

The specific work to be performed includes:

· Continuity of the current VA custom SNP Genotyping procedures and protocols that are in place to ensure no disruption to the high throughput analytical services and/or changes or deviations in the assay and data quality.

· Headquarters and laboratory facilities where all the services are performed in full or in parts should be located within the Continental United States.

· Continue to conduct high-throughput custom research grade genotyping of VA human DNA samples at >97% genotyping call rate and >99% reproducibility on Thermofisher Axiom platform using VA custom SNP chip content with the VA custom protocol and processes.

· Continued conduct of custom high-throughput research grade methylation assay on Illumina Infinium EPIC array platform with >850,000 targets with the VA approved protocol and process.

· Continued custom electronic sample tracking and management system utilizing bar coding for acquiring and storing all sample processing data and metadata including VA approved validation methods to ensure security & traceability of each individual VA samples.

· Continued collection, storage and availability of all customized metadata that are required for data Quality Assurance/Quality Control (QA/QC), assay validation and data trouble shooting etc.

· Strict adherence to VA custom SOP’s currently in practice for sample and data handling/processing including QA/QC.

· All custom QA/QC metrics and threshold currently utilized in the project shall be strictly followed and adhered to. No deviations are permitted.

· The contractor shall run all custom controls as previously tested and approved.

· All personnel employed by the Contractor who monitor, come in-contact or oversee VA samples or data shall be required to have a NACI low level background investigation and security clearance in accordance with the VA IT Security Clause and completed the required training and procedures to comply with these requirements.

The requirement will take place at the contractor’s facility. The sole source is pursuant to FAR 6.302-1 Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements. This notice of intent is not a request for competitive proposals, however; any responsible source who believes it is capable of meeting the requirement may submit a capability statement and supporting documentation to the contracting office no later than Wednesday, March 11, 2020, (10:00 AM, EST). Interest/capability statements may be sent to Michael Haydo at Michael.haydo@va.gov. No telephone responses will be accepted. A determination not to compete the proposed requirement based upon the responses to this notice is solely within the discretion of the Government.