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 requirement is to provide continued high throughput genotyping array, DNA methylation, and proteomic analysis on custom chips that are being used for the molecula analysis of human samples for the VA sponsored Million Veteran Program (MVP) ongoing medical study. The MVP study has already processed the samples of over 800,000 veteran participants, which contained 700,000 genotyping samples, 32,000 methylation samples and 2,000 metabolite sample analysis. The data is currently being actively used by over 31 research teams to investigate various diseases including PTSD, Gulf War Syndrome, Cardiovascular disease, Ageralated macular eye disease, tinnitus, Kidney disease, diabetics, multiple myeloma, Suicidality, Dementia, Schizophernia & biopolar and many others. The continued success of the MVP study necessitates continuity in processes and protocols. The specific work to be performed includes: Continuity with current Exome Genotyping procedures and protocols. Headquarters and laboratory facilities where all the services are performed in full or in parts should be located within the Continental United States. Ability to manufacture or purchase and process VA approved technology and reagents for human genotyping or similar molecular assays on VA approved analysis platform (Illumina or Affymetrix). Ability to conduct high-throughput genotyping of VA human DNA samples at >97% genotyping call rate and >99% reproducibility, and >85% marker pass rate for methylation assay per sample. Demonstrate formal 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. Demonstrate ability to collect, store and make available all meta data that may be required for data Quality Assurance/Quality Control (QA/QC), assay validation and data trouble shooting etc. Ability to produce documentation or electronic evidence of sample handling and processing attributes/audit trail, etc. that can address sample mixing, sample error tracking, sample destruction and data QC related issues. Demonstrate formal SOP s for sample and data handling/processing including QA/QC. Any and all changes to the SOPs should be made only after written permission from the VA PM approving such action. Documented evidence of vendor staff experience in performing high throughput sample and data QC with less than 5% error rate. All the QA/QC metrics and threshold developed in the project previously shall be strictly followed and adhered to. No deviations are permitted unless approved in writing by the VA PM. Documented evidences of project staff experience with providing bioinformatics support for data processing in accordance with the mutually agreed upon workflow and pipeline. Any and all changes to the workflows or pipeline must be pre-approved in writing from the VA PM. The contractor shall run all controls as previously agreed upon. Controls shall be added or changed only with mutually agreed upon sign-off documentation. Ability to propose project staff with minimum qualifications & skillsets in performing high throughput assays on the VA approved platform and bioinformatics experience with data QA/QC, GWAS, SNP and other relevant analysis. All personnel employed by the Contractor who monitor, come in-contact or oversee VA samples or data 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. 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 Tuesday, Feb 20, 2020, (10:00 AM, EST). Interest/capability statements may be sent to Michael Haydo at
[email protected]. 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.