SOLICITATION NOTICE
A -- DNA Processing and Analysis-Yale University Sole Source
- Notice Date
- 6/20/2012
- Notice Type
- Presolicitation
- NAICS
- 611310
— Colleges, Universities, and Professional Schools
- Contracting Office
- Department of Veterans Affairs;VA Boston Healthcare System;Contracting Officer (90C);940 Belmont Street;Brockton MA 02301
- ZIP Code
- 02301
- Solicitation Number
- VA24112R0815
- Response Due
- 7/6/2012
- Archive Date
- 10/4/2012
- Point of Contact
- Cheri K. Wicks (No Phone Calls; email only.)
- Small Business Set-Aside
- N/A
- Description
- The Department of Veterans Affairs, VA Boston Healthcare System, has a requirement for DNA processing and analysis. An Indefinite Delivery, Indefinite Quantity contract for 60 months is anticipated and shall be awarded. It is the Government's belief that only the Yale University Keck Laboratory and Yale Center for Genomic Analysis possess the required capabilities to successfully meet this requirement. It is the Government's intention to solicit and negotiate only with this source. Please refer to the Sole Source Justification. This is not a solicitation; it is notice of intent to sole source a requirement. Inquiries/information received after the established deadline shall not be considered. The submission of any data for review shall not impede award of this contract as planned. The Government does not intend to pay for information solicited. This synopsis is issued pursuant to FAR 6.302-5. JUSTIFICATION FOR OTHER THAN FULL AND OPEN COMPETITION 1.Contracting Activity: Department of Veterans Affairs, VISN 1, VA Connecticut Medical Center, Clinical Epidemiology Research Center (CERC) Transaction numbers: 689-12-3-2115-0129, 689-12-3-2115-0130, 689-12-3-2115-0131, 689-12-1-2116-0029 (One IDIQ contract will be awarded and these four transactions will be the first four task orders issued under the contract.) 2.Nature and/or Description of the Action Being Processed: VA CSP Clinical Epidemiology Research Center (CERC) is requesting to sole source Yale University laboratories Keck and Yale Center for Genomic Analysis for the purpose of DNA processing and analysis of 19,000 participants from project, CSP#572, Genetics of Functional Disability in Schizophrenia and Bipolar Illness using HumanOmni 2.5Exome BeadChip technology as described in the approved protocol. A sub-study of CSP#572, Preliminary Genomic Analyses: Genotyping And Exome Sequencing requires that 600 samples be processed using HumanOmni2.5/Exome beadchip, and be additionally processed using SeqCap full sequencing of the 600 samples. "For Genomic DNA analysis of blood samples using GWAS/genotyping processing and analysis of 19K samples from CSP572 participants using HumanOmni2.5M beadchip technology; "For Genotyping/Exome processing and analysis of 600 samples using HumanOmni2.5MExome; plus second SeqCap sequencing analysis of the 600 sub-study samples for validation. The resulting contract will be an IDIQ and the three listed transactions will be the first three task orders issued. The estimated value of these three task orders will be approximately $1,123,800. 3.Description of Supplies/Services Required to Meet the Agency's Needs: CSP#572 project aims to conduct a genomewide association analysis (19,000 samples), comparing veterans with schizophrenia (4,750 samples) and bipolar illness (4,750 samples) to "psychiatrically healthy" veterans (9,500 samples), thereby investigating genetic risk factors for these disorders. The second primary aim is to determine genetic risk factors underlying several phenotypes reflecting important clinical outcomes among patients with schizophrenia (SZ) and bipolar illness (BP)-including functional disability, cognitive impairment, suicidality, and tardive dyskinesia-and to determine whether/how they overlap with the susceptibility genes for the disorders themselves. As a sub-study of this project, we are to conduct genotyping with exome chip processing of 600 samples (200 SZ, 200 BP and 200 controls) using Illumina HumanOmni 2.5Exome BeadChip. These 600 samples will also be analyzed and processed using SeqCap full exome sequencing validation. 4.Statutory Authority Permitting Other than Full and Open Competition: 38 U.S.C. 8153 and U.S.C. Section 253 (c) (5) as implemented by FAR6.302-2. () (1) Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements per FAR 6.302-1; ( ) (2) Unusual and Compelling Urgency per FAR 6.302-2; ( ) (3) Industrial Mobilization, Engineering, Developmental or Research Capability or Expert Services per FAR 6.302-3; ( ) (4) International Agreement per FAR 6.302-4 (X) (5) Authorized or Required by Statute FAR 6.302-5; ( ) (6) National Security per FAR 6.302-6; ( ) (7) Public Interest per FAR 6.302-7; 5.Demonstration that the Contractor's Unique Qualifications or Nature of the Acquisition Requires the Use of the Authority Cited Above (applicability of authority): Yale University Keck/YCGA is the only a VA-affiliated local institution with full service facility dedicated to providing RNA expression profiling, DNA genotyping, high throughput DNA sequencing, and microRNA analysis services in a research environment. The Microarray Resource is devoted to enabling its users to rapidly and effectively utilize RNA and DNA analysis to answer important biological and biomedical questions and thereby better understand, diagnose, stage, treat, and prevent a wide range of human diseases. Additionally, the Keck/YCGA lab staff (including director, who is the named Genomics Lab PI for this project) has been working with the CERC project team, including informatics and Geneticist team, in support of biostatistics analysis of this project. They have been present and presented at the planning meetings, annual meetings and attend project staff weekly calls. Because of the interface required between the Keck/YCGA and the CERC Informatics team when transferring data and collaboration during preparation of the biostatistics analysis, a local laboratory with past collaboration history will be "key" in getting this project running efficiently and cost-effectively. 6.Description of Efforts Made to ensure that offers are solicited from as many potential sources as deemed practicable: No efforts were made to compete this requirement as that would nullify all efforts already done by the Genomics lab PI and the planning phase of the project. Due to the unique nature of the samples and analysis required, it is doubtful this requirement can ever be opened up to full and open competition. 38 U.S.C. 8153 paves the way and thus encourages the use of academic affiliates when acquiring healthcare resources. 7.Determination by the Contracting Officer that the Anticipated Cost to the Government will be Fair and Reasonable: The pricing will be based upon standard academic salaries and costs per tests offered to other healthcare entities. Sufficient cost data will be requested to support a determination of fair and reasonable pricing as well as a copy of the current audited and negotiated indirect cost rate with the cognizant Federal agency. Use of Salary Wizard and Bureau of Labor Statistics websites will be used to validated the salary and fringe benefits. Therefore, a combination of market research, contracting officer's personal knowledge of similar awards with academic affiliates, comparison of the proposed price with prices found reasonable on previous purchases, and comparison to an Independent Government Cost Estimate under FAR 15.404-1 will be utilized to make a positive determination of fair and reasonable pricing. 8.Description of the Market Research Conducted and the Results, or a Statement of the Reasons Market Research Was Not Conducted: No efforts will be made to compete this requirement as use of another source would nullify all efforts already done by the Genomics lab PI and the planning phase of the project. Due to the unique nature of the samples and analysis required, it is doubtful this requirement can ever be opened up to full and open competition. 38 U.S.C. 8153 paves the way and thus encourages the use of academic affiliates when acquiring healthcare resources. 9.Any Other Facts Supporting the Use of Other than Full and Open Competition: The Keck/Yale Center for Genomic Analysis has been involved with the project from planning phase, with the director of the lab having the role of Genomic Lab PI for CSP#572. The lab DNA processing and analysis described in this document is as described in the study protocol. Additionally, the Keck/YCGA have the expertise and the technology to do the specified GWAS/genotyping and full sequencing exome analysis. 10.Listing of Sources that Expressed, in Writing, an Interest in the Acquisition: No additional sources will be sought due to the reasons stated above; no additional entities will be provided with an opportunity to express an interest in writing. 11.A Statement of the Actions, if any, the Agency May Take to Remove or Overcome any Barriers to Competition before Making subsequent acquisitions for the supplies or services required: Research requirements are unique in nature and often require unique and specialized sources. The staff and leadership of CERC continually monitor the academic environment and are aware of the capabilities of individual affiliates. In the event two or more affiliates are capable of meeting the project requirements, competition between the affiliates will be attempted.
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