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FBO DAILY ISSUE OF APRIL 16, 2010 FBO #3065
DOCUMENT

Q -- GENETIC TESTING FOR TYPE 2 DIABETES FOR HEALTH BEHAVIORS - Justification and Approval (J&A)

Notice Date

4/14/2010
 

Notice Type

Justification and Approval (J&A)
 

NAICS

541712 — Research and Development in the Physical, Engineering, and Life Sciences (except Biotechnology)
 

Contracting Office

Department of Veterans Affairs;VISN 6 Centralized Acquisition Service;300 W. Morgan Street, #1450;Durham NC 27701
 

ZIP Code

27701
 

Archive Date

4/20/2010
 

Point of Contact

Marsha K Harrington-EvansContracting Officer
 

E-Mail Address

Contracting Officer
(Marsha.Harrington-Evans@va.gov)
 

Small Business Set-Aside

N/A
 

Award Number

VA246-P-0556
 

Award Date

4/15/2010
 

Description

DEPARTMENT OF VETERANS AFFAIRSCENTRALIZED ACQUISITION SERVICES - VISN 6 JUSTIFICATION FOR OTHER THAN FULL AND OPEN COMPETITION AS DESCRIBED IN FAR 6.302-1 AND 41 USC 253(C)(1) 1. CONTRACTING AGENCY: The purpose of this memorandum of record is to document the Justification for Other than Full and Open Competition for the Department of Veterans Affairs (VA), VA Medical Center, 508 Fulton Street, Durham, NC, 27701 (Durham VAMC). 2. DESCRIPTION OF ACTION: Sole source award to Duke University Health System (DUHS) Clinical Molecular Diagnostics Laboratory. 3. DESCRIPTION OF SUPPLIES/SERVICES: The Contractor shall provide genomic testing and risk assessment for veterans at risk for Type 2 diabetes (T2DM) for the Durham Health Services Research & Development (HSR&D) Center of Excellence (CoE) in Primary Care. Specific services include developing an accurate, reliable genomic testing for risk of T2DM comprised of sample preparation, transport, DNA extraction, genotyping of markers in KNCJ11, PPARG, and TCF7L2 genes, and results reporting; single nucleotide polymorphisms (SNP) genotyping for KCNJ11, PPARG, and TCF7L2; and temporarily storing samples until all baseline interviews have been completed. 4. PRICING: The total procurement amount is $51,800.00. 5. AUTHORITYCITED: The statutory authority that permits other than full and open competition is 10 U.S.C. 2304(c)(1) and 41 U.S.C 253 (c) (1), and FAR 6.302(1), in that the supplies and services required by the agency are only available from one responsible source. 6. REASON FOR AUTHORITY CITED: Two distinct research competencies are required of the Contractor: (1) access to a Clinical Laboratory Improvement Amendments (CLIA) and College of American Pathologist (CAP)-certified, high-complexity clinical laboratory which can develop a genomic test for Type 2 diabetes risk that uses the following genes: KNCJ111, PPARG, and TCF7L2; (2) a demonstrated level of expertise and qualifications sufficient to perform clinical and genetic risk assessment analyses for T2DM. For logistical efficiency, to avoid the exposure of Durham VAMC patients to representatives of multiple Contractors, and to limit outside access to personal patient information, one (1) Contractor with both competencies described above is required. It is critical that the Contractor have relevant and recent experience with performing laboratory tests for the Durham VAMC, thereby demonstrating awareness of VAMC regulations and the ability to protect the confidentiality of veterans data. Over the past 2 years, the VA has enacted increasingly stringent protocols, policies, directives, and operating procedures for conducting human subject research, especially with regard to access to patient identifiers and personal health information, and with maintaining security of patient data. The Contractor must be up-to-date on VA patient privacy and data security requirements. Recent (< 2 years) laboratory testing experience at the Durham VAMC is specifically requested to assure that the Contractor is familiar with how recent changes in VA requirements are operationalized at this facility. Because of the nature of the collaboration, close geographic proximity (< 10 miles) between the Durham VAMC and Contractor is also required. Specifically, there may be a need for the Durham VA to view the Contractors laboratory techniques and protocols first-hand on-site. Proximity will also allow for frequent interaction with the Durham HSR&D CoE Staff and direct supervision of contract-related activities, efficient and effective oversight, monitoring, and close management. This proximity will also minimize direct travel costs to the VA. A needs analysis was conducted and HSR&D has determined that it is more cost effective to contract with DUHS Clinical Molecular Diagnostics Laboratory for these services versus hiring additional VA staff, and purchasing the equipment/space necessary to perform the testing. Further research revealed that the Contractor has impressive qualifications which uniquely qualify them for the requested services. DUHS Clinical Molecular Diagnostics Laboratorys advantages for the timely, efficient, and effective completion of this project include: a. The proposal submitted to and funded by the Department of Veterans Affairs included the DUHS Clinical Molecular Diagnostics Laboratory as the specified vendor for the requested services. b. The DUHS Clinical Molecular Diagnostics Laboratory is a College of American Pathologist (CAP)-accredited, Clinical Laboratory Improvement Amendments (CLIA)-certified, state-of-the-art, multidisciplinary laboratory that is dedicated to providing patients and physicians with comprehensive and accurate molecular testing. The laboratory performs all of the high-complexity DNA and RNA testing for the Duke University Health System. In 2009, approximately 17,000 tests were performed from a test menu of 35 assays. c. This laboratory currently conducts specialized clinical, including genetic, testing for patients at the Durham VAMC. d. The DUHS Clinical Molecular Diagnostics Laboratory is the only laboratory nationwide with validated assays to genotype single nucleotide polymorphisms in all three diabetes-related genes being studied in this proposal (KCNJ11, PPARG, and TCF7L2). Currently, no other academic clinical laboratory was conducting genotyping on the TCF7L2 gene. Genotyping of the PPARG gene related to diabetes is only conducted at the Center of Nephrology and Metabolic Disorders in Weisswasser, Germany. KCNJ11 genotyping in a clinical laboratory setting can be done throughout Europe, at the University of Chicago, or at Seattles Childrens Hospital. In addition to the close proximity of the DUHS Clinical Molecular Diagnostics Laboratory to the Durham VAMC there is an established courier system that will enable operational efficiencies and effectiveness. 7. FAIR AND REASONABLE PRICE DETERMINATION: Price reasonableness is determined by what was included as part of the research protocol that was reviewed by scientific experts and deemed fair and reasonable for these type of scientific/research expert services as approved for funding by VA Office of Research and Development (ORD), Health Services Research & Development (HSR&D). All research protocols and budgets are peer-reviewed by other scientists and administrators as part of the merit review and funding process. 8. MARKET SURVEY/RESEARCH: Market research was conducted using Google to locate vendors meeting the following criteria: * Geographic proximity; * Recent experience performing laboratory tests for clinical or research purposes for VA Medical Centers; * Demonstrated expertise and qualifications sufficient to perform clinical and genetic risk assessment analyses for T2Dm; * Access to a CLIA- and CAP-certified, high-complexity clinical laboratory capable of developing a genomic test for Type 2 diabetes risk using the following genes: KNCJ11, PPARG, and TCF7L2; * Demonstrated preparedness to immediately execute the contract with minimal modifications. Google search returned 50 results that were examined individually for relevance to the requested services. Google ranks the results by decreasing relevance and after a review of 50 was unproductive, the review ended. No viable contractors besides the Duke University Health System (DUHS) Clinical Molecular Diagnostics Laboratory were found. 9. EFFORTS TO OBTAIN COMPETITION: A market survey was completed for the various laboratories within a ten (10) 10 mile radius to the Durham VAMC in order to see if any met the requisite qualifications. Additionally, qualifications were limited in a manner that would meet the VAs research needs and provide more laboratories with an opportunity to bid on the contract. The VA found that the number of laboratories that provide these services is severely limited in this region and worldwide. 10. BARRIERS TO COMPETITION: It is expensive and time consuming to run a lab that offers all of the genetic testing required for this requirement and it is common for laboratories that offer genetic testing to specialize in such a way that there is not a lot of overlap in services regionally. As genetic testing becomes more prevalent in the field of medicine and health research, the VA anticipates more labs will become CLIA and CAP certified laboratories and will develop capabilities beyond those they currently utilized. 11. INTERESTED SOURCES: No other sources have expressed an interest in this acquisition in writing. 12. CONTRACTING OFFICERS CERTIFICATION: This Contracting Officer certifies that this justification is accurate and complete to this best of my knowledge and belief. Marsha K. Harrington-Evans Contracting Officer
 

Web Link

FBO.gov Permalink
(https://www.fbo.gov/notices/47ea70d4bc3ac9fa5dc2c3d245538b34)
 

Document(s)

Justification and Approval (J&A)
 

File Name: VA246-P-0556 VA246-P-0556_1.DOC (https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=115339&FileName=VA246-P-0556-000.DOC)

Link: https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=115339&FileName=VA246-P-0556-000.DOC

 

Note: If links are broken, refer to Point of Contact above or contact the FBO Help Desk at 877-472-3779.
 

Record

SN02121656-W 20100416/100414235012-47ea70d4bc3ac9fa5dc2c3d245538b34 (fbodaily.com)
 

Source

FedBizOpps Link to This Notice
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