Loren Data's SAM Daily™

FBO DAILY ISSUE OF DECEMBER 07, 2012 FBO #4031
DOCUMENT

66 -- Lyme Disease Testing Supplies (Base + 4 Yrs) VIDAS 30 System - VAMC West Haven CT - Justification and Approval (J&A)

Notice Date

12/5/2012
 

Notice Type

Justification and Approval (J&A)
 

NAICS

325413 — In-Vitro Diagnostic Substance Manufacturing
 

Contracting Office

Department of Veterans Affairs;VISN 1 Network Contracting Office;Acquisitions-90;421 North Main Street;Leeds MA 01053-9764
 

ZIP Code

01053-9764
 

Solicitation Number

VA24113Q0060
 

Archive Date

3/12/2013
 

Point of Contact

Teresa J Cutty
 

E-Mail Address

4-4040
 

Small Business Set-Aside

N/A
 

Award Number

VA241-13-D-0026
 

Award Date

12/3/2012
 

Description

DEPARTMENT OF VETERANS AFFAIRS Justification and Approval For Other Than Full and Open Competition 1.Contracting Activity: Department of Veterans Affairs, VISN 1, VA New England Healthcare System, Network Consolidated Laboratory, Mary-Ann Bridgwood, Program Manager, NCL 113, 940 Belmont St., Brockton, MA 02301 Justification for Other Than Full and Open Competition. 2.Nature and/or Description of the Action Being Processed: New contract request for base plus 4 year option agreement for reagent test kits from Biomerieux for Lyme Disease Testing on the VIDAS 30. Options will be exercised at the discretion of the Government. 3.Description of Supplies/Services Required to Meet the Agency's Needs: Kits for Lyme Disease Testing with an estimated minimum of 60 kits purchased per year 4.Statutory Authority Permitting Other than Full and Open Competition: X (1) Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements per FAR 6.302-1; 5.Demonstration that the Contractor's Unique Qualifications or Nature of the Acquisition Requires the Use of the Authority Cited Above (applicability of authority): The Biomerieux VIDAS 30 was purchased with equipment funds in anticipation of changing the methodology for performing Lyme Disease testing in the West Haven VA Molecular Lab. In the summer of 2011, the supervisor had access to an old VIDAS and was able to perform correlation studies to compare this new system with the current system for Lyme Disease testing. Specificity, sensitivity and patient correlations were performed and compared and the VIDAS 30 Lyme testing method was clinically more comparable to the gold standard (western blot method of Lyme testing). Another factor was that this new test method was also much cheaper than the current methodology. These test kits are specifically made for either the VIDAS 30 or miniVIDAS and only these kits can be run on these analyzers. Biomerieux is the manufacturer and sole source of supply for these test kits and the VIDAS 30 system. 6.Description of Efforts Made to ensure that offers are solicited from as many potential sources as deemed practicable: The cost analysis was performed by the Supervisor for Molecular Diagnostics. These were the 3 test systems/methodologies under consideration during the technical research period. 7.Determination by the Contracting Officer that the Anticipated Cost to the Government will be Fair and Reasonable: The commercial price of these test kits from Biomerieux is $X.XX/kit of 60 tests. Biomerieux is offering the Government discounted pricing. Pricing is deemed fair and reasonable. 8.Description of the Market Research Conducted and the Results, or a Statement of the Reasons Market Research Was Not Conducted: Three different test systems/methodologies were evaluated and or considered during technical research evaluation. The Biomerieux VIDAS 30 method was cheaper and clinically better than the current method in use. The VIDAS method required 15 minutes of tech time while the current method required 45 minutes of dedicated tech time. Turnaround time was improved from 3.5 hours to 1 hour. The VIDAS method also requires less sample manipulation therefore decreasing the potential for contamination, and making it safer for the tech running the assay. The assay showed excellent correlation with the current method and even better correlation with the Lyme Western Blot results. The VIDAS Lyme assay is the most used assay by labs that participate in the College of American Pathologists Proficiency Testing Surveys. No issues have been identified with this assay when reviewing participant summaries. 9.Any Other Facts Supporting the Use of Other than Full and Open Competition: The VIDAS Lyme method provides easy result interpretation. There is no equivocal zone for the VIDAS Lyme IgG results. It is clear cut and rapid allowing optimized treatment depending on the stage of the infection. 10.Listing of Sources that Expressed, in Writing, an Interest in the Acquisition: Three methods were technically evaluated and/or considered. No other sources are sought at this time due to the acquisition of the VIDAS 30 system in FY 2012. 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: A base plus 4 year option provides the VA with the ability to not renew an option if the service or product does not meet the standards and requirements of the VA. This will be reviewed each year before renewing the next year's option.
 

Web Link

FBO.gov Permalink
(https://www.fbo.gov/spg/VA/NoVAMC/VAMCCO80220/VA24113Q0060/listing.html)
 

Document(s)

Justification and Approval (J&A)
 

File Name: VA241-13-D-0026 VA241-13-D-0026 JUSTIFICATION AND APPROVAL.docx (https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=543894&FileName=VA241-13-D-0026-000.docx)

Link: https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=543894&FileName=VA241-13-D-0026-000.docx

 

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

Record

SN02943050-W 20121207/121205234322-721d425a80149728acc77d9824102e1c (fbodaily.com)
 

Source

FedBizOpps Link to This Notice
(may not be valid after Archive Date)

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