Loren Data's SAM Daily™

FBO DAILY - FEDBIZOPPS ISSUE OF FEBRUARY 08, 2014 FBO #4459
DOCUMENT

65 -- PCR Test Kits - Justification and Approval (J&A)

Notice Date

2/6/2014
 

Notice Type

Justification and Approval (J&A)
 

NAICS

325413 — In-Vitro Diagnostic Substance Manufacturing
 

Contracting Office

Department of Veterans Affairs;Network Contracting Office 6;100 Emancipation Drive;Hampton VA 23667
 

ZIP Code

23667
 

Archive Date

2/16/2014
 

Point of Contact

Amy K Pitts
 

E-Mail Address

8-3144<br
 

Small Business Set-Aside

N/A
 

Award Number

VA246-14-P-2302
 

Award Date

2/6/2014
 

Description

DEPARTMENT OF VETERANS AFFAIRS Justification and Approval For Other Than Full and Open Competition 1.Contracting Activity: Department of Veterans Affairs, VISN 6, Asheville Medical Center submits a Justification for Other Than Full and Open Competition in response to procurement request 637-14-1-167-0008. 2.Nature and/or Description of the Action Being Processed: This is a request for other than full and open completion for the procurement of C. Difficile/Epi, CT/NG, and Flu test kits from Cepheid. 3.Description of Supplies/Services Required to Meet the Agency's Needs: : The Asheville VAMC requires C. Difficile/Epi, CT/NG, and Flu test kits which are used on the GenXpert analyzer owned by the station. The estimated cost is $71,743.50. 4.Statutory Authority Permitting Other than Full and Open Competition: 41 USC §253(c)(1), as implemented by FAR 6.302-1. ( X ) (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 ( ) (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): The station purchased PCR analyzers from Cepheid in 2008, and the analyzer is used to test for C. Difficile, MRSA, CT/NG, and Flu. Cepheid is the only manufacturer of test kits for this analyzer. A substantial duplication of cost would be incurred by requiring the station to purchase a new analyzer and test kits, and cause unacceptable delays testing patients for C. Difficile due to the validation process required when a laboratory purchases a new analyzer. The test kits provide results in less than one hour, thereby decreasing potential transmission time and substantially increasing the time to receive treatment for C. Difficile. 6.Description of Efforts Made to ensure that offers are solicited from as many potential sources as deemed practicable: The FDA clearance database was surveyed to find vendors capable of providing automated PCR C. Difficile test kits. Two companies have FDA clearances for test kits, Cepheid and Becton Dickinson. Becton Dickinson test kits cannot be used in the Cepheid analyzer owned by the station, thus Cepheid is the only source for the kits. 7.Determination by the Contracting Officer that the Anticipated Cost to the Government will be Fair and Reasonable: Test costs have been found to be fair and reasonable based on comparison to published prices for the same test and the price to send the test out to a third party lab. 8.Description of the Market Research Conducted and the Results, or a Statement of the Reasons Market Research Was Not Conducted: Market research was not performed for this acquisition. Market research has been performed to determine potential sources for the VISN-6 blanket purchase agreement (BPA) for PCR testing kits, which will begin on 10/1/14. A summary of the BPA market research is as follows: The FDA clearance database was surveyed. Vendors may not sell test reagents in the United States without first obtaining FDA clearance, and only two companies have obtained clearance to provide an automated PCR test for C. Difficile and MRSA. Only Cepheid produces a PCR Kit to test for flu and CT/NG. A second company anticipates releasing a CT/NG test kit in the Spring of 2014. 9.Any Other Facts Supporting the Use of Other than Full and Open Competition: None. 10.Listing of Sources that Expressed, in Writing, an Interest in the Acquisition: None. 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: The two vendors who provide automated PCR tests for C. Difficile are currently renegotiating contracts with the NAC. It is expected both companies will have contact awards by April 2014, at which time a solicitation will be published to GSA eBuy to establish a BPA and both systems will be evaluated.
 

Web Link

FBO.gov Permalink
(https://www.fbo.gov/notices/551c6538a90f1baa970418a691405797)
 

Document(s)

Justification and Approval (J&A)
 

File Name: VA246-14-P-2302 VA246-14-P-2302_1.docx (https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=1196450&FileName=-3077.docx)

Link: https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=1196450&FileName=-3077.docx

 

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

Record

SN03282656-W 20140208/140206234457-551c6538a90f1baa970418a691405797 (fbodaily.com)
 

Source

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

---

| FSG Index  |  This Issue's Index  |  Today's FBO Daily Index Page |