GS-07F-0597T-010.pdf

DEPARTMENT OF VETERANS AFFAIRS

FAR 8 – Justification for Limiting Sources (LSJ) For

Limiting Sources (<SAT)

Acquisition Plan Action ID: 36C44-19-AP-2704

1. Contracting Activity: Department of Veterans Affairs, VISN 04, Lebanon VA Medical Center, 1700 South Lincoln Ave, Lebanon, PA 17042

2. Description of Action: New Requirement / Sole Source / GSA Contract Purchase Requisition number is 642-19-2-315-0097.

Order against: GSA Contract Number: GS-07F-0597T

Manufacturer Name of Proposed Contractor: Cepheid Street Address: 904 Caribbean Drive City, State, Zip: Sunnyvale, CA 94089-1189 Phone: 215-422-2159

3. Description of Supplies:

The estimated value of the proposed action is $ 148,585.00.

The Lebanon VA Medical Center has a Sole Source requirement for Cepheid GeneXpert XVIR2 Molecular Analyzer System to perform definitive, rapid, real-time polymerase chain reaction which integrates a completeon-board nucleic acid purification system with amplification and detection of select pathogens in a self-contained system.

Quantity Model# Description 1 GXXVI-16-D GeneXpert XVI R2 16 Module Configuration

GeneXpert XVI, 16 Testing Site System w/6 Color Modules, Desktop Computer & Dx Software

1 PRINTER-BW B&W Printer for GeneXpert and Smartcycl Printer, Black & White, incl. USB cable.

1 850-0386 Pro APC Power-Saving Back-UPS 1500/120V

4. Authority:

ORDER AGAINST FSS: Authority of the Multiple Award Schedule Program, Title III of the Federal Property and Administrative Services Act of 1949 (41 USC 251, et seq.); Title 40 USC 501, Services for Executive Agencies; and Section 803 of the National Defense Authorization Act of 2002 (PL 107-107) and implemented by FAR 8.405-6.

An urgent and compelling need exists, and following the procedures would result in unacceptable delays(FAR 8.405-6(a)(1)(i)(A);

Only one source is capable of providing the supplies or services required at the level of quality required because the supplies or services are unique or highly specialized;

(FAR 8.405-6(a)(1)(i)(B));

In the interest of economy and efficiency, the new work is a logical follow-on to an original Federal Supply Schedule order and the original order was placed in accordance with the applicable Federal Supply Schedule ordering procedures. The original order was not previously issued under sole-source or limited-sources procedures (FAR 8.405-6(a)(1)(i)(C)); or

5. Rational/explanation to support cited authority: The Lebanon VA Medical Center is requesting a Sole Source purchase for the Cepheid GeneXpert XVIR2-fully automated molecular analyzer to replace the existing Gene Xpert system located in the main laboratory . The existing system has currently exceeded its life cycle. This particular analyzer is manufactured and only distributed through the Cepheid Company.

The General Service Administration (GSA) currently has an existing contract for the purchase of the Gene Xpert system. A notice of intent to sole source was posted to GSA and Federal Business opportunities as required over $25,000.00 and no alternative responses were received from any additional sources.

The unique qualifications of the GeneXpert System are:

A. The GeneXpert System is the only analyzer that can run our existing infectious disease testings, such as: Chlamydia, gonorrhea, MRSA/SA, pre-surgical screenings, flue/RSV. This feature eliminates the need of purchasing multiple analyzers to run our existing infectious disease tests.

Items peculiar to one manufacturer. An item peculiar to one manufacturer can be a particular brand name, product, or a feature of a product, peculiar to one manufacturer).

A brand name item, whether available on one or more schedule contracts, is an item peculiar to one manufacturer (FAR 8.405-6(b)).

B. The GeneXpert System can run tests on demand and deliver molecular diagnostics within hours. Other molecular systems require batch testing and take days to delivery results.

6. BRAND NAME ONLY: This buy is estimated to exceed $25,000 and this documentation will be posted along with the RFQ on e-Buy, as required by FAR 8.405-1(e)

7. Note that this determination satisfies the requirements of FAR 8.405-6. The requirement to prepare a written justification IAW FAR 6.303 does not apply to Federal Supply Schedules.

Andrew Taylor Contracting Officer Date: 05-03-2019

Darlene Seminko Branch Chief, NCO 4 Date: 05-03-2019