-15531.pdf

DEPARTMENT OF VETERANS AFFAIRS

Justification for Single Source Awards IAW FAR 13.106 1 For

Over Micro Purchase Threshold but Not Exceeding the SAT ($250K)

Acquisition Plan Action ID: VA256 18 AP 0739

1. Contracting Activity: Department of Veterans Affairs, VISN 16, Jackson Medical Center, NCO 16 Contracting Jackson Supply Team A. 2237 # 586 19 1 042 0022. Estimated $42,268.20 per year, $211,341.00 total for base and 4 options .

2. Brief Description of Supplies/ Services required and the intended use/Estimated Amount: Base year and 4 possible options Lease of Cepheid GeneXpert Analyzer for the Jackson VAHCS. The Cepheid Infinity is used to perform clinical laboratory testing by PCR for Clostridium difficile/Epi (C.

difficile), MRSA next generation, MTB/RIF, Flu, Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG), and Factor II & Factor V. The system is an upgrade to currently government owned Cepheid GeneXpert analyzers that will remain in use in the clinical laboratory allowing for expansion of services. This will include service and support of the equipment. Jackson VHS is asking for a base plus 4 year. This procurement will include an analyzer with printer. Cepheid GeneXpert Platform is currently in use at Jackson VAHCS.

3. Unique characteristics that limit availability to only one source, with the reason no other supplies or services can be used: A work flow analysis was conducted due to decreased staffing and increased workload. A larger capacity GeneXpert is required to handle our Flu volumes and additional MRSA testing. Microbiology laboratory operation 24/7 is optimal for excellent patient care. Continued use of the Cepheid GeneXpert System currently in use and owned by the VA in addition to a new fully automated molecular Infinity 48 24 system will benefit Jackson VAHCS by consolidating testing, gaining efficiency by reducing technologist time, as well as expanding services.

The Cepheid GeneXpert Reagent Test Cartridges are proprietary to Cepheid and are solely approved for use on the Cepheid GeneXpert systems. Proprietary methods are used by Cepheid to design and synthesize oligonucleotide primers, probes, and dyes specific for each test cartridge. The GeneXpert System can only be used with a GeneXpert cartridge no other cartridge is acceptable.

Reagents and supplies are equipment specific and are compatible with existing equipment currently used in the laboratory. Currently, the reagent analyzers in place are Cepheid brand and are owned by the VA. In order to use other reagents, brand the Government would need to purchase new equipment, re trained employees, terminate multiple service contracts in place for convenience, and delaying the care for veteran patients, which is not economically feasible nor advantageous to the VA.

4. Description of market research conducted and results or statement why it was not conducted:

While distributors identified as available for the private sector and outside the United States, correspondence with the manufacturer indicated that no distributors were authorized for Government (VA) sales. Existing equipment is state of the art and no other vendor could provide all the test required by Jackson VAHCS.

Sources sought was performed trying to identify SDVOB, VOSB and/or SB vendors that could potentially provide the requirement. However, there we no positive responses since the reagents and tests analysis are proprietary to Cepheid, and is the sole distributor. Continue market research will be accomplished to verify if future opportunities can be placed for competition.

5. Contracting Officer's Certification: Purchase is approved in accordance with FAR13.106 1(b). I certify that the foregoing justification is accurate and complete to the best of my knowledge and belief.

Name Date Title

CLAY K JONES 685130 Digitally signed by CLAY K JONES 685130 Date: 2018.09.14 09:29:47 -05'00'