6630--Cephied Equip COVID19

VHAPM Part 813.106 Simplified Acquisition Procedures: Soliciting from a Single Source

Attachment 1: Single Source Justification for SAP under the SAT

VHAPM Part 813.106 Page 1 of 2

Original Date: 08/30/17

Revision 01 Eff Date: 04/23/2018

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: 36C250-20-AP-4591

Contracting Activity: Department of Veterans Affairs, VISN 10, Cincinnati VA Medical Center, 3200 Vine Street, Cincinnati, OH 45220.

2237# 539-20-4-4008-0521

Brief Description of Supplies/ Services required and the intended use/Estimated Amount: Cincinnati PALMS is requesting a new firm fixed price contract. The Cepheid GeneXpert Xpress is the instrument to be provided. It can only be provided by Cepheid. This quote includes 11 GeneXpert Xpress Systems (4 modules) to be set up as Point of Care instruments at specific locations within and outside the main VA hospital in the tri-state areas. The sites include Georgetown CBOC, Clermont CBOC, Bellevue CBOC, Florence CBOC, Hamilton CBOC, Dearborn CBOC, Homeless PACT, Cincinnati VAMC Emergency Department, Cincinnati VAMC Employee Health, Cincinnati VAMC Primary Care Clinic, and Cincinnati VAMC Women s Health Clinic. The quote also includes an Essential Care- Xpress 1-year contract. Essential care includes: Unlimited Standard Hours Phone Support, 2-day On-site Response, Next Day System Swap, Labor and Parts Coverage, and Xpert Check with FSE onsite. This instrument is being integrated into the current CBOC and Microbiology workflow to assist with COVID-19 testing. This instrument is meant to provide rapid and consistent testing to accommodate Veterans. These instruments should be installed as soon as possible to be proactive in COVID testing. This is a one time purchase of equipment with the service contract to be extended after the first year.

The Cepheid Xpress meets all the following requirements that no other instrument currently meets. 1)This technology is already being used by the Cincinnati VAMC Laboratory.

2)Allows for proper distribution of cartridges for the SARS-CoV-2 assay that are already in use.

3)Allows interfacing already in place through RALSand easy integration into the workflow.

4)Provides rapid and consistent results. Presumptive tests are unsatisfactory.

5)Capable of additional series of testing. This instrument will eventually be used for a multiplex SARS-COV-2, FLU, and RSV cartridge.

6) Must be CLIA Waived. This platform will also be used for waived CT/NG and vaginosis testing.

These viruses being detected in one cartridge will allow for a faster turn-around-time- improving patient care, on-site and at offsite locations. The estimated value of the proposed action is $ 367,480.00 to be ordered and delivered as soon as possible. This request for equipment is a one time purchase, but we will have to maintain a service contract after the first year.

Estimated Cost: $327,250.00

Unique characteristics that limit availability to only one source, with the reason no other supplies or services can be used: Cepheid US is the only company providing instrumentation that meets all of our specific needs listed in section 1. Cincinnati already uses Cepheid equipment and supplies that will correlate with these instruments. The interface is already established. The instrument provides accurate rapid testing. It has the capability of testing many other tests to be incorporated into the Point of Care Program. It is easy to use and CLIA Waived.

Other testing devices do not match the capability of this instrument nor the needs for the Cicncinnati VAMC

Description of market research conducted and results or statement why it was not conducted: GSA, VIP, and FPDS were used during market research. The equipment is not offered on GSA eBuy. A search on FPDS confirmed that current purchases of the required equipment were purchased open market, with the large business manufacturer of the required items.

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.

Erik Fallo 08/07/2020

Contracting Officer

Notice of Intent to Sole Source Requirement

The Department of Veterans Affairs, VA Healthcare System, VISN 10 Contracting Activity intends to negotiate a sole source contract under Simplified Acquisition Procedures and the authority of FAR Part 6.302-1, Only One Responsible Source for the following items listed below. The associated NAICS code for this is 334516. The vendor will be Cepheid, 904 Caribbean Dr, Sunnyvale, CA 94089.

Description of equipment requirements:

The requirement is for Stat Profile Prime Plus Analyzer composed of the following:

1) This technology is already being used by the Cincinnati VAMC Laboratory.

2) Allows for proper distribution of cartridges for the SARS-CoV-2 assay that are already in use.

3) Allows interfacing already in place through RALSand easy integration into the workflow.

4) Provides rapid and consistent results. Presumptive tests are unsatisfactory.

5) Capable of additional series of testing. This instrument will eventually be used for a multiplex SARS-COV-2, FLU, and RSV cartridge.

6) Must be CLIA Waived. This platform will also be used for waived CT/NG and vaginosis testing.

These viruses being detected in one cartridge will allow for a faster turn-around-time- improving patient care, on-site and at offsite locations. The estimated value of the proposed action is $327,250.00 to be ordered and delivered as soon as possible. This request for equipment is a one time purchase, but we will have to maintain a service contract after the first year.

A firm fixed price contract with no option years is anticipated and shall be awarded. It is the Government's belief that only the proposed candidate possesses the required capabilities to successfully meet this requirement. It is the Government's intention to solicit and negotiate with only this source.

This notice of intent is not a request for competitive proposals. It is not a solicitation or request for offers. No solicitation package is available. Any response to this notice must show clear and convincing evidence that competition would be advantageous to the Government. Responses must be received no later than 10:00 am on Monday, August 17, 2020.

Erik Fallo

Contract Specialist

Erik.Fallo@va.gov