P03 - JOFOC Redacted.pdf

Request for Sole Source Justification >SAT-$7.5M under FAR 13.5

PM Part 813.5 SAP for Certain Commercial Items Original Date: 08/30/17 Revision 03 Date: 02/11/2021

DEPARTMENT OF VETERANS AFFAIRS

SOLE SOURCE JUSTIFICATION UNDER SIMPLIFIED PROCEDURES FOR CERTAIN COMMERCIAL

ITEMS IN ACCORDANCE WITH FAR 13.5

Acquisition Plan Action ID: Cepheid Sole Source

1. Contracting Activity: Department of Veterans Affairs, Veterans Health Administration, Regional Procurement Office West, Network Contracting Office 21 on behalf of VA Sierra Pacific Network 21 (VISN 21) VA Palo Alto Healthcare System (VAPAHCS).

2. Nature and/or Description of the Action Being Processed VAPAHCS is requesting a 5-year IDIQ contract for the purchase of proprietary Cepheid reagents in order to perform infectious disease testing on the facility owned Cepheid brand GeneXpert and GeneXpress test instruments.

3. Description of Supplies/Services Required to Meet the Agency’s Needs:

VA Palo Alto Health Care System requires Microbiology lab test kits to diagnose VA patients for various infections to include the FLU/RSV, MRSA., STREPA and SARS Cov2. These clinical tests are run on a VA owned GeneXpert Infinity 80 or GeneXpress Cepheid instrument. Below is a list of items requested that will be needed. The requested five (5) year Ordering Period IDIQ contract is for supplies only, no services needed.

The IDIQ ceiling is

Item # Supplies Description/Part Numbers

Supply 1 # GXMRSA-NxG-10 Test Kit 2 # GXCDIFF/EPI-10 - C.Difficile Test Kit

3 # GXFLU/RSV-10

4 # GXCT/NG-10 - CT/NG Test Kit 5 # CT/NGSWAB-50 - CT/NG Swab-50 6 # CT/NGURINE-50 - CT/NG Urine-50 Kit 7 # GXMRSA/SA-BC-10 - XpertMRSA/SA BC test kit

8 # GXMTB/RIF-US-10

9 #GXCARBAR-10 - XPERT CARBA-R, IVD 10

10 Xpert Xpress STREPA-10 (Qty: 150)

Xpert Xpress SARS-Co-V-2-10 (10 pak kit); this item only needed starting 1/1/2022

Original Date: 08/30/17 Revision 03 Date: 02/11/2021

4. Statutory Authority Permitting Restricted Competition:

FAR 13.5 Simplified Procedures for Certain Commercial Items. The statutory authority for applying the Simplified Procedures for Commercial Items of FAR 13.5 is 41 U.S.C. § 1901 and is implemented by FAR 13.106-1(b)(2) for restricting competition on this procurement. Competition is restricted on this procurement for the reason below:

( X ) Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements

( ) Unusual and Compelling Urgency ( ) Industrial Mobilization, Engineering, Developmental or Research Capability or Expert

Services ( ) International Agreement ( ) Authorized or Required by Statute ( ) National Security ( ) Public Interest

5. Demonstration that the Contractor’s Unique Qualifications or Nature of the Acquisition Requiresthe Use of the Authority Cited Above (applicability of

Cepheid GeneXpert/GeneXpress is the current testing platform and is owned by the facility. As is the norm for laboratory test instruments, the reagents and supplies needed to perform testing on the Cepheid instruments are proprietary and only available directly from Cepheid for CONUS acute care facilities. To procure another platform and reagents would be more costly since the Government already owns the testing equipment and only needs reagents.

Sole Source Vendor: Cepheid Mail Address: 904 Caribbean Drive Sunnyvale, CA 94089 Web Site: https://www.cepheid.com

6. Description of Efforts Made to ensure that offers are solicited from as many potential sources as deemed practicable:

The letter provided by Cepheid states that they are the sole manufacturer and distributor of their products. To further support the sole source procurement, a Notice of Intent (36C26121Q1081) was issued on 08/10/2021 and closed on 08/12/2021. No responses were received during that time.

There is only 1 source of the testing supplies that are compatible with the Cepheid GeneXert and GeneXpress test instruments: Cepheid located in Sunnyvale CA. The Government will continue to monitor the marketplace for alternatives when procuring diagnostic test kits.

Original Date: 08/30/17 Revision 03 Date: 02/11/2021

13. Approvals in accordance with the VHAPM Part 806.3 OFOC SOP:

a. Contracting Officer or Designee’s Certification (required): I certify that the foregoing justification is accurate and complete to the best of my knowledge and belief.

Luis Gonzalez Date Contracting Officer

NCO 21

b. One Level Above the Contracting Officer I certify the justification meets requirements for other than full and open competition.

Brooke C. Robison NCO 21 Director of Contracting

Date

c. VHA RPO HCA Review and Approval: I have reviewed the foregoing justification and find it to be complete and accurate to the best of my knowledge and belief and approve for other than full and open competition.

Curtis M. Jordan Date Executive Director, Regional Procurement Office West Head of Contracting Activity (HCA)

01 Sep 21

Luis E. Gonzalez 3565684

Digitally signed by Luis E.

Gonzalez 3565684 Date: 2021.09.01 08:55:40 -07'00'

Brooke C.

Robison 1615983

Digitally signed by Brooke C.

Robison 1615983 Date: 2021.09.01 09:10:40 -07'00'

CURTIS M.

JORDAN 597130

Digitally signed by CURTIS

M. JORDAN 597130

Date: 2021.09.01 13:32:34 -06'00'