P03 JOFOC Notice.docx

VHAPG Part 813.106 Simplified Acquisition Procedures: Soliciting from a Single Source Attachment 1: Single Source Justification for SAP under the SAT

GENERAL INFORMATION

BASE NOTICE TYPE

Network Contracting Office 17

5441 Babcock Road Ste. 302 San Antonio TX 78240

POINT OF CONTACT*

Robyn Nussbaum robyn.nussbaum@va.gov

AWARD INFORMATION

MODIFICATION NUMBER

AWARDEE ADDRESS LINE 1*

AWARDEE ADDRESS LINE 2*

AWARDEE ADDRESS LINE 4*

ADDITIONAL INFORMATION

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AGENCY CONTACT’S EMAIL ADDRESS

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Justification and Approval Notice Justification and Approval Notice

DESCRIPTION

Justification and Approval Notice

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: 36C257-22-AP-0936

JOFOC Log Number: 2022-02-08T13:09:24

1. Contracting Activity: Department of Veterans Affairs, VISN 17, South Texas VA Health Care System (STVAHCS), 2237 number 671-22-2-121-0222

2. Brief Description of Supplies/ Services required and the intended use/Estimated Amount:

NCO 17 intends to award an open market sole source contract for Strep A PCR Reagents for the South Texas VA Health Care System (STVAHCS) Pathology & Laboratory Medicine Service. The STVAHCS has a need for the Xpert Xpress Strep A Reagents compatible with current leased Cepheid Gene Xpert Instrumentation. No other types of substitute or third-party reagents will fit the need of the STVHCS for the reasons notated. The Strep A test is an automated in vitro diagnostic test for the qualitative detection of Streptococcus pyogenes DNA. The test is used to diagnose pharyngitis caused by the Group A Streptococcus (GAS) earlier to allow for proper antibiotic therapy. This is crucial in order to reduce the changes of GAS complication such as Rheumatic Fever and Glomerulonephritis.

The estimated amount for this requirement is $18,792.00 for one year, and $103,837.66 for five one-year ordering periods. Price will be determined fair and reasonable by comparing prices with similar supplies offered within the commercial market.

3. Unique characteristics that limit availability to only one source, with the reason no other supplies or services can be used:

The Cepheid Xpert Strep A test is the only Strep A test approved by the FDA that will run on the STVAHCS’ existing Cepheid Gene Xpert Analyzers. The Strep A test is used to diagnose pharyngitis caused by the Group A Streptococcus earlier to allow for proper antibiotic therapy. The diagnostic use of the Strep A test reagents is based on methods, reference ranges and physician input. Due to the transport and treatment of the patients in various facilities within the STVAHCS, it is imperative that the methods and reference ranges be identical to meet the Standard of Care requirements of the Joint Commission. The proposed vendor, Cepheid, would meet the capacity needs of the Audie L. Murphy Division as well as the needs of the other laboratories within STVAHCS. The vendor has also provided a letter dated November 4, 2021 stating they are the only vendor that is authorized to distribute the Cepheid Gen Xpert Strep A reagents.

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

A Notice of Intent to Intent to Sole Source was published on Contract Opportunities from January 31, 2022 through February 7, 2022. There were no responses.

A search of the VIP database identified zero (0) SDVOSBs and zero (0) VOSBs under NAICS 325413 and “Strep A Reagents” keyword search.

A search of SBA’s Dynamic Small Business Search using NAICS 325413 and keyword “Strep A Reagents” identified zero (0) small businesses.

The Strep A Reagents currently in use are on the South Texas VA Health Care System’s (STVAHCS) contract with Geo-Med. The STVAHCS recently received notification from Geo-Med/Quidel that Quidel is discontinuing production of the Quick Vue Strep A kits due to supply constraint issues. The Microbiology supervisory team has decided to add this testing to their existing Cepheid Gene Xpert system.

Per the using service, there are other types of Strep A Reagents and testing platforms. However, it is not in the best interest for the Government to have to procure a whole new instrumentation, when the STVAHCS currently has a contract in place for the Cepheid Instrumentation. Additionally, the procurement of a new instrumentation and/or reagents would impact Veteran patient testing negatively.

Market research is conducted by the P&LMS Service on a continual basis as new tests are evaluated and technology changes or improves. The major barrier to competition is that diagnostic use of these tests is based on methods, reference ranges and physician input and are highly unique for the treatment of specific disease states. The platform that the Strep A test is run is currently on a base plus four year contract. To purchase a new instrumentation or reagents would not be best value to the Government and would impact patient testing negatively.

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.

Contracting Officer

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