SAM P03 36C260-24-AP-0353 Cepheid.docx

DEPARTMENT OF VETERANS AFFAIRS

Justification and Approval (J&A) For Other Than Full and Open Competition (>SAT) Acquisition Plan Action ID: 36C260-24-AP-0353

1. Contracting Activity: Department of Veterans Affairs, VISN 20, Seattle VA Puget Sound Health Care System, Network Contracting Office 20, 1601 E. Fourth Plain Blvd, Bldg.17, Suite B428, Vancouver WA 98661. PR: 663-24-1-0017.

2. Nature and/or Description of the Action Being Processed: This is a new requirement previously supported by a nine month purchase order. A six-month firm fixed-price purchase order, with the option to extend services will be awarded. The purchase order will be for specific products necessary to perform rapin syndromic infectious disease testing.

3. Description of Supplies/Services Required to Meet the Agency’s Needs: The Cepheid GeneXpert IV platform, and accompanying reagents and supplies, are used for rapid syndromic infectious disease diagnostic testing at PSHCS on veteran’s submitted test samples. The required assays are the Cepheid Multiple Vaginal Panel, Nasal, Sexual Disease Panel System, Clostridium difficile, Influenza Panels with Influenza A & B, Trichomonas, SARS-CoV-2 and SARS-CoV-2 with Influenza A& B and RSV. The estimated value of the acquisition is $414,777.48, per the IGCE, with a period of performance 12/1/2023 - 5/31/2024, with the option to extend up to six (6) months, for an ultimate completion date of 11/30/2024. If 52.217-8 is exercised, the value would be $700,000.00, to accommodate a possible surge in Veteran care.

Item #

Description/Part Number* Qty

Request for Sole Source Justification Format >SAT

VHAPG Part 806.3 OFOC Revision: 02 Effective Date: 11/15/23 Acquisition ID#: 36C260-24-AP-0353

4. Statutory Authority Permitting Other than Full and Open Competition:

( x ) (1) Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements per 41 USC §3304(a)(1) as implemented by FAR 6.302-1;

( ) (2) Unusual and Compelling Urgency per 41 USC §3304(a)(2) as implemented by FAR 6.302-2;

( ) (3) Industrial Mobilization, Engineering, Developmental or Research Capability or Expert Services per 41 USC §3304(a)(3) as implemented by FAR 6.302-3;

( ) (4) International Agreement per 41 USC §3304(a)(4) as implemented by FAR 6.302-4 ( ) (5) Authorized or Required by Statute per 41 USC §3304(a)(5) as implemented by FAR 6.302-5;

( ) (6) National Security per 41 USC §3304(a)(6) as implemented by FAR 6.302-6; ( ) (7) Public Interest per 41 USC §3304(a)(7) as implemented by FAR 6.302-7;

5. Demonstration that the Contractor’s Unique Qualifications or Nature of the Acquisition Requires the Use of the Authority Cited Above (applicability of authority): Pathology Laboratory Medicine Service (PLMS) Seattle (SEA) Microbiology Department has been providing Cepheid infectious assays since 2010 and owns 12 modules contained within the Cepheid GeneXpert IV (4) instrument. The required assays are the Cepheid Multiple Vaginal Panel (MVP), Nasal, Sexual Disease Panel System (SDPS), Clostridium difficile (C. difficile), Influenza Panels with Influenza A & B, Trichomonas, Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2), and SARS-CoV-2 with Influenza A& B and Respiratory Syncytial Virus (RSV). Testing is performed on direct patient samples including stool, urine, nasopharyngeal or nasal/mid-turbinate. Reagents and supplies required to perform this testing must be compatible with owned Cepheid modules.

6. Description of the Market Research Conducted and the Results, or a Statement of the Reasons Market Research Was Not Conducted: Market research was conducted for this requirement, despite being a sole source requirement. The current vendor’s analyzers are designed to utilize consumables, reagents, and supplies manufactured solely for the current vendor (proprietary).

7. Requirements Certification: I certify that the requirement outlined in this justification is a Bona Fide Need of the Department of Veterans Affairs and that the supporting data under my cognizance, which are included in the justification, are accurate and complete to the best of my knowledge and belief.

////Signed David Travelstead Administrative Specialist VAPSHCS - Seattle

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

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

/////Signed José Ronstadt Contracting Officer NCO20

b. One Level Above the Contracting Officer (Required over SAT but not exceeding $750K): I certify the justification meets requirements for other than full and open competition.

/////Signed Brian Corey Chief, Division 1

NCO 20