JA - Over SAT - 36C257-22-AP-4442 - Redacted.pdf

Part 806.3 Other Than Full and Open Competition (OFOC) JOFOC #: 2022-10-05T14:38:47 Attachment 7: Request for Sole Source Justification Format >SAT

Rev: 13 Effective Date: 02/01/22 Page 1 of 4

Justification and Approval (J&A) For

Other Than Full and Open Competition (>SAT)

Acquisition Plan Action ID: 36C257-22-AP-4442

1. Agency: Department of Veterans Affairs (VA)

Contracting Activity: Network Contracting Office 17 (NCO-17) 5441 Babcock Rd., Ste. 302 San Antonio, TX 78240

Purchase Request No.: 674-23-2-034-0002

2. Nature and/or Description of the Action Being Processed:

This procurement is for laboratory analyzer reagents. NCO-17 intends to enter into a sole source contract with Cepheid for the procurement of reagents. The proposed contract will have a base delivery period and four one-year option periods.

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

Item Description Item Number Estimated Annual Quantity Xpert Xpress Flu XPRSFLU-10 450 Xpert Carba-R GXCARVAR-10 10 Xpert C. Difficile GXCDIFFICILE-10 85 Xpert MRSA NxG GXMRSA-NXG-10 720 Xpert MTB/RIF GXMTB/RIF-US-10 20 Xpert Xpress Strep A XPRSTREPA-10 270 Xpert FII & FV GXFIIFV-10 20 Xpert TV GXTV-10 25 Xpert Xpress CoV-2/Flu/RSV Plus XP3COV2/FLU/RSV-10 1200 Xpert Xpress Cov-2 Plus XP3SARS-COV-10 600 MTB/RIF Bundle, Controls MTB/RIF-BU2 6 Xpert Collection Kit, Urine URINE/A-50 10

Base Delivery Period: 1/25/2023 through 1/24/2024 Options: (All Line Items), Quantity: Four (4) Total Estimated Value, Including Options: $REDACTED

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

41 USC §3304(a)(1), as implemented by FAR 6.302-1.

( 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;

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( ) (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):

The Central Texas Veterans Health Care System (CTVHCS), Pathology & Laboratory Medicine Service, owns and operates Cepheid GeneXpert analyzers. The requested reagent items are manufactured to be compatible with the fit, form and function of Cepheid analyzers. Cepheid provided a sole source letter stating that they are the sole manufacturer of Xpert® reagents and are the only authorized distributor for acute care facilities in the United States. The requested Cepheid brand name reagents are essential to the government’s patient testing requirements, thereby precluding consideration of a product manufactured by another company.

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

A special notice, notice of intent to award a sole source procurement, was posted on SAM Contracting Opportunities under RFI 36C25722Q0920 on 7/19/2022. The notice stated that responses from all responsible sources shall be considered. The notice archived in Contracting Opportunities on 8/4/2022 without a response to the notice.

7. Determination by the CO that the Anticipated Cost to the Government will be Fair and

Reasonable:

The Contracting Officer has determined that the anticipated proposed prices will be fair and reasonable. The Contracting Officer will compare the proposed prices to those prices found reasonable in previous Cepheid procurements.

8. Description of the Market Research Conducted and the Results, or a Statement of the Reasons Market Research Was Not Conducted:

A search of the products on the mandatory sources for procurements of supplies, UNICOR and Ability One, revealed that they do not offer laboratory reagents. A search of GSA Advantage revealed that Cepheid offers their instruments on a MAS FSS contract; however, the FSS does not offer consumable supplies. A search on OSDBU’s VIP with keyword “Cepheid” produced no results for SDVOSB and VOSB vendors’ capability narratives. A search in the SBA’s DSBS with keyword “Cepheid” produced no results for small business vendors’ capability narratives.

9. Any Other Facts Supporting the Use of Other than Full and Open Competition:

The CTVHCS microbiology department has used the Cepheid analyzer methodology since 2010. The Cepheid analyzer has the capabilities to perform all MRSA, influenza, TB/RIF, clostridium difficile, FII/FV, Carba-R, RSV and COVID-19 testing, and has the capability to add additional assays that may be needed in the future.

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10. Listing of Sources that Expressed, in Writing, an Interest in the Acquisition:

None

11. A Statement of the Actions, if any, the Agency May Take to Remove or Overcome any Barriers to Competition before Making subsequent acquisitions for the supplies or services required:

The major barrier to competition is that Cepheid manufactures their own analyzers and reagents.

No other vendor can provide Cepheid products to VA facilities. Market research will be performed prior to exercising any options and on subsequent procurements to see if there have been any changes in the market.

12. 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// 11/01/2022

REDACTED Date:

Chief Technologist Pathology & Laboratory Medicine Service Central Texas Veterans Health Care System

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.

//SIGNED// 11/01/2022

REDACTED Date:

Contracting Officer https://dvagov.sharepoint.com/sites/VHAProcurement/VHAPM/VHAPM_Part_806.3.aspx

Rev: 13 Effective Date: 02/01/22 Page 4 of 4

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

//SIGNED// 11/01/2022

REDACTED Date:

Branch Chief, Laboratory Support Team Network Contracting Office 17

Director of Contracting: I certify the justification meets requirements for other than full and open competition.

//SIGNED// 11/01/2022

REDACTED Date:

Director of Contracting Network Contracting Office 17

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 recommend approval (if over $75 million) or approve ($750K to $75 million) for other than full and open competition.

//SIGNED// 12/14/2022

REDACTED Date:

Executive Director, Regional Procurement Office West Head of Contracting Activity (HCA)