36C25719C0156-001.pdf

VHAPM Part 806.3 Other Than Full and Open Competition (OFOC) SOP Attachment 2: Request for Sole Source Justification

OFOC SOP Revision 08 Page 1 of 4 Original Date: 03/22/11 Revision 08 Date: 04/18/2018

Justification and Approval For

Other Than Full and Open Competition

Acquisition Plan Action ID: 36C257-19-AP-0856

1. Agency: Department of Veterans Affairs

Contracting Activity: Network Contracting Office 17 (NCO-17) 7201 W. Interstate 40, Ste. 100 Amarillo, TX 79106-2612

Purchase Request #: 671-19-3-121-0294

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

NCO-17 intends to place an open market sole source contract for the purchase of reagents with vendor Cepheid. The proposed contract action will be awarded as a new firm-fixed-price action for a period of performance of one (1) year and include one (1) option period. The contract will be considered a standing order; where, the reagents will be requested/ordered on an as-needed basis, throughout the periods of performance specified in the contract.

FAR13.5 Simplified Procedures for Certain Commercial Items: This procurement is for commercial items in amounts greater than the simplified acquisition threshold but not exceeding $7 million. In accordance with FAR 13.501(a), Simplified Acquisition Procedures are exempt from the requirements of FAR Part 6, but still require a justification using the format of FAR 6.303-2.

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

The pathology laboratory at the South Texas Veterans Health Care System (STVHCS) requests the following items (estimated annual quantities):

0001: Xpert Diagnostic SA Nasal, Item No.: GXSACOMP-10, Unit: EA, Qty.: 100 0002: Xpert Diagnostic Neisseria, Item No.: GXCT/NG-120, Unit: EA Qty.: 35 0003: Xpert Carba-R, Item No.: GXCARBAR-10, Unit: EA, Qty.: 75 0004: Xpert Xpress Flu, Item No.: XPRSFLU-10, Unit: EA, Qty.: 375 0005: Xpert MTB/RIF, Item No.: GXMTB/RIF-10, Unit: EA, Qty.: 50 0006: Xpert C. Difficile, Item No.: GXCDIFF/EPI-120, Unit: EA, Qty: 2 0007: Xpert MRSA/SA BC, Item No.: GXMRSA/SA-BC-10, Unit: EA, Qty: 30 0008: Xpert Collection Kit, Item No.: SWAB/B-100, Unit: EA, Qty.: 10 0009: Xpert Collection Kit, Item No.: SWAB/A-50, Unit: EA, Qty.: 30 0010: Xpert Urine Kit, Item No.: URINE/A-50, Unit: EA Qty.: 40

Estimated Base Period of Performance: 4/1/2019 through 3/31/2020 Estimated Value (to include all options): $REDACTED

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

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

OFOC SOP Revision 08 Page 2 of 4

Revision 08 Date: 04/18/2018

( X ) (1) Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements per FAR 6.302-1;

( ) (2) Unusual and Compelling Urgency per FAR 6.302-2;

( ) (3) Industrial Mobilization, Engineering, Developmental or Research Capability or Expert Services per FAR 6.302-3;

( ) (4) International Agreement per FAR 6.302-4 ( ) (5) Authorized or Required by Statute FAR 6.302-5;

( ) (6) National Security per FAR 6.302-6;

( ) (7) Public Interest per FAR 6.302-7;

FAR13.5 Simplified Procedures for Certain Commercial Items: The authority for applying the Simplified Procedures for Commercial Items of FAR 13.5 is 41 U.S.C. 1901 and is implemented by for restricting competition on this procurement via FAR 13.106-1(b)(2).

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 South Texas Veterans Health Care System, Pathology & Laboratory Medicine Service, operates a Cepheid GeneXpert analyzer under a separate Cost-Per-Test (Rental) Agreement. The containers for the requested reagents are manufactured specifically for GeneXpert analyzers. The reagents must be compatible in all aspects; form, fit and function, with the existing system. Cepheid is the only known manufacturer of the requested reagents.

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 FBO under RFI 36C25719Q0325 on 2/4/2019. The notice stated that all responsible sources may submit a capability statement, proposal or quotation, which shall be considered by the agency to determine if a comparable source is available and more advantageous for the government. The notice archived in FBO on 2/19/2018 with no responses to the notice.

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

Reasonable:

In accordance with FAR 13.106-3(a)(2)(ii), the Contracting Officer has determined that the anticipated proposed prices, when compared with the prices found reasonable on previous purchases, to be fair and reasonable. A comparison of the proposed prices will be conducted on previous purchases.

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

Market research did not identify an alternative procurement source for this requirement. A search of the mandatory sources of procurement for supplies, GSA, NAC, VIP, SBA DSBS and open market searches only found two large businesses that offered Cepheid products.

OFOC SOP Revision 08 Page 3 of 4

Correspondence with Cepheid stated that they are the sole source for VA procurements. Cepheid stated that large businesses McKesson and Thermo Scientific are only used as distributors for non-acute care facilities.

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

N/A

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:

Cepheid is the only known manufacturer of the requested reagents for their GeneXpert analyzer.

The STVHCS pathology & laboratory medicine service will conduct market research prior to new purchase requirements to determine if there have been any changes in the marketplace.

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.

Signature:

//SIGNED//___________________________3/19/2019____

REDACTED Date:

Laboratory Manager Pathology & Laboratory Medicine Service South Texas Veterans Health Care System

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

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

//SIGNED//____________________________3/19/2019____

Contracting Officer

OFOC SOP Revision 08 Page 4 of 4

b. One Level Above the Contracting Officer (Required over the SAT but not exceeding $700K):

I certify the justification meets requirements for other than full and open competition.

//SIGNED//________________________3/20/2019____

Chief, Division I Network Contracting Office 17