-13478.pdf

VHAPM Part 806.3 Other Than Full and Open Competition (OFOC) SOP Attachment 2: Request for Sole Source Justification Format >$150K

OFOC SOP Revision 06 Page 1 of 4 Original Date: 03/22/11 Revision 06 Date: 08/30/2017

Justification and Approval (J&A) For

Other Than Full and Open Competition (>$150K)

Acquisition Plan Action ID: VA257‐18‐AP‐0391

1. Agency: Department of Veterans Affairs

Contracting Activity: Network Contracting Office 17 (NCO‐17)

5441 Babcock Rd., Ste. 302 San Antonio, TX 78240

Purchase Request #: 671‐18‐3‐121‐0146

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

NCO‐17 intends to enter into an open market sole source contract with Cepheid for the acquisition of reagents and consumable supplies. The proposed contract action will be a standing‐order; where the requested items will be ordered over a period of performance of one year. The proposed contract action will be awarded as a new firm‐fixed‐price contract action.

FAR13.5 Simplified Procedures for Certain Commercial Items:

This procurement is for commercially available in vetro reagents and reagent consumable supplies in accordance with FAR 13.5 Simplified Procedures for Certain Commercial Items and specifically FAR

13.501 Special Documentation Requirements, where acquisitions conducted under 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 reagents and consumable supplies:

Item # Description Part Number Quantity 0001 Kit, SA Comp, 10‐Tests, GX, IVD GXSACOMP‐10 80

0002 XPERT CT/NG‐120 GXCT/NG‐120 25

0003 Kit, FLU, A ADD, GX, 10‐Test, IVD GXFLU‐10A 225 0004 Kit, MTB, IVD, US GXMTB/RIF‐US‐10 20 0005 Kit, C, Difficile, GX, 120 Test, IVD GXCDIFFICILE‐120 2 0006 Kit, MRSA/SA BC, 10 Tests, GX, IVD GXMRSA/SA‐BC‐10 25 0007 Kit, CARBA‐R‐IVD, GX GXCARBAR‐10 75 0008 Cepheid Nasopharyngeal Swab SWAB/B‐100 10 0009 Collection Kit A, Swab, CE‐IVD, 50 SWAB/A‐50 30 0010 Collection Kit A, Urine, 50 URINE/A‐50 40 Estimated Amount: REDACTED

OFOC SOP Revision 06 Page 2 of 4

Revision 06 Date: 08/30/2017

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 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 STVHCS pathology laboratory is currently using a Cepheid GeneXpert Infinity analyzer. The reagent cartridges were designed to work specifically with the GeneXpert line of Cepheid analyzers.

Cepheid is the only known distributor of their reagents and reagent consumable supplies.

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 for this requirement on FBO under 36C25718Q9161 on 3/9/2018. The notice stated that all responsible sources may submit a capability statement, proposal or quotation, which shall be considered by the agency. There were no responses to the notice.

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

The Contracting Officer can anticipate the proposed cost to be fair and reasonable based on a comparison of the proposed prices to those prices found reasonable on previous purchases.

VA257‐16‐P‐0046 VA257‐17‐P‐0460

Description Unit Price Unit Price Kit, SA Comp, 10‐Tests, GX, IVD $REDACTED $REDACTED Kit, FLU, A ADD, GX, 10‐Test, IVD $REDACTED $REDACTED Kit, C, Difficile, GX, 120 Test, IVD $REDACTED N/A Kit, MRSA/SA BC, 10 Tests, GX, IVD $REDACTED N/A Kit, MTB, IVD, US $REDACTED $REDACTED

OFOC SOP Revision 06 Page 3 of 4

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 mandatory sources of procurement for supplies (Xcess, Unicor, Ability One and Wholesale Supply sources) did not identify another vendor that can provide the requested reagents and reagent consumable supplies. A search on GSA Advantage revealed that Cepheid analyzers are sold on the site; however, Cepheid reagents or reagent consumable supplies are not offered. A search of the Office of Small & Disadvantaged Business Utilization’s (OSDBU) Vendor Information Pages (VIP) did not identify a Veteran‐Owned Small Business that offers the requested items. A search of the SBA’s Dynamic Small Business Search (DSBS) with NAICS 325413 and keyword Cepheid identified one (1) vendor match. A review of the vendors capability narrative revealed that the vendor distributes Cepheid SmartCycler reagents and supplies; an instrument that Cepheid is going to, or has, discontinued. As described in number 6 above; a special notice was published on FBO for the requirement, however there were no responses to the notice.

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

Cepheid meets the National Patient Safety Goals and Joint Commision requirement to reduce whole blood volume.

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:

Market research indicates that no other firm can provide the requested reagents and reagent consumable supplies. There are no actions that can be done to overcome competition barriers.

Market research will be conducted on future requirements to determine if changes have been made 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.

//SIGNED//_____________________________ 3/27/2018_______________

Signature Date

REDACTED

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

OFOC SOP Revision 06 Page 4 of 4

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//__________________________ 3/23/2018________________

REDACTED Date Contracting Officer

b. One Level Above the Contracting Officer (Required over$150K but not exceeding $700K): I certify the justification meets requirements for other than full and open competition.

//SIGNED//___________________________ 3/29/2018________________

REDACTED Date Chief, Division I Network Contracting Office 17, SAO‐W