Contract Opportunities JOFOC_Redacted.pdf

VHAPM Part 808.405-6 Limiting Sources Page 1 of 5 Original Date: 08/30/2017 Revision 02 Eff Date: 02/21/2020

VHAPM Part 80 Attachment 2: Request for Source Justification Format >SAT

DEPARTMENT OF VETERANS AFFAIRS

Justification and Approval (J&A) For

Other Than Full and Open Competition (>SAT)

Acquisition Plan Action ID: 36C261-20-AP-4236

1. Contracting Activity: Department of Veterans Affairs (VA), Veterans Health Administration, Regional Procurement Office West, Network Contracting Office 21 (NCO 21) on behalf of VA Southern Nevada Health Care Service

2237: 593-21-1-497-0013

2. Nature and/or Description of the Action Being Processed: The VA Southern Nevada Health Care System requires specialized reagents, test kits and supplies for infectious disease testing to be used on the Cepheid GeneXpert Infinity-48S that is owned by the facility. The Government anticipates a sole source, single award, firm fixed price indefinite delivery/indefinite quantity (IDIQ). The period of performance will be for 5 years.

3. Desc The estimated value of the proposed action is for 5 years. The procurement will provide specialized Cepheid infectious disease reagents, test kits and supplies to the Pathology and Laboratory Medicine Services. These products are critical to the support of VA patient care, and are only available from Cepheid due to their proprietary nature. The reagents, test kits and supplies to be covered under this IDIQ will support the following Cepheid GeneXpert Infinity-48S molecular analyzer-based tests:

GXCARBA-R

GXCDIFF/EPI-10

XPRSFLU-10

XPRSTREPA-10

SWAB/M-100

SDPS-120

CDIFF/EPI-BU1

CARBAR-BU1

XPRSFLU-BU2

STREPA-BU2

480CFA

900-0370

GXCT/NG-10

SWAB/G-50

URINE/A-50

GXMRSA-NXG-SPAK

CT/NG-BU2

GXCT/NG-SPAK

GX-MRSA-NXG-10

GXCDIFFICILE

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

(X) (1) Only One Responsible Source and No Other Supplies or Services Will Satisfy

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

OFOC SOP Revision 10 Page 2 of 5 Original Date: 03/22/11 Revision 10 Date: 09/10/2020

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;

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).

ires the Use of the Authority Cited Above (applicability of authority

The supplies required are proprietary for a highly specialized analyzer that was previously purchased for the medical center. The reagents need to be compatible with the GeneXpert Infinity-48S instrument that is manufactured by Cepheid and is currently in use at VA Las Vegas. Cepheid has a patent for their reagents for this instrument, and is the only distributor.

Procuring the Cepheid reagents prevents a duplication of cost that would occur if multiple testing platforms were purchased, to include training the Government staff on new equipment. The esti items and training on the new system are estimatd at $850,000.00. It would also cause a delay in care due to the length of time to procure and approve another analyzer. Patient care would be negatively impacted by these delays. The Cepheid reagents are essential to the function and continuance of patient care to our nations Veterans at our facility.

Accordingly, Cepheid is the only firm capable of providing the supplies and services described in Section of cost that could not be expected to be recovered through competition and unacceptable delays in fulfilling its requirements.

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

Sources Sought Synopsis: A notice of intent to sole source was issued on June 16, 2020 under 36C26120Q0715 for Cepheid reagents used in the Cepheid GeneXpert Infinity-48S analyzer for the

VA

the Government intends to solicit and negotiate with only one source under FAR 6.302-1. The above authority is cited and justification made based on the determination that the Government's minimum needs can only be satisfied for items available from one source. This is the only source known that can provide this item as the analyzer is a Cepheid machine and Cepheid is the only source that provides the reagents, and they have no authorized resellers or distrubutors. This notice of intent is not a request for competitive proposals. Other persons may identify their interest and received by the close of the notice date of June 19, 2020.

OFOC SOP Revision 10 Page 3 of 5 Original Date: 03/22/11 Revision 10 Date: 09/10/2020

7. Determination by the CO that the Anticipated Cost to the Government will be Fair and Reasonable: The anticipated cost to the Government will be considered fair and reasonable utilizing the information based on a comparison of proposed prices with prices found reasonable on previous purchases. The final contract price will be fair and reasonable as a comparison will be made with current contracts.

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

Based on the market research conducted pursuant to FAR Part 10, VA Acquisition Regulation (VAAR) 810.001-70 Market Research Policy, and PPM 2016-05, there is no reason to believe that that two or more SDVOSBs/VOSBs have the capability to meet this requirement, and the Supreme Court Kin not be met for small businesses either.

A VIP search utilizing NAICS code 325413 yielded 29 SDVOSBs/VOSBs matches. Further VIP search no results were found.

No relevant results were found on the VA NAC, while a GSA e-Library query under SIN 66III Clinical Microbiology Analyzers, Cost-Per Test resulted in 3 large businesses. There is no reason to believe th cts Specialist, reagents used for testing are open market items. There is no reason to believe that existing contracts are able to fulfill this requirement.

Procu t Data System revealed that molecular analyzer reagents, kits, and supplies are proprietary to the this facility, this medical center is limited to the reagents, kits, and supplies for this particular analyzer.

As described in Section 6 above, market research, in accordance with FAR Part 10, was conducted by synopsis of the proposed acquisition, advising industry of the pending acquisition and soliciting inquiries from interested parties. A notice of intent to sole source was posted from 06/16/2020 to 06/19/2020 to betaSAM with no responses.

Based on the market research, the reasoning behind the sole source justification, and VIP search, there is no reason to believe that that two or more SDVOSBs/VOSBs have the capability to meet this req this requirement. Small businesses were not found as well.

9. Any Other Facts Supporting the Use of Other than Full and Open Competition: Specifications, statements of work, and purchase descriptions suitable for full and open competition are not available due to the proprietary nature of reagents being particular to the molecular analyzer.

Cep

OFOC SOP Revision 10 Page 4 of 5 Original Date: 03/22/11 Revision 10 Date: 09/10/2020

10. Listing of Sources that Expressed, in Writing, an Interest in the Acquisition: No responses were received on the Notice of Intent to Sole Source 36C26120Q0715 posted on Contract Opportunities on June 16, 2020.

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 Government will track the life expectancy of the analyzer. When it is time to procure a new analyzer, the procurement for the analyzer and reagents will be competed to the maximum extent practicable. In the future, if another vendor supplies a suitable alternative, their qualifications will be evaluated. The market will be continually assessed to determine if other vendors can provide the required supplies.

Approval is being sought for more than one year, as this is a recurring requirement. A sole source effort is required for the planned time duration for continuity of patient care.

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.

Date

Laboratory Manager VA Southern Nevada Health Care System

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

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

Date

Contracting Officer/ Branch Chief, Supply I

11/04/2020

11/05/2020

OFOC SOP Revision 10 Page 5 of 5 Original Date: 03/22/11 Revision 10 Date: 09/10/2020

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

Date

Director of Contracting, NCO 21

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 $68 million) or approve ($700K to $68 million) for other than full and open competition.

Date

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

05 NOV 20