P03 - JOFOC_Redacted.pdf

PDF 158 KB Posted Apr 4, 2022

Attached to: 6550--MRSA Reagents and Service IDIQ Federal contract opportunity
Solicitation number: 5782239440962
Issued by: Department of Veterans Affairs Veterans Health Administration Veterans Integrated Service Network 12

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36C25222D0035_1.docx	DOCX document	Apr 4, 2022

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VHAPG Part 813.5 Simplified Acquisition Procedures for Certain Commercial Items Attachment 1: Request for Sole Source Justification Template >SAT-$7.5M under FAR13.5

DEPARTMENT OF VETERANS AFFAIRS

SOLE SOURCE JUSTIFICATION UNDER SIMPLIFIED PROCEDURES FOR

CERTAIN COMMERCIAL ITEMS IN ACCORDANCE WITH FAR 13.5

Acquisition Plan Action ID: 36C252-22-AP-1966

1. Contracting Activity: Department of Veterans Affairs, VISN 12, Great Lakes Acquisition

Center, 537-22-3-944-0568, 550-22-3-949-0211, 556-22-3-2947-0017, 578-22-3-944-0962, 585-22-3-944-0573, 607-22-3-944-0281, 676-22-3-944-0266, 695-22-3-944-0587.

2. Nature and/or description of the action being processed: This is a sole source justification for a new, firm-fixed price contract 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 and Laboratory Medicine Service Product Line of the Great Lakes Health Care System (Veterans Integrated Service Network (VISN) 12) is requesting acquisition of reagent test kits, consumable supplies, and instrument service from Cepheid, Inc. (“Cepheid”) to perform clinical testing and identify colonization/infection by the Methicillin-Resistant Staphylococcus Aureus (MRSA) bacteria.

CLIN Item Description Est Qty

Unit

GXMRSA-NXG-

10 KIT

GXMRSA-NXG-10 KIT, 10-TEST, MRSA - Base 877 EA

GX16A1Y

SN 800045

GX 16-16 Advantage Service Agreement.

Advantage Service Agreement Includes:

24x7 Phone Support Onsite 5x10 hours (8-6) Annual Preventative Maintenance Check-up performed by FSE Includes Parts, Labor & Travel(Modules, Computers, etc), (Excludes printers) Software Upgrades included Remote LIS support 98% Uptime Guarantee

1 EA

GX16A1Y

SN 800062

GX 16-16 Advantage Service Agreement.

Advantage Service Agreement Includes:

1 EA

GX16A1Y

SN 800066

GX 16-16 Advantage Service Agreement.

Advantage Service Agreement Includes:

1 EA

GX12A1Y

SN 829545

GX 16-12 Advantage Service Agreement.

Advantage Service Agreement Includes:

1 EA

GX16A1Y

SN 800947

GX 16-16 Advantage Service Agreement.

Advantage Service Agreement Includes:

1 EA

GX16A1Y

SN 800065

GX 16-16 Advantage Service Agreement.

Advantage Service Agreement Includes:

1 EA

GX08A1Y SN

829558

GX 16-8 Advantage Service Agreement. Advantage Service Agreement Includes:

Remote LIS support 98% Uptime Guarantee

GX16A1Y

SN 800054

GX 16-16 Advantage Service Agreement.

Advantage Service Agreement Includes:

1 EA

GX08A1Y

SN 840440

GX 16-8 Advantage Service Agreement. Advantage Service Agreement Includes:

1 EA

GXMRSA-NXG-

10 KIT

GXMRSA-NXG-10 KIT, 10-TEST, MRSA - Option 1 878 EA

GX16A1Y

SN 800045

GX 16-16 Advantage Service Agreement.

Advantage Service Agreement Includes:

1 EA

GX16A1Y

SN 800062

GX 16-16 Advantage Service Agreement.

Advantage Service Agreement Includes:

1 EA

GX16A1Y

SN 800066

GX 16-16 Advantage Service Agreement.

Advantage Service Agreement Includes:

24x7 Phone Support Onsite 5x10 hours (8-6)

Annual Preventative Maintenance Check-up performed by FSE Includes Parts, Labor & Travel(Modules, Computers, etc), (Excludes printers) Software Upgrades included Remote LIS support 98% Uptime Guarantee

GX12A1Y

SN 829545

GX 16-12 Advantage Service Agreement.

Advantage Service Agreement Includes:

1 EA

GX16A1Y

SN 800947

GX 16-16 Advantage Service Agreement.

Advantage Service Agreement Includes:

1 EA

GX16A1Y

SN 800065

GX 16-16 Advantage Service Agreement.

Advantage Service Agreement Includes:

1 EA

GX08A1Y

SN 829558

GX 16-8 Advantage Service Agreement. Advantage Service Agreement Includes:

1 EA

GX16A1Y

SN 800054

GX 16-16 Advantage Service Agreement.

Advantage Service Agreement Includes:

GX08A1Y

SN 840440

GX 16-8 Advantage Service Agreement. Advantage Service Agreement Includes:

Period of Performance and total estimated value:

Period of Performance Price

4/1/2022 – 9/30/2022 (6 months, Base)

10/1/2023 – 3/31/2023 (6-month Option IAW 52.217-9)

Total

4. Statutory authority permitting restricted competition:

FAR 13.5 Simplified Procedures for Certain Commercial Items. The statutory authority for applying the Simplified Procedures for Commercial Items of FAR 13.5 is 41 USC 1901 and is implemented by FAR 13.106-1(b)(2) for restricting competition on this procurement.

Competition is restricted on this procurement for the reason below:

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

( ) Unusual and Compelling Urgency ( ) Industrial Mobilization, Engineering, Developmental or Research Capability or Expert

Services ( ) International Agreement ( ) Authorized or Required by Statute ( ) National Security ( ) Public Interest

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 and Laboratory Medicine Service Product Line is requesting acquisition of reagent test kits and service to perform MRSA testing. The Cepheid Xpert MRSA NxG Assay is the only Food and Drug Administration (FDA) 510(k) cleared test approved for use on the Government owned Cepheid GeneXpert Instrument Systems. Cepheid is the sole manufacturer of the reagents and only authorized distributor within the United States. The Government owned GeneXpert

Systems require original equipment manufacturer (OEM) supplies as there are no substitutes for reagents that are compatible with the existing equipment and the Veterans Health Administration prohibits the use of gray market items in its facilities. To ensure continuity of care, VISN 12 also has the need for GeneXpert® Instrumentation service and emergency repair. Cepheid does not certify or endorse third parties to perform these functions. Due to the complexity of the equipment, the lack of third-party certification for services, and the need for replacement parts, Cepheid is the sole source capable of meeting the government’s need.

6. Description of efforts made to ensure that offers are solicited from as many potential sources as deemed practicable: An Intent to Sole Source notification (578-22-3-944-0962) was posted to sam.gov for a period between 3/3/2022 and 3/8/2022. Zero responses were received.

7. Determination by the CO that the anticipated cost to the government will be fair and reasonable: IAW FAR 8.404(d), GSA has already determined the prices of supplies to be fair and reasonable and ordering activities are not required to make a separate determination of fair and reasonable pricing. Although Cepheid’s VA FSS contract (V797P-5967X) expired in September of 2017, Cepheid is offering these reagents now at the same price that they offered them under that contract. A previous purchase made by NCO 12 (VA69D-17-F-3236 awarded in 2017), which was determined at the time of award to be fair and reasonable IAW FAR 8.404(d), confirms the current pricing matches the previous NAC pricing. Because the NAC CO determined the prices of these supplies to be fair and reasonable when the schedule contract was established; and because Cepheid is continuing to offer these reagents at those same fair and reasonable prices; and because a comparison of these current prices with those under previous PO 36C25220C0031, which was determined to be fair and reasonable, confirm the pricing remains unchanged; the CO has determined that the anticipated cost to the Government will be fair and reasonable IAW FAR 13.106-3(a)(2)(ii).

8. Description of the market research conducted and the results, or a statement of the reasons market research was not conducted:

The Pathology & Laboratory Medicine Service Product Line of the Great Lakes Health Care System (VISN 12) is requesting acquisition of reagent test kits, consumable supplies, and instrument service to perform clinical testing and identify colonization/infection by the Methicillin-Resistant Staphylococcus Aureus (MRSA) bacteria.

VIP searches for NAICS 325413 and keywords, “Cepheid” (brand name), “Xpert” (brand name), and “MRSA” produced zero results.

This requirement was previously provided on a VA FSS contract, contract number V797P- 5967X. A previous GLAC procurement (VA69D-17-F-3236) was completed, using the VA FSS contract, without providing for full and open competition IAW FAR 8.405-6 (Limited Sources).

However, the manufacturer declined to renew the contract with the NAC after expiration for unspecified reasons but is currently offering the same Government-discounted rate of approximately 29% that was provided on the NAC FSS contract. As discussed above, this requirement was also purchased and awarded on PO 36C25220C0031 for a base plus one option year. Prices remain the same from that contract (which was the same as its previous VA FSS contract) to this new requirement.

A search was conducted on the NAC MedSurg catalog and GSA Advantage! catalog for keywords “MRSA” and “reagent” (together). Zero results were returned. Several results were returned on the NAC MedSurg catalog, but none for MRSA reagents together. Searches for Cepheid on the VA’s HTME and NX-Equipment lists also produced zero results.

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.

9. Any other facts supporting the use of other than full and open competition: None.

10. Listing of sources that expressed, in writing, an interest in the acquisition: Cepheid.

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 its GeneXpert analyzer. The requiring and contracting activities will conduct market research prior to new purchase requirements to determine if there have been any changes in the marketplace. A single source effort is required for the planned duration to maximize efficiency of the acquisition process and maintain favorable pricing (best value) for the

Government.

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 DATE

NAME TITLE SERVICE LINE/SECTION

FACILITY

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.

JIM R. HEDMAN

CONTRACTING OFFICER, NCO-12

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.

PARRIS S. WEIDENBACH

BRANCH CHIEF, EQUIPMENT TEAM, NCO-12

File details come from the government source that posted it. Updated Apr 4, 2022.