-17148.pdf

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

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

Justification For Other Than Full and Open Competition

Acquisition Plan Action ID: 36C257-19-AP-3505

1. Agency: Department of Veterans Affairs (VA)

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

Purchase Request No.: 671-19-3-121-0768

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

NCO-17 intends to place an open market sole source purchase order for the purchase of an interim Cost-Per-Test (CPT) program with vendor Cepheid. The proposed contract action will be awarded as a new firm-fixed-price action for a period of performance of two (2) months.

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

The South Texas Veterans Health Care System (STVHCS), Pathology & Laboratory Medicine Service, requests the following for a CPT program:

0001: Equipment Rental/Lease and Equipment Maintenance Services 0001AA: Equipment Rental/Lease, Analyzer; Model: GeneXpert Infinity 48s, 32 Testing Site, Item Number: Infinity48-32, Quantity: 1 0001AB: Equipment Rental/Lease, Analyzer; Model: GeneXpert IV, 2 Testing Site System with Six

(6) Color Modules, Item Number: GXIV-2-D, Quantity: 1 0001AC: Equipment Rental/Lease; Desktop Computer with DX 4.3 Software 0001AD: Equipment Rental/Lease; Two (2) Color Printers 0001AE: Equipment Rental/Lease; UPS 0001AF: Equipment Maintenance Services; Standard Services Include 24/7 Telephone Support, On-Site Maintenance Services (Monday thru Friday, 8:00 AM to 4:00 PM), Annual Preventative Maintenance Service, Parts, Labor & Travel and Software Upgrades 0002: CPT; Xpert C. Difficle/EPI (120), Item Number: GXCDIFF/EPI-120, Est. Quantity: 240 0003: CPT; Xpert MRSA NxG (120), Item Number: GXMRSA-NXG-120, Est. Quantity: 240

Estimated period of performance: 6/15/2019 through 8/14/2019 Estimated value (to include all option periods): $REDACTED

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

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

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

( X ) (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;

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( ) (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;

5. Demonstration that the Contractor’s Unique Qualifications or Nature of the Acquisition Requires the Use of the Authority Cited Above (applicability of authority):

Cepheid provided a letter stating they are the sole manufacturer of Xpert and Xpert Xpress reagent products in the United States and sole distributor to the acute care market in the United States.

Cepheid is the only known manufacturer of the requested reagents for which the reagents packaging materials are a complete form, fit and function for their GeneXpert analyzers.

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 36C25719Q0404 on 2/22/2019. 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 or more advantageous to the government. The notice archived in FBO on 3/17/2019 with 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 has determined that the anticipated offer prices to be fair and reasonable.

The Contracting Officer anticipates Cepheid to offer CPT prices to be the same, or close to, the CPT prices for reagents being paid in the current order 36C25718F0402. [C. Difficile: CPT = $REDACTED, MRSA: CPT = $REDACTED]

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, UNICOR and Ability One, revealed that they do not offer the requested supplies and services. A search of GSA Advantage revealed that Cepheid has an FSS that offers the sale of their equipment; however, their FSS does not offer the requested reagents and equipment rental services. A search of the Office of Small and Disadvantaged Business Utilization’s (OSDBU) Vendor Information Pages (VIP) identified that no veteran-owned business offers the requested supplies and services. As described in number six (6) above, an RFI was published on FBO, but responses to the notice were received. Previous market research efforts noted that large businesses McKesson and Thermo Scientific offer Cepheid reagents; however, correspondence with Cepheid stated those businesses only distribute their products for non-acute care facilities.

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

The Cepheid Xpert C. difficile/Epi Assay is a qualitative in vitro diagnostic molecular test that is used for the rapid detection of toxin B gene sequences and for presumptive identification of 027/NAP1/BIstrains of toxigenic Clostridium difficile from unformed (liquid or soft) stool specimens collected from patients suspected of having C. difficile infection (CDI). Presumptive identification of 027/NAP1/BI strains of C. difficile is by detection of binary toxin (CDT) gene sequences and the single base pair deletion at nucleotide 117 in the tcdC gene. The test is performed on the Cepheid

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GeneXpert Infinity and GeneXpert DX systems and utilizes automated real-time polymerase chain reaction (PCR) to detect toxin gene sequences associated with toxin producing C. difficile. The Cepheid Xpert C. difficile/Epi Assay has a validated sensitivity of 98.7% and specificity of 90.86%.

The Cepheid Xpert MRSA Assay performed in the GeneXpert DX system is a qualitative in vitro diagnostic test designed for rapid detection of methicillin-resistant Staphylococcus aureus (MRSA) from nasal swabs in patients at risk from nasal colonization. The test utilizes automated real time polymerase chain reaction (PCR) to detect MRSA DNA. The Xpert MRSA Assay is intended to aid tin the prevention and control of MRSA infections in healthcare settings. The Cepheid Xpert MRSA Assay has a validate sensitivity of 100% and a specificity of 95%.

The two (2) month bridge order is needed due to some procurement documents for the long-term contract not being approved prior to the expiration (6/14/2019) of order 36C25718F0402. The urgent requirement to continue patient care without a services lapse made it necessary to establish an interim bridge order to facilitate the services while the long-term procurement documents are being approved.

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 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//________________________06/05/2019___

REDACTED Date:

Chief Medical Technologist Pathology & Laboratory Medicine Service South 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.

http://vaww.pclo.infoshare.va.gov/PMWeb/VHAPM_Part_806.3.aspx

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//SIGNED//______________________6/18/2019____

REDACTED Date:

Contracting Officer