P03 - JA Over SAT_ Cepheid_approved.pdf

Part 806.3 Other Than Full and Open Competition (OFOC) Attachment 7: Request for Sole Source Justification Format >SAT

Rev: 13 Effective Date: 02/01/22 Page 1 of 3

DEPARTMENT OF VETERANS AFFAIRS

Justification and Approval (J&A) For

Other Than Full and Open Competition (>SAT)

Acquisition Plan Action ID: 36C246-23-AP-0421

1. Contracting Activity: Department of Veterans Affairs, VISN 06, Network Contracting Office 6 (NCO

6) 565-23-1-049-0029

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

NCO 6 intends to award a new sole source, firm-fixed price contract for the Fayetteville VAMC laboratory, the Fayetteville FHCC and Wilmington WHCC laboratories to Cepheid (large business) for Cepheid service on the Infinity and GeneXpert analyzers in accordance with where acquisitions conducted under Simplified Acquisition Procedures are exempts 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:

This requirement is to provide service on Government owned equipment to include maintenance service, labor, parts, transportation, tools, software upgrades, repairs, and delivery of DNA/RNA test kits/products in support of Automated Real-Time DNA/RNA Testing at the Fayetteville Medical Centers and Health Care Centers. These service activities will allow the Government to accomplish on-demand molecular diagnostic testing for critical infectious diseases such as SARS-Cov-2, influenza, and healthcare associated infections such as MRSA.

The period of performance is for a base and four (4) options years starting 11/19/2022 through 11/18/2027.

Base Year: 11/19/2022 – 11/18/2023 | $68,940.00 Option Year 1: 11/19/2023 – 11/18/2024 | $68,940.00 Option Year 2: 11/19/2024 – 11/18/2025 | $68,940.00 Option Year 3: 11/19/2025 – 11/18/2026 | $68,940.00 Option Year 4: 11/19/2026 – 11/18/2027 | $68,940.00 Total estimate value: $344,700.00

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

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

Effective Date: 02/01/22 Page 2 of 3

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 is the original equipment manufacturer of the Cepheid GeneXpert Molecular Diagnostic Testing Systems and the sole authorized service agent for Cepheid Diagnostic instruments. Cepheid has not authorized distributors to provide service for the Cepheid GeneXpert Molecular Diagnostic Testing equipment in use at the VA Medical Center laboratories.

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

An Intent to Sole Source was posted on 11/07/2022 on Contract Opportunities for the purpose of determining whether to conduct a competitive procurement, but no responses were received.

A Source Sought Notice was not posted.

Cepheid is the equipment manufacturer and does not have partnerships with any small businesses for the service and maintenance of Cepheid GeneXpert Molecular Diagnostic Testing System. Please see paragraph 8 for additional description of the market research performed.

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

Reasonable:

The Contracting Officer will determine that the prices will be fair and reasonable based on comparison of proposed prices with prices found reasonable 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 was conducted to identify available sources and to evaluate the availability of the marketplace. However, Cepheid is currently the sole manufacturer of Xpert reagants, and GeneXpert systems are manufactured exclusively for Cepheid (See attached Sole Source Letter from Cepheid).

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:

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:

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.

Penny Creech Date Lab Manager Fayetteville NC VA Coastal HCS

Effective Date: 02/01/22 Page 3 of 3

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.

Daniel Spaulding Date Contracting Officer Services 3 Network Contracting Office 6

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.

Stephanie Patterson Date Branch Chief Services 3

Network Contracting Office 6 https://dvagov.sharepoint.com/sites/VHAProcurement/VHAPM/VHAPM_Part_806.3.aspx