SSJ 2024-88251 redacted.pdf

JUSTIFICATION FOR SOLE SOURCE PROCUREMENT (OPEN MARKET OR GSA)

UNDER $250,000

Sole source acquisitions may be used on a limited basis and only when the Contracting Officer’s Representative (COR)/Program Official has provided sufficient justification and the Contracting Officer has determined that the circumstances warrant such action. The content for a justification must contain detailed facts and rationale to justify the sole source acquisition. Soliciting from a single source must be done in accordance with FAR 13.106-1(b) or 8.405-6. At a minimum, the following information must be included:

Identification of Program Office, Contracting Activity, and Proposed Requirement, Justification and Program Office Certification:

A. Program Office:

Chronic Viral Diseases branch (CVDB) Division of High Consequence Pathogens and Pathology (DHCPP) National Center for Emerging and Zoonotic Infectious Diseases (NCEZID) Centers for Disease Control and Prevention Atlanta, GA 30329-4018

B. Contracting Activity:

Centers for Disease Control and Prevention Procurement and Grants Office Acquisition and Assistance Branch II 2920 Brandywine Road Atlanta, GA 30341

C. Identification of Requirement:

1. Nature of Action to be Approved by Contracting Officer:

a. Sole source acquisition of: CFX Opus 96 Real-Time PCR System

b. Procurement Request (PR) Number (if available): NA

2. Proposed Vendor and Estimated Procurement Amount (if available):

a. Proposed Vendor: Government Scientific Source (GSA Advantage)

b. Estimated Procurement Amount: $__________

3. Is the requirement on GSA Schedule? ☒ Yes ☐ No

If yes, provide schedule number: MAS/334516

D. Justification:

1. The justification for this non-competitive action is:

Rev. 5/14/19

This procurement is needed to improve quality of measurements by replacing our current CFX 96 Touch Real-Time PCR system. The procurement is for purchasing newer model of CFX 96 system and is needed as instrument manufacturer Bio-Rad technical support for older model equipment will end in December 2026. Bio-Rad confirmed the new CFX Opus Dx as their only replacement for the old CFX Touch. Our current CFX 96 instruments are used for running Novaplex HPV 28 assay for projects that monitor HPV prevalence and impact of vaccine in the United States and for providing subject matter expertise to international public health partners in Low- and Middle-Income Countries (LMICs) who use Seegene HPV assays and/or CFX 96 instruments. For clarity, the CFXs are produced by instrument manufacturer Bio-Rad and are used to runs HPV assays produced by the separate manufacturer Seegene.

CFX-96 Touch instruments will be replaced with two newer model of CFX Opus Dx 96 Real- Time PCR system to maintain the efficiency of setting up multiple assays runs at the same time.

☐ In accordance with FAR 13.106-1(b)(1), “only one source [is] reasonably available” which states that, “For purchases not exceeding the simplified acquisition threshold. (i) Contracting officers may solicit from one source if the contracting officer determines that the circumstances of the contract action deem only one source reasonably available (e.g., urgency, exclusive licensing agreements, brand-name or industrial mobilization). (ii) Where a single source is identified to provide a portion of a purchase because that portion of the purchase specifies a particular brand-name item, the documentation in paragraph (b)(1)(i) of this section only applies to the portion of the purchase requiring brand-name item. The documentation should state it is covering only the portion of the acquisition which is brand- name.”

☐ Urgency ☐ Exclusive licensing agreements/Proprietary data ☐ Brand name required ☐ Industrial mobilization ☐ Other [Continuation of manufacturer warranty] (e.g., compatibility, space issues, continuity, compatibility, etc.)

☒ In accordance with FAR 8.405-6 “Limiting Sources” which states that, “the only circumstances that may justify the action are – (A) An urgent and compelling need exists, and following the procedures would result in unacceptable delays; (B) Only one source is capable of providing the supplies or services required at the level of quality required because the supplies or services are unique or highly specialized; or (C) In the interest of economy and efficiency, the new work is a logical follow-up to an original Federal Supply Schedule order provided that the original order was placed in accordance with the applicable Federal Supply Schedule ordering procedures. The original BPA must not have been previously issued under sole-source or limited-sources procedures.”

☐ Urgency ☐ Only One Source ☒ Logical Follow Up ☒ Brand name required

2. Other facts supporting sole source procurement:

a. What can this product/service do that other products/services cannot do?

CVDB has a need for replacement of currently used CFX 96 instruments with new model of the same system. The other PCR systems were not considered as the

Rev. 5/14/19

Novaplex HPV28 assay is not compatible with those systems, and the assay has been validated by the manufacturer for use with the new CFX Opus system.

Furthermore, our current protocol and process for Novaplex HPV assay have been validated and established using CFX systems. Thus, the procurement has the advantage being compatible with our existing workflow.

b. What other products/services were considered and why did they not meet the need?

As search of GSA Advantage reveals that Government Scientific Source is the only vendor for the CFX OPUS 96 Dx instrument. This system is not listed in ECAT.

As stated in section 2A, other PCR systems were not considered as they were not compatible for running Novaplex HPV assay used in our HPV surveillance and vaccine impact studies.

3. Program Office efforts to seek potential offerors:

CVDB contacted with the Novaplex HPV28 assay manufacturer, Seegene USA, to determine a list of compatible instruments for use with their assay. The BioRad CFX is the only compatible system with their assay. Furthermore, Seegene’s website states, “The CFX96™ Dx/Touch/Opus instrument is to be purchased directly from Bio-Rad. Seegene does not distribute the instrument in the US. PLEASE CONTACT BIO-RAD FOR ORDERING INFORMATION” (https://seegeneus.com/systems/, last checked 6/3/2024). CVDB did not seek manufactures of other PCR system as the procurement is the only compatible system for running Novaplex HPV assay used in our ongoing projects. CVDB performed an internet search to find the best price for the CFX Opus system and found one vendor, Government Scientific Source, from GSA Advantage.

E. Program Office Certification:

I have reviewed this sole source justification and certify the justification is true and accurate to the best of my knowledge and adequate to support other than full and open competition.

Center/Institute/Office COR/Program Official Name/Title: NCEZID/DHCPP/ CVDB/ Niyai Johnson COR/ Troy Querec DNA Team Lead

Center/Institute/Office COR/Program Official Signature:

Certification Date: June 20, 2024

F. Contracting Office Certification:

I have fully relied on the information provided herein and hereby certify that this justification is accurate and complete to the best of my knowledge and belief:

Contracting Officer Name: Click here to enter text.

Contracting Officer Signature:

https://seegeneus.com/systems/