75D30124Q78180_SSJ_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:

Centers for Disease Control and Prevention Division of Core Laboratory Services and Response

NCEZID/DCLSR/PROSB

1600 Clifton Rd NE Bldg 23, Room 461 Atlanta, GA 30329

B. Contracting Activity:

Centers for Disease Control and Prevention Office of Financial Resources Acquisition Branch II 2920 Brandywine Road, Mail Stop K-69 Atlanta, GA 30341

C. Identification of Requirement:

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

a. Sole source acquisition of: BIO-RAD CFX Opus 96 Dx.

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

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

a. Proposed Vendor: Government Scientific Source, Inc.

b. Estimated Procurement Amount: $42,250.50

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

If yes, provide schedule number: MAS/334516 There is only one seller on GSA Advantage, and the price is significantly higher than what was found through market research.

Rev. 5/14/19

D. Justification:

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

☒ 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 (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?

BIO-RAD provides the only real-time PCR system (CFX Opus 96 Dx) that is an open system that offers the ultimate flexibility in commercial assay selection or rapid assay development in a clinical laboratory setting that can multiplex up to 5 targets per sample well. It optimizes assay development with the thermal gradient function. It analyzes and generates traceable, audit-ready reports with electronic signature functionality. It has numerous calibrated fluorophores (Cal Gold 540, Cal Orange 560, Cal Red 610, Cy 5, Cy 5.5, FAM, HEX, Quasar 670, Quasar 705, ROX, Texas 615, VIC, SYBR, Texas Red). All these features are required for PCR validation studies for FDA approval.

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

Thermo Fisher did not have a PCR instrument which contained all of the calibrated fluorophores as BIO‐RAD does. QIAGEN does not have a similar PCR machine that can multiplex up to 5 targets.

Rev. 5/14/19

3. Program Office efforts to seek potential offerors:

Conducted internet search for instruments meeting the performance parameters of the BIO‐ RAD CFX Opus 96 Dx and could not find one.

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: Donnell Warren

Center/Institute/Office COR/Program Official Signature:

Certification Date: 04/30/2024

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: Eric Lyons

Contracting Officer Signature:

Certification Date:

Eric C. Lyons -S S Digitally signed by Eric C. Lyons -

Date: 2024.07.18 15:38:48 -04'00'