REDACTED SSJ for PR 68682.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:

Benjamin Monroe Roybal Campus Building 18/ / Room 1-151 Centers for Disease Control and Prevention Atlanta, GA 30333

End User: Whitni Davidson

B. Contracting Activity:

Centers for Disease Control and Prevention Office of Financial Resources Acquisition Branch

C. Identification of Requirement:

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

a. Sole source acquisition of: EZS Connect benchtop instrument from Qiagen

b. Procurement Request (PR) Number (if available): 00HCVLEC-2022-68416

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

a. Proposed Vendor: Qiagen LLC, 19300 Germantown Road, Germantown, MD 20874-

b. Estimated Procurement Amount: REDACTED

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

If yes, provide schedule number:

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?

EZ2 Connect is a benchtop instrument for automated isolation of nucleic acids from up to 24 samples in parallel, using sealed prefilled cartridges. This benchtop instrument automatically pierces the sealed cartridges, heats samples for incubation, and automates pipetting of beads, buffers, even enzymes, to automate many pretreatment steps that were previously not automatable.

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

The EZ2 Connect is the next generation model for what is currently in use by PRB laboratories, the EZ1 Advanced XL. The EZ2 Connect uses the same extraction kits as the EZ1 and allows the extraction of 24 samples at one time, versus the 14 for the EZ1. Staying with this company allows PRB to continue to use the reagents that have

Rev. 5/14/19 been validated for CLIA and research use. Qiagen is the only company that makes this equipment.

3. Program Office efforts to seek potential offerors:

Conducted internet search. Qiagen is the only maker of this equipment.

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: Benjamin Monroe

Center/Institute/Office COR/Program Official Signature:

Certification Date: August 1, 2022

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: William Brannen

Contracting Officer Signature: William Brannen

Certification Date: August 15, 2022