PR 68720 SSJ for EZ2 Signed_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:

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

A. Program Office:

NCEZID/DVBD/RZB

Roybal Building 24 Room 10103 MS 24-10 Centers for Disease Control and Prevention Atlanta, GA 30329

B. Contracting Activity:

Centers for Disease Control and Prevention Off ice of Financial Resources Acquisition Branch Click here to enter text.

C. Identif ication of Requirement:

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

a. Sole source acquisition of: Procurement of an automatic extraction unit from Qiagen

b. Procurement Request (PR) Number: 000HCVLJE-2022-68720

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

a. Proposed Vendor: Qiagen

b. Estimated Procurement Amount:

3. Is the requirement on GSA Schedule? Yes No

If yes, provide schedule number:

Rev. 5/14/19

D. Justification:

1. The justif ication 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?

Qiagen’s EZ2 Connect is an automated magnetic bead-based extraction system that purif ies reliable, high quality nucleic acid suitable for all different downstream applications. Only QIAGEN offers the combination of 1) full walk-away automation of up to 24 samples with, 2) proven self-contained sealed reagent strip chemistries, and

3) extraction protocols for all different sample types analyzed in the lab for the isolation of gDNA, bacterial DNA, viral NA and Total RNA. The system is cost ef fective in its capability to run 1 to 24 samples without wasting extra reagent or consumables. Each kit contains all reagents and consumables needed to process the samples, so there is no need to order materials separately. The Qiagen extraction chemistry is desirable because many reference laboratories have used the EZ1/EZ2 successfully all over the world. Qiagen is also the sole manufacturer of the proprietary EZ1/EZ2 extraction kits and protocol cards, which is needed to run the unit and eliminates the need for a separate computer. The system is applicable for a variety of sample types including ones that our diagnostic laboratory tests such as blood, serum, plasma, and tissue. The EZ2 footprint is small and does not require the

Rev. 5/14/19

Contracting Officer Signature:

Certif ication Date: Click here to enter a date.