2022-69353.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:

National Center for Immunization and Respiratory Diseases (NCIRD)

NCIRD/ID/VSDB/EVV/ZVT

1600 Clifton Rd, NE Centers for Disease Control and Prevention Atlanta, GA 30333

B. Contracting Activity:

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

C. Identification of Requirement:

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

a. Sole source acquisition of: EZ2 Connect System automated nucleic acid extraction /purification /isolation sysem

b. Procurement Request (PR) Number (if available): 69353

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

a. Proposed Vendor: Government Scientific Source, Inc

b. Estimated Procurement Amount: $52,173.00

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

If yes, provide schedule number: Click here to enter text.

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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?

Program requires an additional sample preparation system for RNA isolation from SC2 viruses to support work being performed in the Influenza Division and response to COVID-19.

The EZ2 Connect meets all required specifications to address the lab’s need, including compatibility with existing procedures and inventory (equipment and kits); ability to integrate with existing information management systems; full start-to-finish automation, error control and safeguard features to protect against contamination. The EZ2 Connect offers flexibility to perform RNA purification from 1 to 24 samples and uses prefilled and sealed cartridges containing the chemistry for nucleic acid extraction, minimizing the risk of cross-contamination. EZ2 offers remote monitoring with QIAsphere and generates reports that include all important run information such as time, sample IDs, protocol, etc.

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

Program compared three (3) systems used for nucleic acid extraction /purification /isolation.

The EZ2 Connect is the only system compatibile with NCIRD’s existing laboratory procedures established for RNA isolation of SC2 viruses and work supporting COVID-19 response. A copy of the full Market Research Report with findings is attached.

Rev. 5/14/19

3. Program Office efforts to seek potential offerors:

Market research was conducted in June – July 2022 to include consideration of required sources as prescribed by FAR Part 8 as well as guidance outlined in FAR Part 6. Program efforts to seek potential offerors included internet search of GSA’s Solutions Finder (Acquisition Gateway), the Interagency Contract Directory (ICD) Portal, and Small Business Administration Professional Network (PRO-Net). The EZ2 Connect System is proprietary to the manufacturer, QIAGEN, and can only be purchased from them or an authorized retailer.

Government Scientific Source (GSS) is a small business (Federal CAGE code 0S908) and authorized retailer of Qiagen manufactured 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: NCIRD/ID/VSDB Charmaine V McKenzie, Public Health Advisor

Contracting Officer Representative Signature and Certification Date

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 Signature and Certification Date https://hallways.cap.gsa.gov/app/#/gateway/best-class-bic https://www.contractdirectory.gov/contractdirectory/ http://pro-net.sba.gov/textonly/pro-net/search.html kfx2 Cross-Out