JA68094revised_06292022signedred.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:

NCIRD

Clifton Roybal Campus Building 17, Room 2017, H17-2 Centers for Disease Control and Prevention Atlanta, GA 30333

B. Contracting Activity:

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

C. Identification of Requirement:

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

a. Sole source acquisition of: Purchase of a Maxwell RSC 48 to support PCR activities, projects, and research.

b. Procurement Request (PR) Number (if available):68094

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

a. Proposed Vendor: Promega

b. Estimated Procurement Amount: $49,367.90

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

If yes, provide schedule number: MAS/334516 tde2 Cross-Out tde2 Pencil

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?

The Maxwell RSC 48 instrument is a highly efficient automated nucleic acid extraction machine. Our lab has a smaller instrument, the RSC 16, and we have confirmed that it works well to extract DNA from the pathogens that we work with.

One bacterial pathogen, Corynebacterium species, has a very thick cell wall that is hard to break open to release DNA. We have successfully extracted DNA from Corynebacterium species with the RSC instrument..

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

The Roche MagNA Pure 24 was considered, but only has half the sample handling capacity of the Promega Maxwell RSC 48. Previous attempts to use MagNA Pure instruments for Corynebacterium extraction were not successful. The Qiagen QiaCube was also considered, but the design of this instrument involves moving liquid samples within the instrument. This can lead to cross-contamination of samples that are tested by sensitive assays, such as real-time PCR. Our lab currently

Rev. 5/14/19 uses a Promega Maxwell RSC 16 instrument, and it has proven to extract good quality DNA from all of our pathogens without contamination.

3. Program Office efforts to seek potential offerors:

Promega is the only vendor that makes Maxwell Instruments. PDL need this Maxwell RSC 48 because is a highly efficient automated nucleic acid extraction machine. Our lab has a smaller instrument, the RSC 16, and we have confirmed that it works well to extract DNA from the pathogens that we work with. One bacterial pathogen, Corynebacterium species, has a very thick cell wall that is hard to break open to release DNA. We have successfully extracted DNA from Corynebacterium species with the RSC instrument. Cl i ck here to enter text.

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: Haydreia Brown Management Program Analyst

Haydreia Brown

Center/Institute/Office COR/Program Official Signature:

Certification Date: June 29, 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: Click here to enter text.

Contracting Officer Signature:

Certification Date: Click here to enter a date.