A13. SSJ SAM.gov.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:

NCEZID| DCLSR

1600 Clifton Road NE, H23-2, Roybal Campus Centers for Disease Control and Prevention Atlanta, GA 30329

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:

b. Procurement Request (PR) Number (if available): 000HCRH1-2024-88191 - Laboratory Equipment

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

a. Proposed Vendor: Hologic Sales and Services 250 Campus Drive Marlborough, MA

01752

b. Estimated Procurement Amount: $0.00

3. Is the requirement on GSA Schedule? Yes No

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

Rev. 5/14/19

1. Justification:

The justification for this non-competitive action is: (NOTE: Must select only ONE of the listed justifications for other than full and open competition and fully support the justification in the following paragraphs. Please delete this note prior to submitting the justification.)

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:

X

Rev. 5/14/19

b. What can this product/service do that other products/services cannot do?

HOLOGIC provides the Panther Fusion System that performs both extractions and PCR together in one instrument. This consolidates testing, increases walkaway time, and enhances the flexibility to grow our lab’s efficiency. It has the ability to run laboratory developed tests (LDTs). The user can validate a new LDT by providing stand-alone primers and probes. The user can multiplex up to 5 targets and use 16 different formulations at one time to validate an LDT.

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

The Roche COBAS 8800 system has a bigger footprint and will need more space in the laboratory. The Abbott m2000 is not a 2 in 1 instrument. It is two pieces of equipment- one for the extraction and one for the PCR.

3. Program Office efforts to seek potential offerors:

Internet search was conducted for the Panther Fusion, and it revealed the Panther Fusion is a proprietary piece of equipment and is only available from Hologic Sales and Services. There are no other companies that can provide the equipment.

D. 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:

Center/Institute/Office COR/Program Official Signature:

E. 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.