SSJ BioAnalytical ICE Order for Signature v2 CO signed 13 June 2024.pdf

Rev. 1/6/14

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, DVBD Dengue Branch Center for Disease Control & Prevention 1324 Calle Cañada San Juan, PR 00920

B. Contracting Activity:

Centers for Disease Control and Prevention Office of Financial Resources Chamblee Campus Bldg. 102 Mail Stop S102-4 4770 Buford Highway Atlanta, GA 30341

C. Identification of Requirement:

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

a. Sole source acquisition of: BioAnalytical Instruments.

b. Procurement Request (PR) Number (if available): 81837

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

a. Proposed Vendor: BioAnalytical Instruments, 1828 Reina de la Flores, San Juan, PR

00928-2821

b. Estimated Procurement Amount: $36,875.00

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

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

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

2. Other facts supporting sole source procurement:

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

The requested reagents, Super Script III Platinum One-Step qRT-PCR, have been approved by the FDA for the molecular diagnostic of several viruses including SARS CoV-2 and Zika by PCR in clinical samples under Emergency Use Authorization. Bioanalytical Instruments is currently the only local authorized distributor for the requested reagents in Puerto Rico.

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

Super Script III Platinum One-Step qRT-PCR was selected because it has been tested previously in our lab and proven to generate high quality data in molecular diagnostics after validation tests performed in the laboratory. SARS CoV-2 is required to ensure consistency of diagnostic test results and research procedures. The use of products from other brand names would require extensive validation procedures.

3. Program Office efforts to seek potential offers:

Bioanalytical Instruments is currently the only local authorized distributor for the requested reagents.

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: Mara L. Garcia, Business Support Specialist, COR I

Center/Institute/Office COR/Program Official Signature:

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 Name: Sheena Delaine

Contracting Officer Signature:

Certification Date: