SAP-Sole-Source-Procurement_Bioanalytical ICE PR 87545 V3 -CO Signed.pdf

CDC

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:

Centers for Disease Control and Prevention Dengue Branch 1324 Cañada St.

San Juan, PR 00920

B. Contracting Activity:

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

C. Identification of Requirement:

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

a. Sole source acquisition of: Procurement of yearly maintenance agreement for the ABI 7500 and Quant Studio equipment from Bioanalytical Instruments, Inc.

b. Procurement Request (PR) Number (if available): 00HCRJD-2024-87545

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

a. Proposed Vendor: Bioanalytical Instruments, Inc. 1828 Reina de las Flores, Suite 203, San Juan, Puerto Rico 00927.

b. Estimated Procurement Amount: $154,832.64

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

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

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?

Bioanalytical Instruments is the authorized local suppliers supplier of Thermo- Fisher and Advanced Instruments and are the only authorized company to provide service for Thermo-Fisher and Invitrogen equipment in Puerto Rico.

Other companies were not considered in order to comply with the FDA requirements.

In the past, we’ve had service contracts with other (non-local) providers of technical service for Thermo equipment and we ran into many complications including service delays due to travel restrictions and visitor request for non- US citizens that takes months to process.

Rev. 5/14/19

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

The Dengue PCR diagnostic tests developed by CDC were validated to be performed in the ABI7500 distributed by Thermo-Fisher and are cleared by the FDA under a 510K approval. This type of approval limits the tests to be run only in the equipment were they were validated. Other companies were not considered, beside Bioanalytical Instruments (the authorized local suppliers supplier of Thermo-Fisher) in order to comply with the FDA requirements for the proper service and maintenance service for these equipment.

3. Program Office efforts to seek potential offerors: N/A

The Program Office needs to seek a local authorized company to provide service to Thermo and Invitrogen equipment in Puerto Rico. The only authorized company is Bioanalytical Instruments.

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, COR

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: Click here to enter text.

Contracting Officer Signature:

Certification Date: Click here to enter a date.