A13 Sole Source Justification 94116 SAM.pdf

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Notice of Intent to Sole Source MALDI-TOF preventative maintenance agreement
Solicitation number
94116
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This document is a Justification for Sole Source Procurement for the Centers for Disease Control and Prevention (CDC), seeking a Complete Care Maintenance Agreement for a MALDI Biotyper (MBT) from Bruker Scientific, LLC. The procurement is being pursued as a sole source acquisition under $250,000, with Procurement Request Number 01036, primarily due to the highly secure nature of the facility and significant barriers to introducing a new vendor. The CDC conducted searches for alternative vendors but found limited viable options, with Electronic Risk Consultants being unsuitable due to campus access restrictions and REMI declining to provide service.

The justification is based on FAR 13.106-1(b)(1), which allows sole source procurement when only one source is reasonably available. The primary rationale includes the extensive security clearance process, time-sensitive operational needs, and the selected vendor's existing operational status within CDC's secured environment. Bruker Scientific is uniquely positioned to deliver the required MALDI-TOF services without delay, making them the preferred vendor despite efforts to explore alternative providers.

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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:

MDB/DFWED/NCEZID

1600 Clifton Rd NE Building 17, Rm 2054 Centers for Disease Control and Prevention Atlanta, GA 30329

B. Contracting Activity:

Centers for Disease Control and Prevention Office of Financial Resources Acquisition Branch 1

C. Identification of Requirement:

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

a. Sole source acquisition of: Complete Care Maintenance Agreement of MALDI Biotyper (MBT) by Bruker

b. Procurement Request (PR) Number (if available): 01036

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

a. Proposed Vendor: Bruker Scientific, LLC40 Manning Road, Billerica, MA 01821

b. Estimated Procurement Amount:

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?

Given the highly secure nature of the facility, selecting a new vendor would introduce substantial delays and additional costs related to clearance processing and access approval. Therefore, to ensure timely and uninterrupted provision of services, this procurement is being pursued as a sole source acquisition.

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

Alternative vendor options were explored; however, several limitations were identified. Communication with potential vendors outside the agency campus has been delayed due to extended pauses in correspondence, particularly during the quote review and clarification process. Additionally, the only other known vendor with physical presence on the agency’s secured campus has confirmed they are not willing to pursue a service agreement of this nature.

Given these constraints and the time-sensitive need for service continuity, no viable alternatives are currently available, further supporting the sole source selection.

Rev. 5/14/19

3. Program Office efforts to seek potential offerors:

To identify alternative vendors capable of supporting the required MALDI-TOF services, a search was conducted using online search engines. Through this process, two potential vendors were identified: Bruker and Electronic Risk Consultants. While Electronic Risk Consultants appeared qualified, their absence from the CDC campus presents a significant barrier to selection, given the extensive clearance and security protocols required for access to our facilities.

Additionally, REMI, a currently established service contract on the CDC campus, was contacted to provide a quote. However, they have confirmed that they will not be pursuing any MALDI-TOF service agreements. These limitations significantly reduce the pool of viable providers.

Due to these factors—limited viable vendor options, campus access restrictions, and time-sensitive operational needs—the use of a sole source procurement is justified. The selected vendor is already cleared and operational within CDC's secured environment, making them uniquely positioned to deliver the required services without delay.

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:

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.

Date: 2025.08.26 13:49:49 -04'00'

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