Sole Source Justification-COSigned__Redacted.pdf

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Notice of Intent to Sole Source - Meso Scale Diagnostics Antibodies and Panel Kits
Solicitation number
2024-86891
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This document is a Justification for Sole Source Procurement under $250,000 for the Centers for Disease Control and Prevention (CDC). The proposed sole source acquisition is for a bulk order of vendor-specific testing plates and reagents from Meso Scale Discovery (MSD). The procurement request number is 000HCJGB-2024-86891, with an estimated procurement amount.

The justification for the sole source procurement is based on FAR 13.106-1(b)(1) and FAR 8.405-6, citing that MSD's products are unique and highly specialized, and there is only one source capable of providing the required supplies at the necessary level of quality. MSD's testing plates and reagents enable quantitative and semi-quantitative measurement of antibodies to specific pathogens, such as SARS-CoV-2, its variants, RSV, and influenza. The bulk order will support ongoing studies evaluating the antibody response to SARS-CoV-2 and RSV. Interested parties may respond to this notice within 15 days, but the government reserves the right to proceed with the sole source procurement.

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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:

NCIRD/CORVD/CRVLB

1600 Clifton Rd Bldg. 18, MS H18-6 Centers for Disease Control and Prevention Atlanta, GA 30329

B. Contracting Activity:

Centers for Disease Control and Prevention Office of Financial Resources Acquisition Branch NOR0/0B0, DVD, & CORVO, IOD/0C

C. Identification of Requirement:

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

a. Sole source acquisition of: The purchase request of a bulk order of vendor specific testing plates and reagents from Meso Scale Discovery

(MSD).

b. Procurement Request (PR) Number (if available): 000HCJGB-2024-86891

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

a. Proposed Vendor: Meso Scale Discovery

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?

MSD results produce a quantitative and semi-quantitative measurement of antibodies to specific pathogens such as SARS- CoV-2, emerging variants to SARS-CoV-2, RSV, and influenza.

One advantage to MSD testing is the ability to test up to 10 different analytes in a single well, thus saving time and reduces the quantity of sample needed for testing. MSD provides a specialized plate reader to be used with the test plates designed to apply electricity to the plate that generates an emitted light from a detection tag applied during the assay. The light is proportional to the bound analyte and is captured by an internal camera that quantifies the analytes of interest. This bulk order of plates and reagents will support laboratory workflow with ongoing studies evaluating the antibody response to SARS-CoV-2 and RSV.

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