A4 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:

NCHHSTP DVH

Roybal Bldg 18, Room 3-123, H18-3 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: Reagents, calibrators and controls to be used in conjunction with the VITROS 3600 Immunodiagnostic system, manufactured by QuidelOrtho Sales Company, LLC : Following reagents are required: A-HBc; HBsAg;

HB Confirmatory kit; HBeAg and Anti-HCV matching complementary controls, calibrators, diluent, check 1 and check 2, wash buffer, signal reagents and consumables that are used on the VITROS Immunodiagnostic system, manufactured by QuidelOrtho Sales Company, will be used to conduct Global Project-for Hepatitis B and C serosurvey for 5000 specimens from Mozambique.

b. Procurement Request (PR) Number (if available): 000HCKED-2026-99090

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

a. Proposed Vendor: QuidelOrtho Sales Company, LLC

b. Estimated Procurement Amount: Service: $97,229.54

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

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

Rev. 5/14/19

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?

This agreement for the VITROS 3600 equipment belonging to the Laboratory branch, Division of Viral Hepatitis, includes Reagents, calibrators, control, diluent, check 1 and check 2, wash buffer, signal reagents and consumables to be used in conjunction with the VITROS 3600 Immunodiagnostic system, manufactured by QuidelOrtho Sales Company, LLC.

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

In Lab branch, the ongoing hepatitis antibody surveillance where diagnostic testing is approved exclusively with the use of the VITROS Immunodiagnostic System from QuidelOrtho Sales Company, LLC. Considering that VITROS system is FDA-approved and highly reliable, it is imperative to continue using the methods offered by VITROS platform consistently as long as it remains available in the US. Using VITROS 3600 system will save time, allow low-volume samples to be tested for most markers and help with the logistics of procurement of kits from just one vendor. The data from the machines will be transferred to the ELIMS (Enterprise Laboratory Information Management System) automatically. A preliminary report

Rev. 5/14/19 will be generated from ELIMS and then subject to a rigorous QC process, to avoid human error.

3. Program Office efforts to seek potential offerors:

The search did not render any results for alternatives to VITROS 3600.

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:

NCHHSTP/DVH/Laboratory Branch/ LaShonda Wise/ Management & Operations Specialist---

Center/Institute/Office COR/Program Official Signature:

Certification Date: May 1, 2026

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: January 5, 2024