JA ORTHO 1_Redacted.pdf

Request for Sole Source Format >SAT GSAM/R 538.7104-3(b) Sole Source Justifications - Federal Supply Schedule Ordering

Procedures

SOLE SOURCE JUSTIFICATION

GSAM/R 538.7104-3(b)

This justification aligns with the deviation outlined in the Revolutionary FAR Overhaul (RFO) for FAR 8.4 - Ordering under the Federal Supply Schedule and GSAM/R 538.71, as required by Executive Order (E.O.) 14275, Restoring Common Sense to Federal Procurement, signed April 15, 2025. Deviation effective date: November 3, 2025.

Acquisition Plan Action ID: 36C247-26-AP-4368

1. Contracting Activity: Department of Veterans Affairs, Network Contracting Office 7, in support of VISN 7 Atlanta’s VA Health Care System at 1670 Clairmont Rd, Decatur, GA 30033. 2237# 508-27-1-2043-0004

2. Description of Action: This acquisition is conducted under the authority of the Multiple- Award Schedule Program (41 U.S.C. 152(3) and 40 U.S.C. 501). This is a follow-on six (6) Month bridge contract needed to continue blood bank ortho clinical reagent lease for the Atlanta VA Medical Center.

Order against: FSS Contract Number: V797D-60637

Name of Proposed Contractor: QUIDELORTHO SALES COMPANY, LLC

Street Address: 9975 SUMMERS RIDGE RD

City, State, Zip: SAN DIEGO, CA 92121

Phone: (585) 453-6147

3. Description of Supplies or Services:

The estimated value of the proposed action is The Atlanta VAMC is in need to continue to provide all resources necessary to accomplish the deliverables to provide MTS A/B/D MONO & REV GRP, MTS A/B/D Monoclonal Grouping, MTS A/B Monoclonal Grouping, MTS ANTI-IGG, 0.8% AFFIRMAGEN, 0.8% RESOLVE A, 0.8% RESOLVE B, 0.8% SURG, Ortho Daily QC SWB CONTROLS, MTS DAT Cards, Antibody Identification Software, MTS ROUND DIL2, and MTS ROUND DIL2+, Ortho 7 % BSA, OV Single Use Dilution Trays, and OV Single Use Evaporation Caps 250 in such quantities as determined by the consumer each month to meet the hospital’s Type and Screen testing demands.

Based on increased demands for Type and Screens, Direct Antiglobulin Testing, and ABO/Rh Confirmations, the end user may adjust the volume of items required to meet the hospital’s demands.

4. Identify the Authority and Supporting Rationale (see below and if applicable, a demonstration of the proposed contractor’s unique qualifications to provide the required supply or service.

GSAM/R 538.7104-3(b)(1)(i): An urgent and compelling need exists and following the ordering procedures would result in unacceptable delays: Due to the limited time frame of the current task order set to expire on 9/30/2026. The extension is necessary to maintain current services without disruptions to patient care. To allow the Contracting Officer (CO) the opportunity to establish proper competition requirements and services under this bridge to allow transitional period.

GSAM/R 538.7104-3(b)(1)(ii): 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; The current vendor is the only one authorized to remain in position to provide these services due to the equipment and reagents are specifically aligned with the software and are only able to be used with the Ortho analyzers. No other vendor is able to set up and have their equipment stood up in under two weeks with training to take on this requirement.

GSAM/R 538.7104-3(b)(1)(iii): In the interest of economy and efficiency, the new work is a logical follow-on 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 order must not have been previously issued under sole source or limited source procedures.

GSAM/R 538.7104-3(b)(1)(iv): It is necessary to place the order with a particular FSS contractor to satisfy a minimum guarantee established in the FSS BPA; or

GSAM/R 538.7104-3(b)(1)(v): A law expressly authorizes or requires that the purchase be made from a specified source.

GSAM/R 538.7104-4: Items peculiar to one manufacturer: The current analyzer that is within the Atlanta VAMC is Orthro VISION and the software that is currently being used is their software. There is not enough time to establish another vendor at this time.

5. Describe Why You Believe the Order Represents the Best Value consistent with

GSAM/R 538.7102-2(b)(4) to aid the contracting officer in making this best value determination: This order represents the best value due to the risk of patient care disruptions if a bridge is not set in place to maintain services while the CO is conducting a competitive RFQ and allow stand up for another vendor if they are awarded the new contract.

Maintaining pricing under FSS Contract established fair and reasonable pricing to save the government over time, but allows transitional time, and competitive pricing to be established among FSS Contract holders rather than sole sourcing this procurement entirely.

6. Describe the Market Research Conducted among schedule holders and the results or a statement of the reason market research was not conducted. The CO conducted Market Research with historical history and posted an RFI out in July to determine competition opportunities and best acquisition strategies for the RFQ. This bridge is to maintain services without disruptions and allow for the RFQ to be posted timely. If an awardee is selected, that is not the incumbent, this will allow them to transition into the VAMC efficiently.

7. Any Other Facts Supporting the Justification: N/A

8. A Statement of the Actions, if any, the agency may take to remove or overcome any barriers that led to the restricted consideration before any subsequent acquisition for the supplies or services is made: There will be an RFQ posted to allow competition amount FSS Contract holders. This is just to maintain services while the RFQ is posted, and possible transitional time to occur.

9. Requirements Certification: I certify that the requirement outlined in this justification is a

Bona Fide Need of the Department of Veterans Affairs and that the supporting data under my cognizance, which are included in the justification, are accurate and complete to the best of my knowledge. I understand that processing of this sole source justification restricts consideration of Federal Supply Schedule contractors to fewer than the number required by GSAM/R 538.71 as directed by FAR 8.4. (This signature is the requestor’s supervisor, fund control point official, chief of service or someone with responsibility and accountability.)

10. Approvals in accordance with the VHAPM Part 806.3 OFOC SOP:

a. Contracting Officer’s Certification (required): I certify that the foregoing justification is accurate and complete to the best of my knowledge and belief.