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-3509

1. Contracting Activity: Department of Veterans Affairs, Networking Contracting Office 7, 501 Greene Street, Hatcher Building – Suite 2, Augusta, GA 30901, in support of Atlanta VAMC, 1670 Clairmont Road, Decatur, GA 30033.

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 requirement is a one-year follow on task order against an FSS contract that is required to continue hematology laboratory services. Period of performance: 11/01/2026-10/31/2027.

Order against: FSS Contract Number: V797D-40235 Name of Proposed Contractor: Sysmex America Inc.

Street Address: 577 Aptakisic Rd.

City, State, Zip: Lincolnshire, IL 60069.

Phone: (216) 210-4155

3. Description of Supplies or Services:

The estimated value of the proposed action is

The Department of Veteran Affairs Hematology Laboratory, Atlanta has a requirement to provide Hematology services to the medical staff and Atlanta VAHCS Atlanta patients. This contract also includes equipment lease in connection with test per reportable. Data management system to manage patient test results. 24/7 telephone technical assistance and on-site service calls Monday – Friday 8am to 5pm. The system is currently employed at Atlanta VAHCS. All laboratory staff have already been trained, and the system is fully compatible with Vista /CPRS Laboratory Information system. As a cost per patient reportable results the Vendor will supply and consumable such as reagents and quality control materials.

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.

Procedures

GSAM/R 538.7104-3(b)(1)(i): An urgent and compelling need exists and following the ordering procedures would result in unacceptable delays:

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; Sysmex (America, INC) is the only vendor authorized, FDA-Approved for high complexity laboratory testing, and uses proprietary reagents for use on the existing validated testing system in the Hematology Laboratory at ATL VAMC. Only Sysmex America consumables can be used on the installed equipment because the items are proprietary and available exclusively from Sysmex. Furthermore, the laboratory staff are currently trained in using this equipment, methodology, and reporting results. Competing this requirement would cause a substantial duplication of costs and effort that could not be expected to be recovered through competition at this time.

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:

5. Describe Why You Believe the Order Represents the Best Value consistent with GSAM/R 538.7102-2(4) to aid the contracting officer in making this best value determination: Sysmex system is already in use at the ATL VAMC P&LMS laboratory.

This high-complexity system is fully implemented, validated, and supported by technologists who are already trained to operate it. The system requires proprietary reagents, controls, consumables, and supplies, and the CPT package reflects the best value. The prices have already been determined fair and reasonable, and no additional determination is required, though additional discounts will be pursued.

6. Describe the Market Research Conducted among schedule holders and the results or a statement of the reason market research was not conducted.

SBS:

Results of SBS search using NAICS 334516 resulted in 341 results, consisting of Veteran Owned Small Business (VOSB) and Service-Disabled Veteran Owned Small Business (SDVOSB). While these businesses appear capable of providing the required services, Procedures the results alone are insufficient to confirm their ability to meet the specific requirements of this acquisition.

Mandatory Sources:

The CO confirmed that this requirement cannot be fulfilled through any mandatory source providers (FPI, Ability One, Agency Inventory, Wholesale supply and Excess from other Agencies), but it can be fulfilled through an existing NAC FSS contract.

SAM.gov A search was conducted using keyword “Hematology analyzers CPT” and checked recent relevant awards- numerous vendors provided similar services. Additionally, a sources sought/intent to sole source was issued on July 22nd, 2026, under # 36C24726Q0645 to gain knowledge of potential qualified vendors that can provide these Sysmex hematology analyzers. One business expressed interest; however, they did not submit any of the requested information, resulting in no responses.

Current Award The current contract (36C24721F0377) was awarded to Sysmex America, Inc on a sole source basis.

GSA

Sysmex America Inc. has an FSS contract (V797D-40235) with these items. The pricing includes all consumables required by the analyzers such as reagents, repair materials, controls, rinse solution and maintenance cleaning solution, and etc.

7. Any Other Facts Supporting the Justification:

The desired instrumentation shall have the capability of performing or reporting the clinical parameters as defined in the performance work statement. The instrument shall have random access capability (if discrete testing is required) and be able to simultaneously perform the complete profile as described below and meet the performance characteristics for accuracy and precision as defined by the 1988 Clinical Laboratory Improvement Act (CLIA) and the Clinical and Laboratory Standards Institute (CLSI). All test parameters currently available on current system to be continued. All parameters need to be FDA approved. Additionally, this high-complexity system is fully implemented, validated, and supported by technologists who are already trained to operate it.

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: Currently, the requirement cannot be fulfilled through competitive methods. However, for future needs, comprehensive market research will be conducted again to determine if the requirements can be put out for competition, provided it is feasible.

Procedures

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.)

AO Supervisor

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.

Contracting Officer

b. One Level Above the Contracting Officer (Required over the SAT but not exceeding $900k): I certify the justification meets requirements for other than full and open competition.

Branch Chief – VISN & Prosthetics Team