SSJ_Redacted.pdf

VHAPG Part 813.106 Simplified Acquisition Procedures: Soliciting from a Single Source Attachment 1: Single Source Justification for MPT up to SAT

Revision: 02 Effective Date: 12/30/2025 Page 1 of 2 Acquisition ID# 36C250-26-AP-4836

DEPARTMENT OF VETERANS AFFAIRS

Justification for Single Source Awards IAW RFO 12 For

Over Micro-Purchase Threshold but Not Exceeding the Simplified Acquisition Threshold

Acquisition Plan Action ID: 36C250-26-AP-4836

1. Contracting Activity: The Department of Veterans Affairs, Veterans Integrated Service

Network (VISN) 10, Cleveland Veterans Affairs Medical Center (CLE VAMC) Network Contracting Office (NCO) 10.

Transaction: 541-26-4-775-2067

2. Brief Description of Supplies/ Services required and the intended use/Estimated Amount:

Network Contracting Office (NCO) 10 intends to award a new firm-fixed-price purchase order for Sysmex XN-L CHECK quality control products for the Sysmex XN-450 hematology analyzer at the VA Kent Imaging and Infusion Center. The quality control products are required to support routine quality control and performance monitoring of the existing Sysmex XN-450 analyzer and to ensure the accuracy and reliability of hematology testing performed in support of patient care.

1 EA XN-450 Sysmex Hematology Analyzer – Existing Equipment 8 EA per year XN-L CHECK, 12 x 3.0 mL (3 levels)

ESTIMATED DOLLAR VALUE:

REQUIRED DELIVERY DATE: 30 Days ARO

3. Unique characteristics that limit availability to only one source, with the reason no other supplies or services can be used: The Government requires Sysmex brand-name XN-L CHECK quality control material specifically compatible with the existing Sysmex XN-450 hematology analyzer at the VA Kent Imaging and Infusion Center. The requested XN-L CHECK, Material No. 213569, is a three-level hematology quality control product specified for use with Sysmex XN-L Series analyzers and is used to monitor analyzer performance and the accuracy and reliability of hematology testing. The Sysmex quote identifies the XN-450 analyzer and XN-L CHECK, 12 x 3.0 mL (3 levels), with a quantity of eight per year.

Sysmex America, Inc. advised that the requested XN-L CHECK is the only quality control product authorized by the OEM for use with the XN-L Series analyzers. Sysmex further advised that the requirement supports use with BeyondCare Quality Manager (BCQM) and IQAP peer-group comparison software, capabilities uniquely offered by Sysmex. These

Effective Date: 12/30/2025 Page 2 of 3 Acquisition ID# 36C250-26-AP-4836 manufacturer-authorized compatibility requirements are necessary to maintain the established quality-control process for the Government's existing Sysmex XN-450 analyzer.

The Government requires the Sysmex brand-name QC material to maintain compatibility with the existing analyzer and established laboratory quality-control procedures. No other brand of QC has been identified by the OEM as authorized for use with the Government's XN-L Series analyzer. Use of an alternate brand would not provide the required OEM authorization or the associated Sysmex quality-management capabilities identified by the manufacturer. Therefore, Sysmex brand-name XN-L CHECK is the only brand reasonably available to meet the Government's minimum requirements

4. Description of market research conducted and results or statement why it was not conducted: The Contracting Officer, working with the service, conducted market research to identify commercially available quality-control materials capable of meeting the Government's needs for the VA Kent Imaging and Infusion Center's existing Sysmex XN- 450 automated hematology analyzer.

Before beginning that research, the Government identified the key requirements the supplies had to provide. At a minimum, the required quality-control material had to be compatible with the Sysmex XN-450 hematology analyzer and support the laboratory's required quality-control testing. The requirement is for XN-L CHECK, 12 x 3.0 mL, three levels, Material No. 213569, with eight units required annually.

On August 13, 2026, the Contracting Officer queried the Government-wide database of contracts and other procurement instruments intended for use by multiple agencies available at www.contractdirectory.gov and other Government and commercial databases that provide information relevant to agency acquisitions. The Contracting Officer reviewed National Contracts, Interagency Contract Directory Portal, ECAT, GSA Advantage, NAC VA National Acquisition Center Contract Catalog Search Tool, NASA SEWP, FPDS-NG ezSearch, DLA, SCMC/DLA Troop Support, BIC/OMB, and FDA resources using the search terms "hematology quality control," "hematology controls," "laboratory quality control," and "hematology reagents." SBA Small Business Search was also reviewed on August 13, 2026, using the applicable NAICS and related search terms.

GSA Advantage identified commercially available quality-control products from several laboratory suppliers. Agilent Technologies products identified were analytical calibration materials intended for analytical calibration, method verification, and laboratory quality control and were not identified as hematology analyzer controls. Inorganic Ventures products identified were analytical quality-control standards intended for calibration and method verification and were not hematology analyzer controls. ZeptoMetrix products identified were molecular testing controls intended to evaluate molecular assays and were not applicable to the Sysmex XN-450 hematology analyzer. Other products identified included laboratory water purification supplies, analytical reference

Effective Date: 12/30/2025 Page 3 of 4 Acquisition ID# 36C250-26-AP-4836 standards, reagents, and other laboratory products intended for applications unrelated to hematology analyzer quality control.

The products identified through GSA Advantage were reviewed against the Government's requirement for compatibility with the existing Sysmex XN-450 analyzer. Although the search identified commercially available laboratory quality-control products, the identified products from Agilent Technologies, Inorganic Ventures, ZeptoMetrix, and the other suppliers were not identified as compatible quality-control materials for the XN-450 and therefore could not satisfy the Government's minimum requirement.

SBA Small Business Search was queried to identify certified SDVOSB/VOSB sources capable of providing the required laboratory quality-control materials. The search identified two businesses: Heightened Senses, LLC and Paul Swisher. Heightened Senses, LLC's listed capabilities concern counter-UAS sensing, UAS integration, and NDAA-compliant technology procurement and do not identify laboratory, hematology, or quality-control supplies. Paul Swisher's listed capabilities concern advanced acoustic detection and AI-powered monitoring systems for defense and research applications and likewise do not identify laboratory, hematology, or quality-control supplies. Neither business was identified as a capable source for the required Sysmex XN-L CHECK material.

The market research therefore did not identify a certified SDVOSB/VOSB source capable of meeting the Government's requirement. The identified commercial laboratory products were also not established as equivalent or compatible with the existing Sysmex XN-450.

The Government's requirement remains specifically for quality-control material compatible with the XN-450, with eight units required annually.

Overall, the market research showed that commercially available laboratory quality-control products exist; however, the products and vendors identified through the databases reviewed were not identified as capable of meeting the Government's specific requirement for quality-control material compatible with the Sysmex XN-450. The requirement is therefore based on the laboratory's established need for the specified QC material supporting the existing analyzer and not merely on a preference for a particular commercial product.

The Nonmanufacturer Rule (NMR) applies to this procurement under NAICS 334516, and SBA has provided a waiver. Market research determined that the VA and SBA Rule of Two could not be met because no certified SDVOSB/VOSB vendors were identified as capable of meeting the Government's requirement. Market research identified multiple commercial sources for the required Sysmex XN-L CHECK quality-control material; however, the identified sources are other than small businesses. Accordingly, this procurement is recommended to proceed as an unrestricted, brand name, open market acquisition for Sysmex XN-L CHECK, Effective Date: 12/30/2025 Page 4 of 4 Acquisition ID# 36C250-26-AP-4836

Contracting Officer's Certification: Purchase is approv ed in accordance with RFO 12. I certify that the foregoing justification is accurate and complete to the best of my knowledge and belief.

Rachelle J. Hamer Contracting Officer

NCO 10

RACHELLE

HAMER

Digitally signed by

RACHELLE HAMER

Date: 2026.08.17 13:44:38 -04'00'