36C25726Q0327.docx

Special Notice Special Notice

GENERAL INFORMATION

Network Contracting Office 17

5441 Babcock Road Ste. 302 San Antonio TX 78240

POINT OF CONTACT*

Contract Specialist Ognian D. Ivanov ognian.ivanov@va.gov 210-694-6302

ADDITIONAL INFORMATION

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DESCRIPTION

NOTICE OF INTENT TO SOLE SOURCE

Contract Opportunity Title: Flow Cytometer System and Extended Service Contract – Sysmex

Solicitation Number: 36C25726Q0327 Posted Date: February 25, 2026 Response Date: March 9, 2026, by 10:00 AM CST

Set-Aside: N/A – Sole Source

DESCRIPTION:

The Department of Veterans Affairs (VA), Veterans Health Administration (VHA), Network Contracting Office (NCO) 17, intends to award a firm-fixed-price contract on a sole source basis to: to Sysmex America, Inc. 577 Aptakisic Road Lincolnshire, IL 60069, for the procurement of a comprehensive Flow Cytometer System for WBC Immunophenotype and T-Lymphocyte Subset testing, along with an extended service contract for existing Sysmex equipment in the Flow Cytometry testing area.

Period of Performance: One (1) base year with two (2) option years.

Contract Type: Firm-Fixed-Price (FFP)

SCOPE OF WORK:

The contractor shall provide the following:

1. Flow Cytometer System meeting the following specifications:

- Compatible with Sysmex PS-10 Sample Processing Unit (Serial Number: 1910009588)

- Footprint: 30"H x 38"W x 30"D maximum

- On-board inventory management and walkaway automation

- Acquisition rate: minimum 30,000 events per second

- Clinical Report Analysis Software capable of reading LMD and FCS file types

- Complete ancillary hardware (UPS, Monitor, CPU, Printer, Scanner, Auto-Handler, QR printer)

- 10-color analysis capability with expansion option

2. Report Software:

- Compatible with Data Innovations and VistA

- Windows 10 platform

- Re-gating capability outside cell acquisition timeframe

- FDA/IVD or RUO clearance

3. Testing Capabilities:

- CD4/CD8 testing (FDA/IVD preferred)

- WBC Immunophenotype testing

- Full CD marker panel availability with minimum 6-month expiration

4. Installation and Validation:

- Delivery, installation, and validation within 90 days of contract award

- Validation per The Joint Commission (TJC) guidelines

- LIS interface setup and connectivity

5. Maintenance and Support:

- Preventative maintenance per manufacturer specifications

- Telephone technical support (0800-1700 business days)

- On-site repair services with same-business-day dispatch

- All parts, materials, and labor at no additional cost

6. Training:

- Three (3) Basic Operator Training slots

- Three (3) Multicolor Flow Cytometry training slots

- One (1) additional Basic or Advanced Operator class per year

- Training materials, handouts, and editable procedures

EXISTING EQUIPMENT TO BE SERVICED:

- Sysmex XF-1600-10, Serial Number: A1023

- Sysmex XF-IPU, Serial Number: SMX1019F31809

- Sysmex PS-10, Serial Number: 1910009588

BASIS FOR SOLE SOURCE AWARD:

This procurement is being conducted as a sole source under the authority of FAR 6.302-1 (Only One Responsible Source). The Sysmex lab equipment is highly specialized and proprietary in nature. Sysmex America, Inc. is the Original Equipment Manufacturer (OEM) and the only source capable of providing:

- OEM-trained and certified technicians following OEM equipment maintenance guidelines

- Compliance with the Medical Equipment Management Plan (MEMP) established by the Environment of Care (EOC) Committee for Healthcare Technology Management (HTM)

- Warranty-compliant service without voiding existing equipment warranties

- Seamless integration with existing Sysmex PS-10 Sample Processing Unit and Sysmex XF-series instruments

- Validated compatibility and interface connectivity with current laboratory information systems

Third-party vendors cannot provide the necessary OEM certification, proprietary technical knowledge, or validated compatibility required to meet VA clinical laboratory standards and patient safety requirements. Service by non-OEM vendors creates unacceptable risk of equipment malfunction, test result errors, and regulatory non-compliance.

This acquisition is for commercial services under FAR Part 12.

SUBMISSION OF CAPABILITIES STATEMENT:

Any interested party that believes it can meet the requirements described above may submit a capabilities statement demonstrating the ability to provide the required Flow Cytometer system, maintenance, and support services for the existing Sysmex equipment listed above.

Responses must include:

1. Evidence of OEM authorization and certification from Sysmex to service Sysmex XF-1600-10, XF-IPU, and PS-10 equipment

2. Demonstration of ability to provide Flow Cytometer system compatible with Sysmex PS-10 Sample Processing Unit

3. Technical specifications showing equivalency to requirements in the Statement of Work

4. Evidence of FDA/IVD clearance for CD4/CD8 testing

5. Proof of ability to interface with Data Innovations and VistA systems

6. Documentation of previous VA or Federal laboratory installations

7. Availability of all required CD marker reagents with 6-month minimum expiration

All responses must be submitted electronically to:

Ognian Ivanov, Contracting Specialist Email: Ognian.Ivanov@va.gov Responses Due: March 9, 2026, by 10:00 AM CST

Responses received after this date and time will not be considered. This is not a request for proposals. No solicitation document is available at this time. Responses to this notice will be used solely to determine whether to proceed with the sole source award or pursue full and open competition.

APPLICABLE FAR PROVISIONS:

This acquisition is being conducted under FAR Part 12 (Acquisition of Commercial Products and Commercial Services), FAR Part 6.302-1 (Only One Responsible Source), and FAR Part 5.203 (Publicizing and Response Time for Commercial Services).

This notice complies with FAR 5.203, which permits a response period of less than 15 days for commercial services acquisitions when reasonable under the circumstances. The 10-day response period provides adequate time for qualified sources to submit capability statements.

Special Notice