36C25026Q0639.docx

Combined Synopsis-Solicitation for Commercial Products and Commercial Services

GENERAL INFORMATION

Network Contracting Office (NCO) 10 6150 Oak Tree Blvd., Suite 300

Independence OH 44131

POINT OF CONTACT*

Contract Specialist Jennifer A. Tisdale jennifer.tisdale@va.gov 216-447-8010 None

PLACE OF PERFORMANCE

Louis Stokes Cleveland VA Medical Center

10701 East Blvd.

Pathology & Laboratory Service

Cleveland Ohio

ADDITIONAL INFORMATION

Combined Synopsis/Solicitation Notice

DESCRIPTION

Combined Synopsis/Solicitation Notice

Combined Synopsis/Solicitation Notice

DESCRIPTION

Combined Synopsis/Solicitation Notice

Page 1 of This is a combined synopsis/solicitation for commercial products and commercial services prepared in accordance with the format Revolutionary FAR Overhaul (RFO) in Federal Acquisition Regulation (FAR) subpart 12.202, “Streamlined Procedures for Evaluation and Solicitation for Commercial Products and Commercial Services,” as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; quotes are being requested, and a written solicitation document will not be issued.

This solicitation is issued as an RFQ 36C25026Q0639. The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular (FAC)2026-01. This solicitation is Small Business set-aside, under FAR Part 12.

The associated North American Industrial Classification System (NAICS) code for this procurement is 334516, Analytical Laboratory Instrument Manufacturing with a business size standard of 1000. The FSC/PSC is 6640.

The Department of Veterans Affairs, Network Contracting Office (NCO)10, Louis Stokes Cleveland VA Medical Center 10701 East Blvd., Cleveland, Ohio 44106 is seeking to purchase the following equipment, DxFlex Flow Cytometer for the Pathology and Laboratory Service Department.

All interested companies shall provide quotations for the following, Brand Name Only:

Supplies/Services requested:

D21047

Statement of Work (SOW):

Contract Number:

Task Order Number:

Follow-on to Contract and Task Order Number:

1. Contracting Officer’s Representative (COR).

Name:

Phone Number:

Fax Number:

E-Mail Address:

2. Contract Title. DxFLEX Flow Cytometer with Autoloader and CytExpert software System.

3. Background:

LAB BACKGROUND

Our laboratory currently performs leukemia/lymphoma immunophenotyping by flow cytometry. To increase the quality, safety, and throughput of patient testing, we propose acquiring the Beckman Coulter DxFLEX Flow Cytometer with the DxFLEX Autoloader and CytExpert for DxFLEX software. The DxFLEX is FDA-cleared in the United States for 10-color in vitro diagnostic use with the ClearLLab 10C Reagent System, enabling a much faster path to clinical go-live compared with developing and validating laboratory-developed tests (LDTs). The DxFLEX platform will streamline sample preparation and data acquisition, improve result accuracy, and reduce manual hands-on time and reagent waste.

CLINICAL NEED AND RATIONALE

We require a modern clinical flow cytometer with automated sample loading, barcode-based positive identification, and stable multicolor detection to support high-confidence leukemia/lymphoma panels. The DxFLEX meets these needs by combining a compact, integrated optical design, high sensitivity detectors, and workflow-oriented CytExpert software with bi-directional LIS connectivity.

4. Scope: The contractor shall provide the following:

PERFORMANCE ADVANTAGES

•Up to 10-color FDA-cleared clinical configuration for ClearLLab 10C (instrument hardware supports up to 13 fluorescence channels for RUO).

•Three solid-state lasers for robust multicolor detection: 405 nm (Violet), 488 nm (Blue), and 638 nm (Red).

•High sensitivity for dim populations: ≤30 MESF-FITC, ≤10 MESF-PE, <50 MESF-PB450, and <25 MESF-APC.

•Fully, digital electronics providing 7 decades (orders of magnitude) dynamic range for accurate separation of populations.

•Nominal acquisition rate of 30,000 events per second with up to 15 parameters (13 fluorescence channels plus forward/side scatter).

•Carryover control with observed beads carryover as low as 0.006% in validation studies (≤0.5% specification).

•Optimized scatter resolution to resolve lymphocytes, monocytes, granulocytes, red blood cells, and platelets.

EASE OF USE AND WORKFLOW IMPROVEMENTS

•DxFLEX Autoloader supports up to 32 (12 × 75 mm) tubes with single-tube mixing and integrated barcode reader for positive sample identification.

•Compact footprint with onboard fluidics (4 L sheath and waste; optional 10 L waste cubitainer) to save bench space and simplify operations.

•Preset, and custom flow rates (10/30/60 µL/min presets; up to 240 µL/min custom) applied consistently across panels for standardized acquisition.

•Automated maintenance cycles including initialize, standby, sample mix, backflush, prime, shutdown (daily clean), and deep clean to reduce downtime and operator variability.

•CytExpert for DxFLEX provides a Compensation Library, auto-threshold, linear gain adjustment, and panel experiment workflows that reduce setup time and minimize errors.

•Bi-directional LIS connectivity to receive orders/specimen IDs and push results back to the LIS, improving traceability and efficiency.

•Ability to save up to 20 million events per file to support rare event analysis and comprehensive data review.

SAFETY, COMPLIANCE, AND TRACEABILITY

•FDA-cleared ClearLLab 10C application for Leukemia/Lymphoma testing in the US; standardized dry-format reagents reduce waste and inventory complexity.

•Barcode verification at the Autoloader to ensure the software Sample ID matches the tube label; can also populate Sample ID from barcode if missing.

•User management and tracking in CytExpert provide access control and audit trails for data integrity.

•Daily QC routines with Levey–Jennings tracking enable continuous monitoring of system perform.

TECHNICAL SPECIFICATIONS (Bullet Points) Optics & Lasers:

•Blue Laser: 488 nm, 50 mW (beam spot ~5 µm × 80 µm) •Red Laser: 638 nm, 50 mW (beam spot ~5 µm × 80 µm) •Violet Laser: 405 nm, 80 mW (beam spot ~5 µm × 80 µm) •Alignment-free integrated quartz flow cell optics with >1.3 NA •Wavelength Division Multiplexing (WDM) detection module with solid-state, high-efficiency, low-noise detectors •Side scatter resolution: ~300 nm

PERFORMANCE & ELECTRONICS:

•Event collection rate: 30,000 events/second with up to 15 parameters •Data resolution: Fully digital with 7 decades dynamic range •Digital sampling rate: 25 MHz •Sensitivity: ≤30 MESF-FITC; ≤10 MESF-PE; <50 MESF-PB450; <25 MESF-APC •Carryover: ≤0.5% beads carryover; observed ~0.006% in study

• Fluorescence channels: Up to 13 (RUO); FDA-cleared for 10-color with ClearLLab 10C in US

FLUIDICS & SAMPLE HANDLING:

•Preset flow rates: 10, 30, 60 µL/min; Custom up to 240 µL/min •Sample formats: 5 mL (12 × 75 mm) polystyrene and polypropylene tubes •Dead volume: ~25 µL (tube), ~20 µL (plate; plate adapter RUO) •Onboard fluidics: Standard 4 L sheath and 4 L waste; optional 10 L waste cubitainer •Automated maintenance cycles: initialize, standby, sample mix, backflush, prime, shutdown (daily clean), deep clean.

SOFTWARE & DATA MANAGEMENT:

•CytExpert for DxFLEX (FCS 3.0) with fully featured acquisition and analysis; license included •Compensation Library stores spillover values; linear gain auto-adjustment of compensation after gain changes •Auto-threshold based on population scaling •Bi-directional LIS connectivity for orders and result reporting •Save up to 20 million events per file; customizable reports; export in multiple formats •Operating system: Windows 10 Enterprise 2019 LTSC x64-bit.

INSTRUMENT DESIGN & INSTALLATION:

•Compact size with Autoloader: ~72 cm × 43.5 cm × 34 cm (L × W × H) •Cytometer weight: ~35.8 kg •All, instrument fluid containers onboard; no external fluidics cart •Power: AC 100–240 V ±10%, 50/60 Hz ±1 Hz; 150 VA normal, 250 VA max •Acoustic noise: <55 dBA (carousel), <60 dBA (measure level) •Environmental: 15–30 °C; RH 15–80% non-condensing; altitude ≤3000 m.

JUSTIFICATION VS. CURRENT WORKFLOW

•Faster clinical go-live with FDA-cleared ClearLLab 10C versus extended LDT development/validation timelines (months vs. 18–24 months).

•Single-platform absolute counts with consistent tube-by-tube mixing via Autoloader to ensure homogeneous samples prior to acquisition.

•Stable tandem dyes and standardized panels reduce compensation complexity and human error.

•Reduced manual prep and maintenance with automated routines, freeing technologist time and lowering consumable waste.

•Enhanced sample traceability via barcode verification and software-based user management and audit trails.

•Compact footprint and onboard fluids minimize space requirements and simplify installation.

PREFERRED FEATURES (Requested) •Three-laser system with high-power solid-state lasers (Blue >20 mW, Red >20 mW, Violet >30 mW – DxFLEX provides 50 mW Blue/Red and 80 mW Violet).

•Internal sample needle rinse and low carryover (≤0.5%; observed ~0.006% beads).

•Fully, digital electronics with wide dynamic range (7 decades).

•High efficiency analysis at nominal 30,000 events per second for increased resolution.

•Internal temperature/environmental specifications that support instrument stability.

•Remote support readiness via software tools and simplified alignment-free optics to minimize downtime.

•Listmode (FCS 3.0) files store protocol information for simplified offline analysis.

•Premade analysis templates available for ClearLLab-based Leukemia/Lymphoma testing.

•IVD-cleared Leukemia/Lymphoma option with ClearLLab 10C in the USance.

5. Performance Monitoring: The Contracting Officer Representative (COR) will monitor contract performance and act as the primary technical representative. Final inspection and acceptance of all deliverables will occur at Cleveland VAMC.

6. Security Requirements: The C&A requirements do not apply, and a Security Accreditation Package is not required.

Place of Performance/Place of Delivery

10701 East Blvd.

Cleveland, Ohio 44106

The full text of FAR provisions or clauses may be accessed electronically at http://acquisition.gov/comp/far/index.html.

Duty hours will be 8:00 AM to 4:00PM, unless instructed otherwise. The Government recognized US holidays are: New Year’s Day, Martin Luther King, Jr. Day, Presidents Day, Memorial Day, Juneteenth, Independence Day, Labor Day, Columbus Day, Veterans Day, Thanksgiving Day and Christmas Day. If the holiday falls on Sunday, it is observed on Monday.

The following solicitation provisions apply to this acquisition:

· FAR 52.203-16 PREVENTING PERSONAL CONFLICTS OF INTEREST (JUN 2020)

· FAR 52.203-17 CONTRACTOR EMPLOYEE WHISTLEBLOWER RIGHTS AND REQUIREMENT TO INFORM EMPLOYEES OF WHISTLEBLOWER RIGHTS (JAN 2023)

· FAR 52.212-1, Instructions to Offerors—Commercial Products and Commercial Services (DEVIATION AUG 2025)

· FAR 52.212-2 Evaluation-Commercial Products and Commercial Services: In accordance with RFO FAR 12.201-1 and FAR 12.201-2 when appropriate, the contracting officer may (1) Insert the provision at 52.212-2, Evaluation-Commercial Products and Commercial Services, in solicitations for commercial products or commercial services.

· FAR 52.212-4, Contract Terms and Conditions–Commercial Items (NOV 2023)

· FAR 52.222-90, Addressing DEI Discrimination by Federal Contractors – effective 24 April 2026

· FAR 52.232-40 PROVIDING ACCELERATED PAYMENTS TO SMALL BUSINESS SUBCONTRACTORS (MAR 2023) FAR 52.233-2 SERVICE OF PROTEST (SEPT 2006) - - Hand-Carried Address: Department of Veterans Affairs, Network Contracting Office 10, Louis Stokes Cleveland VAMC, 10701 East Blvd., Cleveland, OH 44106.

· FAR 52.232-40, Providing Accelerated Payments to Small Business Subcontractor (Nov 2021)

· VAAR 852.203-70 COMMERCIAL ADVERTISING (MAY 2018)

· VAAR 852.212-71 GRAY MARKET AND COUNTERFEIT ITEMS (FEB 2023)

· VAAR 852.232-72 ELECTRONIC SUBMISSION OF PAYMENT REQUESTS (NOV 2018)

· VAAR 852,233-70 PROTEST CONTENT/ALTERNATIVE DISPUTE RESOLUTION (SEP 2018)

· VAAR 852.233-71 ALTERNATE PROTEST PROCEDURE (SEP 2018)

Award will be based upon a comparative evaluation of quotes in accordance with the Simplified Acquisition Procedures of FAR 12. Comparative evaluation is the side by side pairwise comparison of quotes based on factors resulting in a Contracting Officer decision for the quote most favorable to the Government.

The award will be made to the response most advantageous to the Government.

Responses should contain your best terms and conditions.

This procurement is for new items only; no remanufactured or "gray market" items. No remanufacturers or gray market items will be acceptable. Gray market items are Original Equipment Manufacturers (OEM) goods sold through unauthorized channels in direct competition with authorized distributors. Vendor shall be an OEM, authorized dealer, authorized distributor, or authorized reseller for the proposed equipment, verified by an authorization letter or other documents from the OEM, such that the OEM’s warranty and service are provided and maintained by the OEM (include memo/letter with submission). All warranty and service associated with the equipment shall be in accordance with the OEM terms and conditions.

The Government will award a contract resulting from this solicitation to the responsible offeror, whose offer conforming to the solicitation will be most advantageous to the Government, price and other factors considered. The following factors shall be used to evaluate offers:

Price: The Government will evaluate the price by adding the total of all line-item prices. The Total Evaluated Price will be that sum.

Technical or Quality: The quotation will be evaluated to the extent to which it can meet and/or exceed the Government’s requirements as outlined in the solicitation and based on the information requested in the instructions to quoters section of the solicitation.

Past Performance: The past performance evaluation will assess the relative risks associated with a quoter’s likelihood of success in fulfilling the solicitation’s requirements as indicated by the quoter’s record of past performance. The past performance evaluation may be based on the contracting officer’s knowledge of and previous experience with the supply or service being acquired; Customer surveys, and past performance questionnaire replies; Contractor Performance Assessment Reporting System (CPARS) at http://www.cpars.gov/; or any other reasonable basis.

A written notice of award or acceptance of an offer, mailed or otherwise furnished to the successful offeror within the time for acceptance specified in the offer, shall result in a binding contract without further action by either party. Before the offer’s specified expiration time, the Government may accept an offer (or part of an offer), whether or not there are negotiations after its receipt, unless a written notice of withdrawal is received before award.

The award will be made to the response most advantageous to the Government.

Responses should contain your best terms and conditions.

To facilitate the award process, all quotes must include a statement regarding the terms and conditions herein as follows:

"The terms and conditions in the solicitation are acceptable to be included in the award document without modification, deletion, or addition."

OR

"The terms and conditions in the solicitation are acceptable to be included in the award document with the exception, deletion, or addition of the following:"

Quoters shall list exception(s) and rationale for the exception(s), if any.

Award will be based upon a comparative evaluation of quotes in accordance with the Simplified Acquisition Procedures of RFO FAR 12.

Submission of your response shall be received not later than June 18, 2026, by 2:00pm Eastern Standard Time (EST).

Late submissions shall be treated in accordance with the solicitation provision at FAR 52.212-1(f).

Any questions or concerns regarding this solicitation should be forwarded in writing via e-mail to the Point of Contact listed below.

VA Point of Contact:

Jennifer A. Tisdale Contract Specialist Network Contracting Office (NCO)10 Office: 216-447-8010 Email: jennifer.tisdale@va.gov