6640--VISN 8 Mail FIT Kits

Solicitation / RFP / RFQ

This document is related to Solicitation Number 36C24826Q0206 for Mailed Fecal Immunochemical Testing (FIT) Kits for VISN 8. The Contracting Office is Network Contracting Office 8 (NCO 8) in Gainesville, FL.

• The primary requirement is for Mailed Fecal Immunochemical Testing (FIT) Kits.

• A specific attachment, "Mail FIT Kit JOFOC - Redacted," is referenced for further details.

• This appears to be an award notice, not a solicitation. The award number is 36C24826D0024.

• Award Amount: $3,500,000.00

• Award Date: 03-30-2026

• Awardee: POLYMEDCO CANCER DIAGNOSTIC PRODUCTS LLC

Not applicable as this is an award notice.

• Set-Aside: SBA (Small Business Administration)

• Product Service Code: 6640

• NAICS Code: 334516

• The original solicitation number was 36C24826Q0206.

Justification and Approval (J&A) for Other Than Full and Open Competition

This document justifies a sole-source procurement for a Programmatic Mailed Fecal Immunochemical Testing (FIT) Kit Service for colorectal cancer screening for Veterans within Veterans Integrated Service Networks (VISN) 8. The service aims to expand existing efforts and address logistical challenges in managing and shipping FIT kits, thereby improving patient access, reducing turnaround times, and standardizing service delivery.

• Procurement of FIT collection kits and performance of completed tests.

• Assembling FIT collection kits, mailing them to eligible patients, and conducting pre-notification and follow-up communication.

• Approximately 60,000 FIT collection kits to be mailed annually.

• Contract Type: Firm-Fixed-Price Indefinite Delivery / Indefinite Quantity (IDIQ).

• Contractor: Polymedco Cancer Diagnostic Products LLC (sole source).

• Period of Performance: Five (5) ordering periods.

• Estimated Value: $4,650,000.00 ($930,000.00 per year).

• This is a sole-source justification, not a solicitation for proposals.

• A notice of intent was posted to SAM.gov, and no responses were received from other responsible sources.

• The procurement is justified for other than full and open competition based on Polymedco being the sole responsible source and manufacturer of FDA-approved, CLIA-waived FIT kits compatible with existing VA laboratory instrumentation.

• Polymedco is the sole manufacturer and distributor of the required FIT kits in the U.S.

• Substituting kits would require significant retraining, lab revalidation, and could compromise clinical accuracy.

• Market research confirmed no authorized distributors or small businesses capable of performing the required services.

• The Buy American Act does not apply to this acquisition.

Statement of Work (SOW) / Performance Work Statement (PWS)

To provide a mailer collection kit service for Fecal Immunochemical Testing (FIT) for colorectal cancer screening to an estimated 60,000 Veterans annually within the VA Veterans Integrated Service Network (VISN) 8. The service aims to expand programmatic mailed FIT for average-risk Veterans.

• Provide a mailer collection kit service for Veterans.

• Utilize telecommunications to inform Veterans about testing and instructions.

• Mail collection kits for testing.

• Assemble and prepare mailing packets including a labeled FIT kit, a return envelope with postage and return address, and printed labels for FIT kit tubes.

• Include explicit instructions in English and Spanish for kit contents, collection, labeling, and return.

• Perform audits of assembled kits to ensure accurate labeling.

• Conduct follow-up communication with Veterans who have not returned kits.

• Resend kits if samples are unable to be processed and inform the Veteran of the reason.

• Ensure compatibility with existing laboratory instrumentation (Polymedco OC-Auto Sensor Diana and Polymedco OC-Auto Sensor io).

• Provide advance notification to Veterans via text, phone, email, or letter before kit delivery.

• Mail kits weekly with a 7-day cycle from receipt of the VA patient list to mailing.

• Support monthly batches of at least 5,000 mailers and annual quantities up to 60,000.

• Service must be operational within 30 days of contract award.

• Information provided to Veterans must follow a Flesch reading score above 80.

• Use USPS Ground Advantage for returned kits and escalate any delivery delays.

• Submit reports confirming kits mailed, notifications accomplished, and any issues encountered.

• Contractor's FIT testing instrumentation and collection vial combination must be FDA-approved.

• Collection kits must have at least a 14-day inoculated stability.

• The service will be provided to Veterans within VISN 8.

• Return addresses for collection kits include Tampa VAMC, Orlando VAMC, Bay Pines VAMC, North Fla/South Ga VAMC, SAN JUAN VAMC, West Palm Beach VAMC, and Miami VA HCS.

• Pricing includes labor, materials, supplies, direct FIT mailing service, and patient navigation.

• Contractor must supply labs with adequate reagent and instrument maintenance support.

• Invoices must include specific details: Invoice number, Contract number, Number of Units, Unit Cost, Total Cost, Date of Service, and Purchase Order Number.

Notice of Intent to Award as Sole Source

The Department of Veterans Affairs, Network Contracting Office 8 (NCO 8), intends to award a Sole Source, Firm-Fixed Price contract to Polymedco Cancer Diagnostic Products, LLC for the purchase of Fecal Immunochemical Test (FIT) kits for VISN 08 locations. These kits include labor, materials, supplies, and patient navigation for mailing services.

Market research indicates that these services are highly specialized and available only from a single source (Polymedco Cancer Diagnostic Products, LLC) without unacceptable delay or cost duplication. The government believes Polymedco is the sole provider of FDA-approved, CLIA-waived FIT Kits validated for automated high-throughput analysis using the OC-Auto Analyzer. They are also the sole provider for proprietary FDA-cleared analyzers and associated reagents, collection devices, and consumables used for processing results on these specific instruments.

• Contracting Office: Department of Veterans Affairs, Network Contracting Office 8 (NCO 8)
• Contracting Office Address: Gainesville, FL 32601-3460
• Solicitation Number: 36C24826Q0206
• Product Service Code: H266
• NAICS Code: 334516
• Response Date/Time/Zone: January 23, 2026, 12 PM Eastern Time, New York, USA

This announcement is for informational purposes only and is not a request for competitive offers. However, responsible sources who oppose this decision may submit their interest by providing the following information via email to todd.pappas@va.gov by the response deadline:

1. Company Name and Address
2. Primary Point of Contact (phone and email)
3. Federal Supply Schedule (FSS) availability
4. Applicable socioeconomic categories and capabilities
5. Brief descriptions of recent, relevant project experience (1 page max)
6. Business size (related to NAICS 334516)
7. Product and Service Code (H266)

• No solicitation is currently available.
• The government will not be responsible for any costs incurred in preparing responses.
• Telephone inquiries will not be accepted.
• A decision not to compete is solely at the government's discretion.
• The attached document is a Statement of Work (SOW) for the VISN 8 Mailed FIT Program.