6630--NOTICE OF INTENT TO SOLE SOURCE | Polymedco, LLC. DBA Polymedco Cancer Diagnostic | Mail-In Fit Testing

NOTICE OF INTENT TO SOLE SOURCE Polymedco, LLC. DBA Polymedco Cancer Diagnostic Washington DC VA Medical Center

Department of Veterans Affairs, VISN 5, Washington DC VA Medical Center, 50 Irving St NW, Washington, DC 20422, intends to award a Sole Source, Firm-Fixed-Price, 5-year Indefinite Delivery/Indefinite Quantity (IDIQ) contract to Polymedco Cancer Diagnostics Products LLC., 510 Furnace Dock Road, Cortland Manor, NY 10567.

The Contractor shall provide the following:

MFR Number

Description

Qty

FBT-2334498

PATIENT MAILING PACK

6000

NAV-2334498

PATIENT NAVIGATION

6000

The associated North American Industry Classification System (NAICS) code for this acquisition is 334516 Analytical Laboratory Instrument Manufacturing. The NAICS Size is 1,000 Employees. The Product Service Code (PSC) is 6630 Chemical Analysis Instrument.

This procurement is being conducted under Revolutionary Federal Acquisition Regulation Overhaul (RFO) Part 8, Acquisition of Commercial Products and Commercial Services, and in accordance with (IAW) General Services Acquisition Manual / Regulation (GSAM/R) Subpart 538.71 Federal Supply Schedule Ordering Procedures, capable of providing the supplies or services required at the level of quality required because the supplies or services are unique or highly specialized.

A firm fixed price 5-year Indefinite Delivery/Indefinite Quantity (IDIQ) contract is anticipated and shall be awarded. It is the Government's belief that only the proposed candidate possesses the required capabilities to successfully meet this requirement. It is the Government's intention to solicit with only this source.

This notice of intent is not a request for competitive proposals. It is not a solicitation or request for offers. No solicitation package is available. Any response to this notice must show clear and convincing evidence that competition would be advantageous to the Government. Responses must be received no later than Monday, June 1, 2026 at 11:00AM EST. Point of contact is Jameel Gordon, e-mail Jameel.gordon@va.gov.

DESCRIPTION:

Mailed Fecal Immunochemical Testing for Colorectal Cancer Screening-VAMC DC

Scope. The Fecal Immunochemical Test (FIT) is a laboratory test used to check stool samples for hidden blood and is commonly used as a screening method for colorectal cancer. The Contractor shall provide a mailer collection kit service for Veterans at the Veterans Affairs (VA) Medical Center in Washington, DC. The Contractor will use various means of telecommunications to inform Veterans of necessary testing, instructions for proper collection, and mailing collection kits for testing of Veterans annually. Pricing includes labor, materials, and supplies to perform the direct FIT mailing service and the price of patient navigation.

Background. In May 2024, the Assistant Under Secretary for Health (AUSH) for Clinical Services released the Expansion of Programmatic Mailed Fecal Immunochemical Testing for Colorectal Cancer Screening Memorandum, which required VISN Directors to expand the Programmatic Mailed FIT for average risk Veterans to at least 50% of facilities by January 1, 2025, and at least 80% by September 30, 2025.

Medical Center. Washington DC VA Medical Center, 50 Irving St NW, Washington, DC 20422

Performance Requirements.

The contractor will use the list provided by Washington, DC VAMC to mail collection kits weekly, with a 7-day cycle from receipt of the VA patient list to the mailed-out kits.

The contractor shall be able to support the mailing of monthly batches and shall be able to support large quantities annually.

The mailer service must go live within 30 days of contract award.

The contractor shall provide advance notification to the Veteran by text message, phone call, email, and/or a letter notification before the Veteran receives the kit. This notification is required to be completed within the 7-day cycle time.

All the information provided to the Veteran in the kit must follow the Flesch reading score of above 80 for easy-to-read instructions. This includes the introductory letter, sample collection instructions, labeling instructions, and kit return instructions. All information provided to the Veteran will be available in English and Spanish.

The contractor shall assemble and prepare mailing packets to the following specifications.

A labeled FIT kit in an envelope and a return non-window envelope with postage and return address affixed (VA will provide a return address). Print and affix the labels on the fit kit tubes. Standard postage requirements shall be applied to return envelopes to the appropriate lab.

The contractor shall include explicit instructions in English (front page) and Spanish (back page) for what is included in the mailer.

The contractor shall provide instructions on completing the collection, labeling instructions, and sample return instructions.

FIT Kit tubes should be labeled with the following information provided by VA

Last Name, First Name, Initial

Last 4 of Social Security Number (SSN)

Date of Birth (DOB)

Order Number

Date of Collection

Note: Name, Last 4, DOB, and order number will be entered by the Contractor, but the collection date will intentionally be left blank.

Mail assembled packets to Veterans using addresses provided by the VA. The VA will also give the laboratory address where the Veteran will return the collection kit for analysis.

To ensure no Veteran receives a kit inappropriately labeled, the contractor shall perform audits of assembled kits to ensure the name on the labeled tube matches the name on the package s address.Â

The contractor shall conduct follow-up communication by text message, phone call, email and/or a letter notification with Veterans who have not returned kits.

The contractor must be able to supply labs with adequate reagent and instrument maintenance support for increased testing via existing contracts to ensure the continuity of service and support increased testing requirements.

The contractor shall submit reports to Washington, DC VAMC confirming the number of kits mailed, and notifications accomplished to include pre-notifications and follow-up notifications. The report shall also identify any issues with Veteran contact information or returned mailers.

The contractor shall resend kits to Veterans when the sample is unable to be processed due to issues with sample and inform the Veteran of reason for retest.

The contractor will use United States Postal Service (USPS) Ground Advantage for returned kits to track delivery back to lab. The contractor will escalate through the Post Office any kits that are being held beyond 24 hours, so that kits can be delivered to the facility for processing. The contractor will review daily report and if an issue is recognized they will contact the Post Office location.

Services rendered will be verified by a record-keeping system maintained by Washington, DC VAMC, which assures that the VA pays for only those services requested, and only for valid patients of Washington, DC VAMC.

The contractor assumes all risks for work performed under this contract.

FIT Test Performance Requirements

The contractor s automated FIT testing instrumentation and collection vial(s) combination shall be approved by the Food and Drug Administration (FDA) for colorectal cancer screening.

The collection kits shall have at least a 14-day inoculated stability.

The collection kits shall be compatible with existing instrumentation, the Polymedco OC-Auto Sensor Diana and Polymedco OC-Auto Sensor io. They shall remain compatible with laboratory instrumentation even after periodic upgrades.