Mail-In Fit Testing Kits

VHAPG Part 808.405-6 Limiting Sources Revision: 02 Effective Date: 03/02/2026 Acquisition ID#: 36C245-26-AP-2616 LIMITED SOURCES JUSTIFICATION FAR PART 8.405-6 (1) Contracting Activity Department of Veterans Affairs, VISN 5, 688 Washington DC Medical Center. (2) Description of Action The procurement is to procure Fecal Immunochemical Test (FIT) collections kits to Veterans to screen for colorectal cancer (CRC). This acquisition supports the Veterans Affairs CRC Screening outreach program. The action will be awarded as a new requirement under Federal Supply Schedule (FSS) 36F79720D0016. Order against: FSS Contract Number: 36F79720D0016 Name of Proposed Contractor: Polymedco, LLC DBA: Polymedco Cancer Diagnostic Pro Street Address: 510 FURNACE DOCK ROAD City, State, Zip: CORTLANDT MANOR, NY 10567 Phone: 914-930-3223 (3) Description of Supplies or Services: The estimated value of the proposed action is $500,000.00 Proposed action: FSS BPA with a five (5) year ordering period. The service includes assembling the FIT collection kits, mailing the kits, conducting prenotification and follow-up communication with Veterans. It requires approximately 6,000 FIT collection kits to be mailed annually. (4) Identify the Authority and Supporting Rationale (see below and if applicable, a demonstration of the proposed contractor s unique qualifications to provide the required supply or service. FAR 8.405-6(a)(1)(A): An urgent and compelling need exists and following the ordering procedures would result in unacceptable delays: RFO FAR 8.4: Ordering under the Federal Supply Schedule Only one source is capable of providing the supplies or services required at the level of quality required because the supplies or services are unique or highly specialized; Polymedco Cancer Diagnostic Products LLC is the sole manufacturer and distributor of the required FIT kits and the only source that can provide FIT kits. Since there are no authorized distributors of the required FIT kits, Polymedco Cancer Diagnostic Products LLC is the only contractor capable of performing the mailing and notification service required for colorectal cancer screening. The current FIT kit used for colorectal cancer screening is provided to Washington DC VAMC. This service will also provide the instrumentation to analyze the samples collected returned by Veterans. The required collection kits have a 14-day inoculated stability and are compatible with the existing instrumentation, OC-Auto Sensor Diana, and OC-Auto Sensor iO. FAR 8.405-6(a)(1)(C): In the interest of economy and efficiency, the new work is a logical follow-on to an original Federal Supply Schedule order provided that the original order was placed in accordance with the applicable Federal Supply Schedule ordering procedures. The original order must not have been previously issued under sole source or limited source procedures. FAR 8.405-6(b): Items peculiar to one manufacturer: A patent, copyright or proprietary data limits competition. The proprietary data is: These are direct replacements parts/components for existing equipment. The material/service must be compatible in all aspects (form, fit and function) with existing systems presently installed/performing. (5) Describe Why You Believe the Order Represents the Best Value consistent with FAR 8.404(d) to aid the contracting officer in making this best value determination: The order from Polymedco represents the best value as it combines competitive pricing with a high-quality, clinically validated FIT product that meets industry standards for colorectal cancer screening. The mail-in format reduces overhead costs associated with in-office testing while improving patient compliance and accessibility. When evaluated against comparable alternatives, Polymedco s offering delivers a strong balance of cost-effectiveness, reliability, and ease of use, making it the most practical and economical. (6) Describe the Market Research Conducted among schedule holders and the results or a statement of the reason market research was not conducted. Polymedco, LLC. DBA Polymedco Cancer Diagnostic is a small business vendor with FSS Contract #: 36F79720D0016. Market research for the Polymedco mail-in FIT was conducted using industry-standard methodologies, including analysis of existing market data, competitive benchmarking, and evaluation of colorectal cancer screening tends. Additional market research on sam.gov, via contracting displayed contracts awards dating back as far as 10 years from today. An intent to Sole Source was posted on sam.gov (Notice ID: 36C24526Q0535) 5/14/2026 6/1/2026. The were no challenges to the proposed method of a sole source procurement. (7) Any Other Facts Supporting the Justification: Polymedco Cancer Diagnostic Products, LLC is a primary contractor for Federal Supply Schedule (FSS) VA contracts for Fecal Immunochemical Test (FIT) kits, often supporting colorectal screening initiatives. Switching vendors would require replacement of analyzers, revalidation, staff retraining, IT/LIS changes, and updated clinical pathways, resulting in substantial additional cost and unacceptable delay in screening services. This includes mailer kits, lab services, and automated analysis systems under VISN-level procurement. Polymedco FIT kits and analyzers are already provided to VA under Federal Supply Schedule VA FSS contracts, and VA has repeatedly determined they are a reasonably available source for compatible supplies and services throughout multiple VISNs dating back more than 10 years per Sam.gov search history. (8) A Statement of the Actions, if any, the agency may take to remove or overcome any barriers that led to the restricted consideration before any subsequent acquisition for the supplies or services is made: N/A (9) Requirements Certification: I certify that the requirement outlined in this justification is a Bona Fide Need of the Department of Veterans Affairs and that the supporting data under my cognizance, which are included in the justification, are accurate and complete to the best of my knowledge. I understand that processing of this limited sources justification restricts consideration of Federal Supply Schedule contractors to fewer than the number required by FAR Subpart 8.4.