Mail FIT Kit JOFOC - Redacted.pdf

VHAPG Part 806.3 OFOC Page 1 of 6 Revision: 04 Effective Date: 12/15/25 Acquisition ID#: 36C248-26-AP-1767

DEPARTMENT OF VETERANS AFFAIRS

Justification and Approval (J&A) For

Other Than Full and Open Competition (>SAT)

Acquisition Plan Action ID: 36C248-26-AP-1767

1. Contracting Activity: Department of Veterans Affairs (VA), Network Contracting

Office (NCO) 08, in support of Veterans Integrated Service Networks (VISN) 08. This service will be conducted at all the VISN 8 sites.

Purchase Request: 485-26-1-2901-0016

2. Nature and/or Description of the Action Being Approved: In May 2024, the Assistant Under Secretary for Health (AUSH) for Clinical Services released the “Expansion of Programmatic Mailed Fecal Immunochemical Testing (FIT) for Colorectal Cancer Screening” Memorandum, which required VISN Directors to expand the Programmatic Mailed FIT Kit Service for average risk Veterans.

Current station contracts within VISN 8 are limited to Cost Per Test (CPT) and reagent rental models. They do not include provisions for managing or shipping collection kits to patients who seek services through the facilities. Without a structured process for managing and shipping collection kits, patients experience delays in receiving necessary testing materials, which can lead to postponed diagnoses and treatment. These delays compromise continuity of care and may negatively affect clinical outcomes. From an operational standpoint, the absence of centralized kit management increases administrative burden on individual facilities, creates inefficiencies in workflow, and results in inconsistent patient experiences across the region.

Under this procurement, service and instrument rental are covered through the purchase of collection kits and the performance of completed tests on the associated platforms. Implementing a solution that addresses logistical challenges is essential to improving patient access, reducing turnaround times, and ensuring standardized service delivery throughout VISN 8.

The VISN 08 contracting office proposes to procure by other than full and open competition for service to mail Fecal Immunochemical Test (FIT) collection kits to Veterans to screen for colorectal cancer (CRC). Award will be a firm-fixed-price Indefinite Delivery / Indefinite Quantity (IDIQ) sole source contract to Polymedco Cancer Diagnostic Products LLC (Polymedco) consisting of five (5) ordering periods.

The estimated value of the proposed action is $4,650,000.00 ($930,000.00 / Yr)

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Acquisition ID#: 36C248-26-AP-1767

Ordering Period 1: April 1, 2026 – March 31, 2027

Ordering Period 2: April 1, 2027 – March 31, 2028

Ordering Period 3: April 1, 2028 – March 31, 2029

Ordering Period 4: April 1, 2029 – March 31, 2030

Ordering Period 5: April 1, 2030 – March 31, 2031

LIN Item # Description QTY Unit of

Issue Unit

Price Total

FBT-

2333981

VISN 8 - FIT kit assembly, (OC-Auto Sensor io) 60,000 EA $10.50 $630,000.00

FBT-

2333981

VISN 8 - Patient Navigation, mailing and tracking 60,000 EA $5.00 $300,000.00

This Mail FIT Kit Service is assigned FSC H266 and is not IT-related; therefore, FITARA does not apply to this procurement.

3. Description of Supplies/Services Required to Meet the Agency’s Needs:

The Mail FIT Kit Service is designed to increase colorectal cancer screening adherence by mailing FIT kits directly to eligible patients. Pricing for the FIT Kits include mailing envelope, patient letter, outer envelope, sampling bottle, collection paper, bio bag and return mailer. Pricing for Patient Navigation includes Client

Dashboard, Collection Support, Monitoring, Omnichannel Patient Engagement, Technical integration. Price also includes labor, materials, and supplies to perform the direct FIT mailing service and the price of patient navigation. The service includes assembling the FIT collection kits, mailing the kits, and conducting pre-notification and follow-up communication with Veterans. It requires approximately

60,000 FIT collection kits to be mailed to veterans, annually.

4. Statutory Authority Permitting Other than Full and Open Competition: The statutory authority for applying the Simplified Procedures for Commercial Items is 41 U.S.C. § 3304(a)(1) and is implemented by RFO 6.103-1 on this procurement. Competition is restricted on this procurement for the reason below:

( X ) (1) Only One Responsible Source and No Other Supplies or Services Will

Satisfy Agency Requirements per 41 USC §3304(a)(1) as implemented by

RFO 6.103-1.

( ) (2) Unusual and Compelling Urgency per 41 USC §3304(a)(2) as implemented by RFO 6.103-2.

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Acquisition ID#: 36C248-26-AP-1767

( ) (3) Industrial Mobilization, Engineering, Developmental or Research Capability or Expert Services per 41 USC §3304(a)(3) as implemented by RFO 6.103-3.

( ) (4) International Agreement per 41 USC §3304(a)(4) as implemented by RFO 6.103-4

( ) (5) Authorized or Required by Statute per 41 USC §3304(a)(5) as implemented by RFO 6.103-5.

( ) (6) National Security per 41 USC §3304(a)(6) as implemented by RFO 6.103-6.

( ) (7) Public Interest per 41 USC §3304(a)(7) as implemented by RFO 6.103-7.

5. Demonstration that the Contractor’s Unique Qualifications or Nature of the Acquisition Requires the Use of the Authority Cited Above (applicability of authority): Polymedco is the sole manufacturer and distributor of the FDA-approved, CLIA-waived, and the exclusive kits validated for automated high-throughput analysis using the OC-Auto Analyzer. Polymedco is the only contractor capable of performing the mailing and notification service required for colorectal cancer screening. All VISN 8 facility laboratories are already using Polymedco’s platform, which ensures compatibility, reliability, and streamlined workflows. Failure to award this contract would result in delays in colorectal cancer screening, negatively impacting Veteran health outcomes.

Polymedco has patent and distribution rights for these specific FIT kits in the U.S.

and does not authorize alternative distributors. Substituting other kits would require different analyzers, retraining, lab revalidation, and potentially compromise clinical accuracy and program integrity. The current FIT kit used for colorectal cancer screening is provided to seven (7) VA Medical Centers within VISN 8 by Polymedco as part of the Immunochemical Fecal Occult Blood Test (IFOBT). They provide the instrumentation to analyze the collected samples returned by Veterans. The required collection kits have 14-day inoculated stability and are compatible with the existing instrumentation, the Polymedco OC-Auto Micro 80, OC-Auto Sensor Diana, and OC- Auto Sensor iO. Polymedco provided a sole source declaration letter.

6. Description of Efforts Made to ensure that offers are solicited from as many potential sources as possible (including whether a notice was or will be publicized as required by RFO Part 5 and, if not, which exception under RFO Part 5 applies): A notice of intent to award a sole source procurement was posted to the System for Award Management (SAM), Contract Opportunities, under RFI 36C24826Q0206 on 02/08/2026. The notice stated that all responsible sources could submit a capability statement, proposal, or quotation, which the agency shall consider. Interested and capable contractors were to submit offers within fifteen (15) days of the notice’s publication. There were no responses.

7. Determination by the CO that the Anticipated Cost to the Government will be

Fair and Reasonable: In accordance with RFO 12.204(a), a fair and reasonable price will be based upon the comparison of previous pricing of similar analyzers and

VHAPG Part 806.3 OFOC Page 4 of 6

Acquisition ID#: 36C248-26-AP-1767 testing in the market provided by Polymedco. Furthermore, comparison with procurement history and previous pricing may be adjusted to account for the number of kits / locations.

8. Description of the Market Research Conducted and the Results, or a Statement of the Reasons Market Research Was Not Conducted: Market research was conducted via the Small Business Search (SBS) website, Contract Opportunities postings, and review of the Vendor Sole Source Declaration Letter.

Market Research was conducted by VISN 8 customer from 10/01/2025 to 12/1/2025 and by the contracting team from 01/08/2026 to 01/10/2026. A search of the mandatory source, Ability One, revealed that they do not offer the requested mailing services or the product required to be mailed. A search in SBS using NAICS 334516 generated 341 SDVOSB / VOSB result, however Polymedco does not use subcontractors to package and mail FIT Kits.

Polymedco is the manufacturer and sole source for OC-Auto FIT Kits utilized in VA Clinic laboratories. As verified, there are no authorized SDVOSB / VOSB’s that can perform maintenance, repairs or distribute product consumables and reagents.

A review of historical market research indicated that one small business and two large businesses may be capable of providing FIT mailer kits; however, all the resulting contracts were awarded to Polymedco. They are the only contractor that meet the Statement of Work (SOW) requirements for IFOBT CPRR. In addition, due to the nature of this requirement, the Original Equipment Manufacturer (OEM), Polymedco was contacted to inquire if they had any authorized distributors who could also sell the requested CRC collection kits. The OEM responded that they are the sole proprietary manufacturer and domestic distributor of CRC collection kits that are compatible with their analyzers. The Buy American Act does not apply to this acquisition.

Market research confirms there are no authorized SDVOSBs/VOSBs or Small Businesses to perform maintenance or distribute product. It is in the best interest of the government to award a sole source procurement directly to the OEM.

9. Any Other Facts Supporting the Use of Other than Full and Open Competition:

The instrumentation used at the laboratories to analyze the returned samples is provided as part of the IFOBT contracts. These contracts also provide FIT mailers as a line item, which are the same FIT mailers required to support this service contract.

The FIT mailers are proprietary to Polymedco Cancer Diagnostic Products LLC. and designed for use with Polymedco analyzers.

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Acquisition ID#: 36C248-26-AP-1767

10. Listing of Sources that Expressed, in Writing, an Interest in the Acquisition:

Polymedco Cancer Diagnostic Products, LLC

11. A Statement of the Actions, if any, the Agency May Take to Remove or

Overcome any Barriers to Competition before Making subsequent acquisitions for the supplies or services required: Currently, the only vendor capable of providing the FIT collection kits required for this service is Polymedco. The FIT collection kits must be analyzed using the instrumentation already located in the laboratory through a current contract. The inability to acquire other FIT collection kits that would be compatible with the current analyzers would force all medical centers within VISN 8 to procure replacement IFOBT analyzers at a significantly higher cost and cause irregularities in the CRC screening program. Every effort will be made in future requirements to identify vendors who can provide the FIT collection kits, associated mailing, and notification service.

The Contracting activity will continue to encourage brand name or equivalent specifications and will continue to monitor new analyzer products introduced in lab testing in order to identify systems that may meet our specialized needs at a lower cost. A sole source award justification will be posted for this acquisition.

12. 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 and belief.

Date

Supervisory Clinical Laboratory Scientist Pathology & Laboratory Medicine Service

VHAPG Part 806.3 OFOC Page 6 of 6

Acquisition ID#: 36C248-26-AP-1767

13. Approvals in accordance with the VHAPM Part 806.3 OFOC SOP:

a. Contracting Officer Certification (required): I certify that the foregoing justification is accurate and complete to the best of my knowledge and belief.

Contracting Officer North VISN Team

b. One Level Above the Contracting Officer (Required over SAT but not exceeding $900K): I certify the justification meets requirements for other than full and open competition.

Senior Contracting Officer

North VISN Team

c. VHA RPO HCA Review and Approval: I have reviewed the foregoing justification and find it to be complete and accurate to the best of my knowledge and belief and recommend approval (if over $90 million) or approve ($900K to $90 million) for other than full and open competition.

Head of Contracting Activity, East