Sole Source Justification - FIT Maililing Service _Redacted.pdf

Effective Date: 11/01/24 Page 2 of 5

REVISION: 01

Acquisition ID#: 36C257-24-AP-5035

( ) Authorized or Required by Statute ( ) National Security ( ) Public Interest

5. Demonstration that the the Use of the Authority Cited Above: 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 compatible with the instrumentation already provided on separate contracts. 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 six (6) VA Medical Centers within VISN 17 by Polymedco Cancer Diagnostics Products LLC as part of the Immunochemical Fecal Occult Blood Test (IFOBT) Cost-Per-Reportable-Result (CPRR) for contracts 36C25720P0013, 36C25722A0033, 36C25723A0003, 36C25724D0008, 36C25724A0038 and 36C25724D0072. These contracts also provide the instrumentation to analyze the collected samples returned by Veterans. The required collection kits have a 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.

6. Description of Efforts Made to ensure that offers are solicited from as many potential sources as deemed practicable: A notice of intent to award a sole source procurement was posted to the System for Award Management (SAM), Contract Opportunities, under RFI 36C25725Q0045 on 10/08/2024. 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 five (5) days from the publication of the notice, which was 10/15/2024. There were two responses from small businesses for this notice, however, neither of these small businesses had access to the FIT collection kits that are required. The notice was archived in SAM on 11/14/2024.

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

Reasonable: In accordance with FAR 13.106-3(a)(2), the contracting officer has determined that the anticipated proposed prices will be fair and reasonable. The contracting officer will compare the proposed prices with those found reasonable on previous purchases and a comparison with items in a related industry.

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 to determine if there were authorized distributors of the FIT collection kit compatible with the existing instrumentation. Market Research was conducted by VISN 17 from 04/01/2024 to 08/09/2024 and by the contracting team from 08/23/2024 to 11/13/2024. 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 VetCert using NAICS 492110 generated 639 results: 59 VOSB and 580 SDVOSB. However, Polymedco

Effective Date: 11/01/24 Page 3 of 5 does not use subcontractors to package and mail the FIT kits. A Dynamic Small Business Search (DSBS) did not generate any results for the capability to provide the FIT kits and mailing service required. 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 of the resulting contracts were awarded to Polymedco Cancer Diagnostic Products LLC. Polymedco Cancer Diagnostic Products LLC.

was the only contractor that met the Statement of Work (SOW) requirements for IFOBT CPRR. In addition, due to the nature of this requirement, the Original Equipment Manufacturer (OEM), Polymedco Cancer Diagnostic Products LLC., 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 compatible with their analyzers. Based on the market research, it is in the government's best interest to solicit this requirement as a sole source acquisition directly from the OEM, Polymedco Cancer Diagnostic Products LLC., IAW FAR 13.106-1(b)(2).

9. Any Other Facts Supporting the Use of Other than Full and Open Competition: The instrumentation used at the VISN 17 laboratories to analyze the returned samples is provided as part of the IFOBT CPRR 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.

10. Listing of Sources that Expressed, in Writing, an Interest in the Acquisition: Rich Logistics Transport LLC and Fusebox One expressed an interest in this procurement. However, neither small business is an authorized distributor of the required FIT kit. Polymedco Cancer Diagnostic Products LLC is the only contractor capable and interested in providing the mailing service.

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 Cancer Diagnostic Products LLC. Polymedco 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 17 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. NCO 17 and VISN 17 will conduct market research before awarding each task order and on subsequent procurements to determine if there have been any changes in the marketplace.

Effective Date: 11/01/24 Page 4 of 5

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

Deputy Chief Medical Officer, PC ICC Lead Veterans Integrated Service Network (VISN) 17

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

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

Contracting Officer, Laboratory Support Services Network Contracting Office (NCO) 17

b. One Level Above the Contracting Officer: I certify that the justification meets the requirements for a form of competition other than full and open competition.

Branch Chief, Laboratory Support Services (LSS)

c. Director of Contracting. I certify that the justification meets requirements for other than full and open competition.

Director of Contracting

Effective Date: 11/01/24 Page 5 of 5

d. 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 approve for other than full and open competition.

Executive Director, Regional Procurement Office West Head of Contracting Activity (HCA)