SSJ-R_Redacted.pdf

VHAPG Part 813.106 Simplified Acquisition Procedures: Soliciting from a Single Source Attachment 1: Single Source Justification for SAP under the SAT

Revision: 01 Effective Date: 11/15/2024 Page 1 of 2 Acquisition ID#: 538-25-3-054-0115

DEPARTMENT OF VETERANS AFFAIRS

Justification for Single Source Awards IAW FAR 13.106-1 For

Over Micro-Purchase Threshold but Not Exceeding the SAT ($250K)

Acquisition Plan Action ID: 36C250-25-AP-3010

1. Contracting Activity: Department of Veterans Affairs, NCO10, Indianapolis VA Medical Center, Network Contracting Office 10, at 1481 West 10th Street, Indianapolis, IN 46037. VA Form 2237:

583-25-3-054-0115 for Immunochemical Fecal Test with new Diana FIT Analyzer and Reagents.

2. Brief Description of Supplies/ Services required and the intended use/Estimated Amount: This is a new brand name requirement for 4-year option periods (Base + 3 options) for Immunochemical Fecal Occult Testing (iFOBT) analyzer and reagents for the Pathology and Laboratory Service. This acquisition is for laboratory reagents and supplies necessary to perform patient testing on the Polymedco OC Diana FIT -80 Auto instrument. Polymedco OC Diana FIT-80 Auto reagents and supplies are required to perform immunochemical fecal occult blood testing used to screen veteran patients for colorectal cancer. The shipments need to be timely considering usage and expiration dates of these supplies. Estimated usage is 8200 tests a year.

Necessary supplies are:

Mfr # Description Qty# MV5F00 OC-Sensor Diana FIT Analyzer w/ 1 Year warranty 1 MV5F00-SVC1 OC Sensor Diana Extended Service coverage is included for the term of the BPA

VA-CPT1 Cost per Test (1 device per patient reportable) 8200 VAOC-CR Credit for Devices included OCDL Latex Reagent For OC-Sensor Diana (5x15ml) included OCDW OC Diana Wash Solution (1x150ml) included OCQN OC-Sensor Diana Negative Control (5x1ml) included OCQP OC-Sensor Diana Positive Control (5x1ml) included OCDB OC-Sensor Diana Buffer (1x500ml) included OC80C OC-Sensor Diana Calibration Kit (10x1ml, 2x45ml

Diluent) included

TP-5 Thermal Paper (5 Rolls per Box) 5

3. Unique characteristics that limit availability to only one source, with the reason no other supplies or services can be used: Currently the Indianapolis VAMC Pathology and Laboratory Medicine Service (PLMS) uses the Polymedco OC-80 FIT testing instrument. The material/service must be compatible in all aspects (form, fit and function) with existing systems presently installed/performing. The current analyzer will not be supported after year 2025. Therefore, the VA shall provide a replacement of OC-80 FIT testing analyzer with one (1) OC Sensor Diana FIT Analyzer, VHAPG Part 813.106 Simplified Acquisition Procedures: Soliciting from a Single Source Attachment 1: Single Source Justification for SAP under the SAT

Revision: 01 Effective Date: 11/15/2024 Page 2 of 2 Acquisition ID#: 538-25-3-054-0115 all reagents/consumables/service and scheduled maintenance, service, and support on a firm fixed cost-per-result-reportable (CPRR) basis. The reagents and supplies include wash solutions, buffers, calibrators, controls, and consumable/disposable items (instrument cups, thermal paper, etc.)

specific for the acquired analyzer. The service participated in the VA National FIT initiative which currently utilizes Polymedco FIT kits custom made for the patients in the program. Only these reagents and supplies will allow the current equipment to operate properly and provide accurate results. These are also the only approved reagents per the FDA. The need for these and only these reagents and supplies constitutes a proprietary sole/limited source situation and to attempt to vary reagents for use with these instruments would create tainted results and jeopardize patient care. No other supplier/vendor can accommodate the required instrumentation and custom U.S. mail test kits with return system.

4. Description of market research conducted and results or statement why it was not conducted:

DSBS queried using NAICS 334516 and keywords “Fecal Reagents” for SD/VOSB’s with zero vendors found. VetCert query by same NAICS with 234 results. Polymedco Cancer Diagnostic Products, LLC, (OEM) confirmed the Cost Per Tests reagents are proprietary property of Polymedco and there are no authorized resellers/distributors. Sole Source letter provided. OEM is a small business. The VA Rule of Two nor SBA Rule of Two could be satisfied. No solicitation will be made. CO will publicize an Intend to Sole Source Notice in the SAM (GPE) to the OEM, open market. Price is fair and reasonable.

5. Contracting Officer's Certification: Purchase is approved in accordance with FAR13.106-1(b). I certify that the foregoing justification is accurate and complete to the best of my knowledge and belief.

Name Date Title

DWIGHT

PETSCHE

Digitally signed by

DWIGHT PETSCHE

Date: 2025.05.16 08:57:10 -04'00'