S02 SSJ_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 3 Acquisition ID# 36C250-25-AP-4007

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-4007

1. Contracting Activity: The Department of Veterans Affairs, Veterans Integrated Service

Network (VISN) 10, Louis Stokes Cleveland VAMC (CLE VAMC) Network Contracting Office

(NCO) 10.

Transaction: 541-25-3-250-0235

2. Brief Description of Supplies/ Services required and the intended use/Estimated Amount:

Network Contracting Office (NCO) 10 intends to award a new, firm fixed price, brand name purchase order to Mirion Medical (Capintec), Inc.’s authorized distributors; 1st American Medical Distributors, Inc. or DGA Medical for a Captus thyroid probe.

ESTIMATED DOLLAR VALUE:

REQUIRED DELIVERY DATE: 10 Weeks ARO

3. Unique characteristics that limit availability to only one source, with the reason no other supplies or services can be used: Per FAR 11.105 Items peculiar to one manufacturer and 12.4-Unique Requirements Regarding Terms and Conditions for Commercial Items, Mirion Medical (Capintec) is uniquely qualified to provide Captus thyroid probe based on the following:

Multi-Function Capability: Supports automated quality control, bioassay measurements, wipe tests, and lab tests in one integrated system.

Advanced Spectrum Analysis: Equipped with a fully functional 1024-channel Multi- Channel Analyzer (MCA) with automatic and manual calibration.

Timed Activity Mode: Features a programmable repetitive timed measurement function.

User Interface: Enhanced with a large 20-inch all-in-one color touch screen computer, providing a graphical menu-driven interface to streamline operation.

Integrated Hardware: Includes a 1" Well Counter, inkjet printer, and ergonomically designed stand with a fully articulating collimator arm for flexible positioning.

Medical Grade Construction: Features a Corian countertop with a built-in shelf for convenient document storage.

Radiation Sources Included: Comes with Cs-137 and Eu-152 rod sources, each at 0.5 μCi, for calibration and quality checks.

Effective Date: 11/15/2024 Page 2 of 3 Acquisition ID# 36C250-25-AP-4007

Optional DICOM Interface: Enables direct communication with hospital PACS and information systems to transfer patient data and test results.

Custom Protocol and Microsoft Office Compatibility: Ships with standard protocol customization and optional Office Professional 2010 compatibility.

Neck Phantom: A Thyroid Uptake Neck Phantom is included to support quality assurance and calibration.

No alternative manufacturer offers a complete system that meets these specific technical, operational, and compatibility requirements.

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

The OEM, MSPV, DSBS, SAM.gov, National Contracts, Interagency Contract Directory, GSA, ECAT, SEWP, CM, BIC, FPDS and the Internet were reviewed with the following results:

The OEM, Mirion Medical (Capintec), Inc., a large business, was contacted to receive a list of authorized distributors, with a concentration on SDVOSB and VOSB-authorized distributors. The OEM stated that they currently only use 1st American Medical Distributors, Inc., and DGA Medical.

o GSA eLibrary, ECAT, SAM.gov, Interagency Contract Directories, NAC, SEWP, COP-CS, FPDS, SCMC, MSVP, BIC and FDA:

Keywords Used: "thyroid probe" Results: None.

o DSBS:

NAICS Code Searched: 334517 (Analytical Laboratory Instrument

Manufacturing) Keywords Used: "thyroid probe" Results: None could provide the thyroid probe that met the specific technical and regulatory requirements besides 1st American Medical Distributors, Inc., and DGA Medical.

Based on these findings, no alternative vendors were identified that could meet the requirement without significant facility modifications, procurement delays, or operational disruptions. The Nonmanufacturer Rule (NMR) applies to this procurement under NAICS 334517, and the Small Business Administration (SBA) has issued a waiver. The VA and SBA Rule of Two can be met. Therefore this will be competed against the SDVOSB distribuotrs as a SDVOSB set-aside.

Effective Date: 11/15/2024 Page 3 of 3 Acquisition ID# 36C250-25-AP-4007

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. Per FAR 13.106-3(a)(2)(ii), price reasonableness will be based on comparison of proposed prices with prices found reasonable on previous purchases using

FPDS.

Rachelle J. Hamer Contracting Officer

NCO 10

RACHELLE

HAMER

Digitally signed by

RACHELLE HAMER

Date: 2025.06.11 16:52:23 -04'00'