S03 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-4008

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-4008

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: 541-25-3-250-0236

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., 1st American Medical Distributors, Inc. or DGA Medical for dose calibrators.

ESTIMATED DOLLAR VALUE:

REQUIRED DELIVERY DATE: 30 Days 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 dose calibrators based on the following:

Touchscreen Interface

Features a large, full-color touchscreen that simplifies workflow and improves usability compared to traditional button-operated calibrators.

High Sensitivity Ionization Chamber Utilizes a well-type ionization chamber optimized for a wide range of radionuclides, offering precise activity measurement for low- and high-energy isotopes.

Built-in Nuclide Library

Comes with a comprehensive pre-programmed nuclide library, including PET and standard diagnostic isotopes, reducing configuration time and error.

On-board Quality Control Functions Built-in QC features like constancy, linearity, geometry, and accuracy testing streamline compliance with NRC and NHPP regulatory requirements.

Compact and Integrated Design

Effective Date: 11/15/2024 Page 2 of 3 Acquisition ID# 36C250-25-AP-4008

Designed as a space-saving, all-in-one system, with integrated chamber and processing unit, ideal for high-throughput nuclear medicine environments.

Connectivity and Data Output Equipped with USB, Ethernet, and RS-232 ports for automated recordkeeping, integration with electronic health record (EHR) systems, and dose tracking software.

Specialized for PET and SPECT

The CRC-55tPET model is specifically calibrated and configured to handle high-energy positron-emitting isotopes used in PET imaging, which many standard calibrators cannot do accurately.

Regulatory Compliance Fully compliant with NRC and NHPP standards, making it suitable for use in VA and other federally regulated nuclear medicine departments.

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.

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

o Keywords Used: "dose calibrator" o Results: None.

DSBS:

o NAICS Code Searched: 334516 (Analytical Laboratory Instrument

Manufacturing) o Keywords Used: "dose calibrator" o Results: None could provide the dose calibrators 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 337127, and the Small Business Administration (SBA) has not issued a waiver. While the SBA Rule of Two can be met, the VA Rule of Two cannot be met in the absence of an SBA NMR

Effective Date: 11/15/2024 Page 3 of 3 Acquisition ID# 36C250-25-AP-4008 waiver. Therefore, this requirement will be competed as a brand name, small business set-aside.

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: 2025.06.10 17:47:17 -04'00'