S02 SSJ_Redacted.pdf
PDF 215 KB Posted
- Attached to
- ThinPrep System Federal contract opportunity
- Solicitation number
- 36C25025P1634
About this file
This is a Single Source Justification document for a Department of Veterans Affairs (VA) procurement. The VA's Network Conducting Office (NCO) 10 at the Louis Stokes Cleveland VAMC intends to award a firm-fixed-price purchase order to Hologic for ThinPrep Processors. The procurement is for specialized medical laboratory equipment with unique capabilities, including automated sample preparation, integrated chain-of-custody tracking, and compatibility with specific molecular and cytology testing systems. After conducting market research across multiple databases and platforms, the VA determined no other vendors or distributors could provide equivalent equipment, leading to a sole source acquisition from Hologic, a large business. The procurement falls under the Simplified Acquisition Threshold (SAT) of $250,000, with a required delivery date of 90 days after receipt of order, and is scheduled for an effective date of 11/15/2024.
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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# 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-4903
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: 541-25-4-250-0370
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 Hologic for the ThinPrep Processors.
ESTIMATED DOLLAR VALUE:
REQUIRED DELIVERY DATE: 90 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 FAR 12.4—Unique Requirements Regarding Terms and Conditions for Commercial Items—Hologic is uniquely qualified to provide the ThinPrep processors based on the following:
o Automated sample prep for ThinPrep Pap Test, ThinPrep Non-Gyn, and ThinPrep UroCyte® slides.
o Optional tube and slide printers automate labeling.
o Automated aliquoting cuts out the hands-on time required for manual pipetting.
o Integrated chain-of-custody and sample tracking to help ensure proper handling and reduce manual errors.
o Streamlined workflow designed to minimize sample transfer steps, thus improving laboratory efficiency.
o Ergonomic, space-saving design intended for busy laboratories and high-throughput environments.
o Compatibility with Hologic’s ThinPrep Pap Test and select molecular assays, allowing a consolidated approach to cytology and molecular testing.
o Additional benefits are detailed at https://www.hologic.com/hologic-products/cytology/thinprep-genesis-processor
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# 36C250-25-AP-4008
4. Description of market research conducted and results or statement why it was not conducted: Market research was conducted by the Contracting Officer to determine if there were other vendors capable of providing ThinPrep Processors that meet the CLE VAMC's specific requirements. The following sources were reviewed:
The OEM, Hologic, 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 do not use any authorized distributors.
• GSA eLibrary, ECAT, SAM.gov, Interagency Contract Directories, NAC, FPDS, SCMC, MSVP, BIC and FDA:
o Keywords Used: "ThinPrep processor" o Results: There were no results.
• DSBS:
o NAICS Code Searched: 334516 (Analytical Laboratory Instrument
Manufacturing) o Keywords Used: "ThinPrep processor" o Results: There were no results.
The Non-Manufacturer Rule (NMR) does apply to this procurement under NAICS 334516, and the SBA has issued an NMR waiver. The VA and SBA Rule of Two cannot be met, as no authorized distributors were identified or available through the OEM. Therefore, this acquisition will be sole sourced to the OEM, Hologic, a large business.
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: 2025.08.07 16:08:50 -04'00'
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