P03_SSJ Leica CO Signed 1_Redacted.pdf

Revision: 01 Acquisition ID#: 36C241-26-AP-0548

DEPARTMENT OF VETERANS AFFAIRS

Justification for Single Source Awards IAW FAR 13.106-1 For

Over Micro-Purchase Threshold but Not Exceeding the SAT

Acquisition Plan Action ID: 36C241-26-AP-0548

1. Contracting Activity: Department of Veterans Affairs, Network Contracting Office 01, in support of VISN 01, Network Consolidated Laboratory. 2237: 518-26-1-7047-0005

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

Anatomic Pathology Instruments to include (1) HistoCore Pegasus Tissue Processor, (2) Histocore Arcadia C Cold Plates, and (2) HistoCore Autocut Microtomes.

3. Unique characteristics that limit availability to only one source, with the reason no other supplies or services can be used:

HistoCore Pegasus Tisue Processor: Leica Microstystems Inc. is the sole manufacturer of the HistoCore PEGASUS Tissue Processor which is used to prepare human tissue samples for microscopic examination by automating the steps of fixation, dehydration, clearing, and infiltration.

The VA Histology laboratory has been utilizing Leica tissue processors for over a decade. This is a trusted system which is crucial for accurate and consistent results in Anatomical Pathology.

The Tissue Processor must be compatible with the Leica histology instrumentation that is currently in use. Transitioning to a new system would require all Histology-trained Technologists to undergo extensive training on a new instrumentation and ultimately cause delays in patient care (i.e. patient turnaround times for results). Additionally, the Leica PEGASUS Tissue Processor has an integrated i-Scan technology that allows Histologists to track Basket ID, User ID and Reagent Information ensuring a comprehensive overview of the tissue processing workflow and minimizes patient safety issues.

Leica HistoCore PEGASUS unique characteristics:

Provides the capability to run parallel protocols on a single instrument.

Two Independent Dual Retort processes up to 400 samples simultaneously, increasing capacity by 33% per run as compared to a 300 cassettes single-retort tissue processor Track and Trace with iScan - the system provides comprehensive tracking capabilities ensuring accountability and traceability for each action during the workflow Intelligent Reagent Management System - An advanced reagent management system that optimizes reagent use, reduces waste, and ensures consistent tissue quality.

Special Fume Control - The system includes advanced fume control measure providing a safer working environment and compliance with occupational safety requirements.

Anti- Spillage Bottles and Barcoded Consumables - These bottles help prevent spills and maintain organized workflow through easy identification and tracking consumables.

Magnetic Stirrer- Ensures optimal mixing of reagents to improve tissue processing quality.

Automated Reporting

Leica HistoCore Arcadia C Coldplate: Leica Microsystems is the sole manufacturer of the HistoCore Arcadia C cold plate which is used to mold specimens into the hot wax so the histotech

Revision: 01 Acquisition ID#: 36C241-26-AP-0548 can cut the block. The cold plate must be compatible with the Leica histology instrumentation that is currently in use and VA owned. The HistoCore Arcadia C provides a large capacity that can process at least 65 cassettes every 30 minutes. Its self-regulating operational temperature and low adhesion surface ensures tissue specimen integrity and consistent embedding.

Leica HistoCore Autocut Microtome: Leica Microsystems is the sole manufacturer of the HistoCore Autocut Microtome which is specially designed for serial cutting with actively cooled RM CoolClamp and a low temperature block for consistent slice thickness over multiple sections. The Leica HistoCore Microtome is the only known brand that facilitates the alignment/orientation of blocks which have been previously sectioned. Precision orientation to align cut blocks on other instruments minimizes tissue loss for re-cuts, immunohistochemistry and special stain studies.

Additionally, an automatic electronic brake is included to minimize risks of injury during operation.

The Leica Microtome has a rotary wheel on the left/right and allows histotechnologists to select among automated, semi-automated, or manual sectioning modes based on specimen requirements and user preference. This automated feature is ergonomically friendly and allows more flexibility when rotating workstations and training new hires who have previous experience of sectioning resulting in less training and reduction in injuries. Other known brands do not offer automated or fully manual sectioning modes or a rotary wheel on the left and right. Lacking this feature would require manually pushing the blade out, posing a huge safety risk. The AP Laboratory has been using Leica microtomes for over ten years. Introducing another branded microtome would be a safety concern. Additionally, Leica HistoCore replacement parts (i.e. blade holders, block clamps, etc.) are interchangeable among machines that are currently being utilized, thus reducing a delay in patient care should a repair be necessary. Furthermore, utilizing the same equipment will reduce cost by having the ability to perform the preventative maintenance at the same time.

4. Description of market research conducted and results or statement why it was not conducted: With regard to the Leica Histocore Pegasus Tissue Processor and the Leica HistoCore Autocut Microtome, a recent previous purchases, 36C24125P0955 on 09/23/2025 and 36C24125P0947 respectively, were utilized for market research purposes in which OEM Leica Microsystems identified Government Scientific Source as their SB distributor into the Federal Government. LB distributors were identified as well.

With regard to the Leica HistoCore Arcadia C-Cold Plate, through a market research survey sent to OEM Leica Microsystems Representative Madison Smith, Government Scientific was again identified as their SB distributor into the Federal Government.

A sources sought for brand name or equal products was posted on Sam.gov from 11/05/2025 to 11/19/2025 to identify any domestic products in the marketplace. Only one responsible source was received from SB Government Scientific Source. Confirming market research results, the brands proposed were Leica Microsystems Pegasus Tissue Processor, Autocut Microtome, Arcadia C-Cold Plate, all manufactured in China.

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.

Manasés Cabrera Date Contracting Officer

MANASES CABRERA Digitally signed by MANASES CABRERA Date: 2025.11.18 15:03:12 -05'00'