P03_Brand Name Justification Leica Pegasus AK_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#

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: 36C241-25-AP-3-7821

1. Contracting Activity: Department of Veterans Affairs, VISN 01, Boston Medical

Center, 1400 VFW Parkway, West Roxbury, MA, 02132.

2237: 523-25-3-7821-0084.

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

Veterans Affairs (VA) Boston Healthcare System Pathology & Laboratory has a requirement for a Tissue Processor to prepare tissue samples for microscopic examination by automating the process of fixing, dehydrating, clearing and infiltrating tissues with paraffin wax, making them suitable for sectioning and staining. This process is crucial for diagnostic purposes. The desired brand name instrument is the Leica HistoCore PEGASUS Tissue Processor manufactured in China by Large Business (LB) Original Equipment Manufacturer (OEM) Leica Microsystems, Inc.

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

The HistoCore PEGASUS Tissue Processor 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.

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

Revision: 01 Effective Date: 11/15/2024 Page 2 of 3 Acquisition ID#

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 Dimensions must not exceed (W x D x H): 804 x 715 x 1533 mm Number of reagent containers: 17 reagent bottles, 1 condensate bottle Bottle volume: 3.88 L Number of paraffin baths: 4 Capacity: 3.9 L per paraffin bath Melting time: 7 hours at ambient temperature of 23°C-25°C Temperature Settings Range: Paraffin Melting Point setting: 50°C-65°C Standby Temperature Setting: Paraffin Melting Point +1°C and max. 71°C Cassettes Capacity: 2x200 cassettes Temperature (paraffin): Paraffin temperature selectable from 58°C to 85°C Temperature (processing reagents): Ambient temperature or 35°C-65°C Temperature (cleaning reagents): 35°C -85°C Filling vacuum: -60 kPa Draining pressure: 45 kPa

The Tissue Processor must be compatible with the Leica ASP6025 S tissue processor 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.

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

A search conducted on DSBS with NAICS 334516 yielded 295 SDVOSBs. The search term “Histocore” was added, and no results were identified for either SDVOSB or VOSB. A search on DSBS using NAICs 334516 and keyword “Leica” resulted in no VOSBs and 1 SDVOSB that can’t meet the minimum requirements of

Revision: 01 Effective Date: 11/15/2024 Page 3 of 3 Acquisition ID# this acquisition. A Sam.gov search with 334516 was conducted and 450 SDVOSBs were identified. An ADDS UP search using keywords “Pegasus” and “Histocore” resulted in awards to Small Business (SB) Government Scientific Source. A FPDS search with keywords “Histocore Pegasus” identified awards only to SB Government Scientific Sources. A GSA Advantage search yielded no results using keywords “Leica,” “Pegasus,” and item number. A GSA Elibrary search using keywords “Histocore Pegasus” yielded no results. A Market Survey was sent to OEM Leica. It was confirmed that Leica’s preferred SB Federal Government Partner is SB Government Scientific Sources. A letter of authorization for Government Scientific Sources was provided by the OEM and is on file.

A Sources Sought for a Brand Name or Equal Leica HistoCore PEGASUS Tissue Processor was posted on Sam.gov on June 23, 2025, to identify a domestic product in the marketplace. Only one response was received from SB Government Scientific Source. Confirming Market Research results, the brand proposed is the Leica HistoCore PEGASUS 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

Ashley Kenyon Date Contract Officer

ASHLEY

KENYON

Digitally signed by ASHLEY

KENYON

Date: 2025.07.02 07:59:21 -04'00'