P03_Brand Name Justification Autocut Microtome 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 2 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-3832

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:

The Leica HistoCore Autocut Microtome is for the processing of anatomic pathology specimens within the laboratory at VAMC West Roxbury. This is a specialized precision cutting instrument, which accurately and repeatedly slices sections from a block of formalin-fixed paraffin-embedded (FFPE) tissue specimens. FFPE is a form of preservation and preparation for biopsy specimens that aids in examination, experimental research, and diagnostic/drug development and have been used as a staple in research and therapeutic applications for decades.

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

Leica Biosystems 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 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.

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#

The AP Laboratory has been using Leica microtomes for over ten years. Lab personnel are trained on this particular model and are sometimes called to switch stations. Having all identical models will allow staff to rotate stations with confidence, which reduces potential injury and allows for more efficient training of new hires. 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:

Multiple Service Disabled Veteran Owned Small Businesses (SDVOSB) vendors were identified via searches conducted on Sam.gov, VetCert, AddsUp, FPDS, DSBS, GSA Elibrary using NAICS 334516 to search. A narrower search on GSA Advantage with keyword “Leica microtome” identified Large Business (LB) VWR International with contract #GS-07F-119CA.

Through communication with Leica Government Corporate Account Manager Zach Miller, it was learned the GSA listing was in error. Additionally, only Small Business (SB) Government Scientific Source was identified via a Markey Research Survey with Original Equipment Manufacturer (OEM) Leica as the preferred SB distributor to the Federal Government. The OEM provided several LB distributors of this product.

A sources sought for a brand name or equal Microtome was posted on Sam.gov on June 25, 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 AutoCut Microtome, 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 07:31:07 -04'00'