LSJ - Aesculap Rigid Containers - Accessories.doc

VHAPG Part 813.106 Simplified Acquisition Procedures: Soliciting from a Single Source

Attachment 1: Single Source Justification for SAP under the SAT

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: 36C242-24-AP-2121 - Brand Name

1. Contracting Activity: Department of Veterans Affairs, Network/Program Contracting Office 02, James P. Peters VA Medical Center located at 130 West Kingsbridg Road, Bronx, NY 10468, in support of VISN 02, Buffalo VA Medical Center (VHAWNYHS), 3495 Bailey Avenue, Buffalo, New York 14215.

2237: 528-24-2-4403-0016 – Brand Name

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

The Buffalo VA Medical Center is looking to procure brand name Aesculap (J Series) Rigid Containers & Accessories to replace the existing blue wrap Reusable Medical Devices (RMD) instruments. We are looking to replace 49 blue wrap RMD items with rigid containers and their metal, reusable accessories. By doing so, we can guarantee a full, sealed , sterile, rigid container, instead of a manually wrapped blue, paper wrapped RMD instruments, that does not have a full seal.

The estimated value of the proposed action is

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

The Buffalo VA Medical Center is looking to procure J series rigid containers and accessories for the Sterile Processing department. A rigid canister is a sealed, locked container with a metal basket inside full of metal instruments. They all go through a steam cycle in a pre-vacuum steam sterilizer at 275 degrees fahrenheit and 28 PSIs, with a 4-minute minimum steam exposure cycle and a 20-minute minimum dry cycle.

A recent VISN 2 audit inspection found that the current blue-wrapped instruments were not adequately wrapped for sterilization and were not rotated in a First-in-First-out (FIFO) manner. Hence, moving forward, blue-wrapped items that can be placed in a rigid container must be maintained as complete, sterile, and sealed Reusable Medical Devices (RMD) items, unlike manually wrapped, loose, blue-wrapped, paper RMD items.

The Sterile Processing department uses Aesculap rigid containers and accessories for its current 500+ instruments and needs to continue to use this containers. Doing so will maintain a standard of practice. This will ensure staff clarity and errors when dealing with baskets, filter plates, locks, filters, integrators, load stickers, and tray tags. Using a different vendor's product could confuse the VA staff/nurses if having different shaped and colored filters and locks. Such errors could result in the wrong locks and filters placed on the vendor's trays, leading to unsterile trays. Unsterile trays during surgery will cancel cases, thus initiating an Issue Brief and further OSP audits. More importantly, canceled surgical instances could lead to harm to our Veteran patients, a risk we cannot afford to take.

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

Market research was conducted in accordance with FAR Part 10:

The following databases were viewed in the market research for this requirement (VetCert, GSA, SBA/DSBS, and NAC) to find the requested items.

· A NAICS code search of the SBA’s VetCert database resulted in nine hundred twenty-six (926) veteran-owned small businesses (SDVOSBs or VOSBs) doing business under NAICS code 339113. Paring down using additional keywords or advanced searches cannot determine the validity of these results for this requirement. There is no indication that any of these vendors can fulfill the requirement for rigid containers & accessories defined in the statement of work.

· CO conducted a GSA search on 4/4/2024 using the keyword “JK342,” it yields one (1) supplier, as the distributor and Aesculap, Inc. as the original equipment manufacturer.

· Search SBA/DSBS database on 4/4/2024 using the keyword “Rigid Containers,” resulting in zero (0) suppliers.

· Search the National Acquisition Center (NAC) database on 4/4/2024 and found the supplier and the product on and the items.

· A source sought was posted to SAM & GSA on 4/10/2024 and due 4/16/2024 at noon.

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.

Last Updated: 02/01/22