Brand Name Justification_Redact.pdf

VHAPM Part 813.106 Page 1 of 2 Original Date: 08/30/17 Revision 02 Eff Date: 03/31/2020

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: 36C244-21-AP-2536

1. Contracting Activity: Department of Veterans Affairs, VISN 04, Lebanon VA Medical Center 1700 S.

Lincoln Avenue, Lebanon, PA 17042. Purchase Request Number 595-21-2-480-0084

2. Brief description of supplies, intended use, and estimated amount: This is a new brand name requirement for Storz Septoplasty Surgical Kit, associated telescopes and reprocessing containers.

These items are utilized other Malignant issues in the nose causing difficulty breathing. The Storz Telescopes and Instrumentation are required to integrate with the existing Storz Septoplasty, Rhinoplasty and Ear, Nose, and Throat sets currently in use.

Line Item Description Unit Qty Unit Price Estimated Amount 0001 Storz Septoplasty Surgical Kit EA 1

The total estimated contract value:

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

The Karl Storz Surgical Kit and telescopes are compatible with the existing Storz Septoplasty, Rhinoplasty and Ear Nose and Throat systems currently in use within the facility. Veterans Affairs Medical Centers (VAMCs) issued Directive 1116(2) to all applicable end-users. This directive specifies procedures for decontamination, high-level disinfection, and/or sterilization of critical and semi-critical reusable medical instruments, and equipment. VHA Directive 1116(2) states: When instruments must be disassembled for complete cleaning and reprocessing. This equipment complies with VHA Directive 1116(2) sterilizations and standardization. The purchase of any other telescope would also require the purchase of a new system that consist of a camera and medical data management system that is currently in place.

This Brand Name Justification in accordance with 11.105(a)(1) Items Peculiar to One Manufacturer.

This justification shall be posted to Contracting Opportunities upon award in accordance with

11.105 (3).

FAR13.5 Simplified Procedures for Certain Commercial Items: The authority for applying the Simplified Procedures for Commercial Items of FAR 13.5 is 41 U.S.C. 1901 and is implemented by for

VHAPM Part 813.106 Page 2 of 2 Original Date: 08/30/17 Revision 02 Eff Date: 03/31/2020

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

Extensive Market Research (MR) was conducted during the Contract Planning Phase of this requirement. The results of that MR are as follows.

A Sources Sought 36C24421Q0483 was posted to Beta.Sam on March 24, 2021 and closed on April 5, 2021. Only one response was received after the closing date/time from L1 Enterprise (SDVOSB) They also provided a capability statement and authorized distributor letter from Karl Storz Endoscopy America, Inc. Original Equipment Manufacturer (OEM).

A search of the Strategic Acquisition Center (SAC), Medical Surgical Prime Vendor (MSPV), Vendor Information Pages (VIP) and General Service Administration (GSA) websites were also conducted.

There were no responses.

Historical research of this purchase showed that Karl Storz Laryngoscopes in March 2021, for the Lebanon VA, the results also concluded that Karl Storz (Large) and were the only two potential suppliers for this equipment. A previous award number is

Based on the above, an Unrestricted solicitation will be issued on the Open Market.

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.