36C24923P0137.pdf

VHAPG Part 813.5 Simplified Acquisition Procedures for Certain Commercial Items Attachment 1: Request for Sole Source Justification >SAT-$7.5M under FAR13.5

Effective Date: 02/01/22 Page 1 of 4

DEPARTMENT OF VETERANS AFFAIRS

SOLE SOURCE JUSTIFICATION UNDER SIMPLIFIED PROCEDURES FOR CERTAIN COMMERCIAL ITEMS IN

ACCORDANCE WITH FAR 13.5

Acquisition Plan Action ID: 36C249-23-AP-0394

1. Contracting Activity: Department of Veterans Affairs (VA), Network Contracting Office 09 (NCO 09), located at 1639 Medical Center Parkway, Suite 400, Murfreesboro, TN 37129 in support of Louisville Veteran Affairs Medical Center (VAMC).

2. Nature and/or Description of the Action Being Processed: This emergency procurement is for a new firm fixed price contract to procure urology scopes for the Louisville VA Medical Center in accordance with FAR 13.5 Simplified Procedures for Certain Commercial Items and specifically FAR

13.501 Special Documentation Requirements, where acquisitions conducted under Simplified Acquisition Procedures are exempt from the requirements of FAR Part 6, but still require a justification using the format of FAR 6.303-2. Requesting sole source to Alliant Enterprises, LLC., 2140 Oak Industrial Dr NE Grand Rapids, MI 49505.

The total estimated value is: $256,930.00

3. Description of Supplies/Services Required to Meet the Agency’s Needs: The HD Flexible Cystonephro delivers high-definition imaging in a small design along with Narrow Band Imaging (NBI) that is 20% brighter than previous models when used with the CLV-190 processor, enhancing visualization of vessels and other tissues on the mucosal surface. Superslim uretero-renoscope provides optional 275° wide angulation range. A newly redesigned Evolutiontip incorporates smoother edges and also provides an increased light output of 150% compared to previous models.

A variable stiffness shaft improves patient comfort and scope maneuverability, and the scope’s wide 120° field of view and improved deflection helps surgeons to see and treat all areas of the bladder with ease. The flexible fiber uretero-renoscope provids high image quality, a slim design, and durability. The 275° up/down angulation of this flexible ureteroscope is designed to help ease access to stones in the upper, mid and lower calyces, even when working with a laser fibre. The 7.95 Fr super-slim shaft with Olympus’ unique Evolutiontip is designed to help ensure smooth scope insertion and navigation even through tight anatomy for efficient stone treatment.

4. Statutory Authority Permitting Restricted Competition: FAR 13.5 Simplified Procedures for Certain Commercial Items. The statutory authority for applying the Simplified Procedures for Commercial Items of FAR 13.5 is 41 U.S.C. § 1901 and is implemented by FAR 13.106-1(b)(2) for restricting competition on this procurement.

Competition is restricted on this procurement for the reason below:

( ) Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency

Requirements

(X) Unusual and Compelling Urgency ( ) Industrial Mobilization, Engineering, Developmental or Research Capability or Expert

Services ( ) International Agreement

Effective Date: 02/01/22 Page 2 of 4

( ) Authorized or Required by Statute ( ) National Security ( ) Public Interest

Demonstration that the Contractor’s Unique Qualifications or Nature of the Acquisition Requires the Use of the Authority Cited Above (applicability of authority): Market research revealed that acquisition can only be procured by Olympus (large business) or by authorized distributor Alliant Enterprises, LLC. (service-disabled veteran-owned small business). After much research and looking into the capabilities required for urology scopes, it has been determined that this is the only product in the market capable of meeting this procurement. This scope is a highly specialized scope and has been determined by trained medical professionals.

The Louisville Veterans Administration Medical Center requires urology scopes to conduct invasive procedures on veteran patients in routine and emergency circumstances. These scopes enable urologists to treat urological conditions that adversely impact patient care in the facility. The Olympus CYF-VHR cysto-nephro videoscope and URF-P7R Flexible fiber ureteroscope is an endoscope apparatus that can provide high-definition imaging for trained urologists so that they can determine the cause(s) of the development and progression of certain urological conditions. The facility requires urology scopes that can provide additional fields of view and to assist surgeons in viewing all areas of the bladder with minimal difficulty.

This surgical team is already trained and familiar with this scopes and it is compatible with other The surgical team is already familiar with and trailed on this scopes, and it is compatible with other equipment in the operating room. If this contract does not get awarded, the Louisville Medical Center will be required to cancel surgeries due to inadequate surgery instruments in stock. The Louisville Medical Center is experiencing a high volume of repairs needed for surgical instruments, and limited scopes are available at this time.

Description of Efforts Made to ensure that offers are solicited from as many potential sources as deemed practicable: Market research of North American Industry Classification System Codes (NAICS) 339112 found 20 Service-Disabled Veteran Owned Small Business (SDVOSB) and Veteran Owned Small Business (VOSB) on the Vendor Information Pages (VIP) using the keyword “Urology Scope”. Market research conducted on Dynamic Small Business Search (DSBS) returned no results under keyword “Urology Scope”.

The OEM (Olympus) responded stating that they ohly distribute to the Federal Government throught their SDVOSB partner Alliant Enterprises, LLC. SDVOSB. The Alliant Enterprises, LLC. also responded by providing a Sole Source letter from Olympus. Due to the urgent nature of this requirement, a solicitation will not be posted.This requirement will be awarded in accordance with FAR 6.302-2 Unusual and Compelling Urgency procedures.

Determination by the CO that the Anticipated Cost to the Government will be Fair and Reasonable:

Since this is proprietary to one manufacturer, the Contracting officer who awarded the

Effective Date: 02/01/22 Page 3 of 4 contracts had to rely on the CS’s market research to determine the price reasonableness. The scopes can be procured via Olympus’s NAC # 36F79721D0168. However, Alliant Enterprixes, LLC (service disabled veteran owned small business) is a sole authorized distributor and can provide the scopes matching the NAC pricing.

CS reached out to NCOs 07 and 08 and discussed their procurement. Contract for NCO 07 (VA247P1408) was awarded to the OEM distributor (Government Scientitic Source, Inc.) in the amount of $27,903.43. Contract for NCO 08 (VA24812P4879) was awarded to the OEM distributor (Government Source, Inc.) in the amount of $28,959.38.

Based on the market research findings, CO can anticipate the cost of this procurement to be fa r and reasonable.

8. Description of the Market Research Conducted and the Results, or a Statement of the Reasons Market Research Was Not Conducted: Market research of North American Industry Classification System Codes (NAICS) 339112 found 20 Service-Disabled Veteran Owned Small Business (SDVOSB) and Veteran Owned Small Business (VOSB) on the Vendor Information Pages (VIP) using the keyword “Urology Scope”. Market research conducted on Dynamic Small Business Search (DSBS) returned no results under keyword “Urology Scope”. CS verified that the acquisition can only be provided by Olympus (large business) or by authorized distributor Alliant Enterprises, LLC. (service-disabled veteran-owned small business). This requirement is an emergency requirement Alliant Enterprises, LLC. is the sole authorized distributor and can provide the exact pricing as the NAC contract.

9. Any Other Facts Supporting the Use of Other than Full and Open Competition: N/A

10. Listing of Sources that Expressed, in Writing, an Interest in the Acquisition:

Alliant Enterprises, LLC. (Service Disabled Veteran Owned Small Business) 2140 Oak Industrial Dr NE Grand Rapids, MI 49505 Robert Yurko tyurko@allianthealthcare.com 888-307-1144

Olympus NAC# 36F79721D0168 (Large Business) 350 Corporate Parkway PO Box 610 Center Valley, PA 18034

11. A Statement of the Actions, if any, the Agency May Take to Remove or Overcome any Barriers to Competition before Making subsequent acquisitions for the supplies or services required: The VA will continue to research FSS-authorized small business distributors.

12. Requirements Certification:

I certify that the requirement outlined in this justification is a Bona Fide Need of the Department of Veterans Affairs and that the supporting data under my cognizance, which are included in the justification, are accurate and complete to the best of my knowledge and belief.

Effective Date: 02/01/22 Page 4 of 4

Kyline Hantz Date Administrative Officer

13. Approvals in accordance with the VHAPM Part 806.3 OFOC SOP:

a. Contracting Officer or Designee’s Certification (required): I certify that the foregoing justification is accurate and complete to the best of my knowledge and belief.

Phon Phasavath Date Contracting Officer Network Contracting Office 9

a. One Level Above the Contracting Officer (Required over SAT but not exceeding $750K): I certify the justification meets requirements for other than full and open competition.

Branch Chief Network Contracting Office 9