P03 SSJ - Brand Name - Endodry - CO Signed - Signed DR Prnt.pdf

36C241-24-AP-4233

DEPARTMENT OF VETERANS AFFAIRS

SOLE SOURCE JUSTIFICATION UNDER SIMPLIFIED PROCEDURES FOR CERTAIN COMMERCIAL

ITEMS IN ACCORDANCE WITH FAR 13.5

BRAND NAME JUSTIFICATION

Acquisition Plan Action ID: 36C241-24-AP-4233

1. Contracting Activity: Network Contracting Office VISN 1 New England, Regional Procurement Office East on behalf of VAMC White River Junction 215 North Main St, White River Junction, VT 05009-0001.

Estimated Cost:

2237: 405-24-4-7821-0419

2. Nature and/or Description of the Action Being Processed: This procurement is for a new contract awarded as Firm Fixed Price 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.

3. Description of Supplies Required to Meet the Agency's Needs: This is to procure endoscope drying cabinets that meet the requirements set forth by VHA Directive 1116, MMI ST 91, and to close out VISN and National Office of Sterile Processing Services site visit findings.

1 Endodry Adv Cabinet Ss Or Endodry Adv Cabinet Ss Or 2 Model Cas-1000 Assy, Cassette, Transport 3 Model 2-8-611 Assy, Hook-Up, Oly 4 Model 2-8-511 Assy, Hook-Up, Oly 5 Model 2-8-335 Assy, Hookup, Olympus, 3K 6 Model 2-8-210 Assy, Hook-Up Olympus 2K 7 Model 2-8-811 Assy Hkup Oly-Echo+Lift 8 Model 2-8-711 Assy, Hookup, Olympus SK 9 Model 2-8-718 Assy, Hookup, Oly 160/180 10 Install, Endodry Business Day 11 2 Yr Gold Contract Endodry Cabinet 12 Project Design, Program Planning & Coordination

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-l(b)(2) for restricting competition on this procurement. Competition is restricted on this procurement for the reason below:

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

Effective Date: 02/01/2022 Page 1 of 3

5. Demonstration that the Contractor's Unique Qualifications or Nature of the Acquisition Requires the Use of the Authority Cited Above (applicability of authority): Standards for endoscope storage are as follows:

Endoscopes should be stored suspended vertically or horizontally in a cabinet designed for storage in a way to allow circulation of air in accordance with the endoscope manufacturer's written

Instructions for Use (IFU) (e.g., pressure of air flow through channels, diameter of endoscope coil).

When high-level disinfected or liquid chemically sterilized endoscopes are stored vertically, the insertion tube should be as straight as possible, with the distal tip hanging freely. All valves and other accessories shall be removed in preparation for drying and during storage. A tip protector that is made of material that can retain moisture (e.g., sponge) can create an environment favorable for microbial growth. They should not cover the opening of the tip and are meant to be single use unless otherwise specified in the manufacturer's written IFU. Reusable endoscope parts may be stored dry in a containment device designed and intended for this purpose. Due to height constraints of the storage area, the scopes must be stored horizontally and as the Olympus IFU states, forced air must be pushed through the channels if they are stored this way. The Steris

Endodry cabinets meet or exceed the recommended storage specifications. They continuously force air through the channels as recommended and also enable proper tracking of the scopes by using a badge and code to remove them and keep them in their own transport trays for reprocessing.

These trays also ensure that the scopes will be protected from unintentional damages. The only cabinets that were found to meet the requirements were the Steris Endodry cabinets.

This system is already in place in the Sterile Processing Service (SPS) at the White River Junction

VAMC and will require minimal training. They are also compatible with the existing infrastructure, thereby minimizing possible substantial additional cost needed to modify the SPS footprint.

6. Description of Efforts Made to ensure that offers are solicited from as many potential sources as deemed practicable: The SPS department has investigated multiple endoscope cabinet suppliers but due to the constraints of the facility, they were too tall to give the required 18" clearance from the top of the unit. lnnerspace, Med line and Getinge cabinets were found to be outside of the height requirements.

7. Determination by the CO that the Anticipated Cost to the Government will be Fair and

Reasonable: Quote pricing will be compared to the IGCE (Independent Government Cost Estimate) and other quotes. The Government is expecting 5+ quotes to be returned, providing competitive pricing. The procedures of FAR 13.106-3 will be followed in order to determine reasonable pricing.

8. Description of the Market Research Conducted and the Results. or a Statement of the Reasons

Market Research Was Not Conducted: A query of the VetCert database using NAICS 339113 yielded

906 results with no other search parameters available to narrow down the potential list. A search of the DSBS database using NAICS 339113 and keyword "Steris" returned 2 matches. The FPDS database query using keywords "endodry and cabinets" returned 31 results. A query of the GSA elibrary using keyword "steris" returned contract V797D-60613 and further narrowing down the results by using category "A-89 Sterilizer and Sanitizer Equipment" and SDVOSB showed 18 potential vendors. The HTME database did not show any results using keyword "steris". A search of the NAC using "SDVOSB and A-89" showed 18 vendors. Original Equipment Manufacturer (OEM) Steris

Corporation provided the names of two (2) companies authorized to distribute the equipment on this requirement. One (1) SDVSOB - Veterans Healthcare Supply Solutions and one (1) Small

Business (SB) - Surgical Tools FSS Contract #36F79721D0033. One (1) other SDVOSB was identified in a previous procurement - DME LLC. There is no NMR waiver for NAICS 339113.

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

Effective Date: 02/01/2022 Page 2 of 3

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

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: N/ A

12. 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.

ASHLEY

ZANNIKOS

Digitally signed by

ASHLEY ZANNIKOS

Date:2024.07.11 07:30:41 -04'00'

Ashley Zannikos

Contracting Officer

NCOl

Date

b. 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.

DEBORAH

REARDON

Deborah Reardon

Branch Chief

NCOl

Effective Date: 02/01/2022

Digitally signed by DEBORAH

REARDON

Date: 2024.07.1613:14:29 -04'00'

Date