P03. SSJ 36C248-25-AP-2243-prepped-_Redacted.pdf

Effective Date: 11/15/24 Page 1 of 5

REVISION: 01

Acquisition ID#: 36C248‐25‐AP‐2243

DEPARTMENT OF VETERANS AFFAIRS

SOLE SOURCE JUSTIFICATION UNDER SIMPLIFIED PROCEDURES FOR CERTAIN COMMERCIAL

ITEMS IN ACCORDANCE WITH FAR 13.5

Acquisition Plan Action ID: 36C248‐25‐AP‐2243

1. Contracting Activity: Department of Veterans Affairs, Network Contracting Office 08, located at

10,000 Bay Pines Blvd. Bay Pines, FL 33744, in support of VISN 08 Lee County VA Clinic at 2489 Diplomat Parkway East, Cape Coral, FL 33909‐5422.

2237: 516‐25‐2‐215‐0017

2. Nature and/or Description of the Action Being Processed: This proposed procurement is for Brand Name Only Low Temperature Sterilizers and ancillary products 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. The action being reviewed and approved is a brand name only procurement and the action will be awarded as a new firm fixed price purchase order.

3. Description of Supplies/Services Required to Meet the Agency’s Needs: The supplies and/or services to be acquired are two (2) STERIS V‐Pro Max 2 Low Temperature Sterilizers and ancillary products. Brand Name: STERIS V‐Pro Max 2

The estimated procurement value of all items is

Equipment Requirement:

VP50002101‐V‐PRO maX 2 two (2) each.

P011010432‐Kit, VPROMX Castors two (2) each.

SE600962 Install large Hydrogen Peroxide two (2) each.

SE6009810000105‐1st year deep ‐vacuum pump SVC two (2) each.

CATSUB3030‐ConnectAssure Technology enables data two (2) each.

CATPREP3030‐Prepare and configure data two (2) each.

CATINCLAB3031‐ConnectAssure Technology networking service kit for incubators two (2) each.

CATINCSUB3031‐ConnectAssure technology annual subscription for to export data from incubators two (2) each.

• Capable of sterilizing 3D printed devices

• Chamber size must have a minimum capacity of 4. Cubic feet.

• Must be capable of processing non lumened and lumened devices quickly.

• Must have an integrated foot pedal so chamber can open and close in a handsfree method.

• Must have technology to notify user of the amount of remaining sterilant and cup expiration.

• Must have a feature that will confirm loads are dry to prevent cycle aborts.

• Must have electronic record keeping capabilities.

• Must have preprogrammed cycles.

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Acquisition ID#: 36C248‐25‐AP‐2243

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:

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

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

Services ( ) International Agreement ( ) Authorized or Required by Statute ( ) National Security ( ) Public Interest

5. Demonstration that the Contractor’s Unique Qualifications or Nature of the Acquisition Requires the Use of the Authority Cited Above (applicability of authority):

This is a brand name only justification. STERIS V‐Pro is essential to the Government’s requirements, thereby precluding consideration of a product manufactured by another company. Each brand of low temperature sterilizers requires the purchase of their corresponding supplies and equipment.

Both Bay Pines VA and Lee County Medical Center already has STERIS V‐Pro machines on‐site, along with the corresponding equipment and supplies (i.e. Chemical Sterilant, Testing Biologics, Indicators, Racks, Incubators) needed to operate the equipment. If staff, equipment, or supplies are ever needed to be shipped to either location, there will be no issue with the functioning of the equipment or supplies not matching, reducing the downtime of the machine and possible errors by staff, which could lead to harm. Any other manufacturer would require the VA to waste or excess existing on‐hand stock. Additional supplies and further staff training would be required before any other machines to be fully operational.

The Sterile Processing Service (SPS) staff in Bay Pines and in Lee County have been fully trained and have a deep knowledge of the STERIS V‐Pro. For maintenance purposes, VA Biomed engineer team also has been trained and is knowledge in the maintenance of the V‐Pro machines, to validate and service at any time.

Accordingly, Steris Corporation is the only manufacturer capable of providing the supplies and services described in Section III above without the Veteran’s Health Administration experiencing substantial duplication of cost that could not be expected to be recovered through competition and unacceptable delays in fulfilling its requirements.

6. Description of Efforts Made to ensure that offers are solicited from as many potential sources as deemed practicable:

Sources Sought Synopsis: A sources sought notice was issued on Contract Opportunities under notice# 36C24825Q0388 on 02/12/2025 with a due date of 02/19/2025 at 12PM EST. A response was received on 02/12/2025 from an Service‐Disabled Veteran Owned Small Business (SDVOSB) stating interest, but with no other requested information. Two other responses were received on

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Acquisition ID#: 36C248‐25‐AP‐2243

02/12/2025 from a Small Business and a SDVOSB with an authorized distributor letter from the manufacturer of the items needed. Another response was received on 02/19/2025 from an SDVOSB with an authorized distributor letter from the manufacturer as well.

Other Actions: Considerations were made for all types of set asides. Since this is a brand name only requirement from a Large Business manufacturer, no set asides can apply. According to FAR 19.505(a)(1), “This section applies to small business set‐asides above the simplified acquisition threshold and orders issued directly to a small business in accordance with 19.504(c)(1)(ii) above the simplified acquisition threshold”. Additionally, FAR 19.505(a)(2) further states that “This section applies, regardless of dollar value, to the following awards under subparts 19.8, 19.13, 19.14, and 19.15”. Since the item needed is a brand name only requirement from a Large Business manufacturer, no non‐manufacturers would be able to meet FAR 19.505(c)(1)(i) under a set aside.

Furthermore, there are no non‐manufacturer rule class waivers for NAICS 339113 other than for CPAP Device Manufacturing.

7. Determination by the CO that the Anticipated Cost to the Government will be Fair and Reasonable: The anticipated cost will be considered fair and reasonable in accordance with FAR 13.106‐3(a)(2)(i) market research, FAR 13.106‐3(a)(2)(ii) comparison of the proposed price with prices found reasonable on previous purchases and competition.

8. Description of the Market Research Conducted and the Results, or a Statement of the Reasons Market Research Was Not Conducted:

A Veteran Small Business Certification (VetCert) search utilizing NAICS code 339113 yielded 935 Service‐Disabled Veteran Owned Small Business (SDVOSB)/ Veteran Owned Small Business (VOSB) vendors that can possibly fulfill this requirement. Market research efforts include queries on Federal Procurement Data System (FPDS), General Services Administration (GSA) eLibrary and Advantage, VA National Acquisition Center (NAC) Catalog System for Award Management (SAM).

FPDS was queried utilizing the keywords "Low Temperature Sterilizers” and filtered for the Department of Veterans Affairs. The most recent award was made on 06/28/2016 under VA52816F0278 against V797D60613 for “LOW TEMPERATURE STERILIZERS (2)” in the total procurement value of $222,997.18. Another FPDS was queried utilizing the keywords "Steris Vpro Max” and filtered for the Department of Veterans Affairs. 36C26020F0381 was awarded against V797D60613 on 04/28/2020 for “VPRO MAX STERLIZATION SYSTEM FOR PUGET SOUND VAMC” to the large business manufacturer, STERIS CORPORATION, in the procurement value of $425,933.91.

This was procured as an urgent acquisition. A search on FPDS of V797D60613 shows that the last date to order is 05/31/2026.

A query on GSA eLibrary on V797D60613 does not show an itemized Schedule, so each item was searched on GSA Advantage. None of the line items needed was found.

A query was done on the VA NAC Catalog for items on V797D60613, and only one line item was found. The pricing for the open market line items based on a market research quote received from the manufacturer shows that $36,888.04 of the total estimated procurement value of $323,000.02 is open market. Although the open market items are ancillary to the item on contract, it exceeds the micro purchase threshold and needs to meet FAR Part 5 synopsis requirements.

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Acquisition ID#: 36C248‐25‐AP‐2243

A sources sought notice was issued on Contract Opportunities under notice# 36C24825Q0388 on 02/12/2025 with a due date of 02/19/2025 at 12PM EST.

According to the manufacturer, STERIS is a United States Based Company in Mentor, OH and is a Global Company with factories all over the world and the United States. There is reason to believe that the items needed can be made in the United States, meeting the Buy American Act.

As described in Section 6 above, market research, in accordance with FAR Part 10, was conducted by synopsis of the proposed acquisition, advising industry of the pending acquisition and soliciting inquiries from interested parties.

9. Any Other Facts Supporting the Use of Other than Full and Open Competition: None.

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

Associates LLC, Buffalo Supply Inc, DME, LLC, and STERIS Corporation.

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 conduct market research to ascertain if there are changes in the marketplace that would enable future actions to be competed.

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.

Chief, Sterile Processing Service Bay Pines VA Healthcare System

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.

Contracting Officer Network Contracting Office 08

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Acquisition ID#: 36C248‐25‐AP‐2243

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.

Branch Chief, Commodities/Services Contracting Network Contracting Office 08