Justification and Approval_Redacted.pdf

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

PM Part 813.5 SAP for Certain Commercial Items Page 1 of 4 Original Date: 08/30/17 Revision 03 Date: 02/11/2021

DEPARTMENT OF VETERANS AFFAIRS

SOLE SOURCE JUSTIFICATION UNDER SIMPLIFIED PROCEDURES FOR CERTAIN COMMERCIAL

ITEMS IN ACCORDANCE WITH FAR 13.5

Acquisition Plan Action ID: 36C250-22-AP-0141

1. Contracting Activity: Department of Veterans Affairs, VISN 10, Network Contracting Office (NCO)

10, has a requirement for the upgrade of two STERIS sterilizers and one additional STERIS sterilizer for the Sterile Processing Service (SPS), located at the Dayton VA Medical Center, 4100 W. Third Street, Dayton, Ohio 45428. The purchase request number is 552-22-1-866-0002.

2. Nature and/or Description of the Action Being Processed: This will be awarded as a sole-source, firm fixed price, brand name contract to Steris, a Large Business and Original Equipment Manufacturer, for three (3) AMSCO 600 steam sterilizers and site prep renovation for installation.

This requirement is for end of life cycle replacement for two SPS Large Chamber Steam Sterilizers, EE41785 and EE41784, and one new additional sterilizer to assist with increased workload. The two sterilizers will be replaced, along with one new addition of AMSCO 600 units, 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 estimated value for this procurement is $

3. Description of Supplies/Services Required to Meet the Agency’s Needs: This requirement is a special initiative approved for new self-generating steam sterilizers for the SPS at the Dayton VA Medical Center. The purpose of this requirement is to replace two SPS Large Chamber Sterilizers currently at end of life cycle. Additionally, a third sterilizer will be needed to help with increased workload in SPS. All three will be replaced with the STERIS AMSCO 600 units, as this will eliminate the ongoing problems with steam supplied from across campus by the boiler plant. These new units will have their own steam generators that will be supplied by RO/DI water from the existing SPS water treatment system. There will be minor site prep renovation needed to accommodate for the third unit. This site renovation includes all demolition, general construction, plumbing, mechanical, electrical, and fire protection work necessary for removal of existing construction and certain other items and construction of new work indicated.

EF1301142 AMSCO 600 Prevac Steam Sterilizer, 26.5X26.5X63 Electric, Single Door, Vert Slide, Rec, 480V; Includes deinstallation of 2 sterilizers and installation of 3 3 EA SE0000046 Customized Training 1 JB SE60189 Renovation Site Prep 1 JB

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:

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Revision 03 Date: 02/11/2021

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

( ) 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):

There are currently three manufacturers of steam sterilizers for use in medical facilities that have the capacity to steam sterilize surgical instrumentation and are non-lab, Dental, pharmaceutical, or industrial sterilizers.

The pure steam option is needed so we can eliminate steam being piped across campus from the boiler plant and eliminate condensation and corrosion from our processes. Only the Steris/AMSCO 600 will fit into the limited SPS footprint without decreasing the SPS Prep and Decontamination workspace (see attached SPS full and partial floorplan (8)). Any construction needed to accommodate a bigger unit would negatively impact the decontamination area, workflow, and decrease SPS efficiency. Stainless steel walls, ultrasonic units, and sinks would need to be moved and replumbed along with other utilities needing to be moved, this would disrupt current workflow patterns and decrease SPS efficiency.

The Dayton VAMC SPS is limited in space and needs to increase steam sterilization capacity to meet current and future demands. The present location eliminates consideration of Amsco competitors’ due to size of their sterilizers fitting into the current footprint. The AMSCO 600 sterilizers have a minimum footprint that will enable SPS to add a third sterilizer in the space that two sterilizers currently occupy. Maintenance for the new units is accomplished in the front of the units enabling the sterilizers to be placed closer together. The AMSCO 600 chamber size of 26.5X26.5X63 fits into pre-existing location without impinging into the Decontamination area and is comparable to current SPS sterilizers. The use of pure water/steam will decrease the amount of parts being replaced due to corrosion on an annual basis, decreasing sterilizer down time. The Dayton VAMC is currently in a workshare agreement with Wright Patterson Air Force Base (WPAFB) SPS. All equipment between the two sites is the same so there is a familiarity and standardization in case the need arises in a contingency that WPAFB SPS technician’s need to utilize the Dayton VAMC SPS equipment and vice-versa.

6. Description of Efforts Made to ensure that Offers are Solicited from as Many Potential Sources as Deemed Practicable:

An Intent to Sole Source will be posted to sam.gov to provide public notice of the Government’s intent to contract with only one source. Market research will continue to be conducted to determine if future requirements of this magnitude can be competed.

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

Steris carries their AMSCO 400 units on GSA schedule. The price of these sterilizers ranges from around . The informal pricing identified for the AMSCO 600 units is within this comparable price range as other similar products on the market.

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

Market Research Was Not Conducted:

Market research was conducted IAW FAR Part 10.

There are no SB concerns that manufacture this product or can meet set-aside requirements under the Rule of Two. Additionally, there are only two LBs that offer self-generated steam sterilizers. Additionally, market research determined that there is only one source that can meet this requirement and offer the best value to the Government in terms of renovation costs, SPS footprint, and technical specifications.

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

Dayton SPS currently uses Steris equipment. The Biomedical Engineers are trained and educated on maintenance and repair of Steris equipment. Steris holds GSA (V797D-60613) and MAS (GS-30F- 022GA) contracts for equipment and services. Additionally, Dayton SPS has workshare agreements with the WPAFB SPS who also use Steris equipment. Steris has excellent customer service and customer satisfaction among the Dayton SPS staff. Steris products are predominantly manufactured in the US.

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

STERIS Corporation 5960 Heisley Road Mentor, OH 44060-1834 P: 440-354-2600 POC: Devin M. Bunsold

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:

Past procurement history for STERIS steam sterilizers have been conducted, resulting in delivery orders awarded off of GSA contract. However, due to the specific needs of this requirement, only one source was identified through current market research methods. If a future requirement for the same solution is identified, market research will be reaccomplished for potential of promoting amongst all manufacturers capable of meeting the agency’s needs.

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,