JA - signed.pdf

Effective Date: 12/30/2025 Page 1 of Revision: 02 Acquisition ID#: 36C255-26-AP-2289

DEPARTMENT OF VETERANS AFFAIRS

SOLE SOURCE JUSTIFICATION UNDER SIMPLIFIED PROCEDURES FOR CERTAIN

COMMERCIAL ITEMS IN ACCORDANCE WITH Revolutionary FAR Overhaul (RFO)

12.102(b)

Acquisition Plan Action ID: 36C255-26-AP-2289

1. Contracting Activity: Department of Veterans Affairs, NCO 15 Contracting Office located at 3450 S. 4th St, Leavenworth, KS in support of VISN 15, St. Louis Medical Center 657-26-4-1110-0224

2. Nature and/or Description of the Action Being Processed:

This is a brand name sole source justification for the maintenance of Steris Sterilizers. This procurement is to ensure continued service and support of our sterilizing equipment used by our SPS, Surgical, and Path & Lab departments. Coverage includes preventative and corrective maintenance as well as chamber cleanings for relevant equipment.

3. Description of Supplies/Services Required to Meet the Agency’s Needs:

The St. Louis VAMC requires preventative maintenance and also service as needed to maintain the all of Steris sterilizers for the St Louis VA so there isn’t any disruption for any department needing surgical instruments that would pass the these sterilizers. This will include labor, travel, materials, tools, and all incidentals required to complete full service preventative maintenance and/or corrective repairs as needed.

Base Year Price (9/1/2026 - 8/31/2027): $194,319.35 Option Year 1 Price (9/1/2027 - 8/31/2028): $204,037.32 Option Year 2 Price (9/1/2028 - 8/31/2029): $214.237.08 Option Year 3 Price (9/1/2029 - 8/31/2030): $224,952.94 Option Year 4 Price (9/1/2030 - 8/31/2031): $236,196.38 Total Agreement Price: $ 1,073,741.07

4. Statutory Authority Permitting Restricted Competition:

RFO 12.102(b) Simplified Procedures for Certain Commercial Items. The statutory authority for applying the Simplified Procedures for Commercial Items of RFO 12.102(b) is 41 U.S.C.

§ 1901 and is implemented by RFO 12.102(b) 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

( ) 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):

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Acquisition ID#: 36C255-26-AP-2289

Only One Responsible Source- This is a follow-on contract (36C25522P0444) for continued maintenance and service of Steris sterilizers. Steris sterilizers is used for our sterilizing equipment used by our SPS, Surgical, and Path & Lab departments for any surgery or procedures using instruments that need to be sterilized. These sterilizers are important to the hospital and without sterilizers in full operation the facility could ultimately delay patient care due to not having surgical instruments readily available to the staff.

Steris Corporation is the sole provider of maintenance and repair services to Steris brand Sterilizers. Maintenance or service on these sterilizers provided by any other vendor would render all existing warranties null and void and would be unsupported by Steris as they do not authorize or train third party vendors to work on this equipment. Steris provided a sole source letter stating they are the only vendor to maintenance these sterilizers. Seeking full and open competition will result in a substantial duplication of cost to the government that is not expected to be recovered through competition and would create unacceptable delays in fulfilling the agency’s requirements. Purchasing of a new sterilizers is estimated to cost $1.2

– $2.0 million with additional cost for workstations, installation, maintenance, and training of personnel. If the equipment were to be replaced and new equipment installed the hospital would then need to contemplate a new maintenance contract to service the equipment in a similar fashion to currently existing maintenance and repair contract with Steris. These maintenance contracts typically range in cost from $800,000 - $1,100,000 for a base plus option years and replacing the equipment would not negate the ongoing maintenance needs. The sterilizers in use at the facility were replaced between the periods of 2012 – 2022 with a life expectancy of 10-20 years depending on the sterilizer. Upholding this maintenance agreement is ultimately extending the life of each sterilizer, and as a result, mitigating additional costs. Therefore, the replacement sterilizers should continue to be fully operation for periods of 2028 – 2044. However, with Steris maintenance support the sterilizers can continue to be fully operational beyond their anticipated life expectancy.

Steris, as the OEM and equipment service supplier, will ultimately determine when a sterilizer is not in an operational state and requires replacement due to parts no longer being manufactured or supported.

Additionally, typically sterilizers would be purchased during a room construction phase to ensure all water lines and sanitation stations are in place to maximize the efficient input of surgical instruments for these sterilizers.

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

The vendor provided a letter stating they are the sole provider of maintenance and repair services. A sources sought was conducted 5/15/2026 – 5/20/2026. There was only one response from Steris as they submitted a sole source letter stating only Steris can do maintenance and repair on these Steris sterilizers. No responses were received from any outside sources.

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

A fair and reasonable price determination will be made by comparison to the independent Government Cost Estimate that was formulated by using market research of historical pricing from same or similar scope contracts and market price lists in conjunction with the pricing methods.

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Acquisition ID#: 36C255-26-AP-2289

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

A sources sought was conducted 5/15/2026 – 5/20/2026. There was only one response from Steris as they submitted a sole source letter stating only Steris can work on these sterilizers. Searches on GSA, Supply Chain master catalog, small business dynamic search still all resulted in a sole source and Steris is the only vendor who can fulfill this requirement.

Sources sought –Steris was the only vendor to respond that they could meet the entire Statement of Work. No other vendor responded with fulfilling the entire requirement since Steris is the only manufacture that can provide Maintenance to the Steris sterilizers.

on 5/15/2026 – 5/20/2026 seeking input from domestic manufacturers, both large and small, regarding their capability to supply the required Steris sterilizer maintenance agreement. No viable responses were received.

Supply Chain Master Catalog – SCMC shows other VA medical centers with Steris maintenance contract that are open market and not on a mandatory contract.

SBA Small Business Search: Five Small Businesses were found and not all of them were Veteran owned. Further research concluded that there are no two or more SDVOSB or VOSB vendors capable of providing this requirement. From searching on SBA Dynamic search the 5 small businesses that the search resulted in zero of them can fulfill the requirement. This search was based on NAICS code 811210 to find small businesses that can service Steris Sterilizers. Out of these 5 vendors zero have the capability to provide there services for the St Louis VA medical Center. Market research doesn’t indicate there are any authorized vendors who can provide the service for these sterilizers other than Steris. Furthermore, Steris doesn’t provide authorized distributors for these Sterilizers this is handles sole by Steris.

- Multiple Award Schedule (MAS): A search was conducted on MAS, which identified Zero vendor that works with Steris for the maintenance of sterilizers other than Steris. There is no substitute for these services as only Steris has the ability to service their own sterilizers.

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

This equipment is proprietary to Steris so all services and maintenance must be performed by technicians that are trained by the manufacturer in order to meet all required specifications for these sterilizers.

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

Email: KeyAccountsSvcSupport@steris.com Phone 440-392-8839

STERIS Corporation 5960 Heisley Road Mentor OH 44060

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:

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Acquisition ID#: 36C255-26-AP-2289

If future service acquisitions are needed market research will be conducted to see if the market has developed competition in regard to the service providers available for this maintenance. The CO will make sure the equipment is still in use at the hospital and take into consideration the age and condition of the equipment at that time in order to decide if it would be in the Government’s best interest to replace the equipment rather than set up a new service contract.

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.

Name: Matt Moseley Title: Biomedical Engineer Facility: St Louis

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.

Name: Jon Lutmer Title: Contracting Officer Facility: Network Contracting Office (NCO) 15

b. One Level Above the Contracting Officer (Required over $350K but not exceeding $900K): I certify the justification meets requirements for other than full and open competition.

Name: Andrew J Raiber Director Of Contracting

Facility: Network Contracting Office (NCO) 15

c. VHA Advocate for Competition and RPO HCA Review and Approval: I have reviewed the foregoing justification and find it to be complete and accurate to the best of my knowledge and belief and approve $900K to $90 million for other than full and open competition.

JONATHAN

LUTMER

Digitally signed by

JONATHAN LUTMER

Date: 2026.06.05 11:57:53

-05'00'

ANDREW

RAIBER

Digitally signed by ANDREW

RAIBER

Date: 2026.06.09 13:29:45 -05'00'

DARYL BERG

Digitally signed by

DARYL BERG

Date: 2026.06.16 07:53:50 -05'00'