P03 PG_Part808.405-6_Atch2_Limiting_Sources_Justification_OVER_SAT SPS Steris (002).pdf

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SPS Steris Equipment
Solicitation number
36C26325F01088
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This is a Limited Sources Justification document for the Department of Veterans Affairs (VA) Fargo Healthcare System, justifying a sole-source procurement of Steris sterilization equipment valued at $727,222.04. The VA is purchasing equipment for a new sterilization processing space expansion, specifically requiring Steris brand equipment with ConnectAssure monitoring system due to existing infrastructure, compatibility requirements, and integration with current systems.

Key justification points include: the specific equipment will perform cleaning, disinfection, and sterilization of medical devices; changing brands would require significant design modifications and increase project costs; the existing facility infrastructure is specifically designed for Steris equipment; VISN 23 already has a service contract with Steris; and the equipment integrates with the facility's Censitrac instrument tracking system. The procurement will be made against Federal Supply Schedule Contract V797D-60613, with the contract awarded to Steris Corporation located in Mentor, Ohio. The document includes certifications from the SPS Supervisor, Contracting Officer, and Branch Chief, with planned future assessment of competitive alternatives.

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Attachment 2: Request for Limited Sources Justification Format >SAT

VHAPG Part 808.405-6 Limiting Sources Page 1 of 5 Revision: 01 Effective Date: 09/01/2024 Acquisition ID#: 36C263-25-AP-1588

LIMITED SOURCES JUSTIFICATION

ORDER >SAT

FAR PART 8.405-6

Acquisition Plan Action ID: 36C263-25-AP-1588

(1) Contracting Activity:

Department of Veterans Affairs, Network/Program Contracting Office 23, in support of Fargo City VA Healthcare System.

2237: 437-25-4-7712-0024

(2) Description of Action: This acquisition is conducted under the authority of the Multiple- Award Schedule Program (41 U.S.C. 152(3) and 40 U.S.C. 501).

Fargo VA Healthcare System requires new Steris equipment for the SPS expansion located in the VA Medical Center in Fargo, ND.

Order against: FSS Contract Number: V797D-60613

Name of Proposed Contractor: Steris Corporation

Street Address: 5960 Heisley Road

City, State, Zip: Mentor, Ohio 44060-1834

Phone: 440-354-2600

(3) Description of Supplies or Services:

The estimated value of the proposed action is $727,222.04

The Fargo VA Health Care System requires the procurement of Steris sterilization equipment.

The equipment will be able to perform cleaning, disinfection, and sterilization of all reusable medical devices. This equipment provides effective and efficient sterilization which safeguards the health and safety of patients.

The equipment fits into one of three categories:

1) Cleaning - washer/disinfectors, cart washers, chemical scope soap dispensers, sinks

2) Disinfection - scope reprocessors

3) Sterilization - steam sterilizers, gas plasma sterilizers https://www.acquisition.gov/far/part-8#FAR_8_405_6 http://uscode.house.gov/browse.xhtml;jsessionid=114A3287C7B3359E597506A31FC855B3 https://www.gpo.gov/fdsys/pkg/USCODE-2011-title40/pdf/USCODE-2011-title40-subtitleI-chap5-subchapI-sec501.pdf

VHAPG Part 808.405-6 Limiting Sources Page 2 of 5 Revision: 01 Effective Date: 09/01/2024 Acquisition ID#: 36C263-25-AP-1588

The equipment was found on the NAC under contract V797D-60613. In accordance with FAR

8.002 Priorities for use of Mandatory Government Sources. (a)(1)(v) and VAAR 808.002 we are required to use this contract to purchase the required equipment.

(4) Identify the Authority and Supporting Rationale (see below and if applicable, a demonstration of the proposed contractor’s unique qualifications to provide the required supply or service.

FAR 8.405-6(a)(1)(A): An urgent and compelling need exists and following the ordering procedures would result in unacceptable delays:

FAR 8.405-6(a)(1)(B): Only one source is capable of providing the supplies or services required at the level of quality required because the supplies or services are unique or highly specialized.

FAR 8.405-6(a)(1)(C): In the interest of economy and efficiency, the new work is a logical follow-on to an original Federal Supply Schedule order provided that the original order was placed in accordance with the applicable Federal Supply Schedule ordering procedures. The original order must not have been previously issued under sole source or limited source procedures.

FAR 8.405-6(b): Items peculiar to one manufacturer:

A patent, copyright or proprietary data limits competition. The proprietary data is:

These are “direct replacements” parts/components for existing equipment.

The material/service must be compatible in all aspects (form, fit and function) with existing systems presently installed/performing.

(5) Describe Why You Believe the Order Represents the Best Value consistent with FAR 8.404(d) to aid the contracting officer in making this best value determination:

The Fargo VA Medical Center is constructing a new sterilization processing space. Details of the construction such as where the pipes, drains, lights, switches, electrical wires, doors, walls, and more, are located, were all planned with the Steris brand of equipment in mind. Changing the brand at this point would cause changes in design and changes in construction and would significantly increase cost and delay the project immensely. Furthermore, the equipment uses ConnectAssure which is used to monitor the SPS equipment to include performance data, alarm logs, cycle data, service parts and maintenance history. ConnectAssure is proprietary to Steris, is currently TRM approved and is needed to communicate with all other Steris systems. The system further helps to maximize response time and alert technicians to issues. This results in https://www.acquisition.gov/far/part-8#FAR_8_405_6 https://www.acquisition.gov/far/part-8#FAR_8_405_6 https://www.acquisition.gov/far/part-8#FAR_8_405_6 https://www.acquisition.gov/far/part-8#FAR_8_405_6

VHAPG Part 808.405-6 Limiting Sources Page 3 of 5 Revision: 01 Effective Date: 09/01/2024 Acquisition ID#: 36C263-25-AP-1588 less downtime and helps to keep the department functioning. It would be a significant hardship to the Government if the entire system had to be replaced with another program instead of just adding to the new equipment.

VISN 23 has an existing service contract with Steris that covers the relevant equipment. If Fargo were to choose a brand other than Steris, a new service agreement would be required, leading to additional costs for the creation of another contract. The potential savings from competition would not offset the increased government expenditure. Steris equipment is widely used across the country, which will minimize training time as it is user-friendly and simplifies tasks for staff members. Steris products will also integrate seamlessly with Censitrac, our instrument tracking system. Our facility has standardized this system to reduce maintenance, training, and staffing costs.

(6) Describe the Market Research Conducted:

a. Conducted a search on the GSA eLibrary for NAICS Code: “339112” which garnered zero (3) results on the GSA website, however the contractors could not fulfill the requirement.

Conducted a search on the GSA eLibrary for Items: “V797D-60613” which garnered (1) results on the GSA website.

b. Conducted a search on GSA VA Advantage for Items: “SR2221211011” which garnered (1) result on the website for contract V797D-60613.

c. Conducted a search on the NAC for Items: “SR0201210011” which garnered (1) results on the NAC website for contract V797D-60613.

d. Conducted a search on Federal Procurement Database Systems (FPDS) using keywords:

“NAICS Code:” 339112” DEPARTMENT_FULL_NAME: ”VETERANS AFFAIRS,DEPARTMENT OF” and produced 816,782 results showing contracts awarded by the Department of Veterans Affairs.

Conducted a search on Federal Procurement Database Systems (FPDS) using keywords: “UEI Code:” UGGQJGGH6846” DEPARTMENT_FULL_NAME: ”VETERANS AFFAIRS,DEPARTMENT OF” and produced 26,340 results showing contracts awarded by the Department of Veterans Affairs to Steris Corporation.

e. Conducted a search on DSBS SBA using NAICS Code: 339112. The search listed 2 SDVOSBs, 0 VOSBs, 1 WOSBs, 0 EDWOSBs, 1 Hubzone certified and 0 Joint ventures.

VHAPG Part 808.405-6 Limiting Sources Page 4 of 5 Revision: 01 Effective Date: 09/01/2024 Acquisition ID#: 36C263-25-AP-1588

(7) Any Other Facts Supporting the Justification:

All programming and sterilizing system components must integrate with the existing, operational system. Currently, there are no known competing vendors whose products are fully compatible and interchangeable with the current infrastructure or service contract.

By continuing to use Steris equipment at the Fargo VA Medical Center, the Government benefits from cost savings on training, maintenance, service contracts, and any necessary accessories. Using a different sterilizing assembly would result in duplicated costs for the Government and increased challenges with maintenance services and operations.

(8) A Statement of the Actions:

The agency will continue to monitor the marketplace for competitive solutions and include interoperability and open-platform requirements in future acquisitions, where feasible. The requiring service will assess the feasibility of competitive replacements during future planning cycles.

(9) 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. I understand that processing of this limited sources justification restricts consideration of Federal Supply Schedule contractors to fewer than the number required by FAR Subpart 8.4. (This signature is the requestor’s supervisor, fund control point official, chief of service or someone with responsibility and accountability.)

______________________ 07/18/2025 Jill Nelson Date SPS Supervisor Fargo VAMC

VHAPG Part 808.405-6 Limiting Sources Page 5 of 5 Revision: 01 Effective Date: 09/01/2024 Acquisition ID#: 36C263-25-AP-1588

(10) Approvals in accordance with the VHAPM Part 806.3 OFOC SOP:

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

Steve Ashby Date

CONTRACTING OFFICER

NCO 23 / SST2

b. One Level Above the Contracting Officer (Required over the SAT but not exceeding $750K):

I certify the justification meets requirements for other than full and open competition.

Curt LaRose Date Branch Chief

NCO 23 / SST2

https://dvagov.sharepoint.com/sites/VHAProcurement/VHAPM2/VHAPM_Part_806.3.aspx https://dvagov.sharepoint.com/sites/VHAProcurement/VHAPM2/VHAPM_Part_806.3.aspx

2025-07-18T06:55:48-0500
JILL NELSON
2025-07-18T09:10:37-0500
STEVEN ASHBY
2025-07-18T11:34:12-0500
CURT LAROSE

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