6515--ME - EVOLUTION STERIS STERILIZER PO: 663A10152 CS: Robert Hamilton POP: delivery by 11/30/2021

VHAPM Part 808.405-6 Limiting Sources

Attachment 2: Request for Limited Sources Justification Format >SAT

VHAPM Part 808.405-6 Limiting Sources

Original Date: 08/30/2017 Revision 03 Eff Date: 03/18/2021

Page 1 of 4

LIMITED SOURCES JUSTIFICATION

ORDER >SAT FAR PART 8.405-6

Acquisition Plan Action ID: 36C260-21-AP-1162

Contracting Activity: Department of Veterans Affairs, Veterans Healthcare Administration, Regional Procurement Office West, Network Contracting Office 20 behalf of VISN 20, Seattle VA Medical Center. 2237 #: 663-21-4-2563-0013.

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). This is a sole source procurement for steam sterilizers for Seattle VA Medical Center. The Medical Center is in the processes of rebuilding its Sterile Processing Service (SPS) physical plant through a future funded construction project. All supplies and equipment for this project must be purchased this fiscal year to ensure construction is not delayed with all deliverables by 9/30/2021.

Order against: FSS Contract Number: V797D-60613

Name of Proposed Contractor: Steris Corporation Street Address: 5960 Heisley Road

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

Phone: 440-354-2600

Description of Supplies or Services:

The estimated value of the proposed action: $599,586.73

This is a onetime purchase of 4 Evolution Steam PreVacuum Sterilizers 26x37.5x66 , Double Door. The PreVacuum Sterilizers are used to Sterilize all surgical Instrumentation that can withstand the High Temperatures and pressures of the process. This process renders Surgical Instruments Sterile for use in Invasive Surgical procedures and is the most economical and widely used modality.

PART NUMBER

DESCRIPTION

QTY

UE06113100001

Evolution 26x37.5x66 , Prevac, Double Door, LR Hinge,

Rec-2Wall, Steam, 208/240V

4

AX083940005

Evolution 66" Trans. Carriage, Car, & Dock

8

CAT3040

ConnectAssure site license enables automatic collection of documentation from STERIS products

for one department.

1

CAT3030

ConnectAssure Data Export option enables one

STERIS product to export data to a tracking system

4

CAT5050

ConnectAssure annual support includes tech

support, updates, upgrades and bug fixes per site

1

SE601852

Install - Medium Sterilizer

4

SE0000082

Seismic Anchoring (Excludes x-raying the floor,

through bolting, & associated hardware)

4

AX00000300000014

Amsco Evolution Left Hand Piping Skid 90 Degree Rotation Control Bracket

4

UE000000000000005

Seismic Kit 26X37.5 Evolution Hinged Door, House

Steam-Opm 2013

4

SE6018521

Deinstallation - Medium Sterilizers

3

SE6045100071

Disposal of Sterilizer

3

SE010011

1st Year PM Evolution Medium Sterilizer

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)(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:

SPS falls under VHA Directive1116(2) dated 23 March 2016, which includes specific requirements for the standardization of equipment types and for ensuring that reprocessing requirements are met. This Directive applies anywhere sterile processing or High-Level Disinfection (HFD) occurs in VA facilities. AUTHORITY: 38 U.S.C. 7301.

Based on the requirements for SPS laid out in VHA Directive 1116(2) para 6.i.(2)(r), includes specific requirements for the standardization of equipment types and for ensuring that reprocessing requirements are met. This Directive applies anywhere sterile processing or HLD occurs in VA facilities. the Puget Sound VAMC is required to standardize the Reusable Medical Equipment (RME) sterilization and high-Level Disinfection processes. Currently the Seattle VAMC has 6 total SPS processing systems, all are Steris. This order, replaces 3 older Steris units and adds one more. By standardizing this process to Steris, the VAMC will not only meet the requirements under VHA Directive 1116(2), but also improve the safety to both staff and veteran patients.

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: This purchase is the best value in order to comply with the sterilization standardization requirement identified above. In addition, the pricing offered by Steris is comparable to the following historical pricing:

36C24721P0943 Awarded: 06/07/2021 - $219,876.00. The pricing for is for a smaller sterilizer, individual price was $92,462.00, which compares to the individual price for the larger sterilizer.

36C25621P0381 Awarded: 12/23/2020 - $224,036.00. The pricing for is for two similar sterilizers.

Describe the Market Research Conducted among schedule holders and the results or a statement of the reason market research was not conducted. As outlined in para 4, this is requirement is to standardize the facility s SPS systems as the Medical Center s SPS locations are being expanded. The station conducted market research by review of VHA Directives, public law, internet equipment searches, and communication with Steris as the OEM. It was found that Steris is the only source that brings the VAMC in compliance with VHA directives for standardization. No other system was found to be compatible with Steris and not considered for this award.

Any Other Facts Supporting the Justification: There are no other facts necessary to support this justification.

A Statement of the Actions, if any, the agency may take to remove or overcome any barriers that led to the restricted consideration before any subsequent acquisition for the supplies or services is made: Because of the standardization requirement for all SPS processes and equipment, this is a significant limiting barrier to competition among various other vendors. However, if the VISN or facility determines that all SPS equipment requires replacement or standardization is not critical, then the market will be surveyed to determine if there are any other sources who could fulfill the requirement.

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.

CRAIG S. WOLFE Digitally signed by CRAIG S.

484261

WOLFE 484261

Date: 2021.07.26 05:47:52

-07'00'

Craig Wolfe

Assistant Service Line Leader, SPS VA Puget Sound, Seattle

Approvals in accordance with the VHAPM Part 806.3 OFOC SOP:

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

Robert W. Hamilton 902204

Robert Hamilton

Digitally signed by Robert W. Hamilton 902204

Date: 2021.07.26 09:35:00 -07'00'

Contracting Officer

Network Contracting Office 20

RPO West JA Tracker#: 2021-07-26T09:31:24

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.

Peggy L. Bowen

Digitally signed by Peggy L. Bowen 1568934

1568934 Date: 2021.07.27 06:43:39 -07'00'

Peggy Bowen

Chief, Division I (Services, Supply, Prosthetics, WSNC) Network Contracting Office 20 Awarded contract V797D60613 to STERIS CORPORATION for 578701.19000000 on 2021-09-15.