P03 RFO 8_SSJ GSAM 538 v3_BC signed_CO signed_PM signed v2a HCA signed.pdf

Request for Sole Source Format >SAT GSAM/R 538.7104-3(b) Sole Source Justifications - Federal Supply Schedule Ordering Procedures

ACQ-PLAN: 36C241-27-AP-0317 Page 1 of 4

SOLE SOURCE JUSTIFICATION

GSAM/R 538.7104-3(b)

This justification aligns with the deviation outlined in the Revolutionary FAR Overhaul (RFO) for Part 8.4 - Ordering under the Federal Supply Schedule and GSAM/R 538.71, as required by Executive Order (E.O.)

14275, Restoring Common Sense to Federal Procurement, signed April 15, 2025. Deviation effective date: November 3, 2025.

Acquisition Plan Action ID: 36C241-27-AP-0317

1. Contracting Activity: Department of Veterans Affairs, NCO 1, in support of VISN 01, Manchester VA Health Care System.

2237: 608-27-1-7915-0004

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). This is a new, firm-fixed price 36-month lease of Olympus equipment in support of Urology and Gynecology (URO/GYN) surgical procedures.

Order against: FSS Contract Number: 36F79721D0168

Name of Proposed Contractor:

Street Address:

City, State, Zip:

Phone:

OLYMPUS AMERICA INC.

3500 CORPORATE PARKWAY PO BOX

61 CENTER VALLEY, PA 18034

484-896-5000

3. Description of Supplies or Services: Manchester VAMC seeks a 36-month Olympus Surgery Scope Lease. The lease offers an extensive spectrum of clinical care within Urology and Gynecology (URO/ GYN) Surgical services for mission-critical medical equipment of cystoscopes, ureteroscopes, nephroscopes, hysteroscopes, and laparoscopes and their associated hardware devices.

Urology and Gynecology (URO/GYN) surgical scopes are specialized medical instruments used by surgeons to look inside and perform procedures within the urinary tract (urology) and the female reproductive system (gynecology). In urology, these scopes help diagnose and treat conditions in the bladder, urethra, ureters, and kidneys (such as removing stones or tumors). In gynecology, they are used to examine and treat the uterus, fallopian tubes, and ovaries (for example, removing fibroids or polyps, or investigating infertility). These scopes enable minimally invasive surgeries, allowing doctors to see inside the body and operate through small incisions, which leads to faster recovery and less pain for patients.

Manchester Healthcare System must continue to manage and maintain this equipment efficiently while also striving to take advantage of the latest emerging technologies within the rapidly advancing realm of endoscopic medical equipment. This action will result in a firm fixed order with a 12-month base period and two 12-month option periods.

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The service agreement provides full repair and maintenance coverage for all listed Olympus equipment, including 24/7 technical support, priority repairs, prepaid shipping both ways, and all necessary parts and labor. It also offers access to loaner units when available, an online portal for tracking repairs, and included educational training through Olympus Continuum. Additionally, the agreement supports expedited equipment replacement through the Advanced Replace® Program and may include initial pre-effective date inspections and repairs to ensure equipment is in proper working condition.

36-month lease Base: 10/1/2026 – 9/30/27 Option Year One: 10/1/2027 – 9/30/2028 Option Year Two: 10/1/2028 – 9/30/2029

Cost per year: $421,450.02

The total cost is $1,264,350.06

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.

GSAM/R 538.7104-3(b)(1)(i): An urgent and compelling need exists and following the ordering procedures would result in unacceptable delays:

GSAM/R 538.7104-3(b)(1)(ii): 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;

GSAM/R 538.7104-3(b)(1)(iii): 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.

GSAM/R 538.7104-3(b)(1)(iv): It is necessary to place the order with a particular FSS contractor to satisfy a minimum guarantee established in the FSS BPA; or

GSAM/R 538.7104-3(b)(1)(v): A law expressly authorizes or requires that the purchase be made from a specified source.

GSAM/R 538.7104-4: Items peculiar to one manufacturer:

Manchester VAMC currently operates an Olympus-standardized endoscopy environment consistent with VHA's objective of reducing variability in equipment setup and reprocessing. The existing clinical, reprocessing, maintenance, and staff competency processes are established around the Olympus platform. Introducing another manufacturer's endoscopes would require additional manufacturer-specific workflows, including device-specific cleaning and reprocessing instructions, adapters and connectors, leak-testing procedures, inspection and maintenance requirements, and associated staff training and competency processes. Maintaining multiple workflows within the same clinical environment would increase process variability and opportunities for human error, including the

ACQ-PLAN: 36C241-27-AP-0317 Page 3 of 4 potential for application of an incorrect manufacturer-specific reprocessing procedure and resulting infection-control risk. Accordingly, continued use of the Olympus platform preserves the standardized operating environment and directly supports the patient-safety objectives identified in the VHA National Standardization of Endoscopes memorandum.

5. Describe Why You Believe the Order Represents the Best Value consistent with GSAM/R 538.7102-2(4) to aid the contracting officer in making this best value determination:

Fair and reasonable pricing has already been established. FSS program negotiates firm-fixed pricing based on a commercial “most favored customer” pricing concept, including an option for economic price adjustments. All products and services are state-of-the-art and provide national/worldwide coverage.

6. Describe the Market Research Conducted among schedule holders and the results or a statement of the reason market research was not conducted: Searched the SBA using the keywords “Olympus scope lease” and found zero SD/VOSB or SB results. A GSA eLibrary search for “Olympus” revealed a VAFSS 36F79721D0168. The FSS is used through VISN 1 for various surgical scope leases. As part of the market research, the acquisition history was reviewed. The Contract Specialist (CS) has worked with Olympus leases since 2023. Since then, the CS has worked on multiple leasing contracts, all of which were sole-sourced to Olympus. A local BPA, 36C24120A0025, was awarded on 9/23/2020. The period of performance was 9/23/2020 - 9/22/2025; it was used for various equipment but is no longer active. All leasing equipment and services are done only through Olympus’s VAFSS 36F79721D0168. VA Medical Center Manchester Olympus Colonoscopy Lease 36F79721D0168 - 36C24126F0084, awarded 3/12/26 and was sole-sourced. Lease 36F79721D0168 - 36C24124F0193, awarded 7/23/24, was sole-sourced. 36F79721D0168 - 36C24124N054, awarded 4/1/24 was sole sourced. Based on the completed market research, it is in the best interest of the Government for this procurement to be a sole source award to Olympus America, Inc. via the VA FSS 36F79721D0168.

7. Any Other Facts Supporting the Justification: n/a

8. 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:

The government will continue to conduct market research to ascertain if there are updates or changes in the leasing and servicing of gastrointestinal scopes in the marketplace to enable for future requirements to be competed.

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 sole source justification restricts consideration of Federal Supply Schedule contractors to fewer than the number required by GSAM/R 538.71 as directed by RFO 8.4. (This signature is the requestor’s supervisor, fund control point official, chief of service or someone with responsibility and accountability).

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AMBER EWING Digitally signed by AMBER EWING

Request for Sole Source Format >SAT GSAM/R 538.7104-3(b) Sole Source Justifications - Federal Supply Schedule Ordering Procedures

Amber Ewing DATE Health System Specialist

11. 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.

Digitally signed by MANASES CABRERA Date: 2026.09.22 08:05:28 -04'00'

Manasés Cabrera DATE Contracting Officer

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

Digitally signed by SHERYL

SHERYL ANTHONY ANTHONY

Date: 202_6.09.22 07:45:10 -04'00'

Sheryl Anthony DATE Branch Chief, Commercial Team 3

c. VHA RPO HCA Review and Approval (over $900,000 to $90 million): I have reviewed the foregoing justification and find it to be complete and accurate to the best of my knowledge and belief and approve for restricting consideration of the Federal Supply Schedule contractors to fewer than the number required by GSAM/R 538.71 ordering procedures as directed by RFO 8.4.

Brent Goe DATE Acting Executive Director Head of Contracting Activity Regional Procurement Office - East

MANASES CABRERA