P03 HCA SIgned NCO 1 P03 LSJ_OVER_SAT_Olypmus scopes_15MAR_.JL_SA_HCA Approved.pdf

VHAPG Part 808.405-6 Limiting Sources Request for Limited Sources Justification Format >SAT

AP: 36C241-24-AP-2088

Effective Date: 02/01/2022 Page 1 of 5

LIMITED SOURCES JUSTIFICATION

ORDER >SAT

FAR PART 8.405-6

Acquisition Plan Action ID: 36C241-24-AP-2088

(1) Contracting Activity: Department of Veterans Affairs, Network Contracting Office 01, located at 950 Campbell Avenue, West Haven, CT 06516, in support of VISN 1: VA New England Healthcare System. 2237# 405-24-3-2053-0074, Estimated Cost: $6,698,643.48.

(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).

VISN 1 seeks an extensive spectrum of clinical care within gastrointestinal (GI) Endoscopy services. Endoscopes and their associated hardware devices are mission-critical medical equipment clinicians use to apply patient treatment, diagnosis, and therapy directly. VISN 1 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. The VISNs current Olympus contract, 36C24120C0046, has a total contract value $9,104,355.34 with a period of performance end date of 3/31/2024.

VISN 1 locations include:

• VA Boston RCS-Jamaica Plain: 150 South Huntington Ave, Boston, MA 02130

• VA Boston HCS - West Roxbury: 1400 VFW Pkwy, West Roxbury, MA 02132

• VA Boston HCS- Brockton: 940 Belmont St, Brockton, MA 02301

• VA Connecticut HCS - 950 Campbell Ave, West Haven, CT 06516

• WRJ VA HCS - 163 Veterans Dr, White River Junction, VT 05009

• Providence VA - 830 Chalkstone Ave, Providence, RI 02908

• VA Maine HCS - 1 VA Ctr, Augusta, ME 04330

• Manchester VAMC - 718 Smyth Rd, Manchester, NH 03104

• Brockton VAMC – 940 Belmont Street, Brockton, MA 02301

• VA Central Western Massachusetts – 421 North Main Street, Leeds, MA 01053

Order against: FSS Contract Number: 36F79721D0168.

Name of Proposed Contractor: Olympus America Inc.

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Street Address: 3500 Corporate Parkway, P.O. Box 610

City, State, Zip: Center Valley, PA 18034

Phone: 484-896-5000

(3) Description of Supplies or Services:

The estimated value of the proposed action, including all option, is $6,698,643.48. Based on the abovementioned needs and guidance, VISN 1 seeks to acquire GI Endoscopy equipment from the OEM and a service/maintenance plan via a leasing model. The equipment sought is a mix of therapeutic and diagnostics endoscopes, including, but not limited to, colonoscopes, gastroscopes, duodenoscopes, enteroscopes, ERCP scopes, EUS scopes, video processors, and light sources. The scope of equipment should also include all supplementary software and hardware peripherals required to use the equipment. Please refer to the attachment for a complete list of medical equipment models and quantities requested under the leasing model.

The VA shall be able to add or replace OEM endoscopy equipment that meets the scope as needed at a pro-rated rate for the respective model through Olympus and will be processed through an amendment. The amendment will show the equipment changes and the pro-rated cost change. At the time of trade-in and/or disposal of existing scope systems, the site will retain all hard drives for proper disposal.

(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:

The Olympus systems operate by proprietary software/hardware that can only be replaced or expanded upon by the OEM. The OEM provided a sole source letter indicating they are the only vendor to provide the Leasing Model required. Third-party vendors cannot maintain a leasing model for Olympus equipment over a 12-month period, as it would void the OEM warranty. Third-party providers do not have the technical knowledge or levels of support to maintain these critical systems as part of a lease package. The Scope annual option plan is structured so the VA must return the equipment to the OEM upon term completion. Only Olympus has the expertise and services required to maintain the integrity of the scope equipment, video systems, and accessories, provide adequate clinical and technical training, and meet the VA’s needs during the warranty term. As the sole OEM provider of this equipment, all parts and labor shall be acquired from Olympus. Olympus is the only vendor on the market that offers both traditional and specialized endoscope technology. Other vendors on the market offer some of this technology (standard endoscopes) but not all the specialized therapeutic or

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Effective Date: 02/01/2022 Page 3 of 5 ultrasound technology VA New England needs. Procuring from a different vendor would result in having to procure the specialized equipment from Olympus regardless. This would leave a very fragmented system in place for the front-line staff to utilize for patient care while also increasing VA costs to procure two separate systems per site. Accordingly, Olympus is the only firm capable of providing the supplies and services described above without VHA experiencing substantial duplication of cost that could not be expected to be recovered through competition. With the contract in place, discounts from the OEM are offered from the previous GSA contract.

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:

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:

Based on the acquisition history for the VISN 1 Olympus Scope lease over the last seven years, (VA241-17-F-1885, PoP 9/29/2017 – 9/28/2020, 36C24120C0046 09/29/2020 – 09/28/2023, extended 6-months 09/29/2023 – 03/31/2024) Olympus is the only vendor that can provide the equipment and services required to meet the requested requirement. This lease model is the only schedule that can satisfy this requirement. Olympus provided a sole source letter regarding third-party vendors. They do have third-party distributors and resellers to include SDVOSB; however, the issue is that they cannot offer the leasing model that the VISN requires, and they are not authorized to work on the equipment. They would be a middleman, resulting in undue costs risk to the VA and possible non-compliance with the FDA regulations. A search

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Effective Date: 02/01/2022 Page 4 of 5 on VetCert using NAICS 339113 resulted in 912 results none of which can provide the services required. A search on VetBiz using NAICS 339113, keyword Olympus resulted in 1 result, they too cannot provide the services the VISN requires.

(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 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.)

SIGNATURE DATE

Rebecca Hevey, Chief Biomedical Engineer Clinical Engineering

NAME AND TITLE SERVICE LINE/SECTION

VISN 1

FACILITY

REBECCA HEVEY

Digitally signed by REBECCA

HEVEY

Date: 2024.03.19 13:26:28 -04'00'

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(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.

CONTRACTING OFFICER/DESIGNEE’S SIGNATURE DATE

Julie Lemire, Contracting Officer RPOE, NCO 1

NAME AND TITLE FACILITY/NCO/PCO

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.

SIGNATURE DATE

Sheryl Anthony, NCO 1 Branch Chief

NAME

HIGHER LEVEL APPROVAL (Required for orders over $750,000):

c. VHA RPO HCA Review and Approval (over $750,000 to $75 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 FAR Subpart 8.4.

DATE Gerald F. Jacobs

Head of Contracting Activity, East

JULIE LEMIRE Digitally signed by JULIE LEMIRE Date: 2024.03.19 13:30:26 -04'00'

SHERYL ANTHONY

Digitally signed by SHERYL

ANTHONY

Date: 2024.03.19 13:38:27 -04'00'