NCO20-FY23-118 JOFOC 36C260-23-AP-0010 Portland Olympus GI Scopes - HCA Approved 1_Redacted.pdf

Effective Date: 02/01/2022 Page 1 of 4

DEPARTMENT OF VETERANS AFFAIRS

SOLE SOURCE JUSTIFICATION UNDER SIMPLIFIED PROCEDURES FOR CERTAIN COMMERCIAL

ITEMS IN ACCORDANCE WITH FAR 13.5

Acquisition Plan Action ID: AP# 36C260-23-AP-0010 JOFOC Log Number: 2022-10-13T15:32:11

1. Contracting Activity: Department of Veterans Affairs, Veterans Healthcare Administration, Regional

Procurement Office West, Network Contracting Office 20 1601 E. Fourth Plain Blvd Vancouver WA 98661, on behalf of VISN 20, Portland VA Medical Center. 2237 #: 648-22-1-9961-0002

2. Nature and/or Description of the Action Being Processed: This request is for a sole source justification to Olympus America, the manufacturer, as a new firm-fixed price contracts for a base + option lease for Portland VA Medical Center’s Care Surgery Services endoscopy equipment.

3. Description of Supplies/Services Required to Meet the Agency’s Needs: The endoscopy equipment to be provided are video gastroscope, colonoscopevarious fiber scopes, 4K UHD units and processors used for several Surgical Specialties, bonchoscopes, ultrasonic probes, ureteroscopes, and laser systems, light sources, video processor, ultrasound processor, etc. Equipment at the start of the lease will be a mix of factory new and continued utilization of specific scopes from previous lease. Option years will continue to utilize the equipment provided at the start of the lease.

Station Period POP Price Boise Base

OY1

OY2

OY3

Lease Price

Purchase Price Savings to Lease Total 48 month lease

4. Statutory Authority Permitting Restricted Competition:

(X) Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements

5. Demonstration that the Contractor’s Unique Qualifications or Nature of the Acquisition Requires the Use of the Authority Cited Above (applicability of authority): These are direct replacements/technology upgrades for current scopes and accessories in use at the Portland VAMC.

a. The GI endoscopy equipment is mandated by VHA Endoscopes Integrated Procuement Team Standardization of Upper/Lower Gastrointestinal Endoscopes, dated November 16 2020 (See DSHOM memo in eCMS Briefcase). Though the 2010 memo is no longer active, the justification and circumstances that prompted that memo have not changed. Therefore, endoscope standardization is strongly recommended by the National Gastroenterology and Hepatology Program. (see Memo

Effective Date: 02/01/2022 Page 2 of 4 from the National Gastroenterology and Hepatology Program in the eCMS Briefcase). The rationale for the National GI Program to recommend that all stations lease their equipment assures the uniformity of equipment and that the station does not end up with mixed generations of equipment, each with a different processing SOP. There have been several national incidents which have placed Veterans at risk related to improper scope processing. Maintaining consistent equipment is critical to standardizing SPD workflow and processing. All of the reprocessing SOPs, reprocessing accessories, and staff competencies are for our Olympus endoscopes. Changing vendors will necessitate hundreds of hours of staff time for creating new SOPs/competencies, retraining staff in manual cleaning and point of use treatment, and assessing their competency.

b. This is a direct replacement for existing leased equipment. At the start of the lease, factory new slim colonoscopes, ultra-slim gastroscopes, therapeutic gastroscope and 32” 4K UHD monitors will be shipped. Some existing scopes and associated equipment will continued to be leased until upgraded video processors, gastroscopes and adult colonoscopes are available. This upgrade ensures that the VA Medical Center’s can maintain the highest, state of the art, operation, functionality and quality of patient care for our veteran patients and ensure that patient care stays commensurate with or higher than the surrounding community and current standards of care.

c. The new leased equipment must communicate and be directly and seamlessly compatible in form, fit and function with the existing VA owned Olympus equipment already in place at the Portland VA Medical Center. It must connect, interface, and communicate seamlessly with the existing Olympus components without the use of adapters or other interfacing connectors. Each piece of equipment must be specifically designed for direct connection and operation with Olympus equipment. This can only be accomplished through using OEM Olympus equipment and services. Ancillary equipment and supplies are all closely tied to the current scope manufacturer and a change would require updating multiple adapters and disposable supplies related to the endoscope system.

d. The Portland VA is an academic training center for Gastroenterology trainees who rotate through OHSU and Kaiser. Since Olympus is so commonly used in training programs across the country the majority of advanced endoscopists are trained using these endoscopes and have evolved their personal techniques to match the characteristics of these endoscopes. These institutions lease their equipment from Olympus to maintain the most up to date equipment for patient care purposes.

Trainees are involved in all emergency cases that occur on nights and weekends and expose them to the most clinically challenging cases that magnify risk of errors. Providing a standard set of equipment across multiple sites is critical to managing conditions and providing patients the optimal chance of success.

e. Selection of Olympus as the sole source of the equipment is required to ensure the highest level of patient safety and to minimize potential use errors and the resulting litigation caused by alternate (non- Olympus ‘gray market’) equipment as well as potential operational interface errors and patient incident risks caused by the use of after-market interfaces.

6. Description of Efforts Made to ensure that offers are solicited from as many potential sources as deemed practicable: Olympus has one SDVOSB vendor who could offer if the equipment were to be purchased, however, they do not have capability to perform services nor leasing of equipment. Any subsequent endeavor will include the marketplace surveyed for availability of competition.

7. Determination by the CO that the Anticipated Cost to the Government will be Fair and Reasonable: Olympus is still providing the VA their NAC FSS pricing for items that are rolled over and the equipment that is shipped at the start of the contract. The superseding equipment that will be delivered when available is based on an estimated VA NAC FSS pricing. If the VA were to

Effective Date: 02/01/2022 Page 3 of 4 purchase this equipment, we would receive a discounted structure of 20% off GSA list pricing.

Additionally the overall lease pricing for the Portland VAMC is below purchase price, therefore the overall pricing is anticipated to be fair and reasonable and in the best interest to the government.

8. Description of the Market Research Conducted and the Results, or a Statement of the Reasons

Market Research Was Not Conducted: Previous to this current Olympus contract the two FSS Endoscope contract vendors were compared and presented to surgeons, staff and sterile processing services. Olympus scopes were determined to provide the level of operability, resolution, function and versatility to best meet the needs of these various stakeholders. No additional Market Research has been conducted for this continuance lease as the current Endoscopes and ancillary equipment have been determined to meet our expectations during this contract period.

9. Any Other Facts Supporting the Use of Other than Full and Open Competition: For any reason, the equipment were to be purchased, this could be obtained easily through Olympus’ exclusive SDVOSB partner. In the long term view, by leasing this equipment, rather than purchasing, future technologies or standards are easily introduced during the regular intervals of lease renewal.

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

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: Any subsequent endeavor will have the marketplace surveyed to see if there is availability of competition.

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.

Christian M. Navarro Inventory Management Specialist (NX) Portland VAMC

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.

Michael J. Allred Branch Chief (Medical Equipment)

Network Contracting Office 20

Christian M.

Navarro 980636

Digitally signed by Christian M. Navarro 980636 Date: 2023.02.13 12:04:31 -08'00'

MICHAEL

ALLRED

Digitally signed by

MICHAEL ALLRED

Date: 2023.02.13 12:57:50 -08'00'

Effective Date: 02/01/2022 Page 4 of 4

b. One Level Above the Contracting Officer (Required over SAT but not exceeding $750K): I certify the justification meets requirements for other than full and open competition.

S. Dale Allen

Director of Contracting Network Contracting Office 20

c. VHA 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 ($750K to $7.5 million (or $15.0 million for acquisitions described in FAR 13.500(c)) for other than full and open competition.

Curtis M. Jordan Executive Director, Regional Procurement Office West VHA Head of Contracting Activity (HCA)

STEPHEN ALLEN

Digitally signed by STEPHEN

ALLEN

Date: 2023.02.21 06:18:43 -08'00'

CURTIS JORDAN

Digitally signed by CURTIS

JORDAN

Date: 2023.02.21 11:35:36 -07'00'