P03 JOFOC Olympus Urology - JTH.pdf

VHAPG Part 813.5 Simplified Acquisition Procedures for Certain Commercial Items

Effective Date: 02/01/2022 Page 1 of 3

DEPARTMENT OF VETERANS AFFAIRS

SOLE SOURCE JUSTIFICATION UNDER SIMPLIFIED PROCEDURES FOR CERTAIN COMMERCIAL

ITEMS IN ACCORDANCE WITH FAR 13.5

Acquisition Plan Action ID: 36C261-24-AP-1344, FY24-NCO 21-1481

1. Contracting Activity: Department of Veterans Affairs, Veterans Integrated Service Network (VISN)

21, San Francisco VA Health Care System (SFVAHCS), 662-24-1-067-0042

2. Nature and/or Description of the Action Being Processed: This procurement is for a new firm fixed price contract with one base year and four one-year options for the maintenance and repair for an entire suite of various Olympus urology scopes in accordance with FAR 13.5 Simplified Procedures for Certain Commercial Items and specifically FAR 13.501 Special Documentation Requirements, where acquisitions conducted under Simplified Acquisition Procedures are exempt from the requirements of FAR Part 6, but still require a justification using the format of FAR 6.303-2.

This is a sole source procurement to the Original Equipment Manufacturer (OEM), Olympus America Inc. Olympus is to provide repair and maintenance services per the OEM standards in order to meet device uptime requirements and minimize any downtime. This includes providing OEM parts.

3. Description of Supplies/Services Required to Meet the Agency’s Needs: The proposed contract is estimated to be approximately $713,297.50, for 12 month base year, with four one-year options.

The scopes are highly sophisticated flexible instruments that are inserted through the urological orifices. These instruments help to visualize and diagnose disorders, to obtain biopsies, to place stents, to remove tumors, and other treatments. The scopes are connected to a very high intensity light source and a video processing unit. The flexible scope that is inserted into the patient has an embedded high-density video camera that transmits a video image, and a fiber-optic light bundle to transmit the light from the light source into the innards of the patient. The video is obtained with the help of the light from the light source and is processed and stored by the video processing unit.

The Olympus scopes are already being maintained for the urology department at the SFVAHCS.

Being that the Olympus scopes are in use, the SFVAHCS has the light sources and cameras that connect to the Olympus scopes. The light sources and cameras are not interchangeable with any other scope.

Repair Services for the following Olympus Urology Scopes:

• Model: CYF-VH (CYF/HYF, Video) o Serial numbers: 7244935, 7245059, 7245035, 7245031, 7245034, 7245036, 7245033, 7245195, 7245194, 7245189, 7245196, 7245197, 7245191, 7245190, 7245198, 2402164, 2402100, 7245169

• Model: CYF-5R (CYF/HYF, Fiber) o Serial number: 2401087

• Model: URF-V3R (URO, Video) o Serial numbers: 2000490, 2000493

• Model: URF-V2R (URO, Video) o Serial numbers: 2822739, 2822793, 2822584, 2822794

• Model: URF-P6R (URO, Fiber)

Effective Date: 02/01/2022 Page 2 of 3 o Serial numbers: 2835803

4. Statutory Authority Permitting Restricted Competition:

FAR 13.5 Simplified Procedures for Certain Commercial Items. The statutory authority for applying the Simplified Procedures for Commercial Items of FAR 13.5 is 41 U.S.C. § 1901 and is implemented by FAR 13.106-1(b)(2) for restricting competition on this procurement. Competition is restricted on this procurement for the reason below:

(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):

The procurement is a sole source to Olympus America, 3500 Corporate Parkway, Center Valley, PA 18034. There are no other sources of supply/service that will satisfy agency requirements. The Olympus scopes are already in use and maintained for Urology at the San Francisco VAHCS.

In addition, Olympus America Inc. is the only source that can perform repairs/maintenance to the scopes due to the proprietary nature of this equipment, no other company was found that has authorized third-party service providers.

Accordingly, Olympus America Inc., is the only firm capable of providing the supplies and services without the Veteran’s Health Administration experiencing substantial duplication of cost that could not be expected to be recovered through competition.

6. Description of Efforts Made to ensure that offers are solicited from as many potential sources as deemed practicable: An intent to sole source, 36C26124Q0527, to Olympus America, Inc., was posted to Contract Opportunities (SAM.gov) for this procurement on March 29, 2024 with a due date of April 5, 2024; received no responses.

7. Determination by the CO that the Anticipated Cost to the Government will be Fair and Reasonable:

The Contracting Officer will review and determine if the anticipated price is fair and reasonable. FAR Part 13 Open Market Award Decision Documentation Form shall detail how the Government will determine that the anticipated cost is fair and reasonable. The basis of price reasonableness will be determined based on comparison of previous awards, FAR 13.106-3(a)(2)(ii).

8. Description of the Market Research Conducted and the Results, or a Statement of the Reasons Market Research Was Not Conducted: As described in Section 6 above, market research, in accordance with FAR Part 10, was conducted by synopsis of the proposed acquisition, advising industry of the pending acquisition and soliciting inquiries from interested parties. Through market research, the CO has determined that Olympus does not have any authorized third-party firms for scope repair and maintenance services, nor does Olympus sell original equipment manufacturer parts, tools, or jigs to any third party. The use of non-Olympus parts may invalidate the limited warranty, and it will invalidate the reprocessing (cleaning and disinfection) instructions provided in the device's instructions for use. The VetCert database was quired to determine if there where at least two SDVOSB or VOSB contractors available to perform the requires services and there are none that can meet these requirements, due to the proprietary nature of these scopes.

Effective Date: 02/01/2022 Page 3 of 3

9. Any Other Facts Supporting the Use of Other than Full and Open Competition: No other factors are applicable at this time.

10. Listing of Sources that Expressed, in Writing, an Interest in the Acquisition: The only known source is 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:

Olympus is the only source that can perform repairs/maintenance to the scopes due to the proprietary nature of this equipment, Olympus does not have authorized third-party service providers. The Department of Veterans Affairs will continue to monitor the commercial marketplace to determine if other sources are responsible and capable of providing this type of service that meets the needs of VISN 21.

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.

Gabriella Orteza Date Chief Biomedical Engineer

SFVAHCS

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.

Angela Gerlitzki Date Contracting Officer Network Contracting Office (NCO) 21

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.

Jason T. Hill Date Branch Chief - Services Team II

Network Contracting Office (NCO) 21 https://dvagov.sharepoint.com/sites/VHAProcurement/VHAPM/VHAPM_Part_806.3.aspx

VHASFCORTEZG

Typewritten Text 4/19/2024