JA_Redacted.pdf

PM Part 813.5 SAP for Certain Commercial Items Page 1 of 5 Original Date: 08/30/17 Revision 03 Date: 02/11/2021

DEPARTMENT OF VETERANS AFFAIRS

SOLE SOURCE JUSTIFICATION UNDER SIMPLIFIED PROCEDURES FOR CERTAIN COMMERCIAL

ITEMS IN ACCORDANCE WITH FAR 13.5

Acquisition Plan Action ID: 36C256-20-AP-4405

1. Contracting Activity: Department of Veterans Affairs, VISN 16, G.V. (Sonny) Montgomery

VA Medical Center

NCO 16

715 Pear Orchard Road Ridgeland, MS 39157 586-21-3-037-0001

2. Nature and/or Description of the Action Being Processed: This procurement is for an endoscope lease 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 requirement is for the award of a new firm-fixed price contract with a base year plus 2 one-year option periods to Olympus America, Inc for the lease of GI endoscopy equipment.

3. Description of Supplies/Services Required to eeds:

The estimated value of the proposed action is

Base: April 1, 2021 through March 31, 2022 Option Year 1: April 1, 2022 through March 31, 2023 Option Year 2: April 1, 2023 through March 31, 2024

The G.V. (Sonny) Montgomery VA Medical Center, Jackson, MS (GVSMVAMC) has a need to lease endoscopes and related equipment/accessories, as well as obtain a full-service agreement to cover the leased equipment with Olympus America, Inc. The lease enables GVSMVAMC to have access to the required scopes without delay due to repair and Reusable Medical Equipment (RME) turnover at a signification cost savings. VISN 16 has determined to lease all endoscopes rather than purchase due to the exorbitant cost for maintenance, repair, replacement which ensures outdated technology is replaced with the most recent generation. The GI endoscopy equipment to be leased includes the follow items:

QUANTITY MODEL EQUIPMENT DESCRIPTION

9 CF-HQ190L EVIS EXERA III HD COLONOSCOPE

3 PCF-H190DL W/ SCOPEGUIDE

3 OEV-262H HIGH DEFINITION LED LCD MONITOR

10 GIF-H190 EVIS EXERA III HDTV GASTROSCOPE

5 UCR ENDOSCOPIC CO2 REGULATION UNIT

5 MAJ-1985 CYLINDER HOSE WITH SWITCH OVER

PM Part 813.5 SAP for Certain Commercial Items Page 2 of 5

Revision 03 Date: 02/11/2021

5 MAJ-2159 SCOPE POLE KIT

5 MAJ-2165 DRAWER UNIT

5 MAJ-2159 SCOPE POLE KIT

10 MAJ-2216 MAJ-2216 LCD MONITOR ARM 6.5-12kg

5 MAJ-2146 SLIDING KEYBOARD TRAY

10 MAJ-2211 SIDE HANDLES

5 MAJ-1653 DUAL CO2 CYLINDER HOLDER WM-P2

1 N3827430 UPD-3 SCOPEGUIDE PROCESSOR

1 FLP-0008-17 SCOPE GUIDE BED RAIL MOUNT

1 MAJ-1948 COMMUNICATION CABLE 1.8M

1 MAJ-1898 CLV-UPD CABLE

5 WM-DP3 20A WM-DP3 MOBILE WORKSTATION US

3 TJF-Q190V DUODENOVIDEOSCOPE

3 MAJ-2315 SINGLE USE DISTAL COVER 20/bx

1 MAJ-2029 EC-10 RECORDER SET

2 GIF-XP190N ULTRA SLIM SCOPE, 4 WAY

1 IS20334 INPUT UNIT

1 MAJ-2056 DETACHABLE CABLE

1 GIF-2TH180 THERAPEUTIC 2-CHANNEL HDTV

5 CV-SDI-10 HD VIDEO CABLE

5 CV-190 EVIS EXERA III VIDEO PROCESSOR

5 CLV-190 EVIS EXERA III LIGHT SOURCE

1 GIF-1TH190 EVIS EXERA III GASTROSCOPE

1 UM-G20-29R-3 ULTRASONIC PROBE

1 PROSOUND F75 Premier EUS/EBUS Processor

5 OFP-2 FLUSHING PUMP

4 LMD-3251MT/HD SONY 32" HD DISPLAY

3 OEV-262H LCD MONITOR

1 MAJ-2188 SOFTWARE LIGHT PHASE

1 MAJ-2189 SOFTWARE PHASE 2.0

1 HW-EC10-LAPTOP EndoCapsule v2 Laptop ThinkPad

2 MAJ-2027 ENDOCAPSULE ENDOSCOPE SET

Full-Service Agreement

Olympus America, Inc is the preferred brand of scope for VISN 16; as part of the Deputy Under Secretary for Health Operations and Manageme

As required by the memo, the GVSMVAMC adopted the Olympus brand endoscopes as its standard product.

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:

PM Part 813.5 SAP for Certain Commercial Items Page 3 of 5

Revision 03 Date: 02/11/2021

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

( ) Unusual and Compelling Urgency ( ) Industrial Mobilization, Engineering, Developmental or Research Capability or Expert Services ( ) International Agreement ( ) Authorized or Required by Statute ( ) National Security ( ) Public Interest

5. Demonstration that the C Unique Qualifications or Nature of the Acquisition Requires the Use of the Authority Cited Above (applicability of authority):

a. Only One Responsible Source The DUSHOM memorandum dated Dec 6, 2010 specifically identifies the usage of three OEM (original equipment manufacturer) endoscope manufacturers.

VISN 16 Medical Facilities currently use Olympus America, Inc. as the standard throughout the facility. MEDVAMC medical personnel are trained and certified with the current inventory of Olympus America scopes. GVSMVAMC Sterile Processing Services has invested time, effort and manpower developing the necessary Standard Operating Procedures (SOPs), procuring the custom-tailored reprocessing equipment and developed/fielded custom-tailored training to clean, decontaminated, disinfect and sterile Olympus brand scopes. With the trade-in value included for older style/models of endoscopes, Olympus America, Inc. has guaranteed that any/all facilities using Olympus America OEM equipment will consistently have the most current and up-to-date generations.

The potential dollar value of changing equipment and consumables, including construction site prep to de-install and install new sterilizing and disinfecting equipment would be excessive if a new scope manufacturer is selected. Our current scopes are supplied through Olympus America, the OEM. Because of this, only these scopes can interface with the computer towers that operate the scopes and store the results of the procedures. The machines cleaning the scopes have specialized connectors for Olympus and more complicated items such as graspers and cutters.

Furthermore, not competing the lease mitigates the risk of infection, injury, and harm to Veterans due to different processes required for cleaning and handling scopes.

6. Description of Efforts Made to ensure that offers are solicited from as many potential sources as deemed practicable: A source sought notice was posted on Beta.Sam, indicating the Government s intent to sole source this requirement to Olympus America, Inc. The 36C25621Q0292 was issued on December 16, 2020 and closed December 30, 2020. According to market research, the items are available for purchase from Alliant Healthcare. The lease option is exclusively available through Olympus America, Inc.

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

Reasonable: The CO has determined that the anticipated cost to the Government for the items covered by the J&A will be fair and reasonable. A comparison of historical pricing and the proposed price was conducted. It has been determined that the proposed price is 12% less than what was paid on Delivery Order 36C25618F0487.

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

Market Research Was Not Conducted: A query of VetBiz was conducted, this search returned one

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(1) SDVOSB, Alliant Healthcare. This SDVOSB, does not lease Olympus equipment, but is an authorized distributor of Olympus equipment for purchase only. Also, a notice of intent was posted via Beta.Sam in which only one response was received. The responder indicated that they have Olympus equipment for purchase but not for lease. Searches of National Strategic Source Listing, GSA eLibrary, and DSBS, did not yield any potential sources.

9. Any Other Facts Supporting the Use of Other than Full and Open Competition:

This procurement is consistent with the Integrated Product Team (IPT), which was tasked with development of requirements for the national standardization of endoscopes throughout VHA.

The initiative was to facilitate device standardization and to reduce variability in endoscope processing and usage. The repair, maintenance and equipment upgrades will be easier to maintain with just one brand/vendor. This will help reduce the variety of instruments and thus for set-up and re-processing of medical equipment.

function and user interfaces Decision B- ale for standardizing medical equipment, to reduce medical errors and enhance patient safety, sets forth a reasonable basis for the procuring of Olympus on a brand name basis under such circumstances. Furthermore, our Office has held that an imate need to standardize the equipment it uses may provide a reasonable basis for imposing restrictions on competition.

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

Olympus America, Inc.

3500 Corporate Parkway Center Valley, PA 18034-0610

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:

The VA has standardized these products to reduce medical errors and enhance patient safety, however, market research will continue to be conducted to determine how VA will obtain these products in the future.

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.

Date