Karl Storz Justification R.pdf

VHAPM Part 819.7007/7008 Page 1 of 4 Original Date: 08/30/2017 Revision 03 Eff Date: 04/03/2020

DEPARTMENT OF VETERANS AFFAIRS

Justification and Approval (J&A) For

Other Than Full and Open Competition (>SAT)

Acquisition Plan Action ID: 36C242-21-AP-1554

1. Contracting Activity: Department of Veterans Affairs, VISN 02, James J. Peters VA Medical Center 130 West Kingsbridge Road Bronx, NY 10468. Organizational Activity: VA New York Harbor Healthcare System Manhattan Campus 423 East 23rd Street, New York, NY 10010 through 2237#630-21-3-3086-0125 seeks to purchase Karl Storz Surgical Tower and accessories on a non-competitive acquisition.

2. Nature and/or Description of the Action Being Approved:

The proposed action is to purchase as a sole source, firm-fixed price award contract, Karl Storz surgical tower, video-endoscopes and accessories for NYHHS Manhattan campus from L1 Enterprise, Inc (), an SDVOSB vendor. The required Storz 4K video tower system is for multiple areas ncluding, ENT, General, Urology and Video assisted thoracic surgery (VATS).

The surgical tower system is to replace end-of-life (EOL) equipment currently at use at the facility, which is unable to be repaired. The system consists of components that allow surgeons the advantage to visualization and display of significant and critical areas of the body during the surgical workflow. The following technical specifications for this system are:

Native 4k resolution.

Exceptional image quality in both white lights and NIR/ICG modes.

Natural color rendition S-Technologies in white light and in combination with overlay modes.

Laser-free LED light source for white light and NIR/ICG.

Excitation of ICG in the near-infrared range.

Camera head and footswitch control.

Opal1® NIR/ICG technology Overlay mode: NIR/ICG is displayed in green or blue over the white light image.

Intensity map mode: Displays signal intensity in overlay image.

3. Description of Supplies/Services Required to Meet the Agency’s Needs:

New York Harbor Surgery department seeks to replace and purchase Karl Storz 4k surgical tower for patients in need of surgical procedures, which would require endoscopy performance. The video tower (primary monitor) is used when the surgeon is performing video laparoscopic surgical procedures. The rigid endoscope is placed into the patient’s abdomen through a cannula and while in the abdomen is attached to a camera that feed

VHAPM Part 819.7007/7008 Page 2 of 4

Revision 03 Eff Date: 04/03/2020 the image of the abdomen to the video monitor and displayed on a screen. The visualization allows the surgeon to manipulate the dissect and remove or repair any affected tissues. A secondary monitor is attached by video cable to the primary monitor, so the assistant surgeon can see and perform his part of the surgery procedure without having to turn around and look at the primary monitor. Here is the Storz surgical tower system equipment NYHHS intends to purchase:

Item#TM340-4k Video towers and secondaries-32” 4k monitor, 16:9 Aspect ratio W/HDMI 2.0, 12G-SDI and displayport 1.2

Item#WD350-KT-Aida Bella W/smartscreen and software license for updates and upgrades

Item#IMAGE1S-4U-KT-Image1 S connect II with 4U-link, keyboard, and adapter Item#TC301US-Image 1 A X-link, link module for flex video-endoscopes, D1, HX, HX-P Item#TL005-Turret adaptors F/power led 300 LT source Item#UG130U-KT-Slim design surgical cart w/open sides kit with C02 tank holder Item#9402-Variable height secondary monitor stand for monitors Item#TC008-1G2G SDI Cable, 33FT Item#KSZ-39301HCTS-Container system, camera heads DM: 12.3” L X 11” W X 4”H

Total Estimated Value is:

Period of Performance:

4. Statutory Authority Permitting Other than Full and Open Competition: 41 USC §3304(a)(5), 38 U.S.

Code § 8127(c), as implemented by FAR 6.302-5 (Authorized or Required by Statute). COs may use the non-competitive (sole source) procedures authorized in VAAR 819.7007 or 819.7008 up to $5,000,000. Check the specific VAAR clause used below:

(x) 819.7007 Sole source awards to a verified service-disabled veteran-owned small business; or ( ) 819.7008 Sole source awards to a verified veteran-owned small business

5. Demonstration that the Contractor’s Unique Qualifications and/or Nature of the Acquisition Requires the Use of the Authority Cited Above (applicability of authority):

The Karl Storz surgical tower, video-endoscopes and accessories needed are proprietary to Karl Storz endoscopy, they are the only manufacturer of the end of life tower system and accessories, as well as proprietary in providing new replacement scopes and towers. They do have one sole distributor/reseller (L1 Enterprise, Inc), an SDVOSB vendor that sell to VA for them. This requirement will allow VA to trade in old Karl Storz towers and replace numerous Karl Storz rigid endoscopes currently in use. The video mediastinoscopy set is only adaptive to Karl Storz instruments used by the thoracic system and Karl Storz insufflators. The clinical staff are familiar with the current/older model of the Karl Storz surgical system and changing to another system would require additional expenditure for new instruments and equipment.

6. Description of Efforts Made to ensure that offers are solicited from as many potential sources as deemed practicable, including whether a notice was or will be publicized as required by subpart

5.2 and, if not, which exception under 5.202 applies:

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Revision 03 Eff Date: 04/03/2020

Review of all Government search engines were conducted, as well as consulted with Original Equipment Manufacturer (Karl Storz Endoscopy) to find as many potential sources as possible. This included searching Veterans Information Pages (VIP), Small business dynamics (DSBS), Non-expendable (NX) equipment, E-CAT, VANAC, Strategic Acquisition Center (SAC) mandatory contracts, FPDS, GSA E-library and Contract Opportunities. A source sought notice was posted to Contract Opportunities on 04/14/2021. CO received Two (2) responses from SDVOSB vendors, L1 Enterprise, Inc and Alliant Healthcare Products.

The results of the searches completed in GSA E-library, SAC mandatory and Small business dynamics (DSBS) yielded zero (0) potential vendors. A search in ECAT showed that the equipment is available, but the cost of ordering through ordering officers for ECAT exceeds the limit of $250K and since this procurement exceeds that limit the order must be obtained through local Contracting Officers. A search in Non-expendable (NX) equipment yielded a similar tower system called Olympus surgical video endoscopy system through Alliant Healthcare, but it will not meet the agency’s needs because the system is not adaptive or compatible with Karl Storz equipment. A search through NAC showed that Original Equipment manufacturer (Karl Storz Endoscopy) have the equipment available on NAC Contract#V797D-30255.

Based on above criteria, of sections III, V and VI the facility’s investment is greatly reduced by not using a different manufacturer, as all equipment communicates through a dedicated and proprietary critical care infrastructure that exists within the facility.

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

Cost was compared to a previous award found on FPDS using keyword Karl Storz Towers that was purchased in 2017 at Albany VA. The results showed that pricing is lower for 2021 on the same items being purchased. CO found the items available on a VANAC contract through OEM but is confident that seeking trade-in discounts from the distributor/reseller will ensure lower prices than VANAC contract prices.

8. Description of the Market Research Conducted and the Results, or a Statement of the Reasons Market Research Was Not Conducted:

IAW FAR Part 10, market research is detailed in Section VI above. CO also received a letter from OEM, that they have only one distributor/reseller that deal with VA for them and that is L1 Enterprise, Inc.

Market research also shows that vendor meets criteria outlined in VAAR 819.7003.

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

None

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

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Revision 03 Eff Date: 04/03/2020

L1 Enterprise, Inc Alliant Healthcare Products

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:

In order to remove or overcome barriers to competition in future acquisitions for this requirement, the agency would have to continue to review the marketplace to determine if new products/technology is such that it could be cost-effective to replace entire existing physiological Storz surgical tower system.

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

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.

Date

b. One Level Above the Contracting Officer (Required over the SAT but not exceeding $700K): I certify the justification meets requirements for other than full and open competition.

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