P03 - PM_Part819.7007-7008_Atch1_FAR6_JA_OVER_SAT apw 5112021.pdf

Attachment 1: Request for SDVOSB/VOSB Sole Source Justification Format >SAT

VHAPM Part 819.7007/7008 Page 1 of 5 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: 36C25-21-AP-2749

1. Contracting Activity: Department of Veterans Affairs (VA), VISN 10, Louis Stokes Cleveland VA

Medical Center (Cleveland VAMC)

541-21-3-250-0274

2. Nature and/or Description of the Action Being Approved: This procurement is for the Video Integration for the OR Rooms: A, B & C 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 will be awarded as a new firm-fixed-price purchase order.

The Louis Stokes Cleveland VA Medical Center requires the upgrade and expansion of the video integration for operating rooms (OR) A, B & C. The integrated ORs installed were to be a design of the integration that would be placed in seven ORs that required renovation to replace old integration video systems. The three ORs will be identical to the requested system. The clinical workflow currently used in the three ORs would allow for seamless transition to the upgraded and hybrid ORs and would use identical equipment and identical workflow. There are four major workflow processes that are considered for this procurement. These are: image management control, mobile equipment connectivity, image and video capture, and equipment service and troubleshooting.

3. Description of Supplies/Services Required to Meet the Agency’s Needs The supplies being acquired include:

0001 3.00 EA IMAGE1 S CONNECT II WITH 4U-LINK, KEYBOARD, AND ADAPTER

0002 9.00 EA32" 4K MONITOR, 16:9 ASPECT RATIO W/HDMI 2.0, 12G-SDI AND DISPLAYPORT 1.2 0003 3.00 EA COLD LIGHT FOUNTAIN POWER LED RUBINA HIGH PERFORMANCE LED RUBINA/NIR 0004 3.00 EA SLIM DESIGN SURGICAL CART W/OPEN SIDES KIT WITH CO2 TANK HOLDER XUSM0008 0005 3.00 EA TURRET ADAPTOR F/POWER LED 300 LT SOURCE TO OLYMPUS/STRYKER AND WOLF

LIGHT CABLES

0006 3.00 EA SONY UP-DR80MD MEDICAL GRADE PRINTER FOR USE W/USB + OPTIONAL WIRELESS

PRINT

0007 3.00 EA ENDOFLATOR 50L KIT, WITH INTEGRATED SCB MODULE, POWER SUPPLY, 100

240VAC,50/60HZ

0008 3.00 EA DUAL YOKE CO2 HOSE ASSEMBLY TO CONNECT 2 CO2 E-CYLINDER TANKS TO

INSUFFLATOR

0009 3.00 EA KARL STORZ OR1 SCB CONTROL (Gen 4)

0010 3.00 EA OR1 NEO IP

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0011 3.00 EA WEEKEND SERVICES Fri-Sun Installation 0012 3.00 EA OR1 360 SERVICE OR Room A, B, C the estimated value is $718,288.80, and the estimated delivery is within 90 days.

This procurement is for the Video Integration for the OR Rooms: A, B & C 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 phase one, Video Integration for OR rooms A, B and C.

4. Statutory Authority Permitting Other than Full and Open 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:

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):

Louis Stokes Cleveland VA Medical Center currently has Integration and Surgical Endoscopy Equipment from KARL STORZ ENDOSCOPY AMERICA Inc. The VA Cleveland currently owns 16 Storz Integration systems in the following locations: (7) MAIN ORs 1-7, (2) Hybrid ORs 1 & 2, (3) ORs A,B,C, and (4) ENT Clinics 2A

VA Cleveland utilizes StreamConnect as an enterprise application to manage surgical imaging and video content in both the Main ORs and the ENT Clinics. StreamConnect serves as the primary application for access and distribution of surgical imaging and the conduit for data integrity between the capture device and the VA Cleveland’s long term storage solutions. It provides the ability to store surgical imaging within Vista, PACS, and interfaces with Cerner EMR. The user interface of the existing NEO IP integration system and the proposed upgrade remains consistent and reduces the need for extensive training.

The VA also purchased 24 AIDA Bella capture devices that sit on the network. This investment during makes it virtual impossible to use other vendors that would talk to our current systems unless we were to shut down all our OR’s over a long extended period during this time no surgeries could be performed.

VAMC needs to upgrade its equipment as part of a three-phase construction project. The entire Integration and Video architecture will connect with the current StreamConnect System with EHR/VISTA, CERNER compatibility. The camera platforms will have the 4K connect mode upgraded, so that they will function with the new 4K camera heads while maintaining full function with the

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Revision 03 Eff Date: 04/03/2020 existing camera heads currently on site It has been determined that KSEA, is the only vendor that can satisfy this upgrade.

Integration, by its nature, consolidates and distributes information intra-operatively, to EHR Systems, and potentially to many other locations on campus including pathology, Clinics, Physician offices, etc. This upgrade project will utilize several iterations of new and old equipment throughout this upgrade.

KSEA integration and camera platforms are forward and backward compatible by generation, so LSCVAMC will be able to maintain consistency of equipment utilization and device control between old and upgraded versions, over the course of the construction project. Maximizing efficiency of the OR suites by providing useful and innovative technology. Maximizing flexibility of the OR operating room to conduct a variety of surgical procedures by designing rooms for multiple procedure types.

Minimizing cost of ownership by providing longer manufacturer warranties.

All of this equipment is manufactured by Karl Storz Endoscopy America. Karl Storz Endoscopy America utilizes their partner L1 Enterprises a certified SDVOSB as their distributor.

The authority allows sole source awards to SDVOSB based on 38 U.S.C. 8127(c) and the SDVOSB concern has been determined to be a responsible source with respect to performance. Additionally, COs believes the business meets eligibility requirements in 819.7003.

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:

VetBiz, DSBS, FBO, FPDS-NG, GSA, NAC, and eCMS were all searched for Karlstorz and/or 334516 for current & past acquisitions as well as acquisition vehicles such as BPAs, IDIQ, and Federal Supply Schedules.

Additionally this Justification will be posted to the GPE as an Intent to Sole Source prior to award.

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

The anticipated cost to the government is in line with the IGE and market research. The market research quote allows for a nearly 46% overall discount to the government over list pricing.

8. Description of the Market Research Conducted and the Results, or a Statement of the Reasons Market Research Was Not Conducted: Market research was conducted pursuant to FAR Part 10, the Class Deviation – Implementation of the Veterans First Contracting Program as a Result of the U.S. Supreme Court Decision (Class Deviation – Veterans First Contracting Program (VFCP 2016), VHAPM Part 810.001. Vendor met the eligibility criteria outlined in VAAR 819.7003, they are verified in VIP and the action is below the $5M threshold.

VetBiz, DSBS, FBO, FPDS-NG, GSA, NAC, and eCMS were all searched for Karlstorz and/or 334516 for current & past acquisitions as well as acquisition vehicles such as BPAs, IDIQ, and Federal Supply Schedules.

https://www.va.gov/oal/library/vaar/vaar819.asp https://www.acquisition.gov/content/part-5-publicizing-contract-actions https://www.acquisition.gov/content/part-5-publicizing-contract-actions https://www.acquisition.gov/content/part-5-publicizing-contract-actions https://www.acquisition.gov/content/part-10-market-research https://www.va.gov/oal/library/vaar/vaar810.asp https://www.va.gov/oal/library/vaar/vaar810.asp https://vaww.pclo.infoshare.va.gov/PCLO/PMWeb/VHAPM_Part_810.001.aspx https://www.va.gov/oal/library/vaar/vaar819.asp

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

Renovations and upgrades in technology of different components and supplies used in OR rooms have been constantly happening, especially in the last six years. Throughout of this time, our Medical Center has put forth efforts to make available the request of these services and supplies to many vendors available and capable of supplying video integration, however, Karl Storz has been able to provide most of these services. KARL STORZ Integrated OR user interface is identical to the user interface currently installed in the VA Cleveland. Control of existing KARL STORZ Endoscopy equipment and SPIES Platform including image capture, light source, thermaflator and camera settings from the Camera Head. Single server for management of still photos and video imagery captured during surgery and the ability to stream encrypted surgical footage to nodes as well as authorized users at desktop workstations. Mobile equipment connectivity using Karl Storz 4n1 connection plates assures identical method for equipment connection. The 4n1 plate also minimizes the number of buttons on the user interface screen, reducing clutter and allows touch panel identification of connected mobile equipment. Using the 4n1 plate reduces the overall amount of conduit required and locations for equipment plates. Staying with current vendor would reduce costs on equipment and supplies. No additional staff training will ne be necessary as the system is already in use in other ORs.

The Karl Storz user interface installed in the integrated ORs provides two touch image routing and control of medical devices inside the OR. The integration is controlled by a user interface displayed on a HD touch panel. The user interface allows image control to display selected images to a specific surgeons or clinical viewing display, image capture control and medical device control. The image capture is integrated to the user touch panel inside the integrated ORs. Additionally, the existing image capture solutions can connect directly to the StreamConnect archiving and live streaming application that is part of the upgraded ORs.

Replacing the integration with another vendor solution in the ORs would require replacement of the existing image capture solutions to allow connection to an image archiving solution. The image capture solutions the VA currently owns from Karl Storz would plug and play directly into the StreamConnect application leveraging previously purchased equipment. This allows for the highest resolution to be displayed from the camera head to the video monitor. Placing third party vendors between the video chain hardware can impact the intended image quality. Karl Storz provides specific firmware and software to duplicate the viewing experience of the endoscopic camera in integrated or cart-based procedures. Karl Storz’s full control of the image chain simplifies the solution and experience.

The user interface is fixed at the nurse workstation and is the central image control point inside the ORs. Changing vendors would impact workflow and functionality between recently installed ORs and any new integration projects. Using multiple control interfaced would require staff to learn two entirely different image management systems in the ORs as well as deciphering which integration system to access when archived results are needed.

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

Karl Storz Endoscopy-America, Inc. L1 Enterprises Incorporated DUNS: 075293423 CAGE Code: 2N355 DUNS: 800190782 CAGE Code: 4SEC9 2151 Grand Ave 618 W PATRICK ST El Segundo, CA, 90245 FREDERICK, MD, 21701-4028

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Expiration Date: 04/14/2022 Expiration Date: 01/12/2022

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 contracting office along with the medical facility will continue to conduct market research to determine if any new equipment, distributors, or competitors enter the market. The government will continue to utilize the GPE to source the greatest competition possible.

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.

Matthew Fleming Date Management Analyst Louis Stokes 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.

Christopher A. Callihan Date Contracting Officer Network Contracting Officer (NCO) 10

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.

Adam P. Weber Date Branch Chief Network Contracting Officer (NCO) 10

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