J03 - Karl Storz Tower - DC Signed.pdf

VHAPG Part 813.5 Simplified Acquisition Procedures for Certain Commercial Items Attachment 1: Request for Brand Name Justification >SAT-$7.5M under FAR13.5

Effective Date: 02/01/2022 Page 1 of 6

DEPARTMENT OF VETERANS AFFAIRS

BRAND NAME JUSTIFICATION UNDER SIMPLIFIED PROCEDURES FOR CERTAIN

COMMERCIAL ITEMS IN ACCORDANCE WITH FAR 13.5

Acquisition Plan Action ID: 36C257-24-AP-0028 J&A Log Number: FY24 - NCO 17 - 536

1. Contracting Activity: Department of Veterans Affairs, VISN 17, El Paso VA Health

Care System, 5001 North Piedras Street, El Paso, Texas 79930-4210 is looking to procure Karl Storz Rubina towers purchase request number 756-24-1-960-0008.

2. Nature and/or Description of the Action Being Processed: This procurement is for Karl Storz Rubina 4K NIR/ICG technology - for improved outcomes with access to perfusion. Chroma - computer software for true and vivid color reproduction, Clara

- computer software for intracorporeal brightness and shadowing during surgery, and 3D technology - Restores depth perception and Improve precision with complex technical tasks.

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

IMAGE1 S 4k Camera Head and Camera Connect/Modules

• 4k platform for both the camera heads and the camera connect/modules

• True 4K-UHD Acquisition with fluorescence imaging in the near-infrared range for visualization of indocyanine green.

• Modular design for future expandability to 3D, NIR/ICG, Flexible Digital

Endoscopes, etc…

• Built-in Chroma enhancement

• Built-in Clara enhancement

• On-screen Pointer visualization feature

• On-screen Grid visualization feature

• Screen saver for monitor burn-in protection

• Dashboard display with warnings and information application

• Built-in PIP (Picture in Picture)

• 20 Programmable Presets

• 4k Camera Head must be one piece with no separate modular couplers and include an integrated digital zoom 4k Technology:

Camera Connect Unit, Camera Head, and Monitor MUST be 4k through the entire system. 4k has 4 times the resolution of 1080p HD and a wider color gamut. The wider color gamut and high resolution allow surgeons to see a crisp vibrant image that enables them to discern more details.

TRU 4k-UHD with Fluorescence Imaging:

Two 4k CMOS Chip designs One chip is dedicated to white light detection, the second chip simultaneously focuses on the NIR/ICG signal. This design enables the camera

Effective Date: 02/01/2022 Page 2 of 6 head to present the three different NIR/ICG modes (Overlay, Monochromatic, and Intensity Map) in 4k.

Modular design: Camera System MUST be a modular architecture design with separate modules that includes picture-in-picture technology, 4k, NIR/ICG and 3D for future expandability. The camera platform must be compatible with existing camera heads and digital flexible scopes both backward and forward compatible. Modular design enables standardization to one user interface and customizing its functionality and performance on the respective surgical applications.

Chroma Enhancement: Camera Control Unit MUST include Chroma technology.

IMAGE1 S Chroma enhancement increases the visibility and vascularity of blood vessels that minimizes the likelihood of injuring delicate anatomy i.e. carotid artery in transsphenoidal ENT/Neuro surgery.

Clara Enhancement: Camera Control Unit MUST include Clara technology. IMAGE1 S Clara is a unique feature that allows in real time (no visible lag time) to eliminate dark areas in an image, allowing the surgeon to keep their telescope in the right distance from the surgical target and being able to effectively perceive and discern additional content. With other/current systems in the market, the surgeon needed to move his/her telescope closer to the target for proper illumination that reduced space for instruments, lost overview and came with the risk to get mucous on the lens hence impeding clarity of the surgical field - the Clara has the potential to reduce surgical time and reduces errors / complications as the surgeon will not need to remove, clean and reinsert which is time consuming during a procedure.

Pointer Visualization: Camera Control Unit MUST include “Pointer” enhancement. The IMAGE1 S video architecture features pointer visualization overlay that facilitates effective verbal communication between the attending surgeon and his assistant.

Grid Visualization Feature: Camera Control Unit MUST include Grid Visualization feature. Facilitate effective verbal communication between the surgical team members minimizing operating time The IMAGE1 S video architecture features a grid video overlay that facilitates effective verbal communication between the attending surgeon and his assistant.

Screen saver for burn-in protection: Camera Control Unit MUST include Burn-in Screen Saver. If the video system (camera controller, monitor) is not powered off (e.g., in an integrated operating room), the camera output is permanently displayed on the monitor and after some time it is burned into the glass. This burnt-in image is overlaid to the surgical image leading to a significant quality reduction.

Dashboard with warnings and information application: Camera Control Unit MUST include Dashboard with warnings and information application. IMAGE1 S features a

Effective Date: 02/01/2022 Page 3 of 6 dashboard that appears on the monitor as soon as the video tower is powered on. Must include exclamation points to indicate items requiring attention.

PIP (Picture-in-Picture): Camera Control Unit MUST include PIP. IMAGE1 S Picture-in- Picture (PIP) functionality allows simultaneously documenting and viewing two images on one monitor.

Presets: Camera Connect Unit MUST allow 20 presets on the dashboard for the Nurse Circulator to quickly select for the next case. These settings can be stored, deleted, saved to a USB device and, if necessary, restored if somebody inadvertently changes the settings.

2. Power LED Rubina light source:

• Laser-free LED light source with both white light and Near Infrared (NIR) capabilities. Bulb life of 30,000 hours

• Must have device control allowing complete control of the unit from all other components individually.

• Must contain no mercury or lead and be environmentally friendly.

• Light source MUST have a light intensity display feature. After starting the unit, the light intensity will be automatically adjusted to the lowest level to ensure maximum user safety.

• The LED Ruina light source minimizes the likelihood of burning patient tissue by excessive heat from illumination. Provides high light intensity at low power consumption with intelligent cooling for minimal noise emission.

3. Bella 4k AIDA Image Management Unit

Image Management Unit MUST include all of the below features:

• Security: Windows LDAP login, Disable removable media export function, password-protected procedure cabinet, able to support encrypted USB, military level security.

• Must have 4k video capture functionality.

• Auto-populate patient data, VISTA compatible for network access, DICOM export to PACS and vendor neutral storage (VA approved).

• Export patient images/videos to HER, PACS, StreamConnect, DVD, USB

• Both patient and procedural information can be imported from the HER/VISTA

• Advanced surgical feedback

• MPEG4 compression

• Retroactive capture (DVR-like functionality)

• Customizable surgeon settings

• Icon based user interface

• Configurable mandatory patient fields

• Smart touch screen for staff interface

Effective Date: 02/01/2022 Page 4 of 6

This requirement is estimated at $270,000.00 with delivery date within 30 days ARO.

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 or 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 Contractor’s Unique Qualifications or Nature of the

Acquisition Requires the Use of the Authority Cited Above (applicability of authority): Karl Storz is the manufacturer for the Rubina towers and the software utilized for this requirement is Chroma and has Clara which is proprietary to Karl Storz. This particular software allows the equipment to evolve with future technology and is interchangeable 4k, NIR/ICG and 3D for future expandability.

6. Description of Efforts Made to ensure that offers are solicited from as many potential sources as deemed practicable: Market Research Findings; Market research was conducted IAW FAR PART 10. Pursuant to FAR 10.002, this requirement is found to be commercially available; however, IAW FAR 8.002 and FAR 8.003, this requirement cannot be fulfilled through a mandatory source.

7. Determination by the CO that the Anticipated Cost to the Government will be Fair and Reasonable: The contracting officer will compare the previous awards of like items, current market pricing, and the IGCE to determine the price to be Fair and Reasonable.

8. Description of the Market Research Conducted and the Results:

Market Research Findings; Market research was conducted IAW FAR PART 10.

Pursuant to FAR 10.002, this requirement is found to be commercially available;

however, IAW FAR 8.002 and FAR 8.003, this requirement cannot be fulfilled through a mandatory source.

VIP VETBIZ results from verified capable SDVOSBs and VOSBs. Searched VIP under keyword Telescope Autoclave NAICS code 339113 database and zero (1) SDVOSB’s and zero (0) Veteran Owned Small Businesses were capable of meeting this requirement. See Briefcase for attachments under P02.1. Identified and verified capable SDVOSBs and VOSB

Effective Date: 02/01/2022 Page 5 of 6

GSA Advantage Searched GSA Advantage and found 1 Large Business, Karl Storz on contract. Searched results found thirteen (13) Service Disabled Veteran Small businesses under 65 II A ECG/EKG Apparatus. Results are attached in Briefcase under P02-GSA Product Detail. However, when reached out to them they were not able to provide the exact match.

FPDS produced historical information showing that N0023212F4403 V797P2398 ACMI Corporation (Large Business) was awarded Autoclave Telescope Sole Source priced at $22,648.60 on 05/21/2012. Results are attached in Briefcase.

DSBS results from DSBS showed zero (0) Women-owned small businesses, zero

(0) 8 (a) Certified Small businesses and zero (0) Veteran owned small business, zero (0) SDVOSB, zero (0) Hubzone certified showing capabilities under the keyword search Telescope. Results are attached in Briefcase under P02.

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

This procurement will be completed unrestricted and brand name only with two possible vendors to compete this requirement.

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

L1 Enterprises Karl Stroz Endoscopy-America, Inc.

618 W Patrick Street 2151 E. Grand Avenue Frederick, Maryland 21701 El Segundo, California 90245 SDVOSB Large Business (Manufacturer) (Authorized distributor)

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: Contracting will continue to monitor the technology for future acquisitions for these supplies by posting sources sought and surveying industry vendors to remove the barriers to competition that have been identified in the justification and include a milestone schedule for accomplishing these actions.

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.

Ebenezer Ogbonna Acquisition Utlilization Specialist

13. Approvals in accordance with the VHAPM Part 806.3 OFOC SOP:

https://dvagov.sharepoint.com/sites/VHAProcurement/VHAPM/VHAPM_Part_806.3.aspx

Effective Date: 02/01/2022 Page 6 of 6

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.

James C. Easley Contracting Officer

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.

Jeff Morris

NCO 17

Division 1 Chief