Redacted LSJ Ft Belvoir and Ft Lewis.pdf

LIMITED SOURCES JUSTIFICATION (LSJ)

Kinevo 900 Premium Microscope System

1. Defense Logistics Agency (DLA) Troop Support, Medical Supply Chain, Hospital Supply Division, is the contracting activity.

2. The justification is for acquisitions supporting Fort Belvoir in Fairfax County, Virginia, and Madigan Army Medical Center (Madigan AMC) in Joint Base Lewis-McChord, Washington. Both customers are seeking to acquire a microscope system package: Carl Zeiss: KINEVO 900 PREMIUM - KINEVO 900 SYSTEM. The order can be placed against ECAT Solicitation SPE2DH-21-R-0002 Contract Number SPE2DH-22-D-0005, which is valid through February 14, 2027.

3. The acquisitions are for the purchase of the following surgical microscope system package:

Manufacturer: Carl Zeiss Item Description: KINEVO 900 PREMIUM - KINEVO 900 SYSTEM Manufacturer Part Number: 000000-2216-914-01SYSPRE Quantity: 2 Each Unit Price:

Manufacturer: Carl Zeiss Item Description: EXTERNAL SONY 4K MONITOR 3D - KINEVO 900 SYSTEM Manufacturer Part Number: 000000-2216-914-404K3DMO Quantity: 2 Each Unit Price:

Manufacturer: Carl Zeiss Item Description: DICOM - KINEVO 900 SYSTEM Manufacturer Part Number: 000000-2216-914-50DICOMP Quantity: 2 Each Unit Price:

Manufacturer: Carl Zeiss Item Description: MOBILE CART SONY 4K MONITOR - KINEVO 900 SYSTEM Manufacturer Part Number: 000000-2216-914-404KCART Quantity: 2 Each Unit Price:

Total Estimated Dollar Value:

4. The authority waiving the competition requirements is FAR 8.405-6(a)(1)(i)(B), only one source is capable of providing the supplies or services required at the level of quality required because the supplies or services ordered are unique or highly specialized. The use of this authority is necessary to meet the locations’ requirements for two (2) Kinevo 900 Premium – Kinevo 900 Microscope Systems. The microscope system package is necessary because each location’s existing microscopes have exceeded their life expectancy and they are required to be replaced.

The required Microscope System Package must satisfy the following minimum requirements established by the aforementioned locations:

a. Procedures -The system must be able to be used to perform neurosurgery, spinal surgery, and general surgery procedures.

b. Imaging Functions - The system must have four (4) imaging functions that are fully integrated:

intraoperative fluorescence, blue wavelength, yellow wavelength, and infrared.

c. Micro-inspection - The system must have a micro-inspection tool for additional viewing angles.

d. Surgical Navigation - The system must be image guided surgery capable.

e. Controls- The system must have the following three controls: touchscreen, foot switch, and hand switch.

f. Surgical Field Point- The system must be able to lock onto a specific surgical field point while simultaneously allowing microscope head movement.

g. Focal Range - The system must have a working distance of 200 millimeters (mm) to 625 mm (425 mm span).

h. Drift Lock - The system must have an arm drift lock mechanism for more secure positioning/drift elimination.

i. Auto Focus - The system must have the ability to automatically focus on the surgical field.

j. Light Source - The system must have a back-up light source.

k. Co-Observer Tube - The system must have a co-observer tube for dual observation.

l. Active Dampening - The system must have an integrated active dampening system for increased microscopic optical head stability.

m. Automated Balancing - The system must be able to automatically balance itself along all three axes.

n. Positing Angles - The system must be able to move upwards/downwards 125 degrees for more positioning angles.

The surgical microscope will be used for Neurosurgery, Orthopedic Spine, and general surgery procedures.

The imaging functions (intraoperative fluorescence, blue wavelength, yellow wavelength, and infrared) are fully integrated without increasing the microscope head size; this provides safety during tumor surgery and spine oncology procedures. The system has a micro-inspection tool that lets the surgeon see around corners and blind spots. This allows them to focus and move around a structure to visualize the targeted anatomy, reducing risk of injury to both surgeon and patient. The image guided surgery capability allows surgeons to switch between live and pre-surgery patient images. This system can toggle between a touchscreen, foot switch, and hand switch for more control without interrupting the surgery/procedure. The microscope can lock-on to a specific location within the surgical field while still enabling microscope head movement; this results in different viewing angles without losing a locked-on location. The working distance (200mm to 625mm) provides flexibility to perform surgical procedures for the varying size of patients, instruments, and locations of procedures. The arm drift lock mechanism prevents mechanical drift lock/focus loss by securing arm positioning. If the surgical field becomes unfocused, the auto focus feature will immediately fix the microscope’s focus without manual intervention; surgery/procedure can continue effortlessly. The

CUI

back-up light safeguards against primary light source failure; allowing for the continuation of the surgery/procedure opposed to locating another usable microscope instead. The co-observer tube makes co-observation (training and/or assistance) possible and does not move which reduces intraoperative rebalancing (causing view distortion). The Integrated Active Dampening System increases microscopic optical head stability; protection against accidental bumping reduces/mitigates patient risk. The automated balancing increases efficiency and efficacy; the operator(s) do not have to manually adjust the microscope head, stand, and entire unit eliminating human error. Finally, the system’s upward/downward mobility allows for more positioning angles and creates more space for possible adjacent surgical device(s) usage.

The Carl Zeiss microscope system identified above is the only product currently available on ECAT or in the commercial market that meets all minimum clinical/technical requirements indicated above.

5. The Contracting Officer has determined the contract prices of supplies under the Equipment ECAT multiple award program fair and reasonable. DLA Troop Support will seek an additional price reduction since the order will exceed the simplified acquisition threshold. The Contracting Officer has determined that this acquisition represents the best value to the Government consistent with FAR 8.404(d).

6. The Fort Belvoir and Madigan AMC RMC site teams performed clinical requirements assessments through market research in March 2025. They assessed which companies offer a microscope system capable of meeting all minimum requirements. Market research was done via web search, phone calls with potential vendors, the review of the medical master catalog, and the Emergency Care Research Institute (ECRI). The ECRI is a non-profit medical authority that conducts independent medical device evaluations and analysis.

Additional market research was completed by DLA Troop Support in June 2025

7. ECAT vendors have the opportunity to add new products that fall within the scope of the Medical

Equipment ECAT program on a quarterly basis. Therefore, any ECAT vendor may add products, including microscope systems, enhancing competition for future acquisitions.

8. DLA Troop Support continually performs market research of microscopes to identify possible other acceptable sources for future acquisitions, in order to overcome the barriers that led to restricted consideration. Furthermore, DLA will continue market monitoring, however, any new item considered for procurement would be required to meet the Government’s minimum clinical requirements. In the event another vendor outside of the Equipment ECAT Program offers surgical microscope systems, DLA will encourage any such vendor/manufacturer to participate in the Equipment ECAT Program.

9. As the Contracting Officer, I hereby certify that the information contained in this Limited Sources

Justification is accurate and complete to the best of my knowledge and belief.

EVAN LESSIN

Contracting Officer, FSHC

I hereby certify that the requirements that form the basis of this justification are accurate, that these supplies meet the Government's minimum needs, and that this justification is accurate and complete to the best of my knowledge and belief.

Product Specialist

I have reviewed and hereby approve this justification.

MACIEJ OKULICZ-KOZARYN

DLA Troop Support Competition Advocate

OKULICZ

KOZARYN.MACIEJ.

1248273654

Digitally signed by OKULICZ

KOZARYN.MACIEJ.1248273654

Date: 2025.07.15 13:19:32 -04'00'