JA W81K0224Q0030 Redacted.pdf

Control Number: 24-RHCO-P-106

Sole Source Justification and Approval Under FAR 13.501

1. Contracting Activity: Medical Readiness Contracting Office- Pacific (MRCO-P), Joint Base Lewis-McChord Health Contracting Branch, 673 Woodland Square Loop SE, Suite 101, Lacey, WA 98503-1066.

2. Description of Action: This is a new requirement to be awarded as a sole source firm-fixed price contract. This action is funded with Fiscal Year 2023-2025 Defense Health Program Procurement funds.

3. Description of Supplies/Services: This new requirement is for the procurement of two minimally invasive Globus Excelsius GPS Spine Robotic Systems for performing delicate spinal surgery within Defense Health Agency (DHA) medical Treatment Facilities (MTF) located at Madigan Army Medical Center (MAMC) in Joint Base Lewis McChord, Washington and the Mike O’Callaghan Federal Hospital (MOFH) at Nellis Air Force Base, Nevada.

The Globus Excelsius GPS Spine Robotic Systems are a robotic guided spine system with Excelsius surgical instruments that is used to treat multiple spine pathologies. It is used pre-operatively and intra-operatively to plan spinal procedures of both acute and chronic spinal morphology. It is used for both diagnostic and intervention applications, including identification vertebral anatomy and deformities. It can read CT imagery and allows the surgeon to accurately measure disc space to execute surgery in a precise manner avoiding future revisions. This system will be used to assist in the safe and accurate placement of pedicle screws during spine fusion surgeries. It will assist in the placement of minimally invasive (MIS) percutaneous pedicle screws without the use of excessive radiation or the extra cost and steps of using K-Wires, Jamshidis or cannulated pedicle screws.

These Excelsius GPS Spine Robot Systems will increase MAMC’s and MOFH’s quality and ability to provide patient care for spinal diagnosis and procedures.

The estimated total cost of the This is a one-time purchase for MOFH and MAMC.

4. Authority Cited: 41 U.S.C. §1901 as implemented in FAR 13.501(a)(1)(ii), sole source (including brand name) acquisitions under the authority of the Simplified Procedures for Certain Commercial Products and Commercial Services.

5. Reason for Authority Cited: Medical Providers within the DHA Neuro-Spine Surgical Service reviewed the clinical requirements for advanced spinal surgery against the commercially available robotic guided spine systems. It was determined that only the Globus Excelsius GPS Spine Robotic System could meet the DHA’s Clinical requirements. Clinical requirements were developed to determine the minimum characteristics required for a new surgical robotic GPS to assist during spinal procedures and surgeries. These include but are not limited to:

-Must be capable of passively tracking the robotic arm and instrumentation. The Globus Excelsius GPS Spine Robotic System meets this DHA clinical requirement. Other similar products lack this capability or require additional hardware modifications to meet this.

-Must allow the surgeon to interchange hardware and allow the user to implant hardware under navigation without interruption. The Globus Excelsius GPS Spine Robotic System meets this DHA clinical requirement. Other similar products lack this capability.

-Allows for the robotic system to translate on a bed mounted slider to easily reposition robotic arm for full spine access. This must be done without changing the base systems position minimizing operating room workflow disruption. The Globus Excelsius GPS Spine Robotic System does not mount to the bed or directly to the patient allowing for mobility, which meets this requirement. Other similar products mount to patient beds or tables, which limits mobility.

-Must monitor any movement to the patient reference array, in order to guarantee accurate navigation at all times. The Globus Excelsius GPS Spine Robotic Systems allows a surveillance marker which meets this DHA clinical requirement.

The contract specialist contacted the Original Equipment Manufacturer (OEM), Globus Medical Inc. Globus provided to the specialist, in writing, a statement that Globus Medical Inc. does not contract directly with the government, however, they have an authorized distributor that they use to contract with the government, SDV Office Systems LLC. The contract specialist received the OEM’s authorization letter and confirmed with the OEM that SDV Office Systems LLC. is the only authorized distributor. The contract specialist reviewed SDV Office Systems LLC. and found they are a Service-Disabled Veteran Owned Small Business (SDVOSB). Based on the aforementioned information, SDV Office Systems LLC is the only source that can meet the Government’s requirements.

6. Efforts to Obtain Competition:

a. Effective Competition: The Globus Excelsius GPS Spine Robotic System is only manufactured by Globus Medical Inc., the OEM, and only available source to the government is the OEM’s authorized distributor, SDV Office Systems LLC. The notices required by FAR 5.201 shall be posted and any proposals received shall be considered.

A Sources Sought Notice with an attached DRAFT Statement of Work was posted to the Government Point of Entry (Sam.gov) on 16 February 2024 through 01 March 2024. Only one response was received, from SDV Office Systems LLC, the only authorized distributor for Globus Medical Inc.

b. Subcontracting competition: There is no available subcontracting competition for this action.

The proposed awardee, SDV Office Systems LLC, is a SDVOSB concern and is exempt from subcontracting plan requirements in accordance with FAR 19.702(b)(1).

7. Actions to Increase Competition: This is a onetime procurement. Globus Excelsius GPS Spine Robotic Systems are new to Military Treatment Facilities (MTF) under DHA and there is no previous purchase history. Once received, the performance of the Globus Excelsius GPS Spine Robotic Systems will be evaluated to determine if this equipment should be incorporated into to other MTF’s. As such, it is unknown if there any potential future requirements. Ongoing market research will be performed to determine if alternative sources of this service become available.

8. Market Research: Market Research indicates the requirement falls within the commercial products definition as it is a supply customarily used by the general public and has been sold, leased, or licensed to the general public.

Market research has been conducted to identify qualified sources including the posting of a sources sought notice. A review of the National Institute of Health (NIH) National Library of Medicine on robotic spine surgery was conducted to identify FDA cleared devices to support this requirement and commercially available devices. The requiring activity queried government, scientific, and business search engines, to include ECRI. ECRI is an independent, nonprofit organization improving safety, quality, and cost-effectiveness of care across all healthcare setting worldwide.

Additional research was conducted to review systems identified as commercially available including their specifications and comparison made to DHAs clinical requirement. The requiring activity participated in interactive, on-line communications with industry to include teleconferences with manufacturers of spinal telemanipulations systems, January 2022 to present.

The requiring activity reviewed catalogs and other generally available product literature published. Discussions were held between the requiring activity and knowledgeable surgeons across the Government regarding the capabilities offered by the commercial systems in the open market.

9. Interested Sources: To date, no other sources have written to express an interest.

10. Other Facts:

a. Procurement history.

Not Applicable. This is a new requirement for DHA and to date no Globus Excelsius GPS Spine Robotic Systems have been procured by the DOD.

b. Other facts.

None.