AWARD
65 -- Monarch Platform Bronchoscopy System (Robotic) 537A20059
- Notice Date
- 9/26/2022 2:36:26 PM
- Notice Type
- Award Notice
- NAICS
- 339112
— Surgical and Medical Instrument Manufacturing
- Contracting Office
- 252-NETWORK CONTRACT OFFICE 12 (36C252) MILWAUKEE WI 53214 USA
- ZIP Code
- 53214
- Solicitation Number
- 36C25222Q0943
- Archive Date
- 10/26/2022
- Point of Contact
- james.hedman2@va.gov, Jim Hedman, Phone: 414-844-4818
- E-Mail Address
-
james.hedman2@va.gov
(james.hedman2@va.gov)
- Award Number
- 36C25222P1140
- Award Date
- 09/26/2022
- Awardee
- GEO-MED, LLC LAKE MARY 32746 FLK
- Award Amount
- 590700.00000000
- Description
- DEPARTMENT OF VETERANS AFFAIRS SOLE SOURCE JUSTIFICATION UNDER SIMPLIFIED PROCEDURES FOR CERTAIN COMMERCIAL ITEMS IN ACCORDANCE WITH FAR 13.5 Acquisition Plan Action ID: 36C252-22-AP-2804 Contracting Activity: Department of Veterans Affairs, VISN 12, Jesse Brown VA Medical Center, Great Lakes Acquisition Center, 537-22-3-969-0505. Nature and/or description of the action being processed: This is a justification for the new procurement of the Johnson & Johnson Auris Monarch Platform Robotic Bronchoscope, 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. Description of supplies/services required to meet the agency s needs: The Robotic Bronchoscope is used for patients requiring diagnostic procedures by the Pulmonary Service for suspicious pulmonary nodules. It is used to diagnose cancer, infection, inflammation of the lungs. Monarch Platform, Bronchoscopy includes: (1) Monarch Tower (1) Monarch Cart (2) Monarch Controller (1) Monarch Pre-Op Planning System Kit (2) Monarch Navigation Patient Sensors (1) Monarch Navigation Field Generator (1) Monarch Navigation Field Generator Mount (1) Bronchoscope Patient Introducer Mount (1 box) Monarch Navigation Patient Patches (1 box) Bronchoscope Patient Introducer Kit (1 box) Bronchoscope Fluidics Tubing (1 box) Bronchoscope Sheath Valve (1) Demo Bronchoscope (1) Year Monarch Platform Warranty (1) Technical Training Session (1) Year 1 Standard Support The total estimated value is [REDACTED] for a one-time delivery, as soon as possible. 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. ยง 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 and No Other Supplies or Services Will Satisfy Agency Requirements (X) Unusual and Compelling Urgency (X) Industrial Mobilization, Engineering, Developmental or Research Capability or Expert Services (X) International Agreement (X) Authorized or Required by Statute (X) National Security (X) Public Interest Demonstration that the contractor s unique qualifications or nature of the acquisition requires the use of the authority cited above (applicability of authority): This is a brand name only procurement for the Johnson & Johnson Auris Monarch Platform. The Monarch Platform: 1) includes a fully dedicated and integrated camera within the bronchoscope to enable direct visualization throughout the entire procedure; 2) includes maximum visualization of instruments extending from the scope under direct camera visualization for diagnostic and therapeutic applications; 3) is a robotic system that possesses integrated fluidics and aspiration controlled by hand-held pendant controller. In addition, the requested equipment is a robotic bronchoscope that enters the airways and is used to increase the diagnostic yield of pulmonary nodules. It is a soft, flexible, camera that uses GPS navigation to guide the camera to the pulmonary nodule for sampling. The system uses a CT scan to build the map to the pulmonary nodule. The robotic bronchoscopy system integrates a variety of technologies designed to empower physicians with greater reach, uninterrupted vision, and meticulous control in the periphery of the lung. The system maintains vision throughout the procedure, especially during biopsy. The robotic system improves minimally invasive techniques by integrating robotics, micro-instrumentation, endoscope design, sensing, and data science into one platform to enable new categories of care. The robotic bronchoscope reaches deeper into the lung than conventional methods, with greater control and accuracy. The bronchoscope and sheath telescoping design provide stability and control. The sheath can be articulated up to 130 degrees in any direction to create a stable base to advance the small bronchoscope. Once advanced beyond the sheath, the bronchoscope provides an additional 180 degrees of flexion in any direction. This maneuverability is important to navigate the small anatomy of the lungs. Each component of the bronchoscope can be independently articulated, advanced, retracted, and positionally locked, allowing physicians greater control and maneuverability deep in the lung where most small nodules are found. Description of efforts made to ensure that offers are solicited from as many potential sources as deemed practicable: An Intent to Sole Source notification (36C25222Q0943) was posted to the Governmentwide Point of Entry, sam.gov. Two responses were received, both for the Intuitive Surgical, Inc. Ion Platform. One was from SDV Office Systems, LLC, an authorized Intuitive Ion distributor. The second was from Intuitive Surgical, Inc., an Other than Small Business, manufacturer of the Ion Platform. Intuitive informed the CO that its products are on a VA SAC contract, 36C10G19D0092. Determination by the CO that the anticipated cost to the Government will be fair and reasonable: CO will use bases for price reasonableness at FAR 13.106-3(a)(2). Description of the Market Research Conducted and the Results, or a Statement of the Reasons Market Research Was Not Conducted: Several searches were made in VIP for NAICS 339112 and the following keywords with results: Robotic Bronchoscopes : Zero results. Robotic Bronchoscope : Zero results. Bronchoscope : One result, L1 Enterprises, Inc. An additional search of L1 s profile did not indicate a robotic capability of bronchoscopes. Bronchoscopes : Zero results. A search on SAM for Robotic Bronchoscope produced zero results. A search for Robotic Bronchoscope on GSA Advantage yielded zero results. An Intent to Sole Source notification (36C25222Q0943) was posted to the Governmentwide Point of Entry, sam.gov. See paragraph 6. There are two SDVOSBs that are known to provide robotic bronchoscopes: SDV Office Systems, LLC. SDV which offers the Intuitive Surgical Ion System and Geo-Med, LLC which offers the Johnson & Johnson Auris Monarch Platform. Geo-Med, LLC also offers the Monarch Platform on its ECAT contract, SPE2D1-19-D-0001. The nonmanufacturer rule at 13 CFR 121.406(b) prohibits set-aside or sole source under the Veterans First program, VAAR 819.70. This will be a single source to Geo-Med, LLC, an SDVOSB, IAW FAR 13.5 with a brand name justification using the format at 6.303-2, modified to reflect that the procedures in 13.5. Any other facts supporting the use of other than full and open competition: None. Listing of sources that expressed, in writing, an interest in the acquisition: Geo-Med, LLC (SDVOSB) [REDACTED] SDV Office Systems, LLC [REDACTED] Intuitive Surgical, Inc. [REDACTED] 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 Government will continue to conduct market research to ascertain if there are changes in the marketplace that would enable future actions to be competed. 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. SIGNATURE DATE NAME TITLE SERVICE LINE/SECTION FACILITY Approvals in accordance with the VHAPM Part 806.3 OFOC SOP: 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. _____________________________ JIM R. HEDMAN CONTRACTING OFFICER, NCO-12 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. ______________________________ [REDACTED] DVISION MANAGER, NCO-12
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