SOLICITATION NOTICE
65 -- Da Vinci Robotic System
- Notice Date
- 9/2/2010
- Notice Type
- Presolicitation
- NAICS
- 339112
— Surgical and Medical Instrument Manufacturing
- Contracting Office
- Department of Veterans Affairs;Rocky Mountain Network;VISN 19 Contracting;4100 E. Mississippi Avenue, Suite 610;Glendale CO 80246
- ZIP Code
- 80246
- Solicitation Number
- VA25910RQ0257
- Response Due
- 9/9/2010
- Archive Date
- 9/24/2010
- Point of Contact
- David Geary
- E-Mail Address
-
ct
- Small Business Set-Aside
- N/A
- Description
- DEPARTMENT OF VETERANS AFFAIRS VISN 19 Rocky Mountain Network Contracting Center 4100 E. Mississippi Ave. Suite 2110 Glendale, CO 80246 JUSTIFICATION AND APPROVAL TO PROCURE USING OTHER THAN FULL AND OPEN COMPETITION Upon the basis of the following justification, the use of other than full and open competition for the proposed contractual action is hereby authorized pursuant to the authority of 41 U.S.C. 253(c)(5), FAR 6.302-1 Only one responsible source and no other supplies or services will satisfy agency requirements. JUSTIFICATION 1. Identification of Agency and Contracting Activity. Department of Veterans Affairs, VISN 19, Rocky Mountain Network Contracting Center (RMCCC), Glendale, Colorado. 2. Nature/Description of Action. This contracting activity proposes to negotiate a sole source contract with Intuitive Surgical Inc for purchase, installation, and training for the da Vinci Robotic System. 3. Description of Supplies/Services. This is new equipment and will include: One Robotic laparoscopic surgical systems, IS2000 Da Vinci S Surgical System with HD to include the surgeon console, the HD vision system, the four arm patient side system, and the accessories starter kit to include the following: (1) Cannula Mount, Camera, (3) Cannula, Instrument, (3) Drape, Instrument Arm, (1) Drape, Camera Arm, (1) Drape, Camera, (1) Drape, Monitor, (1) Latching Obturator, Sharp, (1) Latching Obturator, Blunt, (1) Box Cannula Seals, (1) Allen Wrench, 1/16", Emergency Stop, (1) Blade Protector; HD Camera Starter Kit to include the following: (1) HD Camera, (1) Scope, 0 Degree, (1) Scope, 30 Degree, (1) Universal Scope Alignment Target, (1) Bifurcated Light Guide Cable, (1) Sterile Adapter, Camera, (1) Sterile Adapter, Camera Arm; Training Instruments Starter Kit to include: (1) Training Potts Scissors, (2) Training Black Diamond Micro Forceps, (2) Training Large Needle Driver, (1) Training DeBakey Forceps; Two Complete Training kits include the following: (2) Small clip applier, (8) large needle driver, (2) DeBakey Foreceps, (2) Cadiere Forceps, (4) ProGrasp Forceps, (4) Maryland Bipolar Forceps, (6) Hot Shears, (4) Permanent Cautery Hook, (2) Permanent Cautery Spatula Instrument, (4) Fenestrated Bipolar Forceps, (2) Tenaculum Forceps, (4) Suture Cut Needle Driver, (2) Hem-o-lok Clip Applier, Large, (2) Dual Blade Retractor, (2) Grasping Retractor (Graptor), (2) 8mm Bladeless Obturator, (2) 8mm Bladeless Obturator, Long, (4) Cannula Seal, (4) Tip Cover Accessory, (6) Cannula, Instrument, (2) Latching Obturator, Blunt, (2) Latching Obturator, Blunt, Long, (2) Drape, Instrument Arm, (2) Drape, Camera Arm, (2) Drape, Vision-Cart Monitor 19", (2) Drape, Camera, (2) Universal Endoscope, 12mm Alignment Target, (2) Sterile Adapter, Camera Arm, (2) Cannula Mount, Camera (ethicon), (4) Wrench, Emergency Grip Release, (2) Bifurcated Light Guide Cable, (2) Illuminator Lamp Module, Single, (2) 3D - 8.5mm Endoscope Starter Kit, (2) 8.5mm Camera Cannula Seals. The acquisition of the system should include shipping and initial installation with a complete on-site maintenance inspection and all necessary systems testing. Estimated cost of this requirement is $2,454,000 based upon past procurements and Item Manager personal knowledge. The da Vinci Robot is needed to perform state of the art robotic procedures. Currently, there are surgeons and Operating Room (OR) staff that are trained to use the system. The system will: 1) Improve the delivery of patient services: The intent is to provide our veteran population the state of art technology which comprises the practice patterns in the private sector; with projections this year to be applicable to greater than 50% of radical prostatectomies to be done for localized prostate cancer. Recent evidence of published reports demonstrated that, in the same environment, the incidence of positive surgical margins is statistically lower with robotic radical prostatectomy when compared with surgical outcomes at the same institution. This procedure produces comparable outcomes of continence and potency to that from institutional experiences with high surgical volumes. 2) Reduce waiting times: Efficient management of access to the OR is the limiting factor in the situation. At the present time, cancer patients are managed equivalently with other urologic care; as such, cancer patients often have long wait times for access to the OR. Orchestrate and manage access of patients with prostate cancer to surgical intervention will be fast tracked into designated blocks on the OR schedule to facilitate their care. 3) Improve staff recruitment and retention in critical positions: Maintaining access to state-of-the-art technology is critical in recruiting resident candidates. 4) Provide co-benefits/services to more than one VA Medical Center: The Urology Section provides tertiary referrals for patients from all sites in VISN 19 for surgical interventions. We would envision that the Eastern Colorado HealthCare System become responsible for the potential robotic prostatectomy candidates diagnosed at other VISN 19 sites. 4. Identification of Statutory Authority. The statutory authority permitting other than full and open competition is 10 USC 2304(c) (1) implemented by the Federal Acquisition Regulation (FAR) Subpart 13.501(a), "Sole Source Acquisitions." FAR 6.302-1-- Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements. 5. Demonstration of Contractor's Unique Qualifications. The operative surgical robotic system manufactured by Intuitive Surgical is the only Food and Drug Administration (FDA) approved master-slave robotic surgical system currently available in the commercial market. The background information on the FDA's role in regulating medical equipment is provided below. The system is the only available technology that can provide the surgeon with the intuitive control, range of motion, fine tissue manipulation capability, and 3-D visualization characteristic of open surgery, while simultaneously allowing the surgeon to work through small ports of minimally invasive surgery. In addition, the Veterans Health Systems Committee (HSC) issued an Executive Decision Memo (EDM), 8-1-2007, for managing the introduction and use of robotic surgery in the VHA. This memo supports the unique FDA qualification detailed above. 6. FedBizzOpps Announcement/Potential Sources. Since the Da Vinci system is the only FDA approved operative surgical robotic system available, efforts to include potential sources has been limited. The staff physicians/surgeons are constantly surveying the professional literature and attending professional development seminars to stay abreast of any developments in this specialized field. This action will be synopsized and published in the Government Point of Entry (GPE), FedBizzOpps. 7. Determination of Fair and Reasonable Cost. Since the Da Vinci robot system is the only FDA approved surgical robotic system, the Government does not have a comparable product available in the commercial market place to compare it to. The Contracting Officer determined that the anticipated cost to the Government will be fair and reasonable based on comparison of pricing with other facilities procuring the same services, and negotiations with the offeror to ensure most advantageous pricing. 8. Description of Market Survey. Market research has demonstrated that at this time the identified manufacturer is the sole source for this operative surgical robotic system requirement. "The Food and Drug Administration first cleared the da Vinci Surgical System in 2000 for general laparoscopic surgeries such as gall bladder removal and for treatment of severe heartburn. Since then, use of the system has increased and expanded into several other surgical areas. These include removal of the prostate (radical prostatectomy); non-cardiac chest procedures involving the lungs, esophagus, and a blood vessel inside the chest cavity (internal thoracic artery); and certain procedures involving surgical incisions into the heart, such as mitral valve repair. In April 2005, the FDA cleared the da Vinci system for gynecological laparoscopic procedures. Surgeons are now able to remove the uterus (hysterectomy) and to remove uterine fibroids (myomectomy) using the device. The system has also been cleared for use in all urologic procedures. And, in 2004, the FDA broadened the application of the da Vinci system for assisting in coronary artery bypass surgery. The da Vinci Surgical System is the only operative surgical device of its kind on the market in the United States. In 2003, Intuitive Surgical bought Computer Motion of Goleta, Calif. Computer Motion was the manufacturer of the Zeus Robotic Surgical System, which is no longer actively being marketed." (Source: http://www.fda.gov/fdac/features/2005/405_computer.html). 9. Any Other Supporting Data. There are no other factors supporting the use of other than full and open competition. 10. Listing of Interested Sources. At this time, this J&A is being processed in advance of the synopsis posting on FBO. If responses to the synopsis indicate additional sources are available, the file will be documented accordingly and the requirement competed among all eligible sources. The manufacturer for this system only sells direct and does not have a distributor network so we cannot generate a list of sources other than the manufacturer. Intuitive Surgical Inc. 1266 Kifer Road, Building 101 Sunnyvale, CA 94086-5304 408-523-2100 11. Actions Taken to Remove Barriers to Competition. None. Until another operative surgical robotic system is approved by the FDA, the Da Vinci system is the only known system capable of meeting the Government's needs for this type of capability. However, should it be determined that VISN 19 has a future requirement for this type service, the Contracting Officer will conduct a market survey to fulfill such requirement.
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FBO.gov Permalink
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- Record
- SN02265745-W 20100904/100902235725-ab31426423a2610e28affdea67861341 (fbodaily.com)
- Source
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FedBizOpps Link to This Notice
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