11-053IntuitiveSurgical.docx

Control # 11-053

JUSTIFICATION AND APPROVAL FOR OTHER THAN FULL

AND OPEN COMPETITION

1. Contracting Activity: This acquisition is for Madigan Healthcare System. The contracting activity is Western Regional Contracting Office.

2. Description of Action: Madigan Healthcare Center request a new IDIQ with Intuitive Surgical, Inc. to be funded with DHP funds for base year and Two (2) option years.

3. Description of Supplies/Services: Contractor shall provide to Madigan Healthcare System, Department of Anesthesia and Operative Services, surgical instruments, disposable and reusable accessories including, but not limited to: daVinci S 5mm and 8mm Endowrist surgical and training instruments, disposable and reusable instrument and system accessories. Only the daVinci S Surgical System overcomes the traditional open surgery and conventional minimally invasive surgery. All items must be 100% compatible with existing daVinci S (Intuitive Surgical) equipment. Total value is $2,000,000.00 for a Base Plus Two (2) Years.

4. Authority Cited: IAW FAR 13.500 – Test Program for Certain Commercial Items and 13.501(a) Sole Source (Including Brand Name) acquisitions. PL 104, 106 Section 4202 (Clinger-Cohen Act).

5. Reason for Authority Cited: Madigan Healthcare System’s operating room has a Government-owned daVinci S (Intuitive Surgical, Inc.) surgical system for robotic assisted surgeries. The equipment is considered mission critical and imperative to maintaining patient care. The exact quantity of instruments, accessories, disposables and reusables needed is growing every month as this is a relatively new system (purchased 16 January 2009) and the requirements are adding up as new surgeons are brought on board with using the system. No other company makes products that work with the daVinci S Surgical System as Intuitive Surgical, Inc. has proprietary rights for all instruments and accessories to be used with this system. There is no commitment to a long term lease. The da Vinci S Surgical system is the only Federal Drug Administration (FDA) approved robotic sugical system.

6. Efforts to Obtain Competition: Market research will be conducted on a continual basis for new technologies that will provide the best value and the most benefit to both surgeons and patients of Madigan Healthcare System.

7. Actions to Increase Competition: The Notice required by FAR 5.201 will be published. No action on the part of this office will decrease this type of barrier to competition.

8. Market Research: Intuitive Surgical, Inc. is the only company that can provide the specific products required for use with the daVinci S system. Market research was conducted on the internet using the Dynamic Small Business, Thomas Register, Federal Supply Schedule, NECO Business Opportunity and Federal Business Opportunities.

9. Interested Sources: The Notice required by FAR 5.201 will be published, and any bids or proposals received shall be considered.

10. Other Facts:

a. Previous contracts awarded to Intuitive Surgical, Inc. are as follows: W91YU0-10-P-0364, dated 19 April 2010; W91YU0-10-P-0555, dated 14 July 2010; W91YU0-11-P-0025, dated 26 October 2010. The Department of Anesthesia and Operative Services purchases products from Intuitive Surgical, Inc. on an increasing basis to keep up with surgical demands.

b. The U.S. Food and Drug Administration (FDA) has cleared the da Vinci® Surgical System for use in urological surgical procedures, general laparoscopic surgical procedures, gynecologic laparoscopic surgical procedures, transoral otolaryngology surgical procedures restricted to benign and malignant tumors classified as T1 and T2, general thoracoscopic surgical procedures, and thoracoscopically assisted cardiotomy procedures.

c. The system can also be employed with adjunctive mediastinotomy to perform coronary anastomosis during cardiac revascularization. The system is indicated for adult and pediatric use (except for transoral otolaryngology surgical procedures). It is intended for trained physicians in an operating room environment in accordance with representative, specific procedures set forth in the Professional Instructions for Use.

d. The da Vinci Surgical System is used in procedures that treat a range of conditions: Bladder Cancer, Colorectal Cancer, Coronary Artery Disease, Endometriosis, Gynecologic Cancer, Heavy Uterine Bleeding, Kidney Disorders, Kidney Cancer, Mitral Valve Prolapse, Obesity, Prostate Cancer, Throat Cancer, Thyroid Cancer, Uterine Fibroids and Uterine Prolapse.

SOURCE SELECTION INFORMATION

(See FAR 2.101 and 3.104-4)