26-008988 - JOFOC.docx

Justification for Other than Full and Open Competition

“Source Selection Information – see FAR 2.101 and 3.104”

1. Identification of the agency and contracting activity.

a. Federal agency and contracting activity. HHS\NIH.

Sponsoring organization. NIH/CC/DPM

b. Administrative Officer information.

· Administrative Officer name. Hiromi Konishi

· Mailing address. 10 Center Dr. BLDG 10 Rm 2C529 Bethesda MD 20892

· E-mail address. Konishi.hiromi@nih.gov

· Telephone number. 301-496-5646

2. Nature and/or description of the action being approved.

a. Acquisition purpose and objectives.

NIH, CC, DPM is requesting the repair/replace of Intuitive Surgical DaVinci XI Scopes. This repair exchange is needed as the scopes are currently broken. The department averages 7 robotic cases a week and it takes 12 hours to turn over the scopes due to the time it takes for the scopes to dry. The scopes provide Urology surgeons the ability to perform Laparoscopic Prostate and Nephrectomy surgery on patients using the DaVinci XI Robot. Without repairing these scopes, the surgeons will not be able to perform surgery using the XI Robot. These scopes are used on every DaVinci XI procedure. Intuitive has a set rate to repair the scope regardless of the full outcome of the repair. Using any other company for repair of these scopes could void the warranty on the Preventative Maintenance Agreement.

b. Project Background.

The Urologic Oncology Branch (UOB) was created in the spring of 1997. The mission of the branch was to develop a clinical and laboratory research program in urologic oncology for the purpose of developing better methods for diagnosis, prevention, and treatment of urologic malignancies and to provide basic and clinical research training for the development of urological surgical physician scientists. The Branch chief, Dr. Marston Linehan, catalyzed a productive collaborative study on familial kidney cancer syndromes that engaged a very large, diverse group on the NIH campus. These collaborations have resulted in a series of seminal and important findings that have established the NCI and this Branch as leaders in renal cell cancer research. These important discoveries, including the identification of the gene responsible for Von Hippel-Lindau (VHL) disease, illustrate the impact and the position of this Branch.

3. Description of the supplies or services required to meet the agency’s needs (including the estimated value).

a. Project title. Repair/Exchange of XI DaVinci Scopes

b. Project description.

This is a replacement of broken scopes request. This will be a one-time replacement of the scopes. The company will send out new scopes in anticipation of the broken scopes being sent back.

This is a one-time repair/exchange

· Requirement type.

Research & development (R&D) R & D support services Support services (non-R&D) Supplies/equipment Information technology (IT) Construction Architect-engineer (A & E) services Design-build X Other (specify): _________Repair exchange ___________

· Type of action.

X New requirement Follow-on Other (specify): ______________________

· Proposed contract/order type.

X Firm-fixed-price Other fixed-price (specify, e.g., fixed-price award-fee, fixed-price incentive-fee): __________ Cost-plus-fixed-fee Other cost reimbursement (specify, e.g., cost-plus-award-fee, cost-plus-incentive-fee): ___________ Time and materials Indefinite delivery (specify whether indefinite quantity, definite quantity, or requirements): ___________ Other (specify): ___________ Completion Form Term form

· Acquisition identification number.

c. Total estimated dollar value and performance/delivery period.

This will be a one-time purchase for replacement of the broken scopes.

4. Demonstration that the proposed contractor(s) unique qualifications or the nature of the acquisition requires use of the authority cited.

Name and address of the proposed contractor(s).

1-844-216-5280

Nature of the acquisition and proposed unique qualifications of the contractor(s).

The da Vinci®Xi™ is CE marked and FDA cleared. Intuitive Surgical, Inc. solely owns all proprietary rights in and to the Systems. Intuitive Surgical, Inc. is sole source manufacturer of the da Vinci®Xi™ Surgical Systems and instrumentation. Intuitive Surgical does not sell this equipment in conjunction with any group purchasing organization or through any distribution channels in the United States. Additionally, Intuitive Surgical is the sole provider of Service for the equipment; there are no other authorized Service providers.

5. Description of the efforts made to ensure that offers are solicited from as many potential sources as practicable.

This is a Sole Source. No other company can provide new DaVinci XI Scopes for purchase/exchange.

6. Determination by the Contracting Officer that the anticipated cost/price to the Government will be fair and reasonable.

Price is considered fair and reasonable.

7. Description of the market research conducted (see FAR Part 10) and the results, or a statement of the reasons market research was not conducted.

Market research revealed that no other company sells/exchanges DaVinci XI Scopes

8. Any other facts supporting the use of other than full and open competition.

No other known factors.

9. Listing of sources, if any, that expressed, in writing, an interest in the acquisition.

There is no other known company on the market that can provide this item.

10. Statement of the actions, if any, the agency may take to remove or overcome any barriers to competition before any subsequent acquisition for the required supplies or services.

Intuitive is the only vendor who can supply the required equipment.

11. Program office certification.

This is to certify that the portions of this justification that have been developed by the undersigned program office personnel, including supporting information and/or data verifying the Government’s minimum needs, schedule requirements and other rationale for other than full and open competition, are accurate and complete.

Project Officer

Project Officer’s Immediate Supervisor

Head of the Sponsoring Program Office

12. Contracting Officer certification.

This is to certify that the justification for the proposed acquisition has been reviewed and that to the best of my knowledge and belief the information and/or data provided to support the rationale and recommendation for approval is accurate and complete.

Contracting Officer