26-007861 - Sole Source Justification (SSJ).docx

JUSTIFICATION FOR LIMITED COMPELTITION

LIMITED SOURCES / BRAND NAME / SOLE SOURCE

($10,000 TO $250,000)

1. Requiring Activity: National Institutes of Health (NIH), Clinical Center (CC), Department of Perioperative Medicine.

2. Contracting Agency: NIH, Office of Acquisition, CC

3. Purchase Request: POTS

4. Description of Requirement: This is a request to put the PMA in place for XI Robot. The purpose of this acquisition is for Department of Peri-operative Medicine to request a Preventative Maintenance Agreement from SDV Medical for the XI Robot. This service is needed to provide Urology surgeons with the ability to perform Prostate and Nephrectomy surgery on patients using the DaVinci XI Robot without interruption based on the Robot being consistently software updated and checked for proper functionality. The National Cancer Institute’s Urologic Oncology Branch uses the da Vinci® Xi Surgical System with HD vision to perform Laparoscopic surgical procedures. Robotic assisted minimally invasive surgery is combined with targeted therapy directed at cancer genes. SDV Medical is a Service-Disabled Veteran-Owned Small Business that is approved to work with Intuitive the Manufacturer of the DaVinci Robot for PMA services.

5. Authority permitting other than full and open competition (Check as applicable):

· GSA Federal Supply Schedules or Blanket Purchase Agreement:

_._ _ FAR 8.405-6(a) (Circle as applicable):

A. An urgent and compelling need exists, and following the procedures would result in unacceptable delays;

B. Only one source is capable of providing the supplies or services required at the level of quality required because the supplies or services are unique or highly specialized; or

C. In the interest of economy and efficiency, the new work is a logical follow-on to an original Federal Supply Schedule order provided that the original order was placed in accordance with the applicable Federal Supply Schedule ordering procedures. The original order or BPA must not have been previously issued under sole-source or limited-source procedures.

__ FAR 8.405-6(b):

Item(s) is peculiar to one manufacture (brand name, product, or feature of a product, is peculiar to one manufacturer, whether available on one or more schedules).

· Open Market:

__X_ FAR 13.106-1(b):

Only one source available (e.g., urgency, exclusive licensing agreement, brand name product, etc.).

6. Justification for action:

To prevent a lapse in service and to meet Joint Commission compliance all equipment that comes in contact with a patient must have a PMA in place. This request is needed to meet this requirement and to prevent out-of-contract costs. Other services that also use the DaVinci XI Robot within DPM are Thoracic and Oncology.

7. Market Research/Other Facts:

The proposed vendor, DVT Medical, is the only company approved by Intuitive Surgical that can provide this service. No other company currently exists that can compete. The da Vinci XI Surgical System 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 Si System 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 other than through SDV Medical.

8. Suggested Sources(s):

None.

9. Steps to improve competition: N/A I hereby certify this justification is accurate/complete to the best of my knowledge and belief.

CUSTOMER SIGNATURE

(Technical Expert)

DATE: ______7/1/26______

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