VA119-14-D-0001-P00018000.docx

See attached document: DJ005 - JA - Davinci Robotic Arms Extention.

FedBizOpps Justification and Approval Notice

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* = Required Field FedBizOpps Justification and Approval Notice Rev. March 2010

ROBOTIC SURGICAL SYSTEM ENTERPRISE WIDE - LAST 2 MONTH

EXTENSION

22408-2697 N 339112 U.S. Department of Veterans Affairs OPAL | Strategic Acquisition Center 10300 Spotsylvania Ave | STE 400 Fredericksburg VA 22408-2697

FAR 6.302-1

VA119-14-D-0001

P00018 $0.00 07-08-2019

INTUITIVE SURGICAL, INC.

1266 KIFER RD

SUNNYVALE

CA

940865206 www.va.gov/OfficeOfAcquisitionOperations/about/sac.asp VA | OALC | OPAL | Strategic Acquisition Center Identification of the agency and the contracting activity, and specific identification of the document as a “Justification for other than full and open competition:

Department of Veterans Affairs (VA)

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

The Department of Veterans Affairs (“VA”) Veterans Health Administration (“VHA”) Medical Centers provide a wide range of surgical services to our Veterans, including traditional surgery, critical care, orthopedics, neurology, oncology, podiatry, urology, and vision care. VA also offers our Veterans advanced surgical techniques comparable to state-of-the-art commercial surgical solutions to include robotic Minimally Invasive Surgery (MIS) procedures within many of the VHA Medical Centers. These techniques as compared against traditional surgical procedures are proven to reduce the risk of infection, minimize blood loss, significantly reduce postoperative pain leading to a faster patient recovery time, reduce patient hospital stay, and contribute to positive psychological outcomes as it pertains to postsurgical scarring.

Regarding the procurement of new systems, VHA requires FDA-approved robotic surgical devices to perform MIS procedures for the following: urologic, general surgery, gynecological, thoracic, thoracic cardiotomy, and ear, nose and throat (ENT) surgeries. FDA approved devices are mandated law. VHA also requires a system that is capable of accommodating a single or dual surgeon console and that provide(s) the surgeon(s) with intuitive controls, range of motion, fine tissue manipulation capability, and 3-D visualization characteristic of open surgery while simultaneously allowing work through small ports of MIS surgery, with associated accessories such as fluorescent imaging, skills practice platform, and replaceable components used during surgery.

Regarding sustainment of existing systems, as noted throughout this J&A, ISI is the only possible source of ISI products and services. The VA decided to maintain the use of ISI products and services with the subject action as well as the replacement contract. The total estimated price of this action including the accessories and associated services does not exceed $7,000,000.00. Purchase Orders will be placed directly from the VISNs to the manufacturer using this modification during the subject period of performance pending the award of a replacement contract for VA119-14-D-0001. All deliveries will be completed within the subject period being placed unless otherwise agreed.

Identification of the statutory authority permitting other than full and open competition: FAR 6.302-1 - Only One Responsible Source

The statutory authority permitting other than full and open competition is 41 USC.3304(a)(1) as implemented by the Federal Acquisition Regulation (FAR) Subpart 6.302-1 entitled, "Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements."