Notice of Intent to Award Sole Source Contracting Activity: Department of Veterans Affairs, VISN 19, Salt Lake City Veterans Affairs Medical Center (SLCVAMC), 500 Foothill Blvd, Salt Lake City UT 84148. The Department of Veterans Affairs intends to award a Firm Fixed-Price sole source contract to Heartware, a small business, under the authority of Federal Acquisition Regulation (FAR) 6.302-1 Only one responsible source and no other supplies or services will satisfy agency requirements , SLCVAMC for Heartware HVAD mechanical circulatory assist device. The applicable NAICS code for this requirement is 339112 "Surgical and Medical Instrument Manufacturing. The Small Business Size Standard is 1,000 employees. Anticipated award date is 29 September 2017. THIS NOTICE OF INTENT IS NOT A REQUEST FOR COMPETITIVE QUOTATIONS. Responsible sources may identify their interest and capability to meet this requirement by submitting such information by 9:00 A.M. EST, on August 31, 2017. A determination by the Government not to compete this proposed contract based upon responses to this notice is solely within the discretion of the Government. All responsible sources may submit a capability statement, which shall be considered by the agency before the intended award date. The Government will not be responsible for any costs associated with the preparation of responses to this notification. All inquiries and submittals must be sent via email to Kim Cooper, Contracting Officer, at
[email protected]. Telephone inquiries will not be accepted. Interested sources who submit data are responsible for appropriately marking information if it is proprietary in nature. DEPARTMENT OF VETERANS AFFAIRS Justification and Approval (J&A) For Other Than Full and Open Competition (>$150K) Acquisition Plan Action ID:___ ________________ Contracting Activity: Department of Veterans Affairs, NCO 19, 6162 South Willow Drive, Suite 300, Greenwood Village, CO 80111. Organizational Activity: George E. Whalen Veterans Affairs Medical Center, Salt Lake City, UT 84148. The Department of Veteran Affairs proposes to enter into a contract on the basis of other than full and open competition for Heartware ventricular assist system. Nature and/or Description of the Action Being Processed: This is a request for a new sole source firm fixed price contract with Heartware for the purchase of Heartware implants required for left ventricular assist device (LVAD) surgeries at the Salt Lake Veteran Affairs Medical Center (SLCVAMC). Description of Supplies/Services Required to Meet the Agency s Needs: The Salt Lake City VAMC is in the initial phase of bringing LVAD surgeries to the facility. Currently all LVAD implants are sourced to the VHA s affiliate University. The premise of bringing these surgeries back to the medical center is to reduce the cost sourcing out patients to the University. The requested items will set up the surgery department to have the necessary items to accomplish this. The HeartWare Ventricular Assist Device system consists of different components that together function as a unit. The (2) HVAD sterile implant kits is a miniaturized, full output device designed to be implanted in the pericardial space. The system promotes rapid pump placement and procedural simplicity. it can accommodate adult patients with smaller body types, yet can generate enough blood flow up to 10 liters per minute to provide life-sustaining support for patients with even the most advanced stages of heart failure. The kit also includes outflow graft that increases procedural efficiency and facilitates attachment to the aorta and a surgical tool kit that consist of all necessary instruments to enable the implant. The (4) HeartWare controller kits are a user-friendly controller that communicates through text and sound. A 2-line LCD screen displays pump parameters, and during alarms provides recommended troubleshooting assistance and alarm type prioritization. The accessories requested are (2) controller DC Adapters, (2) Battery Chargers, (2) Shower bags, (2) Shoulder Packs & (1) pump implant accessory kit. Statutory Authority Permitting Other than Full and Open Competition: ( X ) (1) Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements per FAR 6.302-1; ( ) (2) Unusual and Compelling Urgency per FAR 6.302-2; ( ) (3) Industrial Mobilization, Engineering, Developmental or Research Capability or Expert Services per FAR 6.302-3; ( ) (4) International Agreement per FAR 6.302-4 ( ) (5) Authorized or Required by Statute FAR 6.302-5; ( ) (6) National Security per FAR 6.302-6; ( ) (7) Public Interest per FAR 6.302-7; Demonstration that the Contractor s Unique Qualifications or Nature of the Acquisition Requires the Use of the Authority Cited Above (applicability of authority): HeartWare, a Medtronic subsidiary is the only manufacturer and distributor of the HeartWare Ventricular Assisted device implant. There is a current contract with the VHA s affiliate to perform long-term heart transplant services for SLCVAMC. The continuity of care between the SLCVAMC and the VHA s affiliate University who now perform these very delicate surgeries need to have consistency in procedures to ensure the best possible care to our veterans. The HeartWare HVAD is the standard of care the VHA s affiliate uses and is required at SLCVAMC. This equipment is highly specialized for these types of surgeries. Salt Lake VAMC already uses the HeartWare monitor for monitoring patients who have had the HeartWare HVAD implanted. Description of Efforts Made to ensure that offers are solicited from as many potential sources as deemed practicable: Only one manufacturer can provide the items needed to perform this procedure and be compatible with the current equipment. The manufacturer is a small business and the only distributor at this time.