Medtronic USA, INC

***NOTICE OF INTENT TO SOLE SOURCE*** The Department of Veterans Affairs, RPO East/NCO 7, located at 3700 Crestwood Parkway, Suite 500 Duluth, GA 30096 intends to award a firm-fixed price sole source requirement for Montgomery VA Medical Center to: Medtronic USA 710 Medtronic PKWY Minneapolis, MN 55432 POP: December 14, 2021 to June 13, 2022 The applicable NAICS code for this procurement is 339113 with a business size standard of 750 Employees. The proposed contract is for a Consignment Agreement for which the Government intends to solicit with a single source in accordance with per 41 U.S.C. 4106(c) as implemented by FAR Subpart 16.505(b)(2)(i)(B). This notice of intent is NOT a request for competitive proposals. However, the Government will evaluate all responses that are received by 7:00am EST December 14, 2021 for future procurements. A determination by the Government not to compete the proposed contract based upon responses to this notice is solely within the discretion of the Government. If you have any questions or are an SDVOSB/VOSB Authorized Distributor for the manufacturer of the products, please provide the OEM Authorized Distributor Letter to Leonard Robinson, Contracting Specialist, by email at contact@example.gov Telephone requests or inquires will NOT be accepted STATEMENT OF WORK Consignment Agreement (Stents) B.1 INTRODUCTION/BACKGROUND In the spirit of the Federal Acquisition Streamlining Act, the Department of Veterans Affairs (DVA) and Medtronic Inc hereby enter into a cooperative Memorandum of Understanding (MOU) for a consignment agreement, to further reduce the administrative costs of acquiring supplies/services. B.2 OBJECTIVE This is a VISN 7 Consignment Agreement for Medtronic Inc non-biological implant products and associated items where the Contractor shall provide consigned stock inventory denoted on a PAR level inventory schedule. Contracted pricing for consigned items available on SAC contract VA119-17-D-0012. Facilities currently participating in consigned PAR level inventory are as follows: Dorn VAMC 6439 Garners Ferry Rd, Columbia, SC 29209-1638 Birmingham VAMC 700 19th S. Birmingham, AL 35233 Atlanta VAMC 1670 Clairmont Rd Decatur, GA 30033 Facilities eligible to add a PAR level inventory at any time during the performance period: Dublin VAMC 1826 Veterans Blvd Dublin, GA 31021-3620 CAVHCS - West Campus 215 Perry Hill Rd, Montgomery, AL 36109-3725 Tuscaloosa VAMC 3701 Loop Rd East, Tuscaloosa, AL 35404-5015 Charleston VAMC 109 Bee St, Charleston, SC 29401-5703 Augusta VAMC 1 Freedom Way Augusta, GA 30904 To add a consignment of stock to a VISN 7 facility, the Program Office will initiate a modification request and provide a PAR Level Inventory List, Program POC, COR nomination and training certification and no cost 2237 to the Administrative Contracting Officer (ACO). The ACO will utilize form SF30 for a bilateral modification to the agreement. The modification will include the pertinent information and a PAR Level Inventory List. DELVERY, ORDERING, INVENTORY AND RETURNS Delivery Tickets/Packaging: All deliveries shall contain the following information. Name and Address of Supplier Name and Address of Receiver Product Number, Product Description and Quantity Shipped Serial numbers and or expiration date if applicable Customer PO number and Sales Order number Orders: For items consigned to a VA facility, the Government will utilize the Post Consignment consult and submit to Prosthetics who will verify the use of the item and make the necessary payment to the Vendor which will initiate action by the Vendor to replace the implanted item. Inventory: The contractor agrees to accept the VA Government Purchase Card as the preferred method of payment. Delivery Orders will be issued when deemed appropriated by the VA. The Prescribing Physicians are responsible for selection of items to be used and will have the final approval for acceptance of those products. Consigned Stock Consigned stock is contractor owned inventory consigned to a medical center on a PAR level inventory schedule for use by VA staff on an as needed basis. Contractor will be paid only after consigned items are used by the Government, at the replacement cost indicated in the base contract. The Contractor agrees to deliver replacement items within (48) hours after receipt of an order. Orders for replacement stock of PAR level inventory which include electronically transmitted for non-emergency and/or phoned in for emergency orders; the Contractor agrees to notify the Ordering Office point of contact at the earliest opportunity for any parts/materials that cannot be delivered in accordance with the individual Order delivery requirements. To ensure that the correct items are shipped, the Contractor shall not substitute items without prior approval by Ordering Official. In instances where the Contractor cannot meet the Government's requirement(s), the Contractor shall provide its best estimation for delivery. Replacements will be shipped/delivered FOB Destination. Requests for replacement items will be faxed or emailed through the Contractor's designated Customer Service department. Orders will provide model, size, serial number and expiration date if applicable for the product and quantities used. In no event will patient PII or PHI be transmitted via email without approved encryption. Any patient information should be faxed or redacted if emailed. The COR and the using Service of the participating facility will maintain the consigned stock inventory locally showing all transactions and the total value of consigned inventory at all times by maintaining an inventory report that will include at a minimum (the current schedule of items and required quantities, date of receipt of property, ownership of property, description of property, quantity on hand, value of property, agreement number, record of orders placed for property used during agreement period and acknowledgment of receipt of unused property returned to owner) during the terms of the agreement. The Contractor will be allowed to have access to the consigned inventory upon 24 to 48 hours advance notice to the COR. Upon oral or written approval/notification; can be accompanied by the facility staff (i.e., COR, Implant Coordinator, Service Line Representative or the Supply Chain Management staff). Contractor's personnel shall conduct once per month a physical inventory with the COR and/or facility POC. A copy of the inventory will be maintained by the COR and provided to the facility POC and Contracting Officer. Age of Inventory: The VA Health Care System will utilize Contractor's product on a first-in, first-out basis to the maximum extent practical. COR or facility POC may request that PAR level inventory having less than 90 days sterility/expiration date be removed and replaced. These services will be completed at no additional cost to the Government. The VA is not liable for devices that are allowed to expire if not removed when requested. Government will be responsible for replacing items that have been misused or lost. PAR levels may be changed, removed or added as well as non-consigned inventory added to the agreement upon mutual agreement of the parties. Any such changes must be requested by the Program Office and will be made by written modification to the agreement by a Contracting Officer. Returns: Unused (Unopened and Undamaged) items will be returned to the Contractor at the end of the effective period of this consignment agreement without reimbursement or other financial obligations to the VA. Unused items will be removed from the facilities by the Contractor within thirty (30) days after written notification of completion or cancellation of this consignment agreement. CONTRACTOR RESPONSIBILITIES The Contractor agrees to maintain the specified quantities set forth under an agreed upon schedule at all times during the term of this consignment agreement by promptly replacing like quantities of items that may be used, thus assuring instant availability of all items specified by the VA facilities covered under this agreement. Contractor will remove or replace consigned inventory as necessary when inspected by the Contractor or upon request by the COR or facility POC such as defective or expired items. These replacement services will be completed at no cost to the Government. VA RESPONSIBILITIES VHA Clinicians determine the prosthetic needs of patients as a part of their clinical care and follow-up with the patient to ensure the necessary device(s) are purchased to achieve the optimal clinical outcomes. Clinicians, in consultation with the patient, will decide what device is medically necessary to best meet the need(s) of the patient. When requesting the device, clinicians are required to provide information to the PSAS staff in the form of a patient consult via the Computerized Patient Record System. Prosthetic and Sensory Aids Services (PSAS) are responsible for: Ensuring all requests for the purchase of prosthetic appliances and sensory aids, above the micro-purchase threshold, are entered into the eCMS Planning Module in accordance with the established timelines/standards to include an invoice and other appropriate documentation. Ensuring all requests for the purchase of prosthetic appliances and sensory aids, below the micro-purchase threshold, are directed to the appropriate purchasing unit. Working with the prescribing clinician to ensure consult contains all pertinent information, e.g., quantity, delivery date and location, and any other special requirements. LIABILITY The ownership and title of all consigned items shall remain with the Contractor until such a time said item(s) are used. The Government is liable only for those items used by a participating VISN 7 facility. At the end of the agreement period, unused (unopened and undamaged) items shall be returned to the Contractor without reimbursement or other expenses to the Government. Purchase/Delivery orders will be issued for all unreturned products, including any lost, damaged, stolen or missing consigned inventory. The Government is responsible for storing the consigned inventory and using them as indicated by product labeling. The Government will provide proper storage and security for supplied item(s) and is responsible for expenses incidental to safekeeping within the Government premises. The Government assumes responsibility for any lost, damaged, stolen or missing product. LIABILITY EXCLUSION Neither party shall be liable for any failure or delay in the performance of this Contractual Agreement under extra ordinary circumstances beyond control of each party, i.e., acts of God, including but not limited to earthquake, fire, flood, and the like; wars, embargoes, accidents, and any other acts or order of any government or governmental agency are deemed to be beyond control of said parties. ALTERATION OF QUANTITIES & TECHNOLOGY REFRESH The Contractor Agrees that the total quantity of items furnished under this Agreement can only be changed by mutual agreement with the Contracting Officer. The Contractor also agrees to inform the facility of any technology refresh of products and if requested by COR or facility POC (i.e., Implant Coordinator, Service Line representative or the Supply Chain Management staff), replace the existing items with the newer models pending execution of the contract modification. Any changes due to technology refresh must also be done by mutual agreement with the Contracting Officer in accordance with the base contract. CANCELLATION This agreement may be terminated by either party by giving thirty (30) day written notice. When so doing as directed, the Contractor will remove all unused products furnished for stock at a participating facility within thirty (30) days upon expiration of this agreement or upon receipt of written notice of cancellation. Upon the expiration of this consignment agreement, the VA shall reconcile all consignment stock units as follows: Return stock in saleable conditions (unopened and undamaged package) for credit against the Consignment Stock Level; and/or Issue purchase/delivery order for all unreturned stock, including any lost, damaged, stolen or other missing stocks. SECURITY REQUIREMENTS: The C&A requirements as well as the Security Accreditation Package are not required for this agreement. At no time is VA sensitive information i.e., patient PHI or PII to be transmitted verbally or electronically to the Contractor. PSAS and Contracting Officers will ensure all sensitive information is redacted or excluded from orders to the Contractor. Contractor's Personnel Security Requirements: All contractor employees who require access to the VA Medical Center must follow the Medical Center's Policy for requesting access. Background Investigation - The level of background investigation commensurate with the required level of access is National Agency Check with Written Inquiries. Contractor Responsibilities: The contractor shall prescreen all personnel to ensure they maintain a U.S. citizenship or valid legal status that allows personnel to work within the United States and its Territories. All such personnel shall be able to read, write, speak and understand the English language. The Contractor is responsible for adhering to the policies and procedures regarding security and reporting any suspected violations and security. Substitutions: It is expected that the Contractor shall maintain a local Company Representative to perform under this agreement, however, when such personnel is substituted for any reason, Contractor is to notify the VA's appointed COR/POC prior to any visit to conduct company business at a participating facility B.3 TERMS AND CONDITIONS Regarding Consignment Agreements, the Contractor agrees to the terms and conditions of this Consignment Agreement EXCLUSIVELY WITH the Department of Veterans Affairs, Regional Procurement Office East (RPOE), VISN 7 Contracting. B.4 OBLIGATION OF FUNDS This agreement does not obligate any funds. PERPIOD OD PERFORMANCE The agreements period of performance is from date of award through June 13, 2022. The agreement will be reviewed by the Administrative Contracting Officer and COR annually prior to end of the yearly performance period. The review will include a written determination of need, responsibility, pricing and to ensure future option years are exercised on the base contract. If the ACO makes an affirmative determination, the agreement will continue to remain in effect through the next period of performance. AUTHORIZED REPRESENTATIVES: The primary Contracting Officer (CO) for this Agreement is: Laurinda Millage, Contracting Officer Leonard Robinson, Contracting Specialist The Primary/Alternate Contracting Officer's Representative (COR) for this Agreement is: The Primary COR will be responsible for technical monitoring of the contractor's performance and deliveries. The COR and the Contractor's Representative shall work together to ensure that the scope of the agreement is being met. The COR will interpret specifications or technical portions of the work. The COR is not authorized to perform, formally or informally, any of the following actions: Promise, award, agree to award, or execute any contract, contract modification, or notice of intent that changes or may change this contract. (2) Waive or agree to modification of the delivery schedule. (3) Make any final decision on any contract matter subject to the Disputes Clause. (4) Terminate, for any reason, the contractor's right to proceed. (5) Obligate in any way, the payment of money by the Government. Only a warranted Contracting Officer is authorized to obligate funds on this or any other contract action.