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In accordance with FAR 6.302-1, Only One Responsible Source and No Other Supplies or Services will satisfy agency requirements. The Memphis VA Medical Center intends to negotiate a Sole Source Award w... In accordance with FAR 6.302-1, Only One Responsible Source and No Other Supplies or Services will satisfy agency requirements. The Memphis VA Medical Center intends to negotiate a Sole Source Award with An I.V, LLC. They are located at 4565 Shelby Road, Millington, Tennessee 38053. An I.V. LLC shall furnish all labor, transportation, tools, and parts necessary to provide full-service for Compounding Parenteral Nutrition. The Compounding Parenteral Nutrition system is a proprietary, therefore another firm may not be familiar with this product; and may not be able to address Sources Sought accurately; or accurately provide training for this equipment, which is critical for proper patient care, as well as a sound end product. The Memphis VA Medical Center, which will be the primary location for the delivery of the Compounding Customized, Patient – Specific Parenteral Nutrition products is located at 116 N. Pauline Street, Memphis, TN 38105. This procurement's NAICS code is 325412 - Phamaceutical Preparation Manufacturing, and the size standard is 1,300 employees. The PSC code is Q517 - Medical Pharmacy Services. Requirements – Background. Pharmacy Service at the Lt. Col. Luke Weathers, Jr. VAMC is looking to outsource the Parenteral Nutrition compounding process in order to meet the needs of patients requiring parenteral nutrition. Vendor MUST be able to deliver orders placed late as 3pm by 7pm. Scope. Pharmacy Service at the Lt. Col. Luke Weathers Jr VAMC is requesting customized, patient-specific parenteral nutrition compounding services with same day delivery for the Inpatient Pharmacy. This requirement will be a Base Plus 4 Ordering Periods. Period of Performance is as follows. Base Period: 02/17/2025 – 09/30/2025 Ordering Period 1: 10/01/2025 – 09/30/2026 Ordering Period 2: 10/01/2026 – 09/30/2027 Ordering Period 3: 10/01/2027 – 09/30/2028 Ordering Period 4: 10/01/2028 – 09/30/2029 Specific Tasks The contractor shall provide customized, patient specific PNs with same day delivery. Lt. Col. Luke Weathers, Jr. VAMC Expectations of Vendor: Vendor must be approved by Pharmacy Compounding Accreditation Board Vendor will be visited, at minimum, once annually by Lt. Col. Luke Weathers, Jr. VAMC Pharmacy Services to review compounding practices and requirements. Daily Schedule Vendor Hours of Operation Vendor hours of operation will cover 7 days per week including holidays. Assistance after hours MUST be available 24 hours by phone at no additional charge. Order Transmission Times Parenteral Nutrition may be ordered seven days per week. Vendor will receive orders throughout the day with the cutoff time being 15:00 (3pm). Delivery time Parenteral Nutrition ordered by 15:00 (3pm) will be delivered by 19:00 (7pm). Nonstandard/Late Deliveries Vendor will make every effort to accommodate late or early orders. Delivery will be arranged on a case-by-case basis. Ordering Order will be submitted via fax by Lt. Col. Luke Weathers, Jr. VAMC pharmacist using standardized order form template. Included cover sheet will include ordering pharmacist contact information. All orders will be screened using the Vendor’s standard minimum/maximum values. Vendor will provide Lt. Col. Luke Weathers, Jr. VAMC with inventory information if the change in inventory prohibits parenteral nutrition from being compounded as ordered. Delivery Location of Delivery Vendor will deliver all products to the Inpatient Pharmacy at the Lt. Col. Luke Weathers, Jr. VAMC 116 N. Pauline Street, Memphis, TN, 38105, DB1102 Receipt of Delivery Upon receipt of the Vendor shipment, the receiving Lt. Col. Luke Weathers, Jr. VAMC employee will verify the count of parenteral nutrition bags and sign the Vendor packing list as confirmation of receipt. Lt. Col. Luke Weathers, Jr. VAMC Pharmacy Service will retain one copy of the packing list. Labeling Vendor will label all parenteral nutrition bags in compliance with USP General Chapter <797> and applicable laws and regulations. Labels are to include at a minimum: Patient Name Assigned internal identification number Active ingredient(s) and their amount(s), concentration(s) Administration instructions Rate of administration Storage conditions if other than controlled room temperature Beyond Use Date The contractor solutions shall have a minimum stability of 24-hour expiration as well as all solution bags shall be labeled with expiration date and time. Dosage form Total amount or volume Order volume must be listed on the PN bag. Compound volume must be listed on the PN. Overfill must be listed on the label. Route(s) of administration Indicate the preparation is compounded Compounding facility name and contact information Labels are to include when applicable Route(s) of administration Special handling instructions Warning statements Product Recall Vendor shall notify the Contracting Officer administering the contract within three (3) business days of any recall, removal, modification, or defect of items supplied under contract for appropriate action. Resolution in such circumstances may be made by replacement of item at no cost to the Lt. Col. Luke Weathers, Jr. VAMC, full credit of item toward future purchase, or any other method agreeable to both parties. Any freight costs incurred as a result shall be borne by the Vendor or credited to the Lt. Col. Luke Weathers, Jr. VAMC as appropriate. Returns Any item found to be defective or technically unacceptable, as verified by the Vendor and/or Lt. Col Luke Weathers, Jr. VAMC pharmacy staff, shall be returned to the Vendor and replaced or credited in the same manner as specified under Product Recall. The Vendor shall not be liable for replacement or crediting the Lt. Col. Luke Weathers, Jr. VAMC for any item due to misuse or abuse by the Lt. Col. Luke Weathers, Jr. VAMC personnel. Vendor Communication with the Lt. Col. Luke Weathers, Jr. VAMC Daily communication with the Lt. Col. Luke Weathers, Jr. VAMC pharmacists will occur as needed by telephone or fax to discuss prescription content, order entry, delivery exceptions and to confirm that all orders have been received. Quality Vendor will: Meet all applicable federal, state, and JCAHO requirements for quality assurance. Make quality reporting information available to the Lt. Col. Luke Weathers, Jr. VAMC upon request. If requested, able to provide quarterly quality assurance reports required by USP <797> to include environmental monitoring and control media fill validation, final product testing, personnel credentials status, and employee training. Follow standard operating procedures and guidelines outlined in USP <797>. Comply with all applicable local, state, and federal rules and regulations. Use only fully trained and qualified employees. Ensure all final products are checked by a licensed pharmacist. Security compliance See security requirements below. Record management compliance See Records management obligations below Invoicing Contractor shall submit monthly electronic invoices through VA ‘s invoice presentment and payment system (IPPS). The invoice should be itemized by prescription number and should include PO number, date of service, sold to information, billing period, packing slip number, patient RX number, product group, description, quantity, unit of measure, unit price, extended price and grand total . Invoices summited via Tungsten Network -https://authentication. Tungsten -network.com/login. Contact numbers for Vendor Fax: (901) 872-7595 Call (901) 872-2648 after faxing after-hours or on weekends Phone: (901) 872-2648 After hours: (901) 872-2648 and (901) 485-8199 Lt. Col. Luke Weathers, Jr. VAMC will be notified of any changes in contact information Vendor Expectations of the Lt. Col. Luke Weathers, Jr. VAMC: Order Cutoff Times Orders will be submitted by 15:00 (3pm), except in extenuating circumstances. The Lt. Col. Luke Weathers, Jr. VAMC changes Changes in policies, systems, order forms, and formulary will be communicated to Vendor with sufficient time to respond to the changes. Order Clarification The Lt. Col. Luke Weathers, Jr. VAMC shall respond to Vendor order clarification questions with at least one hour remaining before scheduled delivery. Clarifications can be directed to the pharmacist at the phone number listed on the order cover sheet or the 24/7 Pharmacy phone at (901) 523-8990 ext. 16776. Order Correctness The Lt. Col. Luke Weathers, Jr. VAMC will check all orders for therapeutic correctness before submitting to Vendor. The Lt. Col. Luke Weathers, Jr. VAMC pharmacy personnel will check all Vendor parenteral nutrition against the original provider’s orders before dispensing to the patient. The Lt. Col. Luke Weathers, Jr. VAMC Primary Contacts Ordering Pharmacist: contact information available on fax cover sheet 24/7 Pharmacy Phone: (901) 523-8990 ext. 16776 Pharmacy Resident office: (901) 523-8990 ext. 16745 Inpatient Pharmacy Supervisor: (901) 523-8990 ext. 17362 Sterile Compounding Program Manager: (901) 523-8990 ext. 16003 The Vendor will be notified of any changes in contact information. All questions are to be submitted between 1/29/2025 - 02/02/2025 CST. by 12pm to william.blassingame@va.gov. ______________________________________________________________________ THIS IS NOT A REQUEST FOR COMPETITIVE QUOTES/PROPOSALS AND NO SOLICIATION IS AVAILABLE. Interested parties that can meet the capabilities and requirements, may identify their interest, and submit quotations. This notice of intent is not a request for quotations. Interested parties who believe they can meet the requirements, must submit information about their capabilities no later than 12:00 PM CST, 02/06/2025. All information shall be provided at no cost, or obligation to the Government. No solicitation will be made available. The information must be sent to the Contract Specialist, william.blassingame@va.gov. Responses received will be evaluated; however, the Government's determination not to compete with the proposed procurement based upon responses to this notice is solely at its discretion. Indicate Business Size and Socio-Economic, and that your company is registered I System for Award Management Status www.sam.gov. If no responses are received, the Contracting Department will proceed with the sole source negotiation with An I.V.,LLC. List of Items: ITEM DESCRIPTION QUANTITY UNIT OF MEASURE COMPOUNDING OF CUSTOMIZED, PATIENT-SPECIFIC PARENTERAL NUTRITION INCLUDING LOCAL DELIVERY COST CONTRACT PERIOD: BASE POP BEGIN: 02/17/2025 POP END: 09/30/2025/ ESTIMATE 445 BAGS PER YEAR DELIVERY MUST BE AVAILABLE 7 DAYS PER WEEK. 455 Bags / Per Year