Contingency Chemotherapy Compounding Services, Louis A. Johnson VAMC

Please note the Government intends to issue the solicitation for a Contingency Chemotherapy Compounding Services for the Louis A Johnson VA Medical Center located at 1 Medical Center Drive, Clarksburg, West Virginia 26301. The anticipated performance period is 5 (five) years. All responsible sources may submit an offer, which will be considered. The Government may award the contract based on the initial offer without discussion. The resultant contract will be a Base plus 4 Year, Firm Fixed Price contract. All contractors have to be registered in the SAM Database https://www.sam.gov prior to contract award pursuant to FAR provision 52.204-7. Therefore, prospective offerors are encouraged to register prior to the submittal of quotations/proposals. STATEMENT OF WORK STATEMENT OF WORK AND GENERAL SPECIFICATIONS FOR Chemotherapy Compounding Background Louis A. Johnson Veterans Administration Medical Center (LAJVAMC) Inpatient Pharmacy is need of a contingency contractor to handle hazardous compounding in the event of IV room shutdown. Currently, Pharmacy only has one IV room for compounding and would be unable to handle hazardous compounding if it were shut down for any reason. Specifications Please see below for salient characteristics. Chemotherapy Compounding Base +4 years of chemotherapy compounding services Services Contractor shall provide all chemotherapy agents, IV Tubing, closed system drug transfer devices, and any other items deemed necessary. All Hazardous Chemotherapy Agents will be aseptically compounded based on patient specific orders. Drugs All drugs are to be supplied by the Contractor. Order Procedure Orders will be submitted via a VA secure network or fax. Once submitted, VA staff will confirm receipt of order with the Contractor via phone or email. Shipping/Delivery Procedure Compounded orders shall be transported via Courier, overnight mail service, or any other means necessary to ensure receipt prior to infusion date/time to VA Clarksburg. Shipping is included with the order and there is no additional cost for any items delivered for the weekend. All shipments for weekend delivery will be arranged as needed to ensure delivery can be successfully completed. Billing Contractor shall invoice for billable units for the amount of medication utilized for each individual patient. Regulation Compounding must be done at an FDA 503A compliant facility and meet all state and federal laws. Compounding, labeling, and beyond use dating/expiration dating will be based on USP 797, USP 800 and Federal Law. Contractor shall provide current and future certification reports for the sterile compounding areas and compounding hoods. In the case of any failures, contractor shall provide action plans for corrections of deficiencies and testing results showing the failures have been corrected. Contingency Plan The Contractor shall have a contingency backup plan in the event that the compounding facility is affected by any certification discrepancies, equipment malfunctions, natural disasters, or other matters affecting performance of the contract. Contingency locations must meet the same criteria as stated herein. Delivery Location Attn: (Pharmacy) Louis A. Johnson Medical Center 1 Medical Center Drive Clarksburg, WV 26301 Prior to delivery, Contracting Officer Representative and/or Service Line Representative shall receive shipping information from Contractor and forward to Logistics using the email(s) listed above. The Contractor must comply and provide all necessary information to LAJVAMC. Otherwise, the delivery may be refused and require redelivery at no additional cost to the government. Requested Delivery Date Delivery of supplies is TBD. Period of Performance Base Year: August 27, 2026 August 26, 2027 Option Year 1: August 27, 2027 August 26, 2028 Option Year 2: August 27, 2028 August 26, 2029 Option Year 3: August 27, 2029 August 26, 2030 Option Year 4: August 27, 2030 August 26, 2031 Safety Data Sheet (SDS) If applicable, contractor shall provide three (3) copies of each Safety Data Sheet for every product, chemical, etc. SDS sheets shall be provided for any material on the same day those materials arrive on VA property. Records Management When Federal agencies acquire goods or services, they need to determine what Federal records management requirements should be included in the contract. Federal contractors often create, send, or receive Federal records. Federal contracts should provide clear legal obligations describing how the contract employees must handle Federal records. Agency records officers, procurement counsel, and acquisitions officers must discuss how to integrate records management obligations into their existing procurement processes. NARA has developed the following language to be included as an agency-specific term and condition in Federal contracts for a variety of services and products. The majority of contracts should include language on records management obligations, but each contr