Contingency Chemotherapy Compounding Services Louis A Johnson VA Medical Center

Statement of Work Contingency Chemotherapy Compounding Services Louis A Johnson VA Medical Center STATEMENT OF WORK AND GENERAL SPECIFICATIONS FOR Chemotherapy Compounding Background VA Clarksburg 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 VA Clarksburg. 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 contract should be evaluated individually. For example, the data-rights paragraph (Paragraph 10 below) may not be appropriate for all contracts. Instead, agencies may be better served by one of the established data-rights clauses in the Federal Acquisition Regulations.  This language should not replace specific records management requirements included within Federal information system contracts.  RECORDS MANAGEMENT OBLIGATIONS A.  Applicability This clause applies to all Contractors whose employees create, work with, or otherwise handle Federal records, as defined in Section B, regardless of the medium in which the record exists.   B.  Definitions “Federal record” as defined in 44 U.S.C. § 3301, includes all recorded information, regardless of form or characteristics, made or received by a Federal agency under Federal law or in connection with the transaction of public business and preserved or appropriate for preservation by that agency or its legitimate successor as evidence of the organization, functions, policies, decisions, procedures, operations, or other activities of the United States Government or because of the informational value of data in them.   The term Federal record: Includes LAJVAMC records.  does not include personal materials. applies to records created, received, or maintained by Contractors pursuant to their LAJVAMC contract. may include deliverables and documentation associated with deliverables. C.  Requirements Contractor shall comply with all applicable records management laws and regulations, as well as National Archives and Records Administration (NARA) records p…