Q517--Hazardous Compounding

STATEMENT OF WORK (Hazardous) 1. BACKGROUND: The Gulf Coast Veterans Health Care System has a requirement for compounding hazardous chemotherapy agents for the Biloxi, MS and Pensacola, FL locations. These compounding services are necessary to provide chemotherapy treatments to Veterans diagnosed with specific medical conditions. Gulf Coast Veterans Health Care System has approximately 7-9 patients at each site (Biloxi and Pensacola) on any given day Monday-Friday for Chemotherapy Infusion. Compounding must be done at an FDA 503A compliant facility and meet all state and federal laws. Contract will be a firm-fixed price, Indefinite-Delivery-Indefinite Quantity, contract. Period of performance will be as follows: Base period: October 1, 2024 through September 30, 2025 Option Period 1: October 1, 2025 through September 30, 2026 Option Period 2: October 1, 2026 through September 30, 2027 Option Period 3: October 1, 2027 through September 30, 2028 Option Period 4: October 1, 2028 through September 30, 2029 2. SCOPE OF WORK: Services Non-Personal; Contractor shall provide all chemotherapy agents, IV Tubing, and any other items deemed necessary. All Hazardous Chemotherapy Agents will be aseptically compounded based on patient specific orders. Orders will be submitted via a secure network or fax. Once submitted, VA staff will confirm receipt of order with the Contractor via phone or email. Orders from the JACC will be submitted by 3:00pm CST. Orders from Biloxi will be submitted by 10:30am CST. Compounded orders shall be transported via Courier, overnight mail service, or any other means necessary to ensure receipt prior to infusion date/time to the following locations: Orders for Biloxi, MS: Gulf Coast Veterans Health Care System Inpatient Pharmacy Bldg. 1, Room 2C115 400 Veterans Avenue Biloxi, MS 39531 Orders for Pensacola, FL: Gulf Coast Veterans Health Care System Joint Ambulatory Care Center (JACC) Pharmacy, Room 1B119 790 Veterans Way Pensacola, FL 32507 Items shall be delivered to the VA by 12:00pm, Noon the day after orders are submitted. Compounding, labeling, and beyond use dating/expiration dating will be based on USP 797, USP 800 and Federal Law. A list of the common chemotherapy agents will be provided directly to the Contractor. All drugs are to be supplied by the Contractor. See Attachment 1 for common chemotherapy agents used. This list is not inclusive, and agents may be added or deleted as the mission needs change. Contractor shall invoice for billable units for the amount of medication utilized for each individual patient. 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. Contractor shall update and provide the VHA PBM Assessment Guide for Compounded Sterile Preparations within VAMCs and Outsourced Compounding Pharmacies at time of solicitation response and annually (See Attachment 2) 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. Specifications below for compatibility needs: Bag Spike Rule: All chemo and Mabs Primary IV Set: BD Secondary Set (72213N) Secondary IV Set: CareFusion Low Sorbing Set (for PVC free compounds) In-line Filter: N/A Filter Rules: N/A Infusion Pumps: BD Alaris Smartpumps Special Priming: Prime tubing with base fluid prior to adding medications Total Volume Calcutions Overfills in IV Bags: Total volume only calculatd when specified in order. No adjustments made for overfill. Close System Device: PhaSeal (BD) Pre-meds: none Other: Occasionally need 5-FU in WalkMed bags 3. WORK HOURS: The JACC pharmacy is open to receive medications Monday Friday, excluding federal holidays, from 7:00am to 5:00pm CST. The pharmacy in Biloxi is open to receive medications 24/7. The ten (10) federal holidays observed by the Federal Government for this requirement are: New Year s Day January 1 Martin Luther King Day Third Monday in January Washington s Birthday Third Monday in February Memorial Day Last Monday in May Independence Day July 4 Labor Day First Monday in September Columbus Day Second Monday in October Veterans Day November 11 Thanksgiving Day Fourth Thursday of November Christmas Day December 25 Also included would be any other day specifically declared by the President of the United States of America to be a Federal Holiday. 4. CONTINGENCY PLANNING: The Contractor shall provide a contingency backup plan in the event that compounding facility is affected by any certification discrepancies, equipment malfunctions, natural disasters, or other matters affecting performance of the contract. 5. COMPLIANCE WITH APPLICABLE LAWS AND REGULATIONS: The Contractor shall ensure that services provided to the Government under this contract comply with all applicable laws, statutes, regulations, and guidelines. The Contractor shall also ensure that all services provided to the Government under this contract comply with all Government mandated procedures, standards, and requirements. 6. QUALITY ASSURANCE SURVEILLANCE PROGRAM: The Government will monitor the Contractor s performance under this contract with the below performance objectives: Task ID Indicator Standard Acceptable Quality Level Method of Surveillance Incentive Rating General 1 Orders processed accurately Contractor shall ensure all orders are processed per prescription order 100% Labeling Positive Past Performance & Exercise of Option Period 2 Orders received prior to infusion date/time Contractor shall comply with all safety requirements. 100% Validated receipt of order Positive Past Performance & Exercise of Option Period 3 Contractor maintains certifications required for compounding Contractor shall furnish copies of certificates and complete VHA PBM Assessment Annually 100% Validated receipt of certificates and/or assessment Positive Past Performance & Exercise of Option Period