DRAFT STATEMENT OF WORK GENERAL The purpose of this requirement is to establish a contract with a reverse distributor with destruction capability, hereafter referred to as the Contractor, capable achieving maximum credit return and in processing any related pharmaceutical waste that may arise out of non-returnable pharmaceuticals. The Government's need for on-site and off-site processing function is imperative to assure optimum inventory control and to minimize the violation of laws and regulations, especially in pharmaceutical waste disposal. The contractor shall be compliant with all applicable regulations related to hazardous waste handling. It is the intent that an efficient returns processing method where expired pharmaceuticals shipped to a centralized reverse distributor will reduce total costs in the health care system through a system of inventory controls and report analytics, while maintaining all necessary internal controls to ensure accuracy throughout the entire process. The Government will require a Contractor that can supply inventory scanning software as a service for use by the site and the vendor so a report can be generated to identify and address any item and its box location for any discrepancies so identified discrepancies can be addressed prior to expired inventory leaving the site. The Government will also require the Contractor also be the returns depot for current Prime Vendor so complete direct data from Prime Vendor can be generated with invoices so the site can review all credits provided with actual credit recovery, not estimated return value. Returns to be processed will cover expired pharmaceuticals and pharmaceuticals due to be expire within 120 days. The contractor may not hold any expired pharmaceuticals identified as greater than 120 days from expiration and must immediately destroy identified product. The government will also require a fee for service payment model to ensure the contractor is paid for services provided, and independent of the total amount of credit value achieved. AWARDS The Government requires a one-year base period with a potential five-year period of performance. The Government will make this award based on Technical Capability, compliance with VA requirements, and Past Performance, and Price. The proposed reverse distribution service fee shall be a firm fixed fee per site visit and priced according to class of trade and frequency of site visit. The firm fixed site visit service fee should cover all the contractor s costs including, but not limited to, packaging, shipping, processing, software as a service application, waste disposal, and any other applicable costs or fees incurred in performance of reverse distribution and waste disposal services. Award will be made base year and option year one through four. To be considered for award, offerors are required to submit a proposal for all line items for the base year and each of the four option years. Proposals that fail to include fees for the base year and each of the four option years for all line items will be rejected and will receive no further consideration. ESTIMATED ANNUAL REQUIREMENTS The government guarantees that it will order a minimum of 12 annual site visits for MEDVAMC s Inpatient and Outpatient pharmacies and a minimum for 4 annual site visits for the Beaumont and Lufkin CBOCs for this requirement. REGULATORY COMPLIANCE The Contractor shall be required to provide all plant, materials, and labor needed to process credit returns and/or arrange for proper disposal of designated pharmaceuticals, including Schedule II-V controlled substances. Contractor shall be responsible for complying with all applicable federal regulations such as the Code of Federal Regulation (CFR) Title 21 Food & Drugs, Title 29 Hazardous Materials, Title 40 Protection of the Environment, Title 49 Department of Transportation; U.S. Environmental Protection Agency (EPA), Occupational Safety and Health Administration (OSHA), Food and Drug Administration (FDA), Drug Enforcement Administration (DEA), 41 U.S.C. chapter 67, Service Contract Labor Standards and VA regulations. The Contractor shall also comply with applicable state/local regulations. Accordingly, the Contractor shall arrange for, recommend, and/or advise the returning drug distribution point of the proper means of transporting the returned products to the Contractor's central processing facility. LICENSES, PERMITS, REGISTRATION, INSURANCE All necessary permits and licenses required by Federal, state, and local authorities shall be acquired and maintained by the Contractor for the life of the contract. This includes required licenses, certifications, etc. for individual contractor staff as well as any required permits and licenses for interstate transport, and storage/disposal of hazardous and non-hazardous unserviceable and non-returnable items or returns. This includes but is not limited to DEA, DOT, EPA, FDA, OSHA and individual State regulations. The Contractor shall be a licensed DEA registrant to handle Schedule II - V controlled substances. A copy of all renewals shall be forwarded to the contracting officer for retention in the contract file. The Contractor shall have proper insurance coverage, including environmental remediation if awarded a contract. A copy of such insurance coverage shall be provided to the Contracting Officer, upon request. CONTRACTOR AND SUBCONTRACTOR LICENSE QUALIFICATIONS REQUIREMENTS The Contractor and any respective subcontractors shall maintain all necessary licenses, permits and certifications required by the Resource Conservation and Recovery Act, Clean Air Act, Clean Water Act, Occupational Safety and Health Administration, and all licenses and permits required by local agencies for pharmaceutical for reverse distribution operations. All vehicles shall have proper State and Federal Department of Transportation (DOT) licenses required for the transportation of hazardous wastes. SHIPPING/PROCESSING ARRANGEMENTS A VA Medical Center designated employee will mutually coordinate with the Contractor directly to arrange for a return shipping date. The Contractor shall provide all instructions, forms, labels and DEA approved tamper-proof pouches needed to ship the designated items to a Contractor's central processing facility. Contractor will work on-site to electronically scan and generate a list of all pharmaceuticals and prepare their outdated products for shipment to the reverse distribution facility processing. A copy of the contractor s on-site inventory report will be available in a similar format as the contractor s supplied, facility itemized electronic list. Contractor must also provide software as a service and/or electronic methods to cross reference site electronic record against contractor electronic record to identify discrepancies. Reverse distributor product may not leave site until all discrepancies have been resolved. The Contractor is responsible for the shipment and associated costs from the facility to the Contractor s reverse distribution processing facility. Product status shall be provided via the contractor s web-based reporting system within three (3) business days after processing is complete. The Contractor shall provide on-site servicing within ten (10) business days from the date of the facility request. The Contractor shall not separate returnable from non-returnable pharmaceuticals on-site, instead the Contractor shall package the designated returns and transport them to the Contractor s facility where the determination will be made concerning product that is returnable and product that is waste. The Contractor shall arrange for pick up controlled substance returns from the facility within 1 business day of service unless a delay is requested by site. The Contractor shall arrange for pick up non controlled substance returns from the facility within 3 business days of service unless a delay is requested by site. Chain of custody paperwork shall be prepared for controlled substances and given to the returning facility by the Contractor at the time the package(s) are prepared for shipment. Within thirty (30) days of receiving the returned goods, the Contractor shall process all designated items by sorting, listing, and processing items through either a manufacturer s credit program or the disposal process in accordance with all applicable federal, state and local regulations. The Contractor shall comply with participating customers additional security requirements and procedures for access to facilities. All costs associated with gaining access to any customer facility shall be the responsibility of the Contractor. PHARMACEUTICALS QUALIFYING FOR MANUFACTURER'S RETURN Products qualifying for manufacturer s return are pharmaceuticals, including partials pharmaceuticals, in the original manufacturer containers. Everything else is considered waste and facilities must follow applicable federal, state, and local laws and ordinance for waste disposal. Any items removed during a facility s service event will be processed and associated to a single order that is unique to that service event. PHARMACEUTICALS INELIGIBLE FOR CREDIT FROM MANUFACTURER The Contractor shall list all items (including non-controlled and controlled substances and non-hazardous and hazardous substances) designated for disposal on a disposal manifest. This list will include at a minimum product name, National Drug Code (NDC) or catalog number, quantity, total estimated return value, and reason for non-eligibility for credit. Separate manifests shall be provided for the disposal of Schedule II V controlled substances and when disposing of hazardous waste products as defined by the EPA Resource Conservation and Recovery Act (RCRA) regulations. A Certificate of Destruction including the disposal date, destruction method, destruction location, weight, disposal company name and proof of destruction affidavit shall be available to the returning facility and maintained on the reporting website upon completion of destruction. All Manifests shall be available to the returning facility within 30 calendar days of Contractor's item receipt, with the exception of the Certificate of Destruction/Affidavit which shall be provided within 30 days of the completion of destruction. Shipments to the Contractor that require transport to the disposal location shall be done via approved and licensed vehicles in accordance with federal, state, and local laws and regulations where the processing will be completed. Contractor spills or releases of toxic/hazardous substances into the environment shall be reported to the returning facility immediately. (End of SOW)
