DRAFT STATEMENT OF WORK (SOW) Destruction of Pharmaceuticals Purpose: The Michael E. Debakey VA Medical Center (MEDVAMC) has a new request for destruction of pharmaceuticals due to the lapsing of the VA Pharmacy Benefits Management contract that previously was available system wide within the VA. Scope: The Medical Centers are seeking a means to have legend pharmaceutical, and DEA controlled substances removed from facilities for destruction. These pharmaceuticals will be either expired or in a condition that is not suitable for human consumption. Contractor Requirements: REGULATORY COMPLIANCE: The contractor shall be required to provide all plant, equipment, materials, and labor needed to process proper disposal of Schedule II-V controlled substances designated pharmaceuticals and legend drugs. Contractor shall be responsible for complying with all applicable federal regulations such as the Code of Federal Regulation (CFR) Title 21 Food & Drugs, 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 and consult with regional offices of the federal regulatory agencies that have jurisdiction over their operations to ensure compliance with laws and regulations of host countries. 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 expired or unusable DEA scheduled II-V controlled substances and legend drugs. This includes but is not limited to DEA, DOT, EPA, FDA, OSHA and individual State regulations. The Contractor or designated sub-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. 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 destruction operations. SHIPPING/PROCESSING ARRANGEMENTS: The VA medical centers will communicate with the Contractor directly to establish an agreed upon on-site service date once every quarter. 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. The Contractor will provide work on-site in the pharmacy locations: Alexandria VA Health Care System 2495 Shreveport Hwy 71, Pineville, La 71360 Gulf Coast Veterans Health Care System (3 Locations) 400 Veterans Blvd, Biloxi, MS 39531 790 Veterans Way, Pensacola FL 32507 Sims Nursing Home 4419 Tram Road, Springfield, FL 32401 Southeast Louisiana Veterans Health Care System (2 locations) 2400 Canal Street, Outpatient Pharmacy, New Orleans, LA 70119 7968 Essen Park Avenue, Baton Rouge, LA 70809 VA Shreveport Health Care 510 E. Stoner Road, Shreveport, LA 71101 Michael E. DeBakey VA Medical Center (3 locations) 2002 Holcombe Blvd,Houston VAMC, Houston, TX 77030 3420 Veterans Circle, Beaumont OPC, Beaumont, TX 77707 2206 N. John Redditt Drive, Charles Wilson OPC, Lufkin, TX 75904 Contractor will provide a documented listing of controlled substance pharmaceuticals for return and prepare these for shipment to the processing facility. The returns will be processed using the Contractor s on-site representative. The Contractor is responsible for the shipment and associated costs from the facility to the Contractor s facility. On-site service, disposition shall be provided to each facility following completion of the services. The Contractor shall prepare a list of controlled substance pharmaceuticals removed from the pharmacy and the facility must validate the contents of the list for accuracy. Any discrepancies shall be resolved prior to the removal of the pharmaceuticals from the facility by the Contractor. The contractor representative must sign the document listing the controlled substances transferred from VA to the destruction company and the appropriate DEA Forms (222, 41 etc.). The Contractor shall remove or pick up controlled substance returns from the facility by close of business the same day as service is completed and boxed for return. Large or special pickups requiring separate removal shall be scheduled within 48 hours of service, and daily updates will be provided to the facility until pickup is complete. 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. The Contractor shall process all designated items through the disposal process in accordance with all applicable federal, state and local regulations. The Contractor shall comply with any 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. Delivery Alexandria VA Health Care System 2495 Shreveport Hwy 71, Pineville, La 71360 Gulf Coast Veterans Health Care System (3 Locations) 400 Veterans Blvd, Biloxi, MS 39531 790 Veterans Way, Pensacola FL 32507 Sims Nursing Home 4419 Tram Road, Springfield, FL 32401 Southeast Louisiana Veterans Health Care System (2 locations) 2400 Canal Street, Outpatient Pharmacy, New Orleans, LA 70119 7968 Essen Park Avenue, Baton Rouge, LA 70809 VA Shreveport Health Care 510 E. Stoner Road, Shreveport, LA 71101 Michael E. DeBakey VA Medical Center (3 locations) 2002 Holcombe Blvd,Houston VAMC, Houston, TX 77030 3420 Veterans Circle, Beaumont OPC, Beaumont, TX 77707 2206 N. John Redditt Drive, Charles Wilson OPC, Lufkin, TX 75904 (End of SOW)
