2 Alexandria VA Health Care System Regulated Medical Waste, Biohazardous Waste Management and Disposal, and Pharmaceutical Disposal SCOPE The Alexandria VA Health Care System located at 2495 Shreveport Highway 71 north, Pineville, LA 71360 is seeking a Contractor to provide treatment and disposal of regulated medical waste (RMW), pathological waste, Resource Conservation and Recovery Act waste (RCRA), universal waste, and pharmaceutical controlled substance waste and disposal. The contractor shall be required to provide all plant, equipment, materials, and labor needed to satisfy this requirement. See appendix A for location, description of waste, approximate amount, and pickup schedule. Locations to be serviced include, Alexandria VA Medical Center in Pineville, LA and six (6) other locations which are Community Based Outpatient Clinics (CBOCs) in Louisiana. The CBOC locations include two in Lafayette, Louisiana, one in Jennings, Louisiana, one in Lake Charles, Louisiana, one in Natchitoches, Louisiana, and one in Leesville, Louisiana. The specific services at a minimum shall include all materials, manpower, process equipment, licenses, permits, fees, fuel surcharge, transportation and computerized documentation for the complete treatment and disposal of material referenced in appendix A. BACKGROUND The Alexandria VA Medical Center (AVAMC) consists of the medical center located at 2495 Shreveport Highway, Pineville, Louisiana and six Community Based Outpatient Clinics (CBOC) in Lafayette, Louisiana, Jennings, Louisiana, Lake Charles, Louisiana, Leesville, Louisiana, and Natchitoches, Louisiana. The VAMC is categorized as a primary and secondary care facility. It is a teaching hospital, providing a full range of primary care services with state-of-the-art technology and education. Comprehensive acute and extended health care is provided on a primary and secondary basis in areas of medicine, surgery, psychiatry, physical medicine and rehabilitation, neurology, oncology, dentistry, geriatrics, and extended care. The Medical Center serves a potential veteran population of over 100,000 veterans and an active patient roster of over 37,000. The Alexandria, Louisiana VAMC is a part of VA Network 16, South Central VA Health Care Network, which includes facilities in Mississippi, Louisiana, Arkansas, Oklahoma, Southeast Texas, and Northwest Florida. REQUIREMENTS 3.1 Services provided by the Contractor shall be in accordance with local, state, and federal regulations, including but not necessarily limited to the Louisiana Department of Environmental Quality, (LDEQ), Louisiana Department of Health and Hospitals (DHH), Occupation Safety and Health Agency (OSHA), Environmental Protection Agency (EPA), Food and Drug Administration (FDA), Quality Systems Regulation (QSR), Department of Transportation (DOT), National Environmental Policy Act (NEPA), Drug Enforcement Administration (DEA). 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; 41 U.S.C. chapter 67, Service Contract Labor Standards and VA regulations. 3.2 Contractor shall have in place and maintain a valid contingency plan to meet the requirements of the contract. Contractor shall incur all cost associated with fulfilling this contingency plan at no additional expense to the Government. Contractor shall be liable for all expenses incurred by the Government due to the contractors inability to perform in accordance with these requirements. 3.3 Contractor shall identify any subcontractors and suppliers. Contractor is responsible for supervision, contract compliance and obtaining any necessary documentation from their subcontractors or supplies performing under this contract. If the contractor intends to utilize subcontractors and suppliers other than those initially identified, operating licenses, permits, certificates and any other forms required by regulatory agencies for the new facility must be submitted to the Contracting Officer no later than thirty (30) days prior to change. All cost increases to meet additional regulatory requirements caused by such change of disposal facilities or any other contractor action relative to transport, storage, and/or disposal of regulated medical waste shall be the responsibility of the contractor. 3.4 Contractor shall ensure that the handling and final disposal of Regulated Medical Waste complies with the Department of Transportation (DOT), Environmental Protection Agency (EPA), Department of Health and Environmental Control, Food and Drug Administration (FDA), and applicable Federal, State and Municipal governmental regulations and codes. 3.4.1 Transport Vehicles: Vehicles shall be equipped with fully enclosed leak-resistant cargo body, maintained in a sanitary condition, and secured when left unattended. Vehicles shall bear the transporter s name, State permit and the words Medical Waste or Regulated Medical Waste on the sides of the body. Waste shall not be subject to mechanical stress. Regulated medical waste shall not be combined with other waste. 3.5 The Contractor shall furnish all labor, equipment, sanitized, disinfected, and labeled containers, supplies, materials, transportation, and supervision required to provide pick up, transportation, incineration, or any other acceptable disposal of pharmaceutical waste, from the Alexandria VA Health Care System, 2495 Shreveport HWY 71 North, Pineville, LA., in accordance with the terms and conditions stated herein. The primary point of contact for all communication between the contractor and the Government will be the Contracting Officers Representative (COR). He or she will be appointed by and represent the Contracting Officer. The foregoing is not to be construed as authorization to interpret or furnish advice and information to the contractor relative to the financial or legal aspects of the contract. The contractor shall pick up, transport, and treat and or dispose of pharmaceutical waste in accordance with all applicable State and Federal (Environmental Protection Agency EPA, US Department of Transportation, Drug Enforcement Agency DEA) laws and regulations. The contractor shall possess all necessary permits and licenses, and other permissions mandated by current US EPA and State laws and regulations, must have a current registration to transport pharmaceutical waste with the US Department of Transportation (US DOT) along with any other special transportation approvals required by federal and/or state laws and regulations, and insurance prior to transport and or disposal of subject waste. Vendor to make Quarterly pick-ups from the Roto-clave building (Building 138). Amount of waste to vary but will average around 125 to 150 pounds per quarter, however, occasionally will need to be capable of picking up 175 pounds of pharmaceutical waste per pickup. 3.6 The Contractor shall be responsible for providing proof in their proposal that their off-site or on-site medical/special waste treatment and disposition system for processing untreated RMW/special/infectious waste meets the performance standards, as outlined in TDH 25 TAC Chapter 1, Subchapter K, 1.131-1.137 and TCEQ 30 TAC 330, Subchapter Y, 330.1201- 330.1221. Failure to meet this requirement shall call for immediate termination of requested service stated and required in this contract. The Contractor shall ensure an electronically generated copy of the medical waste manifest or a written record per 30 TAC, Chapter 330.1211 is attached to each electronically generated invoice showing proof of the daily quantity and total monthly amount of medical waste treated in pounds, prior to requesting and receiving payment for services rendered. 3.7 The Contractor shall be responsible for maintaining documentation that his employees or contractors are properly trained, medical tested and wear an appropriate level of personal protective equipment. The Contractor must ensure employee or contractors wear personal protective equipment, prior to engaging in any activities involving maintenance of processing equipment or handling of infectious waste generated by this health care facility per 29 CFR OSHA 1910.1030. 3.7 Controlled substance pharmaceuticals removal. 3.7.1 SHIPPING/PROCESSING ARRANGEMENTS: The VA medical center 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 Contractors central processing facility. The Contractor will provide work on-site in the pharmacy location at 2495 Shreveport Hwy, Pineville, Louisiana 71360. Contractor shall 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. 3.7.2 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. 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 and be prepared to list the VA, IHS, BOP, IHSC and other approved federal agencies as additional insured if awarded a contract. A copy of such insurance coverage shall be provided to the Contracting Officer, upon request. Appendix A Alexandria VA Medical Center is in Pineville, LA and there are six (6) other locations which are Community Based Outpatient Clinics (CBOCs) in Louisiana. The CBOC locations include two in Lafayette, Louisiana, one in Jennings, Louisiana, one in Lake Charles, Louisiana, one in Natchitoches, Louisiana, and one in Leesville, Louisiana. The specific services at a minimum shall include all materials, manpower, process equipment, licenses, permits, fees, fuel surcharge, transportation and computerized documentation for the complete treatment and disposal of material referenced in appendix A. Appendix A

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