STATEMENT OF WORK PART A - GENERAL INFORMATION A.1 Introduction Award a firm fixed price, indefinite quantity, indefinite delivery service contract to a qualified firm with the capability and capacity to provide hazardous, non-hazardous, chemical, universal, and DEA drug waste transport and disposal services monthly/bi-monthly and manpower to transport pharmaceutical waste from satellite accumulation areas (SAA) to the central accumulation area at least weekly and/or as needed. The specific waste above will be collected from one pick-up location at the following locations: Marion VA Medical Center (MRN) 2401 W. Main Marion, IL 62959 Evansville Health Care Center (EHCC) 6211 E. Waterford Boulevard Evansville, IN 47715. Hazardous and pharmaceutical waste will be picked up and transported monthly at MRN and every other month at EHCC. Services performed will include disposal of lab packs; pharmaceutical formulary review; collection containers and bracket/cart installation; technical consulting; electronic record keeping; emergency spill response; train the trainer training for pharmaceutical waste; and annual hazardous waste and DOT training. The contract will include a base year and four renewable option years. The services will be provided in accordance with current federal, state, and local regulations. This contract will not include the disposal of radiological, infectious, or bio-hazardous waste, but may include small qualities for dual waste (i.e., infectious and hazardous waste). A.2 Considerations - Removal of the hazardous, non-hazardous chemical, universal, and DEA drug waste will be normally performed during the hours of 8:00 AM and 4:30 PM, Monday through Friday, excluding National Holidays. The Contracting Officer Representative (COR) is available during those hours for the approval of manifests and other required documentation unless exigent circumstances require services during an unscheduled time period. After-hours access will be coordinated with the Green Environmental Management System (GEMS) Program Manager or the Coordinator's designee. The Contractor and the COR will arrange for a routine (non-emergency) service based upon volume. This will occur on a monthly, bi-monthly, or quarterly basis depending on the rate of generation. To be considered for the contract award, the bidder must possess the necessary technical expertise and resources required by this solicitation in order to be considered for contract award. STATEMENT OF WORK PART B WORK REQUIREMENTS B.1 Requirements and Scope - The contractor shall provide hazardous, non-hazardous chemical, universal, and DEA drug waste disposal services from the Marion VA medical centers. The contractor is required to provide annual hazardous waste and DOT training to a maximum of fifty (50) VA employees (training once per year minimum) located at each medical center. Services shall include all labor, materials, tools, equipment, analysis, travel, transportation, documentation, waste treatment, disposal and support services required to categorize, package, transport, document and dispose of hazardous, non-hazardous chemical, universal, and DEA drug waste from all VISN 15 Heartland, Marion VAMC. The Contractor and the COR for the VISN 15 Heartland Network, Marion VAMC will arrange for a routine (non-emergency) service for each facility based upon volume. This will occur on a monthly, bi-monthly, or quarterly basis depending on rate of generation. The successful offer must possess the necessary technical expertise and resources required by this solicitation in order to be considered for contract award. B.2 Training - This contract will include annual training for all employees who handle hazardous and/or universal waste, at least once per year, designated by the COR (Maximum of 50 employees per facility). The hazardous waste training program will provide training to employees who generate hazardous waste in SAAs and have waste management responsibilities at each medical center, who sign manifests or who are authorized to serve as their respective facility's hazardous waste coordinator. Training will incorporate state specific regulations and include storage, manifest completion, records management, emergency responsibilities, Land Disposal Restrictions, and other pertinent topics. The training will also include DOT Hazardous Materials training that meet the requirements of 49 C.F.R. §§ 172.704(a), (c) and (d). The contractor will be required to provide Resource Conservation and Recovery Act (RCRA) training per the state and federal regulations for all employees with responsibilities for management of hazardous waste at each facility, not to exceed 50 employees for each VAMC facility. The successful contractor will provide DOT training to all employees who ship, prepare, or sign hazardous waste manifests or other hazardous materials shipping papers and are covered under 49 C.F.R.§§ 172.704(a), (c) and (d). The contractor shall provide general training and instruction to the VA employees responsible for handling hazardous and universal waste designated by the COR. The contractor will provide training qualification and a training outline that covers all areas referenced in this section. B.3 Meetings - Quarterly meetings shall be held with the GEMS Program Manager to address contract performance. Should contract deficiencies arise, meetings may be held on a more frequent basis to resolve any/all issues. B.4 Recordkeeping/Reports - Contractor shall have a centralized waste tracking system. The centralized tracking system will include a centralized database for all waste characterizations and determinations, hazardous waste manifests, universal bill of lading for universal wastes, methods of final (end) disposal, final (end) disposal sites, monthly, quarterly, and annual waste generation reports by facility, and training records. The contractor will be responsible for providing a database that will be able to generate reports on hazardous waste activities, waste characterization profiles, annual generation by facility and other information necessary for the successful operation and management of a hazardous waste management program. The electronic database will be provided to the COR upon request in a Microsoft Excel spreadsheet or web-based information access. B.5 Train-The-Trainer Training The Contractor will partner with the GEMS Program Manager to develop medical center specific training to nursing staff on the collection and accumulation of pharmaceutical waste. This training with be conducted in a train-the trainer style by the contractor. B.6 Pharmaceutical Formulary Review Annual Update The contractor will provide an electronic review of the medical center formulary and provide recommendations as appropriate. The completed review will identify all listed waste, characteristic waste, and RCRA-equivalent waste. The review will also identify Department of Transportation packing and labeling instructions. The final review will be submitted in Microsoft Excel spreadsheet in an electronic file. B.7 Consulting Services At the medical center's request the vendor will provide technical expert consulting services on topic related to EPA, state-specific RCRA, DOT, and other environmental regulations. B.8 Twenty-four-hour Spill Response Services - Contractor shall have the capability to provide twenty-four (24) hour per day, seven (7) days per week of emergency response services for spills of hazardous materials and/or wastes, and universal wastes. The contractor shall respond within two (2) hours to spill incidents at each of the medical centers and/or Community Outpatient Clinics (CBOC) to conduct spill mitigation activities, neutralize spilled products, and provide expert advice concerning products and their potential impacts on people and the environment. Response shall include spill cleanup at each the medical centers or CBOC, to handle and dispose of products or product residuals generated as a result of a spill and to prepare required documentation on behalf of the facility. The contractor shall also possess the capability to respond within this two (2) hour on-site framework to assess any potentially unstable/reactive hazardous substance identified, and to affect on-site remote opening and stabilization as appropriate within twenty-four (24) hours. This service will be provided on a 24-7 basis and must be provided on-site within 2 hours of after being notified by the medical centers point of contact. The contractor will be responsible for providing emergency first responder services in the event of a spill of hazardous materials/wastes, radiological wastes, and universal wastes. This service must be available 24 hours per day, 7 days per week and be available with personnel on the scene within 2 hours. If Contractor fails to respond within two (2) hours, VA reserves the right to obtain the required service from another source capable of full performance of these contract requirements, and to charge the contractor with any excess cost which may result there from. The contractor must be able to identify spilled product, conduct spill mitigation activities (e.g., containment, diversion from storm drains), neutralize spilled product, provide expert advice concerning products and their potential impacts, undertake spill cleanup activities, handle, and dispose of spilled product and residuals, and prepare appropriate documentation on behalf of the facility. The contractor will provide their spill procedures for integration into facility level SPCC or contingency plans. The contractor will provide their billing procedure that would be used for spill and emergency response activity. B.9 Supplies and Installation for Pharmaceutical Waste Containers The contractor shall have the capability to supply waste collection containers of various sizes, mounting hardware, foot pedal stands (Listed in Attachment 2) and the labor to install the mounting hardware. STATEMENT OF WORK PART C SUPPORTING INFORMATION C.1 General Task Statement - The successful contractor will be required to provide removal of hazardous, non-hazardous chemical, universal, and DEA drug wastes from all facilities in the VISN 15 Heartland Network. Quantities of each item listed are estimates based on a per item amount at specified facilities. Additional chemical wastes not listed may be added to this contract by amendment by the COR, if such wastes are identified during the process of this contract. Additional chemicals not listed shall not be removed from the premises without written authorization from the COR. All hazardous, non-hazardous chemical, universal, and DEA drug wastes generated by VISN 15 Heartland Network, Marion VAMC facilities will be disposed of by the Contractor in accordance with current Federal, State, and local guidelines governing hazardous, non-hazardous chemical, universal, and DEA drug wastes disposal and destruction. (i) Packaging of chemical wastes will be in the largest container available for that waste stream. Smaller sizes shall be used for partial loads or to meet the disposal priorities or DOT requirements. (ii) Contractor will dispose of hazardous waste in a manner that leaves no future expense potential to the VA or the federal government. Wastes should be disposed of in the following preferred priority:(1) Recycling of chemicals to another party for future use if economically feasible and practical. (2) The treatment of the chemical waste (at a facility approved for such processing by an appropriate state or federal agency) in a manner that renders it no longer a hazardous waste as defined in the 40 CFR series. These processes include (but are not limited to): (a) Reprocessing or recovery followed by recycling/reuse. (b) Chemical neutralization or detoxification. (c) Thermal treatment (e.g., incineration, pyrolysis). (3) The long-term internment (burial) in a secure chemical landfill site approved for such by the appropriate state or federal agency. (iii) Acceptance of the hazardous property (chemical wastes) at a properly permitted treatment, storage, or disposal site does not constitute disposal and/or completion of the contract. It is the prime contractor's responsibility to obtain all necessary documentation to prove that the timely end disposal of all items has been accomplished. (iv) Out of country shipments are prohibited under this contract. (v) The records involving the transfer or destruction of controlled substances must be kept available for two years for inspection and copying by the DEA. To transfer Schedule II substances, the receiving registrant must issue an Official Order Form (DEA Form-222, U.S. Official Forms Schedules I & II) to the registrant transferring the drugs. The transfer of Schedule III-V controlled substances must be documented in writing to show the drug name, dosage form, strength, quantity, and date transferred. The document must include the names, addresses and DEA registration numbers of the parties involved in the transfer of the controlled substances. C.2 Waste Characterization - The Contractor is required to perform characterization of all waste streams identified by each facility using process knowledge, identity of the chemicals, and other types of chemical analysis including but not limited to Toxicity Characteristic Leaching Procedure (TCLP). Chemical wastes shall include but not be limited to ignitable items, corrosives, poisons/ toxics, reactive wastes, and universal waste (i.e., batteries, fluorescent lamps, mercury thermometers and blood pressure cuffs, lead aprons). Work shall be performed in accordance with all applicable, Federal, State, Local and governing regulations. The Contractor will obtain permission from the COR before conducting chemical analysis to be charged against the contract. C.3 Containerizing - The Contractor will be responsible to package bulk wastes into the largest container feasible. The Contractor will be responsible for properly containerizing all lab-packs and for assuming all safety measures to prevent harm or injury to VA patients, visitors, employees, contractor employees (example: PPE) and the environment (example: storm drain covers). The VA CORs, Safety Officer/Specialists, Industrial Hygienists, GEMS Program Managers, or VA Police, or Emergency Preparedness Specialist have the authority under this contract to present a verbal "stop work order" pertaining to job activity they reasonably believe represents an imminent hazard to life, property, or the environment. This verbal order shall be followed up by a written stop work order issued by the COR as soon as feasible after the imminently hazardous situation has been stabilized or abated. C.4 Accidental Release - Should hazardous, non-hazardous chemical, universal, or DEA drug waste be released during the performance of services under this contract, through no fault of the VA facilities, the Contractor will be responsible for all costs associated with the satisfactory remediation of the incident. This will include the cost of all labor and materials as well as any actual damages incurred to the facility and harm caused to patients, visitors, and staff of the medical center. The remediation efforts shall be performed to the satisfaction of the cognizant regulatory authorities and the medical center's GEMS Program Manager. C.5 Contractor Furnished Materials and Equipment - The Contractor will furnish all containers, packing material, and any other necessary equipment and documentation for lab packs. The contractor may, on occasion, be requested to furnish other waste storage containers (e.g., for bulk wastes). Contractor shall provide a list of containers and pricing with their proposal. Should the government require this service, contractor shall invoice the container in accordance with list submitted with their pricing proposal. C.6 Location of Pick-Up Points - The Contractor shall be responsible for the' pickup of hazardous, non-hazardous chemical, universal, and DEA drug wastes from a multiple. storage locations throughout the medical centers. The location points may be identified at the time of notification of need for removal service: Access to the waste storage area and pick up locations is to be coordinated with COR or designated representative at . each facility. C.7 - Building Occupancy - The VA will maintain full occupancy of the site for the duration of the services required under this contract unless an exigent emergency situation requires localized evacuation (e.g., discovery of potentially unstable wastes). The Contractor shall not interfere or hinder the daily operations of the VA while performing services during other than exigent circumstances. C.8 Documentation C.8.1 Compliance - The Contractor is required to comply with all Federal, State, and local regulations, policies and procedures regarding tracking, record keeping, manifesting and documentation of all hazardous, non-hazardous chemical, universal, and DEA drug wastes. The contractor will be required to comply with all changes to such Federal, State, and local regulations and procedures which occur during the term of this contract. The Contractor will provide to each medical center's GEMS Program Manager any additional certifications that may be required because of changes in such laws. C.8.2 Removal - The Contractor will provide all manifests and documentation that apply to the removal and disposal of hazardous, non-hazardous chemical, universal, and DEA drug waste activities conducted by its workforces and/or its subcontractors. The Contractor will furnish a properly executed and legible copy of the appropriate manifests required to document the safe shipment and proper disposal of hazardous, non-hazardous chemical, universal, and DEA drug waste generated by each medical center under the terms of this contract. C.8.3 Transportation - Prior to the removal and transport hazardous, non-hazardous chemical, universal, and DEA drug wastes generated by each VISN 15 Heartland Network, Marion, and Evansville VAMC facilities the Contractor will obtain approval and signature for each manifest from the VA Facility's COR or his/her designee verifying that the Contractor has accepted the waste from the VA and that the waste was properly shipped for treatment or disposal. Manifests not signed by the COR, or his/her designee will not be deemed valid. The Generator Copy, Generator State Copy and Destination State Copy of the executed manifest (signed manifest will be provided to the facility within 30 days) will be provided to the VA Facility COR or the Safety Office and to Acquisition/Logistics when hazardous, non-hazardous chemical, universal, and DEA drug waste is disposed of as applicable and before the removal of any waste from facility. C.8.4 Time Limits - In addition to providing the manifests, the Contractor will provide a properly executed and signed disposal certificate for each manifest to the VA COR within thirty (30) calendar days of removal of waste from this facility. The disposal certificate will clearly indicate that all waste has been properly disposed of and will specify the site and date of disposal or incineration (90-day requirement). Exceptions to this must be approved by the COR and/or GEMS representative. C.8.5 Electronic Data - All manifests, waste determinations, waste generation data, shipping information and other data required for the proper execution of this contract will be maintained by the contractor in an electronic database. This system should enable tracking of generator status, generate monthly, quarterly, or annual reports, and enable tracking of compliance dates. The electronic database will be provided to the COR upon request in a Microsoft Excel spreadsheet or web-based information access and/or at the end of the contract, whichever comes first. C.9 Capability Requirements/Delivery and Performance Schedules C.9.1 Training and Experience - Contractor representatives who perform services under this contract must be competent, experienced, and qualified to perform such services listed herein. All work performed will be first class in accordance with established good waste management practices. The Contractor shall submit proof of appropriate training and experience for vendor personnel performing services. C.9.2 Delivery Schedule - It is the intent of this contract to have a regular pick-up on either, bi-monthly or monthly, depending on the need. The responsible COR or his/her designee shall notify the Contractor of the necessity for the pick-up for unusual circumstances outside of the normal schedule. The Contractor must coordinate all pickups with the facility COR. The Contractor will be required to pick up waste within seven (7) calendar days of telephonic notification by VA representative. C.9.3 Government Estimates - The Government requires services on a recurring basis. There shall be no penalty or additional costs incurred should a medical center require more or less than the estimated pickups or disposal volume outlined in the schedule of costs. C.10 Safety Requirements - In the performance of this contract, the Contractor shall take such safety precautions as the COR or his/her designee may determine to be reasonably necessary to protect the lives and health of VA patients, visitors, staff and the general public. The COR or his/her designee will notify the Contractor of any noncompliance with the foregoing provisions as well as the recommended corrective action. The Contractor shall, after receipt of such notice, immediately correct the conditions to which attention has been directed. Such notice, when served in person on the Contractor or his/her representative at the site of work, or telephonically to Contractor's designated representative, shall be deemed sufficient for the purpose of the previously mentioned. If the Contractor fails or refuses to comply promptly to satisfactorily abate the hazardous condition or situation, the Contracting Officer may issue an order stopping all or any part of the work (and hold the Contractor in material breach of this contract). C.11 Chemo and Antineoplastic Pharmaceutical Waste Each VISN 15 Heartland Network, Marion VAMC facility collects RCRA Pharmaceutical Waste in the Chemotherapy Preparation Rooms. Per VA policy once full, these containers are NOT to be opened. These containers do not contain infectious waste. Disposal of these containers will include the proper disposal of the container and its contents (chemotherapeutic agents and antineoplastic agents). STATEMENT OF WORK PART D LICENSES & PERMITS (SUBMITTALS) D.1 The Contractor will, without additional cost to the VA provide and maintain all licenses and permits for operational personnel, trailers, containers, vehicles, and other resources required for proper removal of hazardous, non-hazardous chemical, universal, and DEA drug wastes in accordance with all applicable Federal, State, Municipal, and local regulations [e.g. OSHA, EPA, CFR (DOT) including, but not limited to HM-18]. If appropriate licenses are not maintained in accordance with Federal, State, and local requirements, the VA may terminate the contract effective upon discovery. The VA reserves the right to halt work if the COR determines work is being done in an unsafe/unhealthy manner or that could harm the environment. VA will not incur additional costs if work is halted for good cause. D.2 Required Submittals - The following shall be provided to the COR with bid proposal submission for evaluation purposes and annually within thirty (30) days of the renewal date of this contract with any changes to original submission clearly identified and highlighted: (a) Current waste transporter permit(s) (b) List of all transfer stations, treatment, storage, and disposal facilities (TSDFs) including incineration, wastewater and sludge treatment facilities that shall be utilized during this contract to include the capacity of these facilities and the waste codes for the waste streams they are permitted to accept by treatment technology. Address, phone number and other contact information shall be provided. The VA reserves the right to inspect each of these facilities before approving its use or at any time during or after contract period while VA wastes are present. (c) Copy of Operator permit(s) (d) Certificates of training and experience of staff and/or personnel who will perform site work under this contract (all technicians that will work on VA premises will be expected to have received at least the minimum training required by law as specified in 29CFR 1910-120, 40 CFR Parts 260-265 and 49 CFR Parts 171-178. (f) Provide the contractor's experience in hazardous waste packaging, transport, and disposal. (g) Provide a copy of US EPA identification number(s) certificate for each business entity operated by the contractor that will provide service regarding any aspect of VA waste disposal program (i.e., storage, transfer, incinerator sites). (h) Provided a copy of certificate of registration with the State EPA as a hazardous waste transporter for each business entity operated by the contractor that will provide hazardous waste transportation services for any aspect of VA waste disposal program. (i) Provide written acknowledgement of responsibility for acquisition of all applicable business licenses and permits required by law. Contractor shall certify that it acknowledges and is in possession of all required business licenses and permits. (j) Provide a list of any violations and/or citations that the contractor has received for non-compliance with any hazardous waste laws, permit requirements, and/or OSHA requirements for the past three years from the date of submission. Contractor shall include information on all related business entities including associated firms that are owned by the contractor or owned by a common parent company that will be involved in any portion of the processing of VA waste disposal program. If no discharge or violations have occurred, contractor must provide a statement that certifies no discharges or violations have occurred. (k) Provide a plan describing Standard Operating Procedures (SOPs) that will be followed while conducting normal hazardous, non-hazardous chemical, universal, and DEA drug wastes management activities. The contractor shall describe: 1. Site safety and contingency procedures (e.g., spill management). 2. Operational procedures and site management structure. 3. Supplies and equipment practices. 4. Material sampling procedures. 5. Hazard assessment and categorization procedures. 6. Packing procedures. 7. Quality assurance and quality control procedures to ensure materials are properly identified, categorized, and packaged, and paperwork is properly completed. 8. Procedures for gaining waste acceptance into a transfer/ disposal facility. 9. Contractor and project management procedures. (I) Provide the following information regarding the hazardous waste fleet owned and operated by the contractor: 1. Basic description of transportation services offered and capabilities. 2. Fleet description of number, types, and ages of vehicles. 3. Description of service and maintenance programs. 4. Types of materials licensed to haul. 5. Latest DOT or MCS rating (include a copy of the last inspection). 6. The DOT compliance record. 7. Description of driver qualifications including training programs, and experience. 8. Provide evidence that background checks have been performed on all employees that will perform any duties under this contract. (m) Provide the following information on the contractor's emergency response (ER) capabilities (or any changes to original submission): 1. Contractor's ER policies. 2. ER capabilities and experience and limitations. 3. Type of ER equipment maintained (specify if owned or subcontracted and from whom). 4. Personnel availability, training, and experience. 5. Contractor's emergency response procedure shall describe: a. How to request an emergency response. b. How the contractor notifies personnel and initiates response action. c. Incident command procedures followed by the contractor. d. ER work practices. e. ER protection of health and safety practices. f. ER invoicing policy. . (n). Provide a detailed site-specific safety plan that will be used to ensure that workers and nearby population will be adequately protected during packaging and removal operations. (0) Provide information identifying any proposed subcontractors and identifying services to be performed by the subcontractors. Contractor must submit evidence that subcontractor is qualified and legally able to provide services. (ALL subcontractors must be approved by the COR prior to performing any duties under this contract). (p) Provide a list of names, titles, addresses, telephone numbers (including cellular), pager/beeper numbers; facsimile numbers and e-mail addresses of key managers, supervisors, customer service and field service personnel performing under this contract. (q) Provide written Standard Operating Procedures (SOPs) for the collection, handling, accumulation, sampling, lab testing, characterization, packing and shipping of hazardous, universal, and non-hazardous wastes. (r) Provide a single point of contact with a backup. (s) Costs for all Supplies and Services
