Description
NOTE: Schedule of Supplies/Services and Prices/Costs (Offeror must submit a price for each line item) The following applies to bulk hazardous, non-hazardous, universal (i.e., lamps, aerosol cans, mercury-containing manufactured items, etc.) and specialty (i.e., hazardous pharmaceutical, non-hazardous pharmaceutical and dual [hazardous chemical and bio- hazardous combined]) wastes and the price is for disposal only and does not include the cost of the container, chemist time, driver’s time, or transportation. When pricing is per pound, it is per net contents (i.e., excluding container weight). Overpacks are to be billed by treatment cost for internal container size plus the cost of the overpack container and overpack handling fee. Waste profile/sampling approval to be included in pricing, as well as any state hazardous and/or specialty waste transportation fees that may apply. PART I - BASE YEAR The Contractor shall provide hazardous, non-hazardous, universal (i.e., lamps, aerosol cans, mercury-containing manufactured items, etc.) and specialty (i.e., hazardous pharmaceutical, non-hazardous pharmaceutical and dual [hazardous chemical and bio- hazardous combined]) waste services to include supplies, labeling, lab-packing, consolidation, collection, shipment, manifesting, regulatory inspection, auditing, training, consulting and emergency spill response for the Iowa City VA Health Care System (ICVAHCS) for a one year (12 month) period. The Contractor must comply with all applicable Federal (U.S. Environmental Protection Agency [US EPA], U.S. Occupational Safety and Health Administration [US OSHA], U.S. Department of Transportation [US DOT], etc.), State (Iowa Department of Natural Resources [IDNR], etc.), interstate, national consensus standards (Joint Commission [JC]), and local requirements, rules, regulations and laws relative to the handling, removal, manifesting, transportation, management, disposal and/or treatment of hazardous, non-hazardous, universal and specialty wastes. The hazardous and non-hazardous pharmaceutical waste program used by the Contractor must utilize the same identification scheme and accumulation containers as are in-use at the ICVAHCS. Specifically, this identification scheme utilizes ½ inch diameter adhesive dots applied to the pharmaceuticals that are regulated as hazardous when they become a waste (a black dot is for hazardous compatible waste and a black dot with an orange triangle in the center with a black exclamation point in its center is for hazardous incompatible wastes). The accumulation containers in use are Covidien brand and “black” 2-gallon and 8-gallon containers (i.e., Model # 8607RC and Model # 8602RC) are used to accumulate hazardous pharmaceutical wastes. Further, Covidien brand “blue” 2-gallon and 8-gallon containers (i.e., Model # 4008STC and Model # 4002STC) are used to accumulate non-hazardous pharmaceutical wastes. The ICVAHCS includes the following facilities: Iowa City VA Medical Center; Burlington, IA Community-Based Outpatient Clinic (CBOC); Cedar Rapids, IA CBOC; Coralville, IA Clinic; Decorah, IA CBOC; Dubuque, IA CBOC; Galesburg, IL CBOC; Ottumwa, IA CBOC; Quad Cities (Davenport, IA) CBOC; Quincy, IA CBOC; Sterling, IL CBOC; and Waterloo, IA CBOC. The Contractor will conduct up to twenty-six (26) waste pickups (or visits) per year. Specifically, a maximum of four (4) waste pickups per year will be conducted at the Iowa City VA Medical Center’s Main Hazardous Waste Container Storage Area (Room #B110, Building #40) for the removal and disposal of hazardous, non-hazardous, universal (i.e., lamps, aerosol cans, mercury-containing manufactured items, etc.) and specialty (i.e., hazardous pharmaceutical, non-hazardous pharmaceutical and dual [hazardous chemical and bio-hazardous]) wastes. Further, up to two (2) waste pickup per year for the removal and disposal of hazardous, non-hazardous and specialty (i.e., hazardous pharmaceutical, non-hazardous pharmaceutical and dual [hazardous chemical and bio-hazardous]) wastes at each of the following eleven (11) affiliated facilities: Burlington, IA Community-Based Outpatient Clinic (CBOC); Cedar Rapids, IA CBOC; Coralville, IA Clinic; Decorah, IA CBOC; Dubuque, IA CBOC; Galesburg, IL CBOC; Ottumwa, IA CBOC; Quad Cities (Davenport, IA) CBOC; Quincy, IA CBOC; Sterling, IL CBOC; and Waterloo, IA CBOC. The following line items presented under Sections A, B & C should be used to estimate the hazardous, non-hazardous, universal and specialty wastes to be removed and disposed of during the year. These are typical wastes that have been removed and disposed of in the past but are not meant to limit the contract to these items or containers. Section A: Hazardous and Universal Wastes (Non-Pharmaceutical Wastes and Non-Dual Wastes) Pickup/Shipment/Disposal IEstimated Cost-Base year- Sections A+B+C+D Since it is difficult to price this service without knowledge of what items will need to be disposed of, the vendor will certify that the “lowest commercial price” will be provided for this service. “Lowest commercial price” means the lowest price at which a sale was made to the public for this service and that the vendor does not provide this service to any other customer at a lower price. PART II – OPTIONAL YEARS 1. DESCRIPTION OF WORK The Contractor shall provide hazardous, non-hazardous, universal (i.e., lamps, aerosol cans, mercury-containing manufactured items, etc.) and specialty (i.e. hazardous pharmaceutical, non-hazardous pharmaceutical and dual [hazardous chemical and bio- hazardous combined]) waste services that include supplies, labeling, lab-packing, consolidation, collection, shipment, manifesting, regulatory inspection, auditing, training, consulting and emergency spill response for the Iowa City VA Health Care System (ICVAHCS) for the base period of one (1) year (period of performance: April 5, 2023 through April 4, 2024), with four (4) optional year renewals. Renewal of an Option Year is subject to availability of the next fiscal year funding-FAR 52.232-19. The Contractor must comply with all applicable Federal (US EPA, US OSHA, US DOT, etc.), State (IDNR, etc.), interstate, national consensus standards (JC), and local requirements, rules, regulations, and laws relative to the handling, removal, manifesting, transportation, management, disposal and/or treatment of hazardous, non-hazardous, universal and specialty wastes. Offers shall be provided in a binder with dividers and table of content. All requested information shall be included in binder. LOCATIONS (See Attachment 1 for List of Points of Contact) REQUIREMENTS AND SCOPE The Department of Veterans Affairs, Iowa City VA Health Care System (ICVAHCS) intends to award a Firm Fixed Price contract to a qualified firm with the capability and capacity to provide lab-packs, removal and disposal services for hazardous, non- hazardous, universal (i.e., lamps, aerosol cans, mercury-containing manufactured items, etc.) and specialty (i.e. hazardous pharmaceutical, non-hazardous pharmaceutical and dual [hazardous chemical and bio-hazardous combined]) wastes from the ICVAHCS locations within Iowa and Illinois in accordance with current federal, state and local regulations. Services shall include all supplies, 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, universal and specialty wastes from the ICVAHCS. Further, the hazardous and non-hazardous pharmaceutical waste program used by the Contractor must utilize the same identification scheme as is in-use at the Facility. This identification scheme uses ½ inch diameter adhesive dots applied to the pharmaceuticals that are regulated as hazardous when they become a waste (a black dot is for hazardous compatible waste and a black dot with an orange triangle in the center with a black exclamation point in its center is for hazardous incompatible wastes). The Contractor and the Facility Contracting Officer’s Representative (Facility COR) from the ICVAHCS located within Iowa will arrange for a routine (non-emergency) service for the facility based upon volume. This will occur on a bi-weekly, quarterly, or other periodic basis depending on rate of generation. The successful offeror must possess the necessary technical expertise and resources required by this solicitation to be considered for contract award. The minimal needs that the government will accept for performance of these services are outlined under Section 4-Licenses and Permits and Section 5.2, FAR Clause 52.212-2 entitled, EVALUATION-COMMERCIAL ITEMS (Jan 1999). RECORDKEEPING/REPORTS: Contractor shall have a centralized waste tracking system that is exportable to the VA system via a Microsoft Excel spreadsheet. The centralized tracking system will include a centralized database for all waste characterizations and determinations, hazardous waste manifests, universal bill of lading for non-hazardous wastes, methods of final (end) disposal, final (end) disposal sites, monthly, quarterly, and annual waste generation reports by facility, training records, and a tracking system for hazardous materials spills.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. This will be readily exported to a format such as Microsoft Excel. INSPECTIONS: The contract will include bi-weekly and monthly inspections and movement of hazardous and non-hazardous pharmaceutical wastes from all satellite accumulation areas at the ICVAHCS. The accumulation areas will be inspected according to guidelines based upon Federal/State regulations and requirements. The inspection checklist will be made available electronically to the facility and reports generated to identify problem areas by facility, satellite accumulation area, by date or other fields deemed appropriate. This contract will not include the disposal of infectious, bio-hazardous, radiological, or pathological waste except for dual (chemical hazardous and bio- hazardous combined) waste. This will be a Blanket Purchase Agreement (BPA)t: The Government shall order the following minimum number of services provided by this contract: (a) Yearly Renewal Options: 100% of the total amounts of services described therein. DESCRIPTION/SPECIFICATIONS/STATEMENT OF WORK General Task Statement: The successful Contractor will be required to provide removal and disposal of hazardous, non-hazardous, universal (i.e., lamps, aerosol cans, mercury-containing manufactured items, etc.) and specialty (i.e., hazardous pharmaceutical, non-hazardous pharmaceutical and dual [hazardous chemical and bio-hazardous combined]) wastes at the Department of Veterans Affairs, ICVAHCS. Additional chemical wastes may be added to this contract by amendment by the Contracting Officer 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 Contracting Officer. Statement of Work: Hazardous and Universal Wastes (Non-Pharmaceutical Wastes and Non-Dual Wastes) The Contractor shall provide services that include supplies, labeling, consolidation, lab- packing, shipment, manifesting, regulatory inspection, consulting and emergency spill response services for the removal and disposal of hazardous, universal, and non- hazardous wastes (non-pharmaceutical and non-dual wastes) from the ICVAHCS (Iowa City VA Medical Center). The period of performance for this contract is from April 5, 2023 through April 4, 2024. Contractor will provide appropriate protection for his/her employees that complies with OSHA and CDC guidelines that include barrier precautions, i.e., gloves, masks, eyewear and/or waterproof gowns, aprons, (lab) coats or respirators as necessary. The Facility COR and/or his/her designee will notify Contractor of areas within the medical center or unusual circumstances requiring personal protective equipment (PPE) beyond standard practices. Contractor will comply with all applicable Federal (US EPA, US OSHA, US DOT, etc.), State (IDNR, etc.), interstate, national consensus standards (JC), and local requirements, rules, regulations, and laws relative to the handling, removal, manifesting, transportation, management, disposal and/or treatment of hazardous, universal, and non-hazardous wastes. Contractor will obtain and retain all necessary permits and/or licenses regarding the handling, removal, transportation and incineration or other acceptable disposition method as regulated by State and Federal US EPA regulations for hazardous and universal waste. This includes any laws in other states that apply to the transportation of hazardous and universal wastes across state lines. Potential successful Contractors may be asked for documentation that will help determine vendor responsibility and whether the transporter is aware of and in compliance with (these) regulatory requirements. While in storage at the Iowa City VA Medical Center, all hazardous, universal, and non-hazardous wastes will be properly separated and/or segregated in a central location (Iowa City VA Medical Center’s Main Hazardous Waste Container Storage Area [Room B110, Building #40]) by Facility staff members. Before shipment off-site, the Contractor will properly inventory, package, lab-pack, label and manifest each container of waste. The labels will be provided by the Contractor. The Contractor will conduct up to four (4) pickups (or visits) for hazardous, universal, and non-hazardous wastes from the Iowa City VA Medical Center’s Main Hazardous Waste Container Storage Area (Room B110, Building #40) per year or on an “as-needed” basis. These pickups will also include the removal and disposal of specialty wastes (i.e., hazardous pharmaceutical waste, non-hazardous pharmaceutical waste and dual [hazardous chemical and bio-hazardous combined] waste) generated at the Iowa City VA Medical Center. The preferred operation schedule is 8:00 a.m. to 4:30 p.m. at regularly scheduled time(s) as required by the Facility. Any additional work required by the Contractor must be approved by the Facility COR and/or his/her designee. In addition, the Contractor’s on-site staff members must check in with the Facility COR or his/her designee prior to beginning any work and after completion. The Contractor’s on-site staff shall have training in hazardous waste handling, packaging, labeling, manifesting, and emergency procedures. This training shall include US EPA, US OSHA, IDNR, and US DOT (including HM 181) regulations. Hazardous and Non-Hazardous Pharmaceutical Wastes The Contractor shall provide services that include supplies, labeling, consolidation, lab- packing, shipment, manifesting, regulatory inspection, consulting and emergency spill response services for the collection, removal, and disposal of hazardous and non- hazardous pharmaceutical wastes from the ICVAHCS. The collection, removal and disposal of hazardous and non-hazardous pharmaceutical wastes will occur at multiple locations within the ICVAHCS (Iowa City VA Medical Center; Burlington, IA Community- Based Outpatient Clinic (CBOC); Cedar Rapids, IA CBOC; Coralville, IA Clinic; Decorah, IA CBOC; Dubuque, IA CBOC; Galesburg, IL CBOC; Ottumwa, IA CBOC; Quad Cities (Davenport, IA) CBOC; Quincy, IA CBOC; Sterling, IL CBOC; and Waterloo, IA CBOC) and may include collection and removal from Pharmacies, Clinical areas, and Research Laboratories. Pharmacy formulary (inventory) waste characterization lists will be provided by the Contractor twice per year (i.e., six months apart) that at a minimum, separates pharmaceuticals into the following categories: compatible, incompatible, and DEA and State scheduled drugs. The period of performance for this contract is from April 5, 2023 through April 4, 2024. Contractor will provide appropriate protection for his/her employees that complies with OSHA and CDC guidelines that include barrier precautions, i.e., gloves, masks, eyewear and/or waterproof gowns, aprons, (lab) coats or respirators as necessary. Facility COR and/or his/her designee will notify Contractor of areas within the medical center or unusual circumstances requiring personal protective equipment (PPE) beyond standard practices. Contractor will comply with all applicable Federal (US EPA, US OSHA, US DOT, etc.), State (IDNR, etc.), interstate, national consensus standards (JC), and local requirements, rules, regulations, and laws relative to the handling, removal, manifesting, transportation, management, disposal and/or treatment of hazardous and non- hazardous pharmaceutical wastes. Contractor will obtain and retain all necessary permits and/or licenses regarding the handling, removal, transportation and incineration or other acceptable disposition method as regulated by State and Federal US EPA regulations for hazardous and non-hazardous pharmaceutical wastes. This includes any laws in other states that apply to the transportation of hazardous and non-hazardous pharmaceutical wastes across state lines. Potential successful Contractors may be asked for documentation that will help determine vendor responsibility and whether the transporter is aware of and in compliance with (these) regulatory requirements. The hazardous and non-hazardous pharmaceutical waste program used by the Contractor must utilize the same identification scheme and accumulation containers as are in-use at the ICVAHCS. Specifically, this identification scheme in uses utilizes ½ inch diameter adhesive dots applied to the pharmaceuticals that are regulated as hazardous when they become a waste (a black dot is for hazardous compatible waste and a black dot with an orange triangle in the center with a black exclamation point in its center is for hazardous incompatible wastes). The accumulation containers in use are Covidien brand and “black” 2-gallon and 8-gallon containers (i.e., Model # 8607RC and Model # 8602RC) are used to accumulate hazardous pharmaceutical wastes. Further, Covidien brand “blue” 2-gallon and 8-gallon containers (i.e., Model # 4008STC and Model # 4002STC) are used to accumulate non-hazardous pharmaceutical wastes. The Contractor will provide ICVAHCS clinical and support staff members with initial and annual training thereafter associated with the pharmaceutical waste program utilized. This pharmaceutical waste program training can be delivered by “face-to-face” classroom, computer-based or web-based methods. Collection of hazardous and non-hazardous pharmaceutical wastes: Iowa City VA Medical Center – Hazardous and non-hazardous wastes will be collected and removed from all clinical areas (i.e., in-patient wards, intensive care units, out-patient clinics, emergency room, pharmacies, etc.) in the Iowa City VA Medical Center. Empty waste collection containers will be placed after the filled waste containers are collected. The filled waste collection containers will be transported by Contractor’s on-site staff using Contractor provided carts to the Iowa City VA Medical Center’s central hazardous and non-hazardous pharmaceutical waste container storage area (Room BS05, Main Hospital Building #1) for temporary on-site storage. The full hazardous and non-hazardous pharmaceutical waste containers will then be transported by Facility staff members to the facility’s Main Hazardous Waste Container Storage Area (Room B110, Building #40) for proper separation, segregation, and final on-site storage. Before shipment off-site, the Contractor will properly inventory, package, lab-pack, label and manifest each container of waste. The labels will be provided by the Contractor. Affiliate Sites: Burlington, IA Community-Based Outpatient Clinic (CBOC); Cedar Rapids, IA CBOC; Coralville, IA Clinic; Decorah, IA CBOC; Dubuque, IA CBOC; Galesburg, IL CBOC; Ottumwa, IA CBOC; Quad Cities (Davenport, IA) CBOC; Quincy, IA CBOC; Sterling, IL CBOC; and Waterloo, IA CBOC - Hazardous pharmaceutical waste collection containers will be placed and maintained in an interior location (i.e. clinical area, utility room, soiled linen room, etc.) at each affiliate site. Filled waste collection containers will be collected and replaced by the Contractor with empty collection containers up to twice per year. Before shipment off-site, the Contractor will properly inventory, package, lab-pack, label and manifest each container of waste. The labels will be provided by the Contractor. The Iowa City VA Medical Center may require a minimum of two (2) hazardous and non-hazardous pharmaceutical waste collection visits in all clinical areas per month. The Contractor will conduct up to twenty-six (26) waste pickups (or visits) per year. Specifically, a maximum of four (4) waste pickups per year will be conducted at the Iowa City VA Medical Center’s Main Hazardous Waste Container Storage Area (Room B110, Building #40) for the removal and disposal of hazardous, non-hazardous, universal (i.e., lamps, aerosol cans, mercury-containing manufactured items, etc.) and specialty (i.e., hazardous pharmaceutical, non-hazardous pharmaceutical and dual [hazardous chemical and bio-hazardous combined]) wastes. Further, up to two (2) waste pickup per year for hazardous and non-hazardous pharmaceutical wastes, and specialty (i.e., hazardous pharmaceutical, non-hazardous pharmaceutical and dual [hazardous chemical and bio-hazardous combined]) wastes may be conducted at each of the following eleven (11) affiliated facilities: Burlington, IA Community-Based Outpatient Clinic (CBOC); Cedar Rapids, IA CBOC; Coralville, IA Clinic; Decorah, IA CBOC; Dubuque, IA CBOC; Galesburg, IL CBOC; Ottumwa, IA CBOC; Quad Cities (Davenport, IA) CBOC; Quincy, IA CBOC; Sterling, IL CBOC; and Waterloo, IA CBOC. The preferred operation schedule is 8:00 a.m. to 4:30 p.m. at regularly scheduled time(s) as required by the Facility. Any additional work required by the Contractor must be approved by the Facility COR and/or his/her designee. In addition, the Contractor’s on-site staff must check in with the Facility COR and/or his/her designee prior to beginning any work and after completion. The Contractor’s on-site staff shall have training in hazardous waste handling, packaging, labeling, manifesting, and emergency procedures. This training shall include US EPA, US OSHA, IDNR, and US DOT (including HM 181) regulations. Contractor will be required to use the Freight Elevator only (applies to Main Hospital Building #1, Iowa City VA Medical Center only) when collecting the hazardous and non-hazardous pharmaceutical waste from the clinical areas. Dual (Hazardous Chemical and Bio-Hazardous Combined) Wastes The Contractor shall provide services that include supplies, labeling, consolidation, lab- packing, shipment, manifesting, regulatory inspection, consulting and emergency spill response services for the removal and disposal of hazardous dual (hazardous chemical and bio-hazardous combined) wastes four (4) times per year from the ICVAHCS (Iowa City VA Medical Center) and up to twice (2) per year from the following eleven (11) affiliated facilities: Burlington, IA Community-Based Outpatient Clinic (CBOC); Cedar Rapids, IA CBOC; Coralville, IA Clinic; Decorah, IA CBOC; Dubuque, IA CBOC; Galesburg, IL CBOC; Ottumwa, IA CBOC; Quad Cities (Davenport, IA) CBOC; Quincy, IA CBOC; Sterling, IL CBOC; and Waterloo, IA CBOC. As a result, stabilizations of this waste may be required and could occur up to twenty-six (26) times per year on dates that meet the requirements of applicable US EPA and IDNR regulations, and the needs of the Department of Veterans Affairs. The period of performance for this contract is from April 5, 2023 through April 4, 2024. Contractor will provide appropriate protection for his/her employees that complies with OSHA and CDC guidelines that include barrier precautions, i.e., gloves, masks, eyewear and/or waterproof gowns, aprons, (lab) coats or respirators as necessary. Facility COR and/or designee will notify Contractor of areas within the medical center or unusual circumstances requiring personal protective equipment (PPE) beyond standard practices. Contractor will comply with all applicable Federal (US EPA, US OSHA, US DOT, etc.), State (IDNR, etc.), interstate, national consensus standards (JC), and local requirements, rules, regulations, and laws relative to the handling, removal, manifesting, transportation, management, disposal and/or treatment of hazardous dual (hazardous chemical and bio-hazardous combined) wastes. Contractor will obtain and retain all necessary permits and/or licenses regarding the handling, removal, transportation and incineration or other acceptable disposition method as regulated by State and Federal US EPA regulations for hazardous dual (hazardous chemical and bio-hazardous combined) wastes. This includes any laws in other states that apply to the transportation of hazardous dual wastes across state lines. Potential successful Contractors may be asked for documentation that will help determine vendor responsibility and whether the transporter is aware of and in compliance with (these) regulatory requirements. While in storage at the Iowa City VA Medical Center, all hazardous dual (hazardous chemical and bio-hazardous combined) waste will be properly separated and/or segregated in a central location (Iowa City VA Medical Center’s Main Hazardous Waste Container Storage Area [Room B110, Building #40]) by Facility staff members. Before shipment off-site, the Contractor will properly inventory, package, lab-pack, label and manifest each container of waste. The labels will be provided by the Contractor. The Contractor will conduct up to four (4) pickups (or visits) for hazardous and non-hazardous wastes from the Iowa City VA Medical Center’s Main Hazardous Waste Container Storage Area (Room B110, Building #40) per year or on an “as-needed” basis. These pickups will also include picking up, removal and disposal of other wastes (i.e., hazardous waste, hazardous pharmaceutical waste, non-hazardous pharmaceutical waste, and universal waste) generated at the Iowa City VA Medical Center. The preferred operation schedule is 8:00 a.m. to 4:30 p.m. at regularly scheduled time(s) as required by the Facility. Any additional work required by the Contractor must be approved by the Facility COR and/or his/her designee. In addition, the Contractor’s on-site staff members must check in with the Facility COR and/or his/her designee prior to beginning any work and after completion. The Contractor’s on-site staff shall have training in hazardous waste handling, packaging, labeling, manifesting, and emergency procedures. This training shall include US EPA, US OSHA, IDNR, and US DOT (including HM 181) regulations. Contractor Furnished Materials and Equipment: The Contractor must utilize the same hazardous and non-hazardous pharmaceutical waste identification scheme and accumulation containers as are in-use at the ICVAHCS. Specifically, this identification scheme utilizes ½ inch diameter adhesive dots applied to the pharmaceuticals that are regulated as hazardous when they become a waste (a black dot is for hazardous compatible waste and a black dot with an orange triangle in the center with a black exclamation point in its center is for hazardous incompatible wastes). The accumulation containers in use are Covidien brand and “black” 2-gallon and 8-gallon containers (i.e., Model # 8607RC and Model # 8602RC) are used to accumulate hazardous pharmaceutical wastes. Further, Covidien brand “blue” 2-gallon and 8-gallon containers (i.e., Model # 4008STC and Model # 4002STC) are used to accumulate non-hazardous pharmaceutical wastes. The Contractor will provide ICVAHCS clinical, pharmacy, and other key support staff members with initial and annual training thereafter associated with the pharmaceutical waste program utilized. This pharmaceutical waste program training can be delivered by “face-to-face” classroom, computer-based or web-based methods. The Contractor will furnish all labels, collection containers, mounting equipment (for use in clinical areas), packing materials for shipping and disposal containers for the hazardous and non-hazardous pharmaceutical wastes and dual (hazardous chemical and bio-hazardous) wastes. Further, the Contractor will provide labels, containers and packing material for shipping 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 the list submitted with their pricing proposal. Licenses and Permits: The Contractor will, without additional cost to the Government, provide and maintain all licenses and permits for operational personnel, trailers, containers, vehicles and other resources required for proper removal and disposal of hazardous, non-hazardous, universal and dual (hazardous chemical and bio-hazardous combined) wastes in accordance with all applicable Federal, State, Municipal, and local regulations (e.g., US EPA, US OSHA, joint Commission, US DOT [including, but not limited to HM-18]). If appropriate licenses are not maintained in accordance with Federal and State requirements, the VA may terminate the contract effective upon discovery. The VA reserves the right to halt work if the Contracting Officer and/or COR determine 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. The following shall be provided to the Contracting Officer 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: Current waste transporter permit(s) the Contractor and subcontractors 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. Copy of Operator permit(s) Certificates of training and experience of Contractor/subcontractor 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). Provide the Contractor’s/subcontractor experience in hazardous waste handling, packaging, transport, and disposal. Provide a copy of US EPA identification number(s) certificate for each business entity operated or contracted by the Contractor that will provide service regarding any aspect of VA waste disposal program (i.e., storage, transfer, incinerator sites). Provided a copy of certificate of registration with the State as a hazardous waste hauler for each business entity operated by the Contractor that will provide hazardous waste transportation services for any aspect of VA waste disposal program. 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. Provide a list of any violations and/or citations that the Contractor and subcontractors have 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. Provide a plan describing Standard Operating Procedures (SOPs) that will be followed while conducting normal hazardous waste management activities. The Contractor shall describe: Site safety and contingency procedures (e.g., spill management). Operational procedures and site management structure. Supplies and equipment practices. Material sampling procedures. Hazard assessment and categorization procedures. Packing procedures. Quality assurance and quality control procedures to ensure materials are properly identified, categorized, and packaged, and paperwork is properly completed. Procedures for gaining waste acceptance into a transfer/disposal facility. Contractor and project management procedures. Provide the following information regarding the hazardous waste fleet owned and operated by the Contractor: Basic description of transportation services offered and capabilities. Fleet description of number, types, and ages of vehicles. Description of service and maintenance programs. Types of materials licensed to haul. Latest US DOT or MCS rating (include a copy of the last inspection). The US DOT/Iowa DOT compliance record. Description of driver qualifications including training programs and experience. Provide evidence that background checks have been performed on all employees that will perform any duties under this contract. Provide the following information on the Contractor's emergency response (ER) capabilities (or any changes to original submission): Contractor's ER policies. ER capabilities and experience and limitations. Type of ER equipment maintained (specify if owned or subcontracted and from whom). Personnel availability, training, and experience. Contractor's emergency response procedure shall describe: How to request an emergency response. How the Contractor notifies personnel and initiates response action. Incident command procedures followed by the Contractor. ER work practices. ER protection of health and safety practices. ER invoicing policy. (m). Provide a detailed site safety plan that will be used to ensure that workers and nearby population will be adequately protected during packaging and removal operations. 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 Facility Industrial Hygiene/GEMS Program Manager and Contracting Officer prior to performing any duties under this contract). The Government reserves the right to prohibit the Contractor from employing the services of a subcontractor who does not possess the ability to satisfactorily perform in accordance with the provisions of this solicitation. The use of a subcontractor or subcontractors does not relieve the Contractor any requirements set forth in this solicitation. The Contractor is responsible for ensuring that any subcontractor(s) perform in accordance with the terms and conditions of this solicitation. Subcontractors will also comply with (j) of this section. 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. Provide written Standard Operating Procedures (SOPs) for the collection, handling, accumulation, sampling, lab testing, characterization, packing and shipping of hazardous wastes, hazardous pharmaceutical wastes, non-hazardous pharmaceutical wastes, and dual (chemical hazardous and bio-hazardous combined) wastes. Provide a single point of contact for each Facility with backup. Location of Pick-Up Points: The Contractor shall be responsible for the pickup of hazardous wastes, hazardous pharmaceutical wastes, non-hazardous pharmaceutical wastes, universal wastes and dual (chemical hazardous and bio-hazardous combined) wastes from multiple storage locations within the IC VAHCS (Iowa City VA Medical Center; Burlington, IA Community-Based Outpatient Clinic (CBOC); Cedar Rapids, IA CBOC; Coralville, IA Clinic; Decorah, IA CBOC; Dubuque, IA CBOC; Galesburg, IL CBOC; Ottumwa, IA CBOC; Quad Cities (Davenport, IA) CBOC; Quincy, IA CBOC; Sterling, IL CBOC; and Waterloo, IA CBOC). 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 the Facility COR or his/her designated representative at each facility. Building Occupancy The VA will maintain full occupancy of the sites for the duration of the services required under this contract unless an exigent emergency 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. The Contractor will be required to use the service elevator only in Building #1, Main Hospital Building at the IC VA Medical Center. Movement of wastes on the patient elevators at the Iowa City VA Medical Center is prohibited. Documentation 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 wastes, hazardous and non-hazardous pharmaceutical wastes, universal wastes, and dual (chemical hazardous and bio-hazardous combined) 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 the Government any additional certifications that may be required because of changes in such laws. The Contractor will provide all manifests and documentation that apply to the removal and disposal of hazardous wastes, hazardous and non-hazardous pharmaceutical wastes, universal wastes, and dual (chemical hazardous and bio-hazardous combined) wastes 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 wastes, hazardous and non- hazardous pharmaceutical wastes, universal wastes, and dual (chemical hazardous and bio-hazardous combined) wastes generated by the Government under the terms of this contract. Prior to the removal and transport of hazardous wastes, hazardous and non- hazardous pharmaceutical wastes, universal wastes, and dual (chemical hazardous and bio-hazardous combined) wastes generated by the IC VAHCS, the Contractor will obtain approval and signature for each manifest from the Facility’s COR or his/her designee verifying that the Contractor has accepted the waste from the VA and that the waste will be properly shipped for treatment or disposal. Manifests not signed by the Facility COR or his/her designee will not be deemed valid. The Contractor will provide the “Generator’s Initial Copy” of each executed manifest (signed by the Generator and Contractor representatives) to the Facility COR or his/her designee before hazardous, non-hazardous, universal, or dual wastes are removed from the Facility. In addition to providing the “Generator’s Initial Copy” of any hazardous, universal, or dual waste manifest, the Contractor will provide to the Facility COR or his/her designee within sixty (60) days of removal of any hazardous, universal, or dual wastes from the Facility, a properly executed copy of the “Designated Facility to Generator” form. The “Designated Facility to Generator” form will clearly indicate that all waste has been properly disposed of and will specify the site and date of disposal or incineration. Exceptions to this requirement must be approved by the Facility COR or his/her designee. 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 format that is exportable to a Microsoft Excel format for input into the VA system. This system should enable tracking of generator status, generate monthly, quarterly, or annual reports, and enable tracking of compliance dates. Removal of the hazardous wastes, hazardous and non-hazardous pharmaceutical wastes, universal wastes and dual (chemical hazardous and bio-hazardous combined) wastes will be normally performed during the hours of 8:00 AM and 4:30 PM, Monday through Friday, excluding National Holidays. The Facility 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. Capability Requirements/Delivery and Performance Schedules: 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. It is the intent of this contract to have a regular hazardous and non-hazardous pharmaceutical waste pickup (or visit) occur in all clinical areas of the Iowa City VA Medical Center (ICVAHCS) on either a bi-monthly or monthly schedule. The responsible Facility COR or his/her designee shall notify the Contractor of the necessity for the pickup for unusual circumstances outside of the normal schedule. The Contractor must coordinate all pickups with the Facility COR or his/her designee. The Contractor will be required to pick up waste within seven (7) calendar days of telephonic notification by government representatives or must be able to respond within 2 hours in the event of a spill or other emergency. The hazardous and non-hazardous pharmaceutical waste inspections at the ICVAHCS will be conducted every two weeks, along with manifesting/packing/shipping performed. The Government requires services on a recurring basis. There shall be no penalty or additional costs incurred should the ICVAHCS require more or less than the estimated pickups or disposal volumes. Definitions /Acronyms: Contract Working Hours : The period of performance by the Contractor which services shall be performed within the contract scope. The minimum coverage for which the government will accept is defined as "8:00 AM through 4:30 PM, Monday through Friday, excluding National Holidays.” CO - Contracting Officer : The person with the authority to enter, administer, and/or terminate contracts, and make related determinations and findings, including changes within the original contract scope, on behalf of the Department of Veterans Affairs. COR - Contracting Officer Representative: Any person(s) designated in writing by the contracting officer to act for the CO within the limits of the delegated authority. Under this contract, the COR (or Facility COR) shall be the VA person who is qualified to render advice and assistance to the Contractor’s service personnel. The Facility COR shall also be responsible for certifying that services performed have been satisfactorily rendered in accordance with contract terms. Contractor Service Representative: Authorized service representative(s) of the Contractor who have been provided by the Contractor to the VA in writing for the purpose of coordination and performance of service. Federal Holidays observed by the VA: New Year's Day (January 1) Birthday of Martin Luther King, Jr. (Third Monday in January) Washington's Birthday (Third Monday in February) Memorial Day (Last Monday in May) Juneteenth National Independence Day (June 19) Independence Day (July 4) Labor Day (First Monday in September) Columbus Day (Second Monday in October) Veterans Day (November 11) Thanksgiving Day (Fourth Thursday in November) Christmas Day (December 25) Identification, Check-in, Parking, Dress, and Smoking Regulations: The vendor's employees shall always wear visible VA Contractor identification while on VA premises. Dress shall consist of uniforms, khakis, or similar clothing along with work shoes. Jeans are not allowed. Contractor employees shall report to the Facility COR or his/her designee’s office once on site prior to commencement of work and obtain a VA Contractor badge which must be always worn while at the ICVAHCS. During off-hours emergency response activities Contractor personnel should check in with VA Police if the Facility COR or his/her designee is not available. Smoking is prohibited at the ICVAHCS. Possession of weapons or contraband is prohibited and shall subject Contractor employee to arrest and termination from future performance under this contract. Enclosed containers, including tool kits, shall be subject to search. Violations of VA regulations may result in citation answerable in the United States (Federal) District Court, not a local district, state, or municipal court. Invoices and Payment. Payment of services rendered under this contract will be made upon satisfactory completion of each service and receipt of a properly prepared invoice and submitted by the Contractor to the payment address shown elsewhere herein (See Attachment 1-List of COR and Addresses to submit invoices). Invoices shall reference the Contract Number and Purchase Order Number, Manifest Number(s), provide a complete and accurate description of services/supplies delivered/rendered, including dates of performance, amounts, unit prices, extended totals, and any other data relevant for payment purposes. The Government shall not authorize payment until such time that the Facility COR or his/her designee receives all properly executed and signed documentation. NOTE: ANY ADDITIONAL CHARGES CLAIMED MUST BE APPROVED BY THE CONTRACTING OFFICER IN WRITING BEFORE SERVICE IS COMPLETED! Record Management Obligations. Applicability This clause applies to all Contractors whose employees create, work with, or otherwise handle Federal records, as defined in Section B, regardless of the medium in which the record exists. Definitions “Federal record” as defined in 44 U.S.C. § 3301, includes all recorded information, regardless of form or characteristics, made or received by a Federal agency under Federal law or in connection with the transaction of public business and preserved or appropriate for preservation by that agency or its legitimate successor as evidence of the organization, functions, policies, decisions, procedures, operations, or other activities of the United States Government or because of the informational value of data in them. The term Federal record: includes Iowa City VA Health Care System (ICVAHCS) records. does not include personal materials. applies to records created, received, or maintained by Contractors pursuant to their ICVAHCS contract. may include deliverables and documentation associated with deliverables. Requirements Contractor shall comply with all applicable records management laws and regulations, as well as National Archives and Records Administration (NARA) records policies, including but not limited to the Federal Records Act (44 U.S.C. chapter 21, 29, 31, 33), NARA regulations at 36 CFR Chapter XII Subchapter B, and those policies associated with the safeguarding of records covered by the Privacy Act of 1974 (5 U.S.C. 552a). These policies include the preservation of all records, regardless of form or characteristics, mode of transmission, or state of completion. In accordance with 36 CFR 1222.32, all data created for Government use and delivered to, or falling under the legal control of, the Government are Federal records subject to the provisions of 44 U.S.C. chapters 21, 29, 31, and 33, the Freedom of Information Act (FOIA) (5 U.S.C. 552), as amended, and the Privacy Act of 1974 (5 U.S.C. 552a), as amended and must be managed and scheduled for disposition only as permitted by statute or regulation. In accordance with 36 CFR 1222.32, Contractor shall maintain all records created for Government use or created while performing the contract and/or delivered to, or under the legal control of the Government and must be managed in accordance with Federal law. Electronic records and associated metadata must be accompanied by sufficient technical documentation to permit understanding and use of the records and data. ICVAHCS and its contractors are responsible for preventing the alienation or unauthorized destruction of records, including all forms of mutilation. Records may not be removed from the legal custody of ICVAHCS or destroyed except for in accordance with the provisions of the agency records schedules and with the written concurrence of the Head of the Contracting Activity. Willful and unlawful destruction, damage or alienation of Federal records is subject to the fines and penalties imposed by 18 U.S.C. 2701. In the event of any unlawful or accidental removal, defacing, alteration, or destruction of records, Contractor must report to ICVAHCS. The agency must report promptly to NARA in accordance with 36 CFR 1230. The Contractor shall immediately notify the appropriate Contracting Officer upon discovery of any inadvertent or unauthorized disclosures of information, data, documentary materials, records, or equipment. Disclosure of non-public information is limited to authorized personnel with a need-to-know as described in the [contract vehicle]. The Contractor shall ensure that the appropriate personnel, administrative, technical, and physical safeguards are established to ensure the security and confidentiality of this information, data, documentary material, records and/or equipment is properly protected. The Contractor shall not remove material from Government facilities or systems, or facilities or systems operated or maintained on the Government’s behalf, without the express written permission of the Head of the Contracting Activity. When information, data, documentary material, records and/or equipment is no longer required, it shall be returned to ICVAHCS control, or the Contractor must hold it until otherwise directed. Items returned to the Government shall be hand carried, mailed, emailed, or securely electronically transmitted to the Contracting Officer or address prescribed in the [contract vehicle]. Destruction of records is EXPRESSLY PROHIBITED unless in accordance with Paragraph (4). The Contractor is required to obtain the Contracting Officer's approval prior to engaging in any contractual relationship (sub-contractor) in support of this contract requiring the disclosure of information, documentary material and/or records generated under, or relating to, contracts. The Contractor (and any sub- contractor) is required to abide by Government and ICVAHCS guidance for protecting sensitive, proprietary information, classified, and controlled unclassified information. The Contractor shall only use Government IT equipment for purposes specifically tied to or authorized by the contract and in accordance with ICVAHCS policy. The Contractor shall not create or maintain any records containing any non- public ICVAHCS information that are not specifically tied to or authorized by the contract. The Contractor shall not retain, use, sell, or disseminate copies of any deliverable that contains information covered by the Privacy Act of 1974 or that which is generally protected from public disclosure by an exemption to the Freedom of Information Act. The ICVAHCS owns the rights to all data and records produced as part of this contract. All deliverables under the contract are the property of the U.S. Government for which ICVAHCS shall have unlimited rights to use, dispose of, or disclose such data contained therein as it determines to be in the public interest. Any Contractor rights in the data or deliverables must be identified as required by FAR 52.227-11 through FAR 52.227-20. Training. The COR is responsible for confirming training has been completed according to agency policies, including initial training and any annual or refresher training. Flowdown of requirements to subcontractors The Contractor shall incorporate the substance of this clause, its terms and requirements including this paragraph, in all subcontracts under this [contract vehicle], and require written subcontractor acknowledgment of same. Violation by a subcontractor of any provision set forth in this clause will be attributed to the Contractor. SAFETY REQUIREMENTS In the performance of this contract, the Contractor shall take such safety precautions as the Contracting Officer or his/her designee may determine to be reasonably necessary to protect the lives and health of VA patients, visitors, staff, and the public. The Contracting Officer 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.