PWS Reverse Distribution Center Hazardous Waste Disposal REV.docx

VISN 19 Reverse Distribution Center Hazardous Waste Disposal Performance Work Statement

1. DESCRIPTION OF SERVICES

1.1 INTRODUCTION:

a. The VISN 19 Reverse Distribution Center (RDC) located in Cheyenne, Wyoming occupies leased space. The RDC operates under the Resource Conservation and Recovery Act’s (RCRA) Subpart P for hazardous waste pharmaceuticals and provides a centralized processing center for organizing and returning potentially creditable, expired or soon-to-expire, un-used, non-dispensed, pharmaceuticals for manufacturer credit. Operations at the RDC consist of record-keeping and handling potentially creditable, expired or soon-to-expire, un-used, non-dispensed, pharmaceuticals in manufacturer original containers. Items received are sorted according to source facility and manufacturer. Items deemed as non-returnable become waste and require removal, hauling and disposal services.

1.2 SCOPE:

a. The Contractor shall provide disposal of Environmental Protection Agency’s (EPA), Resource Conservation and Recovery Act (RCRA) defined hazardous pharmaceutical waste. Services must 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 wastes from the RDC.

b. The Contractor, and Subcontractor if applicable, shall provide and maintain all licenses and permits to conduct waste removal to final disposal.

c. The Contractor shall possess the necessary technical expertise and resources required by this solicitation to be considered for contract award.

d. The Contractor shall provide disposal for spills/releases of hazardous materials/wastes. Not to include any remediation waste.

e. The Contracting Officer (CO) may designate a Contractors Officers Representative (COR) to act for him/her in furnishing technical guidance and advice to generally monitor the work to be performed under this contract. Such a designation will be in writing and will define the scope and limitation of the COR’s authority. A copy of the designation shall be furnished to the Contractor.

f. The COR will arrange for routine (non-emergency) waste pickup based upon rate of generation. However, out-of-cycle pickups may be required for episodic events.

g. Services will be provided during a 12-month base period f9ollwed by 4 one-year Government option periods.

h. Work will normally be performed between the hours of 8:00 AM and 4:00 PM local time, Monday through Friday, excluding National Holidays. The facility COR or satellite designees are available during those hours for the approval of manifests and other required documentation, unless unusual circumstances require services during an unscheduled time period.

1.3 DEFINITIONS OF SERVICES

· Reverse Distributor - means any person that receives and accumulates prescription pharmaceuticals that are potentially creditable pharmaceuticals for the purpose of facilitating or verifying manufacturer credit. Any person, including forward distributors, third-party logistics providers, and pharmaceutical manufacturers, that processes prescription pharmaceuticals for the facilitation or verification of manufacturer credit is considered a reverse distributor.

· Hazardous Pharmaceuticals – Pharmaceuticals under Subpart P that are characteristic or listed and are not eligible for reverse distribution, are over the counter, prescription, or supplements.

· Characteristic Hazardous Waste –

· Ignitable - Wastes that are hazardous due to the ignitability characteristic include liquids with flash points below 60 °C, non-liquids that cause fire through specific conditions, ignitable compressed gases, and oxidizers.

· Oxidizer is an example of ignitable. It is a substance such as chlorate, permanganate, inorganic peroxide, or a nitrate, that yields oxygen readily to stimulate the combustion of organic matter.

· Corrosive - Wastes that are hazardous due to the corrosivity characteristic include aqueous waste with a pH of less than or equal to 2, a pH greater than or equal to 12.5 or based on the liquids ability to corrode steel.

· Reactive - Wastes that are hazardous due to the reactivity characteristic may be unstable under normal conditions, may react with water, may give off toxic gases and may be capable of detonation or explosion under normal conditions or when heated.

· Aerosols can be a characteristic of reactivity if they are capable of detonation or explosive reaction when subjected to a strong initiating source or if heated under confinement.

· Toxic - Wastes that are hazardous due to the toxicity characteristic are harmful when ingested or absorbed. Toxic waste presents a concern as they may be able to leach from waste and pollute groundwater.

· Listed Hazardous waste - A waste is determined to be a hazardous waste if it is specifically listed on one of four lists (the F, K, P and U lists) found in title 40 of the Code of Federal Regulations (CFR) in Part 261 and meets either the process based or sole active ingredient requirements.

· Subpart P removes these listed characteristics for pharmaceuticals. Locations may still have unused commercial U-listed chemicals outside of pharmaceuticals; acetone, methanol, phenol, and xylenes. There will be no P-listed waste outside of Subpart P.

· The VA does not have any K-listed. There are processed based F-listed wastes that may include spent non-halogenated solvents.

· Non-hazardous Pharmaceuticals- pharmaceuticals that are not characteristic or listed as described above.

· Bulk Chemo – classified under the National Institute of Occupational Safety and Health (NIOSH) Table 1 as a hazardous drug or antineoplastic but is not a RCRA hazardous waste pharmaceuticals.

2.0 SPECIFIC REQUIREMENTS:

2.1 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 of hazardous and non-hazardous chemical waste in accordance with all applicable Federal, State, Municipal, and local regulations (e.g. OSHA, DEA, EPA, DEP, 49 CFR (DOT). 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.

2.1.1 Current waste transporter permit(s)

2.1.2 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, EPA identification 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 prior to, during or after contract period.

2.1.3 Copy of Operator permit(s)

2.1.4 All technicians/chemists that will work on VA premises will be expected to have received at least the minimum training required by law as specified in state requirements and in 29 CFR 1910.120, 40 CFR Part 263 and 49 CFR 172 and site-specific training by existing personnel and or project manager prior to working at each site. Technicians/chemists must be fully trained in how to label and properly store hazardous waste for the state they are working in

2.1.5 Provide the contractor’s experience in hazardous waste packaging, transport, and disposal. Provide details of contracts of similar nature and similar size, particularly regarding hospitals and universities. Provide a copy of waste minimization audits that the contractor has successfully conducted and examples of waste minimization opportunities realized.

2.1.6 Provide a copy of US EPA identification number(s) and certificate for each business entity operated by or that will have waste shipped to, that the contractor that will use to provide service regarding any aspect of the VA waste disposal program (i.e. storage, transfer, and/or incinerator sites).

2.1.7 Provided a copy of certificate of registration with the State or EPA as a hazardous waste hauler for each business entity owned or operated by the contractor that will provide hazardous waste transportation services for any aspect of VA waste disposal program.

2.1.8 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 for each site that may handle or manage VA waste. The 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, the contractor must provide a statement that certifies no discharges or violations have occurred.

2.1.9 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/CHP compliance record.

7. Description of driver qualifications including training programs, and experience.

8. Provide evidence that background checks have been conducted on all employees that will perform duties under this contract.

9. The usage of any alternative fuel vehicles and or use of alternative fuels

10. Prohibition of idling procedures.

2.1.10 Provide written Standard Operating Procedures (SOPs) for the collection, handling, accumulation, sampling, lab testing, characterization, packing and shipping of hazardous waste.

2.1.11 Provide a certificate of all appropriate insurance.

2.2 LOCATIONS AND FREQUENCIES

RDC is located at:

5353 Yellowstone Road Suite 221 Cheyenne, WY 82009

Reverse Distributors are not categorized by generator size and have specific requirements. When waste is generated, it can only be stored for 180 days.

At most there will be two picks up a year, but the government reserves the right to not have a pickup some years due to lack of waste.

2.4 WASTE MANAGEMENT, REMOVAL, DISPOSAL INVOICING:

a. The Contractor shall be responsible for the collection of hazardous waste pharmaceuticals. The wastes shall be segregated, when necessary, by hazard class, chemical compatibility, and/or land disposal restriction and labeled appropriately.

b. The Contractor shall consolidate all wastes in the manner most cost effective and beneficial to the Government. The Contractor shall have the capability to supply waste collection containers of various sizes, mounting hardware, labels, foot pedal stands and labor to install if necessary.

c. The Contractor shall properly containerize all lab-packs and assume all safety measures (example: PPE) to prevent harm or injury to VA patients, visitors, employees, Contractor employees and the environment (example: storm drain covers). The VISN GEMS Program Managers, VISN Safety Manager, VISN Pharmacy Executive and local RDC Pharmacists 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 must be followed up by a written stop work order issued by the Contracting Officer as soon as feasible after the imminently hazardous situation has been stabilized or abated.

d. Should waste be released during the performance of services under this contract, through no fault of the VA facilities, the Contractor shall be responsible for all costs associated with the satisfactory remediation of the incident. This shall 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 must be performed to the satisfaction of the appropriate regulatory authorities, the VISN GEMS Program Manager or designee and the CO.

e. The Government requires services on a recurring basis.

1. Based on the frequencies listed in Section §2.2, the Contractor shall present a schedule to the CORs within 30 days of award. If the agreed upon schedule cannot be met at any time, the Contractor shall provide the following in writing to the COR; the reason for the delay and the anticipated date when the shipment will be made. This notification must be made within 24 hours of identifying the conditions causing the delay.

2. The Contractor shall have a large enough fleet to meet the frequency needs of Section §2.2 and have access to, or own enough, TSDFs to ensure waste is removed timely.

f. There shall be no penalty or increased costs of service rates should the RDC require more or less than the estimated pickups or disposal volume outlined in the schedule of costs. In the event an out-of-cycle pick up is requested, the Contractor shall schedule shipment of material within seven (7) calendar days of receipt of a written/verbal request from the COR and make pickup within 30 calendar days after receipt of the written/verbal request. If pickup cannot be scheduled or executed on the agreed upon date, the Contractor shall provide the following in writing to the COR; the reason for the delay and the anticipated date when the pickup will be made. This notification must be made within 24 hours of identifying the conditions causing the delay.

g. The Contractor shall provide all manifests, waste profiles, land bans, certificates of destruction and recycling, and documentation that apply to the removal and disposal of hazardous waste conducted by its workforces and/or its Subcontractors in compliance with all current Federal, State, and local regulations, policies, and procedures. Upon request the Contractor shall provide an electronic copy of the manifest within forty-eight (48) hours prior to the onsite services. All documentation completed by the Contractor shall be properly executed and neatly hand- written or typed to ensure the legibility of all copies. Locations will submit an inventory prior to pickup and ask the Contractor to provide a cost estimate and how each waste stream will be packaged for transport. Certificates of disposal shall include the disposal method for each waste stream. Contractor shall use a calibrated scale to accurately record the weight of each waste container on all shipping documents.

h. Prior to the removal and transport of hazardous, universal, and non-hazardous waste generated by the VA, the Contractor shall obtain approval and signature for each manifest from the COR or designee verifying that the Contractor has accepted the waste from the VA and that the waste was properly shipped for treatment or disposal. The Generator copy, Generator State Copy and Destination State Copy of the executed manifest will be provided to the RDC staff. A signed Designated Facility copy of each manifest certifying receipt of the waste covered by the manifest must be provided to the facility within thirty (30) calendar days of initial transport. All parties shall use eManifest via RCRAid.

i. All hazardous and non-hazardous materials generated by VISN 19 facilities must be disposed of by the Contractor in accordance with current Federal, State, and local guidelines governing regulated hazardous and non-hazardous wastes. Comment by Schick, James R.: Does this need to be updated to reflect services only applicable to RDC?

j. The Contractor shall dispose of hazardous waste in a manner that leaves no future expense potential to the VA or the federal government. Chemicals will be disposed of in the following preferred priority:

1. Recycling of chemicals for future use.

2. Fuel blending or energy recovery.

3. Incineration at a Part B permitted incineration.

4. Treatment of the chemical waste (at a facility approved for such processing by an appropriate state or federal agency) using neutralization, stabilization or landfill in a manner that renders it no longer a hazardous waste as defined in 40 CFR Part-268/Subpart-D.

5. The long-term internment (burial) in a secure landfill site approved for such by the appropriate state or federal agency.

k. Acceptance of the hazardous waste at a properly permitted treatment, storage, or disposal site does not constitute disposal and/or completion of the contract. The Contractor shall obtain and provide necessary documentation to prove that the timely end disposal of all items has been accomplished including certificates of recycling and final disposal certificates within 375 calendar days of the shipment date.

l. Shipments outside of this country are prohibited under this contract unless prior approval is received in writing from the COR.

m. Waste amounts identified on the pricing sheet are only estimates.

2.5 TRAINING:

a. Training shall include a review of the contractors Standard Operating Procedures (SOPs) that will be followed while conducting normal hazardous waste 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 and analysis procedures.

5. Hazard assessment and categorization procedures.

6. Material collection, handling, accumulation, packing and labeling 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.

10. Written green purchasing program and provide environmentally preferable options for supplies as defined in Section §6.0(b).

11. Security program for onsite operations.

b. Training can either be virtual or face-to-face.

3.0 WASTE MINIMIZATION:

To comply with the Pollution Prevention Act §13101(b) and VA Directive 0057 VA Environmental Management Program, the VA must establish a ways to reduce or eliminate the amount of any hazardous substance, pollutant or contaminant entering any waste stream or otherwise released into the environment (including fugitive emissions) prior to recycling, treatment or disposal. To assist, the Contractor shall routinely evaluate industry disposal options that provide less environmental impact (e.g., waste to energy, recycling). The Contractor shall evaluate the VA’s removed waste streams annually for opportunities for waste management efficiency and minimization and provide each VA Healthcare System with a written report identifying which waste streams were reviewed and any opportunities for consideration. This report shall also include any purchases of containers that meet affirmative procurement standards.

4.0 DELIVERABLES:

a. For Proposal:

1. All items stated in Section §2.1 of this PWS

2. A summary of the Contractor’s experience in hazardous waste storage, packaging, transport, and disposal. Provide details of contracts of similar nature and similar size, particularly regarding hospitals and research facilities. Provide three(3) references with current contact information for each requirement.

3. Provide three (3) examples of waste minimization audits that the Contractor has successfully conducted, and examples of waste minimization opportunities realized. The submission should include examples of waste minimization practices or programs that the Contractor has developed for other facilities. Specific examples from healthcare or research facilities are preferred.

b. Duration of Contract:

1. The Contractor shall provide all manifests, land bans, certificates of destruction and recycling, and documentation that apply to the removal and disposal of hazardous waste conducted by its workforces and/or its subcontractors in compliance with all current Federal, State, and local regulations, policies, and procedures and in accordance with the quality standards and timelines established in Section §2.4 of this PWS.

2. The Contractor shall provide a quarterly report to the COR/POC within ten (10) calendar days of the end of the fiscal quarter that identifies types and weights of wastes shipped from each facility listed in Section §2.1 and provides a breakdown of the costs of services and the specific services provided to each facility in the previous months.

3. The Contractor shall be required to attend quarterly program meetings with the COR/POC and CO to address contract performance. These meetings may take place virtually or at one of the VISN 19 facilities. Should contract deficiencies arise, meetings may be held on a more frequent basis to resolve any/all issues. The Contractor shall provide draft meeting minutes to the COR for review within seven (7) calendar days of the meeting and final minutes within seven (7) calendar days of the COR’s draft review. The minutes will accurately document meeting participants and the discussions and decisions that took place during the meeting.

5.0 RECORDKEEPING/REPORTS:

a. Contractor shall have a centralized waste tracking system that can be used via the internet and that can export all hazardous waste data to the VA via a Microsoft Excel spreadsheet, or other manner approved by the COR/POC. The centralized tracking system will include a database for all waste characterizations and waste analytics, universal bill of lading for universal wastes, methods of final (end) disposal, certificates of disposal, and invoice copies.

b. All manifests, waste analytics, waste generation data, shipping information and other data required for the proper execution of this contract shall be maintained by the contractor in an electronic database format that is exportable through Microsoft Excel or other manner approved by the COR/POC. This system should enable tracking of generator status, generate monthly, quarterly, or annual reports, and enable tracking of compliance dates.

6.0 CONTRACTOR FURNISHED MATERIALS AND EQUIPMENT:

a. The contractor is responsible for providing all transportation, equipment, materials, and labor to perform the services set forth in the Agreement.

b. The contractor shall furnish all lab pack and overpack containers, packing material for lab packs, labels, and any routine field supplies to package waste for transport at no additional cost to the government. The Contractor shall give preference for the following materials used at VA sites:

1. EPA designated items listed in EPA procurement guidelines at 40 CFR part 247

2. USDA designated items listed in procurement guidelines 7 CFR part 3201, Subpart B

3. EPA designated items on EPA’s Comprehensive Procurement Guidelines

c. Service costs shall include level D PPE and nitrile gloves.

d. The contractor shall furnish bulk waste storage containers. The contractor shall provide a list of containers meeting affirmative procurement standards and pricing with their proposal. Containers shall be replaced one for one when picked up.

7.0 GOVERNMENT FURNISHED PROPERTY AND SERVICES:

a. The VA will not provide any equipment, fuel, personnel, or facilities to the Contractor for the execution of this contract. Should an emergency arise, only the necessary basic lifesaving and life support measures will be provided during the emergency.

b. The VA will furnish electricity and water at existing outlets for use as may be required for the work to be performed under the contract.

8.0 IDENTIFICATION, CHECK-IN, PARKING, AND SMOKING REGULATIONS:

The vendor's employees shall always wear visible identification while on VA premises. Contractor employees shall call facility the COR, or POC in §2.2, once on campus prior to commencement of any work. During off-hours emergency response activities Contractor personnel should check in with VA Police if the VA COR or designee is not available. Smoking is prohibited on any VA property. Possession of weapons or contraband is prohibited and may subject contractor employees to arrest and termination from future performance under this contract. Enclosed containers, including tool kits, must 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.

9.0 INVOICES AND PAYMENT:

Payment of services rendered under this contract will be made in arrears 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. Invoices must 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.

A copy of the invoice will be sent to the Facility COR. The Government must not authorize payment until such time that the VA Contracting Officer’s Representative receives all properly executed and signed documentation.

NOTE: ANY ADDITIONAL CHARGES CLAIMED MUST BE APPROVED BY THE CO IN WRITING BEFORE SERVICE IS COMPLETED!

11.0 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 general 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.

All of the Contractor’s personnel shall uphold the same standard of conduct and performance as all other federal employees and services shall be performed in compliance with VA policies and procedures. All policies and regulations pertaining to protection of patient privacy (HIPPA) and the safeguarding of patient information must be observed. The Contractor shall protect sensitive information at all times and notify the COR if they come across any sensitive information.