Statement of Work - DEA Hazardous Drug Waste.docx

STATEMENT OF WORK (SOW)

DEA Hazardous Drug Removal & Disposal

Background The successful contractor shall provide all secured containers, installation, removal, replacement, packaging, shipping, and disposal of waste Drug Enforcement Agency (DEA) Schedule Controlled pharmaceutical wastes at the Department of Veterans Affairs, Eastern Colorado Healthcare System (ECHCS). Before the work, the Contractor shall provide a practical and economical hazardous drug (DEA controlled substance) disposal system (with associated hardware) and implement it with the approval of the Contracting Officer, Pharmacy Service, and Green Environmental Management System (GEMS) Program Manager for the Rocky Mountain Regional VA Medical Center (RMRVAMC).

Scope

Changeout and inspection walkthroughs by Contractor are for Eastern Colorado Health Care System (ECHCS). Work shall be performed in accordance with all applicable, Federal, State, Local and all governing regulations. {Note: “Hazardous Waste” means wastes that are so designated under the Resource Conservation and Recovery Act (RCRA) in 40 CFR Part 261.3. “Universal Waste” is a specific subset of “Hazardous Waste” and is defined in 40 CFR Part 273, and 6 CCR 1007-3 Part 273.}

The Contractor shall accomplish only compliant collection and transfer of wastes from satellite accumulation points within the VA Facility to the central accumulation point.

Only professional and respectful coordination shall be utilized with the VA Facility.

When within VA Facility property, the Contractor shall maintain cleanliness compliant with applicable hospital infection control standards for their equipment, vehicles, and staff. See Appendix A for where collection and accumulation points are generally located in RMRVAMC. The Contractor shall then compliantly package and ship from the VA Facility to only disposal locations certified for this purpose under applicable federal and state environmental compliance regulations.

This work requires a PIV card issued by the VA with shall be in possession of the Contractor’s employees beforehand, or as scheduled with the Contracting Officer, or their designated representative. The processing time for obtaining the PIV card shall be the responsibility of the Contractor at a cost already included in the proposal.

Wastes may be stored at multiple locations throughout the medical center complex with approval of the GEMS Program Manager. The Contractor shall be responsible for properly containerizing all lab-packs and shipping containers, 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 Contracting Officer, or their designated representative, has 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 Contracting Officer as soon as possible after the imminently hazardous situation has been stabilized or abated.

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 VA Facility and harm caused to patients, visitors, and staff of the medical center. The remediation efforts shall be performed to the satisfaction of the GEMS Program Manager.

Wastes generated by the VA Facilities shall be managed and disposed of by the Contractor in accordance with current Federal, State, and local guidelines governing regulated hazardous and non- hazardous chemical wastes.

Salient Characteristics Should Include

· System shall securely fit into existing locations without modifications to existing infrastructure, staff use, ergonomics, security, and performance.

· Maximum system dimensions: 5.5 in. D x 9.25 in. W x 9.5 in. H.

· Secure and locking wall bracket for container storage which can only be installed to behind the wall structural supports.

· One-way disposal path for waste.

· Deactivation, deterring and solidification agent to prevent drug diversion.

· Disposal must be performed by vendor and be done via incineration.

Contractor Furnished Materials and Equipment

The Contractor shall furnish all containers and packing materials for waste disposal/shipment.

Licenses and Permits

The Contractor shall, 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 wastes under this contract in accordance with all applicable Federal and Colorado Department of Public Health and Environment (CDPHE) laws and regulations. If appropriate and current licenses are not maintained in accordance with Federal and CDPHE requirements, the VA may terminate the contract effective upon discovery. The VA reserves the right to halt work if the Contracting Officer and/or POC 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.

Documentation

For each disposal brand to be considered, the Contractor shall submit a functioning example to the Contracting Officer, or their designated representative, for review and approval before the work. The Contractor shall comply with all Federal, State, and local regulations, policies and procedures regarding tracking, record keeping, manifesting and documentation of wastes. The contractor shall comply with all changes to Federal, State, and local regulations; procedures which occur during the term of this contract; and current versions of applicable regulations. The Contractor shall provide to the Government any additional certifications that may be required because of changes in such laws.

The Contractor shall provide all manifests and documentation (e.g., land disposal restrictions, certificates of destruction, etc.) that apply to the removal and disposal of hazardous, universal, and non- hazardous chemical wastes conducted by its workforces and/or its subcontractors. The Contractor shall furnish a properly executed and legible copy of the appropriate manifests required to document the safe shipment and proper disposal of waste generated by the Government under the terms of this contract. Contractor shall immediately correct any identified deficiencies discovered in manifests and documentation in a timely manner.

Prior to the removal and transport of waste generated by the VA, the Contractor shall obtain approval and signature for each manifest from the ECHCS POC or the ECHCS GEMS Program Manager 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 ECHCS POC or the ECHCS GEMS Program Manager 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 respective VA Facility within 30 days) shall be provided to the ECHCS Safety Office when waste is disposed of, as applicable, and before the removal of any waste from the VA Facilities. Use and compliance with electronic Environmental Protection Agency (EPA) manifest system is mandatory by the contractor.

In addition to providing the manifests, the Contractor shall provide a compliantly executed and signed disposal certificate for each manifest to the ECHCS POC within sixty (60) 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. Exceptions to this must be approved by the Contracting Officer, or their designated representative, in writing.

The contractor shall provide an annual report summarizing the prior year’s waste shipments – types of waste, classifications, and weights to the POC on or before December 1.

Capability Requirements/Delivery and Performance Schedules

Removal of the hazardous, universal, and non-hazardous chemical wastes will be normally performed during the hours of 8:00 AM and 3:00 PM, Monday through Friday, excluding National Holidays. The POC is available during those hours for the approval of manifests and other required documentation unless exigent circumstances require services during an unscheduled period.

Contractor representatives who perform services under this contract (to include those coming to ECHCS facilities for pick-ups) must be competent, experienced, and qualified to perform such services listed herein. The Contractor shall submit proof of appropriate training and experience for vendor personnel performing services in accordance with applicable regulations. The Contractor representatives shall be required to obtain PIV badge and wear appropriate personal protective equipment (provided by the Contractor) for certain locations such as, but not limited to, Operating Rooms, Medication Rooms, and Treatment Rooms. It is the intent of this contract to have regular pick-up depending on the VA Facility’s needs. The Contracting Officer, or their designated representative, or the GEMS Program Manager, shall notify the Contractor of pick-ups for unusual circumstances outside of the normal schedule. Typically, RMRVAMC should be picked up during normal business hours once per week. The Contractor must coordinate all pickups with the Contracting Officer, or their designated representative, GEMS Program Manager. The Contractor will also be required to pick up waste within seven (7) calendar days of telephonic and email notification by government representatives. The Government requires services on a recurring basis. There shall be no penalty or additional costs incurred should the VA require more or fewer than the estimated pickups or disposal volume outlined in Appendix A.

Appendix A.

Clinics:

Note:

RMRVAMC Room numbers are classified using facility code letter, floor level, and room number as follows in this example:

K2-234 K – Building K 2 – 2nd Floor 234 – Room Number

5. Place of Performance.

Contractor shall support the following locations within Eastern Colorado Health Care System (ECHCS). Additional locations may be incorporated into the contract through a formal modification process initiated upon receipt of notification from the Contracting Officer (CO) following the award of the contract.

1. Rocky Mountain Regional VA Medical Center 1700 N. Wheeling Street Aurora CO 80045 Quantity: 40 containers

2. PFC Floyd K. Lindstrom Clinic at Colorado Springs 3141 Centennial Boulevard Colorado Springs, CO 80907 Quantity: 1 container

3. Pueblo Outpatient Clinic 4776 Eagleridge Circle Pueblo, CO 81008 Quantity: 1 container

4. Golden Outpatient Clinic 1020 Johnson Road Golden, CO 80401 Quantity: 1 container

5. Valor Point Domiciliary 7350 W Eastman Place Lakewood, CO 80227 Quantity: 1 container

6. Castle Rock Outpatient Clinic 3753 Dacoro Lane Castle Rock CO 80109 Quantity: 1 container

7. Lieutenant Colonel John W. Mosley VA Clinic 21825 East Quincy Avenue Aurora, CO 80018-3155 Quantity: 1 container

8. Jewell VA Clinic 14400 East Jewell Avenue Aurora, CO 80012-5689 Quantity: 1 container