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DISCLAIMER: This Sources Sought is issued solely for information and planning purposes and does not constitute a solicitation. Neither unsolicited proposals nor any other kind of offers will be considered in response to this Sources Sought. Responses to this notice are not offers and will not be accepted by the Government to form a binding contract. Responders are solely responsible for all expenses associated with responding to this Sources Sought. All information received in response to this RFI that is marked Proprietary will be handled accordingly. Responses to the Sources Sought will not be returned. At this time, questions concerning the composition and requirements for a future Request for Quote will not be entertained.

SUBJECT: The Department of Veterans Affairs is conducting market research in order to provide Controlled Substance Removal (Destruction Only) Services for the entire VISN (See SOW for locations below, entire VISN 5) VA Medical Center. The Government anticipates awarding a 5 year firm fixed price SATOC (Single Award Task Order Contract) that will provide the support services listed within the below Draft Statement of Work.

OBJECTIVE: See attachment.

RESPONSE INSTRUCTIONS:

Name and Address of Company
Any small business designation as certified by the Small Business Administration
A through description of experience in managing support requirements of this nature.

CONTACT INFORMATION: Any questions related to this Sources Sought shall be directed to Mark Smith at Mark.Smith25@va.gov. All information regarding Capabilities Statements or any other proprietary information relative to this Sources Sought shall be submitted via email to Mark.Smith25@va.gov no later than 3:00 PM EST on 11/17/2021.

Proposed Statement of Work

1. Contract Title: Destruction of expired Controlled Substance medications (IDIQ)

2. Background: This is a new request for an IDIQ contract for destruction of controlled substance pharmaceuticals due to the lapsing of the VA Pharmacy Benefits Management contract that previously was available system wide within the VA. VA will not accept reverse distribution and will only accept destruction of these pharmaceuticals.

3. Scope. The Medical Centers within VISN 5 are seeking a contractor to process and remove DEA scheduled controlled substances from VISN 5 facilities for destruction. These pharmaceutical s will be either expired or in a condition that is not suitable for human consumption.

4. Specifications/Characteristics:

Contractor Requirements
REGULATORY COMPLIANCE:
The contractor shall be required to provide all plant, equipment, materials, and labor needed to process proper disposal of Schedule II-V controlled substances designated pharmaceuticals and legend drugs.  Contractor shall be responsible for complying with all applicable federal regulations such as the Code of Federal Regulation (CFR) Title 21 Food & Drugs, Title 40 Protection of the Environment, Title 49 Department of Transportation: U.S. Environmental Protection Agency (EPA), Occupational Safety and Health Administration (OSHA), Food and Drug Administration (FDA), Drug Enforcement Administration (DEA), 41 U.S.C. chapter 67, Service Contract Labor Standards and VA regulations. The Contractor shall also comply with applicable state/local regulations and consult with regional offices of the federal regulatory agencies that have jurisdiction over their operations to ensure compliance with laws and regulations of host countries. Accordingly, the Contractor shall arrange for and/or advise the returning drug distribution point of the proper means of transporting the returned products to the Contractor’s central processing facility.

LICENSES, PERMITS, REGISTRATION, INSURANCE:
The contractor is required to be licensed with the Drug Enforcement Agency (DEA) as a reverse distributor to handle Schedule II V Controlled Substances.
All necessary permits and licenses required by Federal, state, and local authorities shall be acquired and maintained by the Contractor for the life of the contract including required licenses, certifications, etc. for individual contractor staff.
Any required permits and licenses for interstate transport, and storage/disposal of expired or unusable DEA scheduled II-V controlled substances and legend drugs including, but not limited to DEA, DOT, EPA, FDA, OSHA and individual State regulations.
A copy of all renewals shall be forwarded to the contracting officer for retention in the contract file.
The Contractor shall have proper insurance coverage, including environmental remediation. A copy of such insurance coverage shall be provided to the Contracting Officer, upon request.

CONTRACTOR LICENSE QUALIFICATIONS REQUIREMENTS:
The Contractor maintain all necessary licenses, permits and certifications required by the Resource Conservation and Recovery Act, Clean Air Act, Clean Water Act, Occupational Safety and Health Administration, and all licenses and permits required by local agencies for destruction operations.

SHIPPING/PROCESSING ARRANGEMENTS:
The VA medical centers will communicate with the Contractor directly to establish an agreed upon on-site service date once every other month (six times per year). The Contractor shall provide all instructions, forms, labels and DEA approved tamper-proof pouches needed to ship the designated items to a Contractor’s central processing facility. The Contractor will provide work on-site in the following pharmacy locations:

Baltimore VA Medical Center
10 North Greene Street
Baltimore, MD 21201
Phone: 410-605-7000, Toll Free: 1-866-441-0287

Perry Point VA Medical Center
VA Medical Center
Perry Point, MD 21902
Phone: 410-642-2411, Toll Free: 1-800-949-1003

Beckley VAMC
200 Veterans Ave
Beckley, West Virginia 25801
Phone: 304-255-2121, Ext., 4798

Louis A. Johnson VA Medical Center
1 Medical Center Drive
Clarksburg, WV 26301
Phone: 304-623-3461

Hershel Woody Williams VA Medical Center
1540 Spring Valley Drive
Huntington, WV 25704
Phone: 304-429-6755, Ext., 2310

Martinsburg VAMC
510 Butler Avenue
Martinsburg, WV 25405
Phone: 304-263-0811, Ext. 3141

Washington DC VAMC
50 Irving Street NW
Washington, DC 21001
Phone: 202-745-8000

                     
REQUIREMENTS:

Service Frequency:
At a minimum of every other month or more often as requested by each facility Pharmacy Chief, the contractor shall be required to process all designated Controlled Substances through the disposal/destruction process in accordance with all applicable federal, state, and local regulations.

On-Site Process:
The Contractor shall comply with any participating customers additional security requirements and procedures for access to facilities. All costs associated with gaining access to any customer facility shall be the responsibility of the Contractor. The contractor shall package the items for destruction on-site at the facility within Pharmacy. The contractor shall remove or pick up controlled substance returns from the facility by close of business the same day as service is completed and boxed for return. Large or special pickups requiring separate removal shall be scheduled within 48 hours of service, and daily updates will be provided to the facility until pickup is complete. The Contractor is responsible for the shipment and associated costs from the facility to the Contractor s facility.

Disposal Manifest:
The Contractor shall list all controlled substances designated for disposal on a disposal manifest (chain of custody paperwork) and a DEA form 222 (when appropriate) will be generated and a copy left within the pharmacy and the narcotic vault with facility validation for accuracy prior to the removal of medications from the facility. Any discrepancies shall be resolved prior to removal of the pharmaceuticals from the facility by the Contractor. The manifest list will include at a minimum product name, National Drug Code (NDC) or catalog number, strength, dosage form, and quantity. The contractor representative must sign the document listing the controlled substances transferred from VA to the destruction company and the appropriate DEA Forms (222, 41 etc.).

Certificate of Destruction:
A Certificate of Destruction for controlled substances including the disposal date, destruction method, destruction location, weight, disposal company name and proof of destruction affidavit shall be provided to the returning facility and maintained on the reporting website upon completion of destruction. All Manifests shall be provided to the returning facility within 30 calendar days of Contractor’s item receipt, with the exception of the Certificate of Destruction/Affidavit which shall be provided within 30 days of the completion of destruction.

5. Delivery.

See the locations list above in #4.