S205--Controlled Substance Disposal Services

B.2 STATEMENT OF WORK Background Information VA Medical Center pharmacies are required to dispose of expired or unusable DEA scheduled controlled substance once quarterly. Scope Pharmacy Service located in Fayetteville, Little Rock and North Little Rock AR and Springfield, MO has a need for DEA registered controlled substance retrieval and destruction from each site. This requirement will be for services provided quarterly for each location or as designated by each site. Pharmacy locations require on-site processing and collection of controlled substances to minimize the violation of laws and regulations. especially in the area of pharmaceutical waste disposal. The contractor shall be compliant with all applicable regulations related to controlled substance handling and destruction (as required in 21CFR 1317). Returns to be processed will cover expired controlled substance pharmaceuticals and controlled substances due to expire in the future or ones that are otherwise unusable. **NO CREDIT FOR RETURNS TO BE COLLECTED OR HELD FOR LATER DATE** 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. 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, recommend, 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: 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. This includes required licenses, certifications, etc. for individual contractor staff as well as any required permits and licenses for interstate transport, and storage/disposal of expired or unusable DEA scheduled II-V controlled substances. This includes but is not limited to DEA, DOT, EPA, FDA, OSHA and individual State regulations. The Contractor or designated sub-contractor shall be a licensed DEA registrant to handle Schedule II - V controlled substances. 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 and be prepared to list the VA, IHS, BOP, IHSC and other approved federal agencies as additional insured if awarded a contract. A copy of such insurance coverage shall be provided to the Contracting Officer, upon request. CONTRACTOR AND SUBCONTRACTOR LICENSE QUALIFICATIONS REQUIREMENTS: The Contractor and any respective subcontractors shall 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 center or outpatient clinic will communicate with the Contractor directly to establish an agreed upon on-site service date. 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 pharmacy locations or as agreed upon: VA Pharmacy Fayetteville 1100 North College Ave. Fayetteville, AR 72703 VA Pharmacy Springfield CBOC 1850 W. Republic Rd. Springfield, MO 65807 VA Pharmacy McClellan Veterans Hospital · 4300 W 7th St, Little Rock, AR 72205 VA Pharmacy Towbin 2200 Fort Roots Drive, North Little Rock, AR 72114 Other Sites To Be Determined estimate travel costs per mile. Contractor will provide a documented listing of controlled substance pharmaceuticals for return and prepare these for shipment to the processing facility. The returns will be processed using the Contractor s on-site representative. The Contractor is responsible for the shipment and associated costs from the facility to the Contractor s facility. On-site service, disposition shall be provided to each facility following completion of the services. The Contractor shall prepare a list of controlled substance pharmaceuticals removed from the pharmacy and the facility must validate the contents of the list for accuracy. Any discrepancies shall be resolved prior to the removal of the pharmaceuticals from the facility by the Contractor. 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.). 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. Chain of custody paperwork shall be prepared for controlled substances and given to the returning facility by the Contractor at the time the package(s) are prepared for shipment. The Contractor shall process all designated items through the disposal process in accordance with all applicable federal, state and local regulations. 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. CONTRACT ADMINISTRATION AUTHORITY: The Contracting Officer is the only person authorized to approve changes task orders or modifications to the requirements under this contract on behalf of the Government. In the event the Contractor makes any changes at the direction of any person other than the Contracting Officer, such changes shall be considered to have been made without authority and any adjustments in price involved as a result of unauthorized changes to the contract will not be ratified. Each facility will have a designated Contracting Officer s Representative (COR) who will serve as a point of contact for all matters pertaining to the technical aspects of the contract. At time of contract award, or upon appointment the Contractor will be furnished with a copy of the COR s appointment letter. CORs have limited authority as delineated by the cognizant Contracting Officer in their appointment letter and cannot make any commitment obligating the Government. In addition to designated CORs that will be responsible for all technical aspects of the contract, each facility will have a designated Ordering Officer or Contracting Officer. Only NCO 16 personnel officially designated as warranted contracting officers may place orders under this contract. Ordering Officers do not have the authority to negotiate, make any commitments or changes that will affect the terms and conditions of this contract. TECHNICAL EXHIBIT 1 Performance Requirements Summary The Contractor service requirements are summarized into performance objectives that relate directly to mission essential items. The performance threshold briefly describes the minimum acceptable levels of service required for each requirement. These thresholds are critical to mission success. Performance Objective Standard Performance Threshold Method of Surveillance PRS # 1. The Contractor shall provide sufficient staffing of narcotic inventory specialists to complete narcotic pick-up in each area in one work day from 8-4:30. This includes all paperwork needed to satisfy all local and federal rules and laws outlined in SOW. The Contractor provided adequate staffing in order to complete all tasks outlined in PWS within an 8 hour day between the hours of 8:00am and 4:30pm Monday through Friday between the timeframe of 78-89 days since last pickup. 100% POC monitor inventory process / printed reports, with corrections/ final reports checked and corrections made if necessary / report to COR. PRS # 2 The Contractor shall provide all reporting requirements outlined in SOW that meet or exceed all local or federal laws and rules described in SOW. Contractor provides all inventory reports in Microsoft format in the correct time frame outlined by SOW. 100% Facilities / Inventory POC will report to COR on the day of pickup and again when final invoices are received. PRS # 3 The contractor shall supply all material needed to pick up narcotics for destruction, produce reports, and ship narcotic medication to Contractor s site of destruction. Communicate with local POC 100% Facilities/Inventory point of contact will report to COR PRS # 4 The Contractor shall not leave each site until all needed reports and paperwork match completely according to local and federal law/rules. Use of printed lists from contractor and VA site must match completely and be signed with wet signature 100% Facilities/ Inventory point of contact will report to COR