Loren Data's SAM Daily™

SAMDAILY.US - ISSUE OF MAY 18, 2023 SAM #7842
SOLICITATION NOTICE

Q -- FY23: Quarterly Service Collection & Disposal of Expired Drugs

Notice Date

5/16/2023 11:36:11 AM
 

Notice Type

Combined Synopsis/Solicitation
 

NAICS

562219 — Other Nonhazardous Waste Treatment and Disposal
 

Contracting Office

248-NETWORK CONTRACT OFFICE 8 (36C248) TAMPA FL 33637 USA
 

ZIP Code

33637
 

Solicitation Number

36C24823Q1189
 

Response Due

5/19/2023 4:00:00 PM
 

Archive Date

06/03/2023
 

Point of Contact

Karina A Miranda, Contract Specialist, Phone: 561-517-1533
 

E-Mail Address

Karina.miranda@va.gov
(Karina.miranda@va.gov)
 

Awardee

null
 

Description

This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in Federal Acquisition Regulation (FAR) subpart 12.6, Streamlined Procedures for Evaluation and Solicitation for Commercial Items, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; quotes are being requested, and a written solicitation document will not be issued. This solicitation is issued as an RFQ. The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular 2015-4573 effective 12-27-2022. Please provide your quotes by Friday, May 19, 2023 by 4PM. This solicitation is set-aside for: SDVOSB The associated North American Industrial Classification System (NAICS) code for this procurement is 562219, with a small business size standard of $47 million. The FSC/PSC is Q517. The Department of Veterans Affairs Network Contracting Office 8-West Palm Beach, FL is seeking an SDVOSB to provide all necessary labor, materials, tools, equipment, and supervision for the installation and delivery of the Perimeter Wireless Camera System: All interested companies shall provide quotations for the following: See attachment Scope of Work, See attachment B Price Cost Schedule, See attachment C Clauses & Provision, See attachment D Wage Determination. Place of Performance/Place of Delivery Department of Veterans Affairs West Palm Beach VAMC(548) 7305 North Military Trail West Palm Beach, FL 33410-6400 The full text of FAR provisions or clauses may be accessed electronically at http://acquisition.gov/comp/far/index.html. The following solicitation provisions apply to this acquisition: FAR 52.212-1, Instructions to Offerors Commercial Items. FAR 52.212-3, Offerors Representations and Certifications Commercial Items www.sam.gov registration is required to be complete at time of submission of response. Offerors must complete annual representations and certifications electronically via the System for Award Management (SAM) website located at https://www.sam.gov/portal in accordance with FAR 52.212-3, Offerors Representations and Certifications Commercial Items. If paragraph (j) of the provision is applicable, a written submission is required. The following contract clauses apply to this acquisition: FAR 52.212-4, Contract Terms and Conditions Commercial Items (OCT 2018) FAR 52.212-5, Contract Terms and Conditions Required to Implement Statutes or Executive Orders (JUN 2020) ADDENDA 2 to 52.212-2 (a) Gray market items are Original Equipment Manufacturers (OEM) goods sold through unauthorized channels in direct competition with authorized distributors. This procurement is for new OEM medical supplies, medical equipment and/or services contracts for maintenance of medical equipment (i.e. replacement parts) for VA Medical Centers.  No remanufactures or gray market items will be acceptable.   (b) Vendor shall be an OEM, authorized dealer, authorized distributor or authorized reseller for the proposed medical supplies, medical equipment and/or services contracts for maintenance of medical equipment (i.e. replacement parts), verified by an authorization letter or other documents from the OEM, such that the OEM s warranty and service are provided and maintained by the OEM.  All software licensing, warranty and service associated with the medical supplies, medical equipment and/or services contracts for maintenance of medical equipment shall be in accordance with the OEM terms and conditions. (c) The delivery of gray market items to the VA in the fulfillment of an order/award constitutes a breach of contract.  Accordingly, the VA reserves the right enforce any of its contractual remedies. This includes termination of the contract or, solely at the VA s election, allowing the Vendor to replace, at no cost to the Government, any remanufactured or gray market item(s) delivered to a VA medical facility upon discovery of such items.  The following subparagraphs of FAR 52.212-5 are applicable: All quotes shall be sent to the karina.miranda@va.gov Award will be based upon a comparative evaluation of quotes in accordance with the Simplified Acquisition Procedures of FAR 13. Comparative evaluation is the side by side pairwise comparison of quotes based on factors resulting in a Contracting Officer decision for the quote most favorable to the Government. The purpose of this solicitation is to establish a contract with a reverse distributor with destruction capability, hereafter referred to as the Contractor, capable achieving maximum credit return and in processing any related pharmaceutical waste that may arise out of non-returnable pharmaceuticals. The Government's need for on-site and off-site processing function is imperative to assure optimum inventory control and to minimize the violation of laws and regulations. The contractor shall be compliant with all applicable regulations related to hazardous waste handling. It is the intent that an efficient returns processing method where expired pharmaceuticals shipped to a centralized reverse distributor will reduce total costs in the health care system through a system of inventory controls and report analytics, while maintaining all necessary internal controls to ensure accuracy throughout the entire process. The Government will require a Contractor that can supply inventory scanning software as a service for use by the site and the vendor so a report can be generated to identify and address any item and its box location for any discrepancies so identified discrepancies can be addressed prior to expired inventory leaving the site. The Government will also require the Contractor also be the returns depot for current Prime Vendor so complete direct data from Prime Vendor can be generated with invoices so the site can review all credits provided with actual credit recovery, not estimated return value. Returns to be processed will cover expired pharmaceuticals and pharmaceuticals due to be expire within 120 days from authorized agencies approved to participate in the VA s Pharmaceutical Prime Vendor (PPV) program. The contractor may not hold any expired pharmaceuticals identified as greater than 120 days from expiration and must immediately destroy identified product. The government will also require a fee for service payment model to ensure the contractor is paid for services provided, and independent of the total amount of credit value achieved to avoid previous and current regulatory violations identified during current ongoing investigations. AWARDS The Government requires a one-year base period with a potential five-year period of performance. The Government will make this award based on Technical Capability and ability to address current issues identified by regulatory bodies, Past Performance, and Price. The proposed reverse distribution service fee shall be a firm fixed fee per site visit and priced according to class of trade and frequency of site visit. The firm fixed site visit service fee should cover all the contractor s costs including, but not limited to, packaging, shipping, processing, software as a service application, waste disposal, and any other applicable costs or fees incurred in performance of reverse distribution and waste disposal services. Award will be made base year and option year one through four. To be considered for award, offerors are required to submit a proposal for all line items inside and outside the Customs Territory of the United States for the base year and each of the four option years. Proposals that fail to include fees for the base year and each of the four option years for all line items will be rejected and will receive no further consideration. ESTIMATED ANNUAL REQUIREMENTS Miami VAHS estimated pharmaceutical expired returns for 2021 to 2022 averaged $678,000 annually. The Government guarantees that it will order a minimum of 20 annual site visits from this solicitation. The total ceiling for West Palm Beach VAHS will be a total of 110 site visits, inclusive of the base year all four option years and the 6-month option to extend. REGULATORY COMPLIANCE The Contractor shall be required to provide all plant, materials, and labor needed to process credit return and/or arrange for proper disposal of designated pharmaceuticals, including Schedule II-V controlled substances for the Customs Territory of the United States. Schedule II-V returns are not permitted from outside the Customs Territory of the United States. Contractor shall be responsible for complying with all applicable federal regulations such as the Code of Federal Regulation (CFR) Title 21 Food & Drugs, Title 29 Hazardous Materials, 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 hazardous and non-hazardous unserviceable and non-returnable items or returns. This includes but is not limited to DEA, DOT, EPA, FDA, OSHA and individual State regulations. The 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 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 reverse distribution operations. All vehicles shall have proper State and Federal Department of Transportation (DOT) licenses required for the transportation of hazardous wastes for each jurisdiction in which they will be operating under this contract. SHIPPING/PROCESSING ARRANGEMENTS Miami VAHS designated employee will mutually coordinate with the Contractor directly to arrange for a return shipping date. The Contractor shall provide all instructions, forms, and labels needed to ship the designated items to a Contractor's central processing facility. Contractor will work on-site to electronically scan and generate a list of all pharmaceuticals and prepare their outdated products for shipment to the reverse distribution facility for processing. A copy of the contractor s on-site inventory report will be available in the same format as the contractor s supplied, facility itemized electronic list. Contractor must also provide software as a service and/or electronic methods to cross reference site electronic record against contractor electronic record to identify discrepancies. Reverse distributor product may not leave site until all discrepancies have been resolved. The Contractor is responsible for the shipment and associated costs from the facility to the Contractor s reverse distribution facility. Product status shall be provided via the contractor s web-based reporting system within three (3) business days after processing is complete. The Contractor shall provide on-site servicing within ten (10) business days from the date of the facility request. The Contractor shall not separate returnable from non-returnable pharmaceuticals on-site, instead the Contractor shall package the designated returns and transport them to the Contractor s facility where the determination will be made concerning product that is returnable and product that is waste. The Contractor shall arrange for pick up controlled substance returns from the facility within 1 business day of service unless a delay is requested by site. The Contractor shall arrange for pick up non controlled substance returns from the facility within 3 business days of service, unless a delay is requested by site. 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. Within thirty (30) days of receiving the returned goods, the Contractor shall process all designated items by sorting, listing, and processing items through either a manufacturer's credit program or through the disposal process in accordance with all applicable federal, state and local regulations. The Contractor shall comply with participating customers additional security requirements and procedures for access to facilities. PHARMACEUTICALS QUALIFYING FOR MANUFACTURER'S RETURN Products qualifying for manufacturer s return are pharmaceuticals, including partials pharmaceuticals, in the original manufacturer containers. Everything else is considered waste and facilities must follow applicable federal, state, and local laws and ordinance for waste disposal. Any items removed during a facility s service event will be processed and associated to a single order that is unique to that service event. PHARMACEUTICALS INELIGIBLE FOR CREDIT FROM MANUFACTURER The Contractor shall list all items (including non-controlled and controlled substances and non-hazardous and hazardous substances) designated for disposal on a disposal manifest. This list will include at a minimum product name, National Drug Code (NDC) or catalog number, quantity, total estimated return value, and reason for non-eligibility for credit. Separate manifests shall be provided for the disposal of Schedule II V controlled substances and when disposing of hazardous waste products as defined by the EPA Resource Conservation and Recovery Act (RCRA) regulations. A Certificate of Destruction including the disposal date, destruction method, destruction location, weight, disposal company name and proof of destruction affidavit shall be available to the returning facility and maintained on the reporting website upon completion of destruction. All Manifests shall be available 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. Shipments to the Contractor that require transport to the disposal location shall be done via approved and licensed vehicles in accordance with federal, state, and local laws and regulations where the processing will be completed. Contractor spills or releases of toxic/hazardous substances into the environment shall be reported to the returning facility immediately. PAYMENTS Awards shall be paid directly from the Government, not through credits, under a firm fixed fee. The firm fixed site service fee is assessed either monthly or quarterly based upon a prior agreed to service level commitment. For monthly service, site is invoiced on the 20th of each month. Monthly site service must be scheduled prior to the 20th of each month. For quarterly service, site is invoiced on the 20th of the month of service. Quarterly site service must be scheduled prior to the 20th of the last month of the quarter. The firm fixed site visit service fee should cover the contractor s costs including, but not limited to, packaging, shipping, processing, software as a service application, waste disposal, and any other applicable costs or fees incurred in performance of reverse distribution and waste disposal services. Within 15 days from receipt of award, the VA National Acquisition Center Contracting Officer shall be notified by the contractor awarded a contract under this solicitation if any business-to-business-agreements cannot be reached with the VA PPV. Failure or refusal to reach agreement with the VA PPV shall constitute sufficient cause for terminating the contract under Federal Acquisition Regulation Part 52.212-4(m), Contract Terms and Conditions-Commercial Items, Termination for Cause unless such failure is unintentional and for valid and justifiable reasons despite good faith discussions. The Contractor is encouraged to establish a working relationship with each manufacturer and comply with each manufacturer s return goods policy to ensure maximum credit receipt and reduce the cost of returning non-returnable items. The Contractor is responsible for contacting the manufacturer to ensure that credits are received in accordance with the negotiated timeframe stated in each return goods policy and to assist in resolving issues of inadequate or non-payment of outstanding credits. If manufacturers have an established reverse distributor that handles their credit and return process, the awarded Contractor shall make every effort to work with these reverse distributors that have current agreements directly with the manufacturers. The site service fee is fixed and there will be no adjustments based on credits received. NOTE: There may be instances where more favorable return good policies have been negotiated on Federal Government contracts. In order to take advantage of more favorable return policies, the Government Contracting Officer will assist in providing a copy of the negotiated agreement(s) to the Contractor. There may be manufacturers that will only accept returns directly from the facility and will only provide credits through their own reverse distributor. If known, the Contractor shall identify in its proposal, those manufacturers that will not accept products through this Reverse Distribution Program. WEB-BASED TRACKING OF CREDITS To ensure adequate tracking of credits from inception to disposition, the Contractor shall make available the PPV confirmation of itemized credit statements received from the manufacturers at least monthly. To ensure full visibility of all credit amounts against the item(s) credited, the contractor must also be a reverse distributor for the PPV. The contractor shall instruct manufacturers to issue all credits directly to the PPV since the PPV has credit accounts established for each authorized user of the PPV Program for purposes including reverse distribution. Any credits received by the Contractor from the manufacturer shall be forwarded to the PPV within ten (10) business days from date of receipt. In addition, each agency/facility that receives credits directly from the manufacturers as a result of reverse distribution processing will be instructed to notify the Contractor of receipt of such credits so that the Contractor can update their electronic reporting system. Credits will be deposited into the individual facility accounts by the PPV upon receipt of itemized credit statements for each individual facility provided by the Contractor. The credit statements provided by the Contractor to the PPV shall include the customer account number and appropriate invoice number to facilitate this process and for tracking purposes. Based on the above, any arrangements to facilitate the processing of credits through the PPV must be made solely between the Reverse Distributor and the PPV. Any fees associated with this arrangement shall not be removed from the facility credits due. Credits may NOT be used by VA PPV customers for additional value-added services from the Contractor, such as report customization or additional site visits, for VA facilities. IMPLEMENTATION PLAN Billing requires the ability to accept both credit card (Visa and MasterCard) and invoice options depending on the value of the transaction. Individual orders will specify the local options. Additional information regarding invoicing procedures is included in the clauses. CONTINGENCY PLAN The contractor shall submit and maintain a plan for contingency operations, which identifies the ability to provide uninterrupted support of the requirements outlined in this solicitation under emergency and/or contingency conditions. REPORTS The Contractor shall make available a return detail report by manufacturer to each returning facility within (30) calendar days after processing for all credit returns. This report should include at a minimum, the customer account number, applicable order or invoice number, product name, NDC or catalog number, lot or batch number, quantity returned, date returned, unit of measure, estimated return value, and a list of non-returnable pharmaceuticals with the weight and cost for disposal. An additional credit report shall be provided showing both the estimated credits and actual credits received, including total actual credit received and credit received by unit of measure for each NDC, as well as the date that the credit was issued, and identify contractor fees taken for each pharmaceutical return. The contractor shall make available copies of the manufacturer credit memos with this report to ensure adequate tracking of credits from inception to disposition. Separate reports shall be provided for Schedule II V controlled substances and for hazardous waste to include weight of disposal. The Contractor shall provide a web-based reporting tool that will generate the following reports: Order Credit Credit Detail Returns Analysis Returns Dashboard Aging Dashboard Manufacturer Analysis Manufacturer Analysis Detail Master Store Detail VA Reporting Requirements: Each NDC processed should contain the minimal data points: Contract Number Account Number ITAG Number Order Number Receive Date Original Process Date NDC Product Name Manufacturer Name DEA Class Expiration Date Returnable Flag Waste Reason Code Hazardous Flag Unit Price Quantity Estimated Return Value (Extended Price) Recall Flag Aged Flag Unaged Flag Aging Processing Date Manufacturer Debit Memo Number Return Authorization Number Item Disposition* Item Status Amount Credited Prime Vendor Credit Memo Number Amount Waiting Credit DASHBOARD REPORTING REQUIREMENT The reverse distribution vendor shall provide a web-based corporate level dashboard and reverse distribution information system available to the user at each facility or each agency for the purpose of managing, tracking and comparing the processing of unused pharmaceutical returns across the government service or agency. The web-browser based application is the preferred and required type of digital dashboard specified by this contract. The reverse distribution information system shall provide for multiple levels of access based upon the users level within the government service or agency (e.g., office of the surgeons general, regional or local facility) and shall provide data elements based upon standard variables (see paragraph 17, reporting requirements for metric and key performance indicators). The digital dashboard and reverse distribution information system shall be configured to track the flow of business processes associated with the return, destruction, disposal, waste, credit or other disposition of unused pharmaceuticals processed from the agency through the reverse distributor. The system shall provide graphic representation (i.e., dials, graphs, charts, etc.) of high-level processes and allow for drill down into low level data, with the purpose of allowing agency executive level leaders the ability to view and make comparisons of return processes and data across the agency. The dashboard shall use standardized metrics and key performance indicators and display these data points to allow comparison between different levels of the agency (i.e., agency or service level, and regional level). The digital dashboard shall display data elements in both a control panel format and database table format. Users will be able to generate and export data from the control panel into a downloadable spreadsheet (e.g., Excel spreadsheet). The digital dashboard and reverse distribution information system will allow users to monitor the return of unused pharmaceuticals through the vendor and compare the activities of the various levels (i.e., agency or service level, and regional level). Features and benefits of the dashboard and reverse distribution information system shall include: visual presentation of performance measures; ability to identify and correct negative trends; measure of efficiencies/inefficiencies; ability to generate detailed reports showing new trends; overall visibility of the activities across an agency or service; efficient identification of data outliers and correlations. The dashboard application will provide decision makers with the input necessary to manage the reverse distribution business process by providing a web-based graphical user interface designed to display summaries, graphics (e.g., charts, graphs, gauges) in a portal-like framework to highlight important information and benchmark across a corporate, regional and treatment facility level so that the amount of pharmaceutical credits across the systems can be maximized. TRAINING REQUIREMENTS The Contractor shall provide, at no cost to the Government, orientation and training down to the facility level on the various reports and functionality of reports to assist the facilities in monitoring and tracking potential credits. Training shall include actual demonstration and operation of the web-based electronic service request ordering system. In addition, the Reverse Distributor shall provide updates and system changes, and training prior to the adoption of changes as they occur throughout the term of the contract. Training should be provided on-site at each participating customer s facility. The contractor shall notify all sites 14 calendar days before the date of their scheduled training. Training shall cover at a minimum the following: Full web access and reports training, including targeted data extrapolation. Credit detail reports displaying estimated and actual credits. Potential inventory management strategies. An instructional user guide with step-by-step instructions on the above topics shall also be provided via a link on the reporting website. A contact person and telephone number shall be provided to each facility in the event additional instruction is necessary or if there is a change in personnel. CONTRACT ADMINISTRATION AUTHORITY The Contracting Officer is the only person authorized to approve changes 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 VA personnel officially designated as Ordering Officers under the Reverse Distribution contract or 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. Ordering Officer Designations pertain only to the VAMCs. Other Government Agencies will place orders in accordance with their facility policies and procedures. FEDERAL GOVERNMENT HOLIDAYS The following information is provided to assist the Contractor in scheduling returns when on-site service is required: New Year's Day January 1st Martin Luther King's Birthday Third Monday in January President's Day Third Monday in February Memorial Day Last Monday in May Independence Day July 4th Labor Day First Monday in September Columbus Day Second Monday in October Veterans Day November 11th Thanksgiving Day Fourth Thursday in November Christmas Day December 25th *If these holidays fall on a Saturday or Sunday, the contractor should contact the returning facility to determine on which day (Friday or Monday) they will be observed. PHARMACEUTICAL PRIME VENDOR The following represents the current VA Pharmaceutical Prime Vendor as of the date of this solicitation. The Contractor will be given notice via e-mail within 90 days when a change occurs. McKesson Corp. Pharm. Group 1220 Senlac Drive Carrollton, TX 75006 Point of Contact: Ms. Lori White, V.P. National Accounts Phone: 972-446-5758 Fax: 972-446-5337
 

Web Link

SAM.gov Permalink
(https://sam.gov/opp/2151d4bd8f7749e595a02619f338f1e4/view)
 

Place of Performance

Address: Department of Veterans Affairs Network Contracting Office 8 (NCO 8) West Palm Beach VA Medical Center 7305 North Military Trail, Palm Beach Gardens, FL 33410-6400, USA

Zip Code: 33410-6400

Country: USA
 

Record

SN06683733-F 20230518/230517212021 (samdaily.us)
 

Source

SAM.gov Link to This Notice
(may not be valid after Archive Date)

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