36C24125Q0579.docx

SUBJECT*

Medication Reverse Distribution

GENERAL INFORMATION

SET-ASIDE

VAMC Connecticut

950 Campbell Ave Manchester NH 03104

POINT OF CONTACT*

Contract Specialist Jerry Choinski Jerry.Choinski@va.gov 203-932-5711

PLACE OF PERFORMANCE

830 Chalkstone Avenue

Providence RI

ADDITIONAL INFORMATION

AGENCY’S URL

URL DESCRIPTION

EMAIL DESCRIPTION

Sources Sought Notice Sources Sought Notice

DESCRIPTION

Sources Sought Notice

This is a Sources Sought notice only. This is not a request for quotes and no contract will be awarded from this announcement. The Government will not provide any reimbursement for responses submitted in response to this Source Sought notice. Respondents will not be notified of the results of the evaluation.

If a solicitation is issued it shall be announced at a later date, and all interest parties must response to that solicitation announcement separately. Responses to this notice are not a request to be added to a prospective bidders list or to receive a copy of the solicitation.

The purpose of this announcement is to perform market research to gain knowledge of potential qualified sources and their size classification relative to NAICS 562211 (Hazardous Waste Collection) with a size standard $47.0 million. The Department of Veterans Affairs (VA), Network Contracting Office 1 (NCO 1) is seeking to identify any vendor capable of providing services to the Providence, RI VAMC facility and establishing a contract with a reverse distributor, hereafter referred to as the Contractor, capable of assisting the Department of Veterans Affairs (VA) Veterans Integrated Service Network 1 (VISN 1), in processing expired, and unusable pharmaceuticals from each site, including DEA registered controlled substances.. All services shall be performed in accordance with the terms and conditions specified in this solicitation and in compliance with the performance work statement.

This Sources Sought notice provides an opportunity for respondents to submit their capability and availability to provide the requirements described below. Vendors are encouraged to submit information relative to their capabilities to fulfill this requirement, in the form of a statement that addresses the specific requirement identified in this Sources Sought. Information received from this Sources Sought shall be utilized to facilitate the Contracting Officer’s review of the market base, for acquisition planning, size determination, and procurement strategy.

Submission Instructions: Interested parties who consider themselves qualified to perform the services are invited to submit a response to this Sources Sought Notice by 12:00 EST, 1st of August 2025. All responses under this Sources Sought Notice must be emailed to Jerry.Choinski@va.gov with Sources Sought #36C24125Q0579 in the subject line. Telephone inquiries will not be accepted or acknowledged, and no feedback or evaluations will be provided to companies regarding their submissions.

Interested parties should complete the attached Sources Sought Worksheet. Parties may submit additional information related to their capabilities, provided it contains all the requirements contained in the Sources Sought Worksheet. Responses to this Sources Sought shall not exceed 8 pages. In addition, all submissions should be provided electronically in a Microsoft Word or Adobe PDF format.

Attachment 1 Sources Sought Worksheet

QUALIFICATION INFORMATION:

Company / Institute Name: _______________________________________________________ Address: ______________________________________________________________________ Phone Number: ________________________________________________________________ Point of Contact: _______________________________________________________________ E-mail Address: ________________________________________________________________ Unique Entity Identifier (UEI) #: ___________________________________________________ CAGE Code: __________________________________________________________________ SAM Registered: (Y / N) Other available contract vehicles applicable to this sources sought (GSA/FSS/NASA SEWP/ETC): __________________________________________________________________

SOCIO-ECONOMIC STATUS:

VIP Verified SDVOSB: (Y / N) VIP Verified VOSB: (Y / N) 8(a): (Y / N) HUBZone: (Y / N) Economically Disadvantaged Women-Owned Small Business: (Y / N) Women-Owned Small Business: (Y / N) Small Business: (Y / N) NOTE: Respondent claiming SDVOSB and VOSB status shall be registered and Center for Veterans Enterprise (CVE) verified in VetBiz Registry www.vetbiz.gov.

BASED ON THE RESPONSES TO THIS SOURCES SOUGHT NOTICE/MARKET RESEARCH, THIS REQUIREMENT MAY BE SET-ASIDE FOR SDVOSB, VOSB, SMALL BUSINESSES OR PROCURED THROUGH FULL AND OPEN COMPETITION.

CAPABILITY STATEMENT:

Provide a brief capability and interest in providing the service as listed in Attachment 2 Statement of Work with enough information to determine if your company can meet the requirement. The capabilities statement for this Sources Sought is not a Request for Quotation, Request for Proposal, or Invitation for Bid, nor does it restrict the Government to an ultimate acquisition approach, but rather the Government is requesting a short statement regarding the company’s ability to provide the services outlined in the SOW. Any commercial brochures or currently existing marketing material may also be submitted with the capabilities statement. This synopsis is for information and planning purposes only and is not to be construed as a commitment by the Government. The Government will not pay for information solicited. Respondents will not be notified of the results of the evaluation.

Providence (650) Pharmaceutical Reverse Distribution Performance Work Statement

1. General / Scope The purpose of this solicitation is to establish one contract with a reverse distributor, hereafter referred to as the Contractor, capable of assisting the Department of Veterans Affairs (VA) Providence Healthcare System, in processing expired, and unusable pharmaceuticals from each site, including DEA registered controlled substances. Returns will be separated into those that are deemed returnable for credit through the VA’s Pharmaceutical Prime Vendor (PPV), and non-credit worthy pharmaceuticals.

The Pharmacies will require on-site processing and collection of all medications including controlled substances, to minimize the violation of laws and regulations, especially in the area of pharmaceutical waste disposal or credit. 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 medications, including controlled substance pharmaceuticals, and medications due to expire in the future or ones that are otherwise pharmacy deemed unusable, including patient returned medications.

Return vendor / contractor requirements:

0. Locations This contract will be for Providence, RI VA Medical Center only. Located at 830 CHALKSTONE AVENUE PROVIDENCE, RI 02908.

1. Contracting requirements

1. Regulatory The Contractor shall be required to provide all equipment, packaging materials, and labor needed to process and arrange for proper reverse distribution or disposal of designated pharmaceuticals, including Schedule II-V controlled substances, for contracted facilities. 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. Accordingly, the Contractor shall arrange for, recommend, and/or advise the VISN 1 VA pharmacy of the proper means of transporting the products for manufacturer credit to the Contractor's central processing facility.

1. Licenses, Permits 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 and any affiliated subcontractors 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 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. The Contractor and any respective subcontractors 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.

1. Contractor/Subcontractor 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.

1. Shipping/Processing arrangements Each facility will contact the Contractor directly to arrange for return credit service date. The Contractor shall schedule on-site servicing within ten (10) business days from the date of the facility request (service to be provided within 21 days) and provide all instructions, forms, labels, and DEA required tamper-proof containers/pouches (as applicable) that are needed to transport the designated items to a Contractor's central processing facility. The Contractor shall comply with any participating facilities’ additional security requirements and procedures for access to facilities.

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. The VA facility designee will validate the contents of the Contractor’s inventory for accuracy by comparing it to the facility’s own return inventory. 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. All discrepancies shall be resolved prior to the removal of the pharmaceuticals from the facility by the Contractor. Reverse distributor product may not leave site until all discrepancies have been resolved.

All services required as part of the pick-up must be included in the firm-fixed price. If the pick-up order requires more than one day to complete, the Contractor shall ensure that all controlled substance returns are reviewed and boxed for shipping from the facility by close of business on the same day of service. Chain of custody paperwork including a signed receipt for all Schedule III-V and DEA Form 222 for Schedule II shall be prepared for controlled substances and given to the returning facility by the Contractor at the time the package(s) are prepared for transport. During reverse distribution processing, if any controlled substances are destroyed, the DEA registered reverse distributor must submit a DEA Form 41 to the DEA when the controlled substances have been destroyed. The DEA Form 41 shall not be used to document the transfer of controlled substances from the pharmacy to the reverse distributor. If requested, a copy of the DEA Form 41 shall be made available to the pharmacy point of contact.

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.

Product status shall be provided via the contractor’s web-based reporting system within three (3) business days after processing is complete. Each site visit/pickup shall be assigned a single order/job processing number by the contractor. No batch processing of credits received by the vendor is permitted. Credits received and documented for each order/job number must be kept separate. This includes down to the NDC-level credits received.

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.

Up to twice a year, there may be a need for destruction of a large volume may be required, based on the site. This large volume can include pallets of fluids, oral, or injectable medications. It would require the contractor to be able to coordinate take away and destruction of these large volumes, as they cannot be packed up and shipped by the local VA pharmacy. These pharmaceuticals may or may not be eligible for credit.

1. Credits and Reconciliation

2. Pharmaceuticals eligible for credit Products qualifying for manufacturer’s return are pharmaceuticals, including partials pharmaceuticals, present at any VA sites. Items not in an acceptable container will be deemed ineligible for credit.

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.

2. Pharmaceuticals ineligible for credit 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.

2. Tracking of Credits and Reconciliation To ensure adequate tracking of credits from inception to disposition, the Contractor shall make available the pharmacy prime vendor (PPV) (Currently McKesson, listed below) 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. To ensure adequate tracking of credits from inception to disposition, the Contractor shall make available the NDC-level itemized credit statements received from the manufacturers. 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 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. 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.

The debit/credit memos shall be provided by the Contractor to each facility receiving credits and used for comparison of records/transactions of credits pending and credits received. On a quarterly basis, the Contractor and each facility will work together to reconcile any discrepancies between the facility records and the Contractor records. Discrepancies that cannot be resolved shall be brought to the attention of the VISN contracting officer representative (COR) who will further review and provide information to the contracting officer. Discrepancies resolution will be included on the quality assessment plan (QASP).

The Contractor shall provide a web-based customer portal that allows for both individual facility and VISN aggregate and item-level detail reports. VISN and local facility designees at each facility must be allowed access to track, monitor, and reconcile reverse distribution services and activities. The Contractor shall provide web portal and report access training to end users within 60 calendar days of contract start date and then as required thereafter.

The online reporting system shall be configured in such a way to track the reverse distribution process at the itemized level from start (return) to finish (credit or destruction). An electronic inventory-submission portal for notification of credit eligibility shall be available to ensure accurate assessment of pharmacy returnable items prior to on-site servicing. The reports on the portal shall be exportable to Microsoft Excel for reconciliation and analysis purposes. The web portal shall include reporting to identify open orders/jobs and order/job summaries.

1. Reporting Requirements The Contractor is responsible for providing detailed reports and data to the facility and VISN CORs within a reasonable time frame. The facility and VISN CORs shall be notified if the Contractor experience any delays. The Contractor must also provide software that allows for cross referencing the site’s electronic record of reverse distribution inventory and credits against the contractor electronic record to identify discrepancies. Facility designees are authorized to utilize Contractor software if no PHI/PII or other VA sensitive data is released/captured.

The Contractor shall provide a web-based reporting tool that will generate the following reports:

The information should be available for each facility and as VISN aggregated data.

1. Plan / Contingency Plans Offerors shall submit a written proposed plan detailing implementation of the Pharmaceutical Reverse Distribution Program including details on how billing will be completed. 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. Recognizing that some facilities may prepare their pharmaceutical returns monthly, the Government anticipates no more than sixty (60) calendar days from the date of award to transition facilities over to the new contract. Additional information regarding invoicing procedures is included in the clauses.

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.

1. Contracting Authority

(a) The Contracting Officer is the only person authorized to approve changes or modifications to the requirements under this contract on behalf of the Government.

(b) 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.

(c) The 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.

(d) 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 VAMC. Other Government Agencies will place orders in accordance with their facility policies and procedures.

1. Payments The exact payment of the Firm-Fixed fee to be made to the contractor shall include only the awarded contracted fees for reverse distribution services as defined in this contract and shall be paid directly from the Government and not through credits.

Invoices must be provided by the reverse distribution vendor to the returning facility within 30 calendar days of on-site service.

The Firm Fixe site visit service fee should cover contractor’s cost 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 the reverse distribution and waste disposal services.

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.

1. 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 Washington’s Birthday Third Monday in February Memorial Day Last Monday in May Juneteenth National Independence Day June 19th 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

Note: If a holiday falls on a Saturday or Sunday, the contractor shall contact the returning facility to determine on which day (Friday or Monday) the holiday will be observed.

1. Prime Vendor information 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 6555 State Highway 161 Irvington, TX 75039

Point of Contact:

Ms. Lori White, V.P. National Accounts Phone: 972-446-5758 Fax: 972-446-5337

Location prime vendor account will be provided after award.