Notice of Contract Action - 36C25026Q0321 - PWS.pdf

The Department of Veterans Affairs (VA), VA Northeast Ohio Healthcare System (VANEOHS), intends to solicit offers for pharmaceutical reverse distribution services supporting all VANEOHS pharmacy locations. The Contractor shall provide on-site reverse distribution, processing of controlled and non-controlled pharmaceuticals, credit facilitation through the VA Pharmaceutical Prime Vendor (PPV), and compliant destruction of non-returnable pharmaceuticals under a firm-fixed, flat-fee service model.

Reverse distribution services for VA have been inconsistent in recent years, and a prior national contract was subject to an Office of Inspector General (OIG) audit and recommendations.

VANEOHS has relied on a software-driven, labor-intensive process that required local personnel to research, track, package, and coordinate returns to multiple vendors and to use a separate vendor for controlled substance returns, resulting in significant workload and delays in receipt of credits. VANEOHS now requires a single, comprehensive solution with on-site service visits to reduce local workload, improve efficiency, and ensure regulatory compliance, using a fee structure that is not commission-based or tied to recovered credit value.

Performance Work Statement (PWS)

Title Reverse Distribution for VA Northeast Ohio Healthcare System (541-26-3-022-1515).

Objectives The objective of this requirement is to obtain a single Contractor to:

Perform on-site pharmaceutical reverse distribution at all VANEOHS pharmacy locations.

Process both controlled and non-controlled pharmaceuticals for maximum eligible manufacturer credit.

Provide compliant destruction for all non-returnable pharmaceuticals, including hazardous waste.

Operate under a firm-fixed, flat-fee, per-site-visit pricing model that is independent of credit value.

Scope The Contractor shall provide reverse distribution services for all seven VANEOHS pharmacy sites for a base year plus four (4) option years. Services shall include on-site visits, inventory and processing of returns (expired and short-dated within 120 days), credit facilitation through the VA PPV, and destruction of non-returnable items. The firm fixed site-visit fee shall include all Contractor labor, travel, equipment, packaging, shipping, processing, tracking, reporting, and waste disposal.

Requirements and Tasks

4.1 Task 1 – On-Site Service Visits

The Contractor shall perform on-site reverse distribution service visits at all VANEOHS pharmacy locations. During each visit, the Contractor shall:

Scan and identify pharmaceuticals for return.

Generate a list of all items selected for return.

Prepare products for shipment to the Contractor’s processing facility.

Include expired pharmaceuticals and pharmaceuticals due to expire within 120 days.

All items removed during a service event shall be processed and associated with a single order unique to that service event. The Contractor shall provide a cross-reference method that allows the facility to identify any item and the corresponding box location in the event of a discrepancy, and no product shall leave the facility until all discrepancies are resolved.

On-site services shall be performed only by the Contractor’s employees (no subcontracted labor) and in accordance with all facility procedures and security requirements. VA personnel will be assigned to observe and assist as needed and to protect VA sensitive information during on-site work.

Minimum visit frequency:

Inpatient Pharmacy – every other month (6 visits/year)

Outpatient Pharmacy – every other month (6 visits/year)

Kent Infusion Center Pharmacy – quarterly (4 visits/year)

Akron CBOC Pharmacy – quarterly (4 visits/year)

Canton CBOC Pharmacy – quarterly (4 visits/year)

Parma CBOC Pharmacy – quarterly (4 visits/year)

Youngstown CBOC Pharmacy – quarterly (4 visits/year)

Additional service visits shall be available upon request for an additional fee.

4.2 Task 2 – Flat Fee Service Model

The Government requires a flat-fee service model. The firm fixed site-visit fee shall cover, at a minimum:

Inventory of both controlled and non-controlled pharmaceuticals.

Packaging and shipping.

Processing of returns.

Destruction of non-returnable items.

Return and credit tracking.

Training.

All other costs necessary to perform reverse distribution and waste disposal services.

The site service fee shall be fixed and shall not be adjusted based on credits received, and credits shall not be used by customers as payment for, or to obtain, additional value-added services from the Contractor.

4.3 Task 3 – Processing of Controlled and Hazardous Returns

The Contractor shall prepare and provide chain-of-custody documentation for all controlled substance returns at the time packages are prepared for shipment. The Contractor shall possess DEA Power-of-Attorney representation letters authorizing execution of DEA Form 222 for scheduled products and shall comply with all applicable regulations for hazardous waste handling.

4.4 Task 4 – Disposal of Non-Returnable Items

The Contractor shall list all items designated for disposal (non-controlled, controlled, non-hazardous, and hazardous) on a disposal manifest that includes at a minimum:

Product name.

NDC or catalog number.

Quantity.

Total estimated return value.

Reason for non-eligibility for credit.

Separate manifests shall be provided for Schedule II–V controlled substances and for hazardous waste. The Contractor shall provide a Certificate of Destruction to the facility and maintain it upon completion of destruction.

4.5 Task 5 – Credit Tracking

The Contractor shall collaborate with local personnel to maximize credits and track returns. To provide full visibility of all credit amounts, the Contractor must be a reverse distributor for the VA’s current Pharmaceutical Prime Vendor (PPV).

The Contractor shall instruct manufacturers to issue all credits directly to the PPV, which maintains credit accounts for each authorized user. Credits shall be deposited into individual facility accounts by the PPV upon receipt of itemized credit statements for each facility provided by the Contractor.

4.6 Task 6 – Reporting

Within thirty (30) calendar days after processing each return shipment, the Contractor shall provide each facility with a return detail report by manufacturer that includes, at a minimum:

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.

List of non-returnable pharmaceuticals with weight and cost for disposal.

The Contractor shall also provide a credit report showing estimated versus actual credits, including:

Total actual credit received.

Credit received by unit of measure for each NDC.

Date the credit was issued.

The Contractor shall make copies of manufacturer credit memos available with the reports to ensure tracking of credits from inception to disposition. Separate reports shall be provided for Schedule II–V controlled substances and for hazardous waste, including disposal weight.

4.7 Task 7 – Training

The Contractor shall provide orientation and training at the facility level on all reports and processes to support monitoring and tracking of potential and realized credits.

Security and Compliance

5.1 Information Security

Certification and Accreditation (C&A) requirements do not apply; a Security Accreditation Package is not required. Contractors and subcontractors are subject to the same federal laws, regulations, standards, and VA Directives and Handbooks as VA personnel regarding information and information system security.

5.2 Check-In Requirements

Contractor personnel shall report to the appropriate department Supervisor or designated point of contact (POC) to sign in before work begins and submit any mobile media devices for virus scanning as required. Upon completion of work, Contractor personnel shall brief the Supervisor or POC on services performed and sign out.

5.3 Regulatory Compliance

The Contractor shall provide all plant, materials, and labor required to process credit returns and/or arrange for proper disposal of designated pharmaceuticals, including Schedule II–V controlled substances, within the Customs Territory of the United States; Schedule II–V returns from outside this territory are not permitted.

The Contractor shall comply with all applicable federal, state, and local regulations, including but not limited to:

21 CFR (Food & Drugs).

29 CFR (Occupational Safety and Health).

40 CFR (Protection of the Environment).

49 CFR (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.

Applicable VA regulations.

The Contractor shall consult with regional offices of applicable regulatory agencies to ensure compliance and shall arrange for, recommend, and/or advise on proper transport of returned products to the Contractor’s central processing facility.

5.4 Licenses, Permits, Registrations, and Insurance

The Contractor shall obtain and maintain all permits, licenses, and registrations required by federal, state, and local authorities for the life of the contract, including those for staff and for transport, storage, and disposal of hazardous and non-hazardous items. This includes, but is not limited to, DEA, DOT, EPA, FDA, OSHA, and individual state requirements.

The Contractor shall be a licensed DEA registrant authorized to handle Schedule II–V controlled substances and shall provide copies of all renewals to the Contracting Officer. The Contractor shall maintain appropriate insurance coverage, including environmental remediation, and provide proof of coverage to the Contracting Officer upon request.

5.5 Contractor and Subcontractor Qualifications

The Contractor and any subcontractors shall maintain all licenses, permits, and certifications required under the Resource Conservation and Recovery Act, Clean Air Act, Clean Water Act, OSHA, and all local requirements for reverse distribution operations. Vehicles used to transport hazardous waste shall hold all required state and federal DOT licenses for each jurisdiction in which they operate under this contract.

Government-Furnished Equipment/Information No Government-Furnished Equipment (GFE) or Government-Furnished Information (GFI) will be provided.

Place of Performance Services shall be performed for the following VA Northeast Ohio Healthcare System locations:

Wade Park Inpatient and Outpatient Pharmacies 10701 East Blvd.

Cleveland, OH 44106

Kent Infusion Center Pharmacy 3838 Cascades Blvd.

Kent, OH 44240

Akron CBOC Pharmacy 95 W. Waterloo Rd.

Akron, OH 44319

Canton CBOC Pharmacy 733 Market Ave. South Canton, OH 44702

Parma CBOC Pharmacy 8787 Brookpark Rd.

Parma, OH 44129

Youngstown CBOC Pharmacy 1815 Belmont Ave.

Youngstown, OH 44504

Period of Performance The anticipated period of performance is twelve (12) months from date of award, plus four (4) twelve-month option periods, to be exercised at the Government’s discretion.