Draft SOW Revised 7-26-22.docx

Draft Statement of Work (SOW) Pharmacy Reverse Distribution Software Application Subscription for the VA Northern California Healthcare System July 26, 2022

1. General Information:

The purpose of this service would be to maintain compliance with VHA Directive 1108.01 and Title 21 Code of Federal Regulations and provide proper disposal of expired pharmaceuticals that are deemed damaged, expired, returned through the mail, unusable, or otherwise unwanted that are lawfully possessed by registrant.

2. Objectives/Requirements:

Any contractor that reverse distributes an expired pharmaceuticals must be registered as a reverse distributor and must be compliant with all applicable federal, state, and local laws and regulations governing reverse distribution. Services required under this contract shall be performed in accordance with Federal Laws including but not limited to Title 21 Code of Federal Regulations. Contractor shall be compliant with any requirements of the VA as listed in this contract.

3. On-Site Process:

Expired pharmaceuticals that are deemed damaged, expired, returned through the mail, or unusable will be processed through a cloud based application which will provide detailed information regarding the credit value of the product to help the VA better manage the inventory and reduced waste. The Reverse Distributor Contractor will issue credits through the Prime Vendor.

4. Description of Items Eligible for Transfer:

Vendor shall accept any Scheduled CII-V medications being held for destruction obtained through return mail or otherwise deemed unusable or expired. All forms of medication shall be accepted such as tablets, capsules, suppositories, liquids, refrigerated items, patches, films, topicals, unused syringes containing medication but may not be limited to this list. Scheduled CII-V medications not contained in original manufacturer bottle packaging shall also be accepted for return. All controlled medications shall be counted and verified by vendor in presence of pharmacy staff member and VA accountable officer.

5. Software or Web-based System:

Vendor shall provide the Contracting Officer Representative (COR) and designated pharmacy staff access to software programs or web-based programs to identify which products have been sent for destruction. The Contractor shall list all controlled substance medications 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 value.

Training shall be provided to COR and designated staff on utilization of this software. Representative or customer service should be available and able to provide efficient service support for staff for as needed assistance or questions at no additional charge for the entire duration of the resulting contract.

Web Based platforms must conform to VA rules, regulation and policy and must be reviewed by the ISSO before any agreement can be made. In addition to ISSO review, cloud-based platforms must be Fed Ramp compliant or have solidified plans to be compliant within a time frame necessary to carry out the duties of the contract.

6. Performance Standards:

Vendors shall have recent proven experience as a pharmaceutical reverse distributor to perform reverse distribution processing and waste disposal services in the volume required by VANCHCS Pharmacy Service.

Vendor shall meet all requirements as listed in this contract as well as perform all processes compliantly with all federal laws and regulations.

Vendor shall be able to communicate efficiently for all VANCHCS Pharmacy needs of this contract. Vendor shall be available for any inquiries by VANCHCS Pharmacy staff. Invoicing shall be timely and provided within ninety days of each on-site service.

If services do not conform to contract requirements, the government may require the contractor to perform services again at no additional cost to the government. If defect in services may not be corrected by reperformance, the government shall have authority to reduce contract price to reflect the reduced value of the service performed.

7. Place of Service:

Representative shall provide on-site service to:

Department of Veterans Affairs VA Northern California Health Care System Pharmacy Service Mather Hospital Building 650, Room# 1B201 10535 Hospital Way Add pharmacy location Mather, CA 95655

DEA BD5275599

Martinez Outpatient Clinic Pharmacy Building 19, Room# 155 150 Muir Road Martinez, CA 94553

DEA BD3365168

Chico Outpatient Clinic Pharmacy Building 1601, Room# 169 1601 Concord Avenue Chico, CA 95928

DEA BD7214430

Redding Outpatient Clinic Pharmacy Building 3455, Room# PH11 3455 Knighton Road Redding, CA 96002

DEA BV1328699

McClellan Outpatient Clinic Pharmacy Building 98, Room# 1G00 5342 Dudley Boulevard McClellan Park, CA 95652

DEA BD6962600

Contractor shall provide education/training and guidance on software products used. This may be done in person, virtually, or by telephone.

8. Invoice and Charges:

The Vendor shall not add or substitute service fees without prior approval from the contracting officer.

Invoices shall be issued within ninety days after contract start date . Each invoice fee shall not exceed previous quoted agreement as agreed to in this contract to be billed by flat service fee. Payment receipts shall be confirmed by contractor in writing via email or confirmation process.

Any inquiries that VANCHCS Pharmacy may have through representative or customer service shall be provided at no additional charge at any time. Access to software should be available at any available time at no additional charge. Meetings in person, virtual or by phone including but not limited to discussion about process of returns or destruction tracking shall be provided as necessary to VANCHCS pharmacy at no additional charges.

9. Confidentiality:

Contractor shall be compliant with all security statutes including HIPAA (Health Insurance Portability and Accountability Act). Failure to comply with security statutes and confidentiality of patient information may result in financial sanctions and contractor shall be held liable if they are the cause of the breach of information.

VHA Supplemental Contract Requirements for Combatting COVID-19

1. Contractor employees who work in or travel to VHA locations must comply with the following:

a. Documentation requirements:

1) If fully vaccinated, contractors shall show proof of vaccination.

i. NOTE: Acceptable proof of vaccination includes a signed record of immunization from a health care provider or pharmacy, a copy of the COVID-19 Vaccination Record Card (CDC Form MLS-319813_r, published on September 3, 2020), or a copy of medical records documenting the vaccination.

2) If unvaccinated, contractors shall show negative COVID-19 test results dated within three calendar days prior to desired entry date. Test must be approved by the Food and Drug Administration (FDA) for emergency use or full approval. This includes tests available by a doctor’s order or an FDA approved over-the-counter test that includes an affiliated telehealth service.

3) Documentation cited in this section shall be digitally or physically maintained on each contractor employee while in a VA facility and is subject to inspection prior to entry to VA facilities and after entry for spot inspections by Contracting Officer Representatives (CORs) or other hospital personnel.

4) Documentation will not be collected by the VA; contractors shall, at all times, adhere to and ensure compliance with federal laws designed to protect contractor employee health information and personally identifiable information.

2. Contractor employees are subject to daily screening for COVID-19 and may be denied entry to VA facilities if they fail to pass screening protocols. As part of the screening process contractors may be asked screening questions found on the COVID-19 Screening Tool. Check regularly for updates.

a. Contractor employees who work away from VA locations, but who will have direct contact with VA patients shall self-screen utilizing the COVID-19 Screening Tool, in advance, each day that they will have direct patient contact and in accordance with their person or persons who coordinate COVID-19 workplace safety efforts at covered contractor workplaces. Contractors shall, at all times, adhere to and ensure compliance with federal laws designed to protect contractor employee health information and personally identifiable information.

3. Contractor must immediately notify their COR or Contracting Officer if contract performance is jeopardized due to contractor employees being denied entry into VA Facilities.

1. For indefinite delivery contracts: Contractor agrees to comply with VHA Supplemental Contract Requirements for any task or delivery orders issued prior to this modification when performance has already commenced.