SOW FINAL.docx

EAST ORANGE VAMC

Statement of Work:

Vendor will comply with USP 797 and USP 800 regulations and prepare chemotherapy using aseptic technique. The prescriptions will be prepared pursuant to a valid order electronically signed by a VA oncologist, nephrologist or ophthalmologist credentialled to prescribe chemotherapy, and verified by a VA pharmacist. The order will be faxed to Vendor by 11:30 am on the day prior to the intended treatment appointment. The chemotherapy prescription will be compounded according to recognized pharmacy regulatory guidelines. The final product will be compatible with the Equashield® closed system transfer devices and Vendor will attach EAST ORANGE VA’s preferred tubing for administration.

The final product will be shipped in accordance with manufacturers’ requirements for drug stability and refrigeration. The final product will arrive in EAST ORANGE not later than 8 AM the day of treatment. The packaging will have all required labeling to identify the contents of the packages as hazardous. Invoices will be sent to the EAST ORANGE VA pharmacy procurement technician containing sufficient information as to allow verification of receipt of each item billed.

General Agreement Information:

· VA shall deliver all orders via facsimile.

· A VA Pharmacist will call Vendor approximately one hour after faxing the orders to ensure all orders were received via fax and discuss any questions related to the orders.

· All orders will be delivered no later than 8 AM on the date of intended treatment

· All final products will be reviewed by VA Pharmacists for accuracy compared to the original order. A 97% or better rate of accuracy is expected.

· When there is a product shortage, the VA pharmacist and Vendor pharmacist will collaborate to secure product or determine a suitable alternative promptly.

· Both VENDOR and VA Pharmacy will maintain chain of custody documentation as required by law.

· Vendor will maintain all necessary documentation for certification of hoods and compounding areas, gloved fingertip testing and media fill tests, viable particle tests and competencies of all staff involved with compounding chemotherapy.

· Certifications, testing results and competency documentation will be made available to VA upon request.

· If the appropriately ordered admixed and/or compounded pharmaceuticals, therapy, drug, oral, injectable, IV-spiked bag and/or supplies fail to be delivered or fail to be timely delivered due to issues with the Vendor designated courier(s), Vendor shall be responsible for the provision of replacement drug within the most efficient span of time thereafter, at no additional cost to VA.

· VA will not sell or transfer Vendor products to others.

· Confidentiality and Non-disclosure

· Patient Privacy and HIPAA Compliance. The parties recognize that each is a covered entity within the meaning of the federal Health Insurance Portability and Accountability Act (“HIPAA”) and agree to protect and respect the Patients’ rights to privacy and confidentiality concerning their medical and pharmaceutical records. Each party agrees to comply with HIPAA and other applicable state and federal privacy laws. Failure by either party to abide by these requirements shall be a basis for immediate termination of this Agreement.

· Non-disclosure. In the course of performing under this Agreement, either of the parties may receive, be exposed to or acquire confidential information including but not limited to, all information, data, reports, records, summaries, tables and studies, whether written or oral, fixed in hard copy or contained in any computer data base or computer readable form, as well as any information identified as confidential of the other party (“Confidential Information”). Without limiting the foregoing, the parties acknowledge and agree that this Agreement, including the pricing terms of this Agreement, constitutes Confidential Information. For purposes of this Agreement, Confidential Information shall not include Protected Health Information, the security of which is the subject of this Agreement and is provided for elsewhere. The parties, including their respective employees, agents or representatives (i) shall only use the other party’s Confidential Information as necessary and appropriate for the performance of this Agreement, (ii) shall not disclose to any third party the other party’s Confidential Information except as otherwise permitted by this Agreement, (iii) only permit use of such Confidential Information by employees, agents and representatives having a need to know in connection with performance under this Agreement, and (iv) advise each of their employees, agents, and representatives of their obligations to keep such Confidential Information confidential. This provision shall not apply to Confidential Information: (1) after it becomes publicly available through no fault of either party hereto; (2) which is later publicly released in writing by the party hereto owing such Confidential Information; (3) which is lawfully obtained from third parties without restriction; or (4) which can be shown to be previously known or developed by either party hereto without use of or reference to the Confidential Information.