P01 LB SOW 2021 Compounding Chemotherapy Meds.docx

STATEMENT OF WORK

1. SCOPE

Manufacturing and delivery of compounded chemotherapy drugs, to an FDA 503A compliant facility diagnosis for the treatment of cancer patients receiving services at VA Long Beach Healthcare System, Pharmacy Service. Delivery services must meet all DOT requirements for shipment and delivery of Compounded Chemotherapy Medications. The period of performance is October 1, 2020 to September 30, 2021.

PARTICIPATING VA HEALTHCARE SYSTEM:

VA Long Beach Healthcare System 5901 E. 7th Street Pharmacy Service Long Beach, CA 90822

2. ROUTINE ORDERS

Upon completion of compounding, products will be transported VIA FedEx to VA prior to Chemotherapy Infusion Date. Must be able to provide next day delivery.

3. LIST OF HAZARDOUS COMPOUNDED CHEMOTHERAPY DRUGS

** Must be able to provide entire list on an as needed basis and on the terms and conditions stated within this statement of work.

There will be approximately (30) thirty patients on any given day, Monday through Friday for chemotherapy infusion for approximately 52 weeks. Below is a list of the common chemotherapy drugs will be provided directly to the vendor. Must be able to supply and deliver all hazardous compounded chemotherapy drugs listed below.

** All orders are based on need.

The period of performance is October 1, 2020 to September 30, 2021.

Ado-Trastuzumab Azacitidine Bortezomib Cabazitaxel Carboplatin Carboplatin Etoposide Carboplatin Fluorouracil Carboplatin Gemcitabine Carboplatin Pemetrexed Carfilizomib Cisplatin Cisplatin Docetaxel Cisplatin Etoposide Cisplatin Ifosfamide Cyclophosphamide Dacarbazine Docetaxel Docetaxel Carboplatin Doxorubacin Vincristine Cyclophosphamide Doxorubicin Doxorubicin Bleomycin Dacarbazine Doxorubicin Bleomycin Vinblastine Dacarbazine Doxorubicin Cyclophosphamide Doxorubicin Vincristine Cyclophosphamide Etoposide Etoposide Carboplatin Ifosfamide mesna Etoposide Cisplatin Etoposide Vincristine Doxorubicin Fluorouracil Gemcitabine Cisplatin Gemcitabine Docetaxel Gemcitabine PB Paclitaxel Irinotecan Irinotecan Fluorouracil Liposomal Irinotecan Methotrexate Methotrexate Hydrocortisone Mitomycin Mitomycin Opth Oxaliplatin Oxaliplatin Fluorouracil Paclitaxel Paclitaxel Carboplatin PB Paclitaxel Gemcitabine Pemetrexed Pemetrexed Carboplatin Pertuzumab Romidepsin Topotecan Ado-trastuzumab emtansine Carfilzomib Cisplatin Gemcitabine Cyclophosphamide Cyclophosphamide Vincristine Cytarabine Erlbulin Mesylate Etoposide Carboplatin Ifosfamide Etoposide Carboplatin Ifosfamide Mensa Floxuridine Leucovorin Fludarabine Cyclophosphamide Gemcitabine Gemcitabine Carboplatin Idarubicin Irinotecan Carboplatin P. B. Paclitaxel P. B. Paclitaxel Gemcitabine Pentuzumab Carboplatin Docetaxel Vincristine Vinorelbine Vinorelbine Cisplatin

Notice: No remanufactures or gray market items/ supplies will not be acceptable. Interested parties of RFI/RFQ must be an authorized reseller, distributor, or dealer of the O.E.M. (Original Equipment Manufacturer). Verification can be provided by an authorization letter or other documents from the OEM. Equipment shall be in accordance with the OEM terms and conditions. No exceptions, must be a manufacturer authorized distributor.

Must be registered in System for Award Management upon bid of this request for quote.

5. DELIVERY LOCATION, NORMAL WORK HOURS AND INSTRUCTIONS:

VA LONG BEACH HEALTHCARE SYSTEM:

Delivery Location – Pharmacy Service, Bldg. 164 Normal Work Hours – 7:00am to 4:00pm, Monday through Saturday

*The Pharmacy staff will contact the vendor directly for all supply and delivery orders.

4. PACKAGING AND MARKING

a) Items must be properly packaged to prevent damage during shipping, handling, and storage.

b) All outer packages must contain the complete purchase number, obligation number and contract number in addition to the shipping address. The purchase number and obligation number will be provided by the individual at the time of ordering. The contract number will be provided upon notice of contract award.

c) Packaging List: A packing list/slip shall be enclosed with each shipment indicating the purchase/obligation and delivery order number, contract number, items/quality ordered and items/quality shipped.

d) Temperature Monitoring of packages: The contractor shall provide an active temperature logging device in all shipments. This is to confirm the temperature stays within the specified range for each of the drugs shipped.

5. RECALLED AND DEFECTIVE PRODUCTS

The Contractor will immediately notify the Contracting Officer of any recalls of product or other important product safety issues. As appropriate, the Contractor will replace and/or reimburse recalled / defective products at no cost to the Government. The Contractor may be liable for costs of processing recalls, i.e. administrative and clinical services to replace recalled / defective products.

6. SAFETY GUIDELINES AND REQUIREMENTS

The Contractor shall perform all functions of the contract in compliance with Occupational Safety and Health Administration (OSHA), FDA, NRC, Joint Commission safety guidelines and Department of Transportation (DOT) requirements. The Contractor shall self-report any violations to the Point of Contact (POC) within twenty-four (24) hours. The contractor shall share quality testing data of their products each quarter to include: Surface Sampling, Microbial Sampling, and Media Fill Test Procedures (Fingertip Sampling).

7. NATIONAL HOLIDAYS OBSERVED BY THE GOVERNMENT

The President of the United States of America may declare additional days as a Federal holiday, and if so, this holiday will automatically be added to the list above. When a holiday falls on a Sunday, the following Monday shall be observed as a Federal holiday. When a holiday falls on a Saturday, the preceding Friday shall be observed as a Federal Holiday.

8. CONTRACTOR DELIVERY PERSONNEL

All contractor personnel are required to wear clothing bearing the name of the Contractor and wear a badge that has the Contractor name. Contractor personnel must have a picture I.D. and must be able to speak English.

9. PARKING AND SPEED LIMIT

Park only in areas designated by the POC or otherwise directed by Police and Security Service personnel. The Contractor shall display on each of its vehicles the company name in a size that is clearly visible. Upon receipt of award, the Contractor shall submit a list of employees and vehicles to the POC of each facility. The Contractor shall conform to the speed limit set at each Government facility. Should Contractor personnel receive a citation for parking, speeding or other infraction from VA Police & Security, the offenses will be handled in Federal Court as they are Federal offenses.

10. INVOICE AND PAYMENT

No advanced payments will be authorized. The contractor shall submit invoices on a weekly basis. The invoice must have at a minimum, the contract number, assigned purchase order, assigned obligation number, date order was placed, date order was shipped, and any additional necessary detailed information to identify service rendered. Payment on invoice may be delayed in invoice(s) are not completed properly.