Statement of Work - Rubidium May 26.pdf

STATEMENT OF WORK

SCOPE

The intent of this Request for Quote (RFQ) is to enter a Firm Fixed-Price Contract to provide Rubidium generator supplies to the VA Greater Los Angeles Healthcare System (VAGLAHS).

The Contractor shall provide all labor, supervision, and transportation necessary to meet the needs of the monthly deliveries for the VA Greater Los Angeles Healthcare System

(VAGLAHS).

Rubidium RB 82 chloride injection is indicated for Positron Emission Tomography (PET) imaging of the myocardium under rest or pharmacologic stress conditions to evaluate regional myocardial perfusion in adult patients with suspected or existing coronary artery disease. Using this tracer gives better images and better diagnostic accuracy and gives smaller radiation doses to patients and occupational workers than previously used methods.

Rubidium RB 82 Chloride injection is used in adults to help diagnose heart disease. It is used in a positron emission tomography (PET/CT) scan to help the doctor see an image of a patient’s heart. This medicine shows how much blood is getting to the heart muscle when patients are resting or exercising (stressed). Rubidium RB 82 belongs to the group of medications called radiopharmaceuticals (radioactive agents). The FDA approved RB-82 in 1995. Since that time, the application of PET/CT for cardiac imaging has become a robust tool to image patients’ hearts. In contrast to the use of the Tc-99m Sestamibi procedure of SPECT/CT in the past, the new PET/CT method can obtain calcium scores is an added benefit to assess a patient's long-term prognosis.

The radiopharmaceutical Rubidium-82 generator is a closed system used to produce rubidium RB 82 chloride injection for intravenous administration. The radiation of the generator is shielded in a generator cart. The generator and the generator cart are connected. The technologist would activate the production of the Rubidium-82 by pushing a button whenever the radiopharmaceutical is needed.

Requested Items:

BASE YEAR: 7/1/2021 – 6/30/2022

Item Period of

Performance Capacity Unit

Rubidium RB-82 Generator with associated accessories.

*Vendor must list each associated accessory that goes with the generator.

7/1/2021 – 6/30/2022

To serve eight (8) patients a day / 2,080 patients a year (12 months).

Year

Cart/System Lease/Rental Per Month for 12 Months

7/1/2021 – 6/30/2022

1 Year

OPTION YEAR 1: 7/1/2022 – 6/30/2023

Item Period of

Performance Capacity Unit

Rubidium RB-82 Generator with associated accessories.

*Vendor must list each associated accessory that goes with the generator.

7/1/2021 – 6/30/2022

To serve eight (8) patients a day / 2,080 patients a year (12 months).

Year

Cart/System Lease/Rental Per Month for 12 Months

7/1/2021 –

OPTION YEAR 2: 7/1/2023 – 6/30/2024

Item Period of

Performance Capacity Unit

Rubidium RB-82 Generator with associated accessories.

*Vendor must list each associated accessory that goes with the generator.

7/1/2021 – 6/30/2022

To serve eight (8) patients a day / 2,080 patients a year (12 months).

Year

Cart/System Lease/Rental Per Month for 12 Months

7/1/2021 –

SALIENT CHARACTERISTICS The generator must have and provide the following salient characteristics:

o Automated Daily Quality Control o Automatic Tracking of Radiation Volume to eliminates manual data entry.

o Able to reprint labels from the generator computer in the event labels get lost.

o Data must store on the computer for 5 years.

o The generator system must be in digital features not analog

REQUIREMENTS

o Shipment of the new generator must arrive 2 days prior to the expiration date of the current.

o The vendor should provide a quote for complete accessory sets to go with the machine. The vendor should quote enough accessory sets to provide eight (8) patients plus one QC run per day, five (5) days a week, 52 weeks a year. Each vendor should specify what items their accessory sets contain.

TRAINING

The contractor shall provide on-site education training. The purpose is to certify all Nuclear Medicine Technologists such that they are competent to operate the Rubidium Generator.

ROUTINE ORDERS

Delivery as scheduled.

DELIVERY LOCATION AND NORMAL WORK HOURS

All items must be delivered as specific below except for the Federal Holidays.

• Delivery Location - Nuclear Medicine Service, Room 0072 and Building 500 at 11301 Wilshire Blvd, Los Angeles, CA 90073.

• Normal Work Hours – 7:30am to 4:30pm, Monday thru Friday

PACKAGING AND MARKING

The Contractor shall package, mark and transfer all radioactive material in accordance with all applicable local, state, and federal regulations.

• Items must be adequately packaged to prevent damage during shipping, handling, and storage.

• All outer packages must contain the complete purchase order number, obligation number and contract number in addition to the shipping address. The purchase order 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.

• 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.

The Contractor shall meet all requirements of regulatory agencies for deliveries of radioactive generator between facilities and shall strictly adhere to these requirements.

QUALITY ASSURANCE

The Contractor shall immediately notify the Using Service Point of Contact (POC) of any recalls of product or other important product safety issues. In the event that a quality control or material defect is suspected and/or detected by any VA POC, the Contractor will be requested to provide any consultation necessary to alleviate any suspicion and/or defect by the following:

• Provide technical expertise.

• Provide professional examination of product; submit results and recommendations to the Contracting Officer.

• Make expedient replacement of any product suspected of being deficient.

• The Contractor shall provide any additional technical support deemed necessary for the technical staff, physicians, and patient education.

• The vendor shall credit the government for the number of days that a generator is not available for use including shipping problems, recalls and quality control issues.

SAFETY GUIDELINES AND REQUIREMENTS

The Contractor shall perform all functions of this 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 COR within twenty-four (24) hours. The contractor shall provide MSDS sheets (Material Safety Data Sheets) and updates as necessary on all delivered products to the medical center.

BADGES

All Contractor personnel are required to wear identification (LD.) badges during the entire time they are on the VA Healthcare System grounds. I.D. badges must have picture identification, name of the individual and the represented company depicted on it.

PARKING POLICY

It is the responsibility of Contractor personnel to park only in designated parking areas. Parking information is available from the VA Police. The VA shall not validate or make reimbursement for parking violations of the Contractor's personnel under any circumstances.

INVOICE AND PAYMENT

No advanced payments will be authorized. The invoice must include, the contract number, assigned purchase order, assigned obligation number, date order was placed, date order was shipped, name of preparation, quantity, and amount. Payments may be delayed if invoice(s) are not completed properly.

SECURITY CONSIDERATIONS

The Contractor may require access to secured areas during the performance of their duties for any individual delivery orders only as regulated by the current rules and regulations involving all Contractors when entering a VISN facility. The Contractor will not have access to any Federally Controlled Information Systems.

VA POLICY

Smoking is permitted only in designated areas. Possession of weapons is prohibited.

Enclosed containers, including tool kits, are subject to search. Violations of VA regulations may result in citations answerable in United States (Federal) District Court.