Statement of Work.pdf

STATEMENT OF WORK

RADIOPHARMACEUTICAL SUPPLY CONTRACT

MONTANA VA HEALTHCARE SYSTEM

FORT HARRISON, MONTANA

This requirement is for radiopharmaceuticals for the Montana VA Healthcare System.

These products will be used for human administration during diagnostic nuclear medicine studies.

DESCRIPTION OF SERVICES / REQUIREMENTS

1. Normally orders shall be placed mid to late workday and delivery shall be no later than 7:30 a.m. the following workday. Due to the demands of the Medical Center care requirements; there shall be no restriction to the number of orders which may be placed by VA or the number of delivers which may be required per day.

In the event that the requirements may be determined in advance, a longer delivery time will be scheduled accordingly.

2. Depending upon the availability of the product, the Contractor shall make deliveries within three (3) hours when orders are placed during business hours between 7:30 a.m. to 4:30 p.m. Monday through Friday.

3. The Contractor will provide 24 hour on call service for emergent procedures, both within and outside of normal business hours. Times designated as outside of normal business hours are:

a. Monday through Friday from 4:30 pm to 7:30 am

b. Weekends from Friday at 4:30 pm until Monday at 7:30 am

c. Federal holidays

• New Year’s Day

• Martin Luther King Day

• President’s Day

• Memorial Day

• Juneteenth

• Independence Day

• Labor Day

• Columbus Day

• Veterans’ Day

• Thanksgiving Day

• Christmas Day

d. In addition, any other day specifically declared by the President of the United States as a federal holiday. It should be noted, if a holiday falls on Saturday, it is observed on Friday. If a holiday falls on Sunday, it is observed on Monday.

4. Orders can be placed by telephone and/or facsimile transmission.

5. The Contractor will provide one (1) 20mCi Cobalt 57 sheet source every two years, as listed in the Schedule of Supplies section of this document. The used sheet sources will be removed from the Nuclear Medicine area and properly disposed of by the Contractor. The sheet source will measure approximately

16.4 inches by 24.2 inches but is dependent upon the make and model of gamma camera in use at the time.

6. All products provided under this contract shall meet all requirements of the Nuclear Regulatory Commission (NRC). All products provided under this contract shall be packaged and shipped in accordance with the requirements of the NRC and Department of Transportation (DOT). All products returned will also be packaged in accordance with the requirements of the NRC and the DOT.

7. All packaging of radioactive material must be clearly labeled “RADIOACTIVE” on the outside of the shipping carton.

8. The Contractor will comply with all OSHA manufacturing, packaging, and shipping regulations.

9. The Contractor will submit invoices monthly, in arrears, for all products delivered since the previous billing cycle. Invoices will be submitted electronically via the OB10 website.

10. All shipping containers will be returned to the Contractor.

QUALITY CONTROL

1. The Contractor will perform all quality control procedures as required by Federal and State regulatory agencies.

2. The contractor shall guarantee the quality of all radiopharmaceuticals. Quality Control will include percent tag, Molybdenum 99 breakthrough, and Aluminum breakthrough testing as appropriate. The Contractor will provide Quality Control on each agent dispensed. The Contractor shall provide complete documentation on Quality Control results upon request.

3. The contractor shall provide a quarterly linearity source, as listed in the Schedule of Supplies section of this document. The activity requested can range from 25 to 100 mCi.

4. RECALLED AND DEFECTIVE PRODUCTS: The Contractor will immediately notify the Contracting Officer’s Representative (COR) and/or the Imaging Service Supervisor of any product recalls 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 the cost of processing recalls, i.e. administrative and clinical services to replace recalled/defective products.

QUALIFICATIONS

The Contractor must be licensed by the Nuclear Regulatory Commission (NRC) and be regularly established in the business of providing radiopharmaceuticals for medical use. The Contractor is required to meet USP 825 compounding standards and will furnish proof of compliance on demand.

TERM OF CONTRACT

This contract is effective in one-year increments for a period of five (5) years from date of award. The contract is subject to availability of funds and must be renewed by the government on an annual basis. The Contractor shall perform no services after September 30th of any year until the Contracting Officer authorizes such services in writing. The government has the right to terminate this contract for convenience of the government.

RECORD KEEPING

1. The Contractor shall label all supplies with the amount of radiopharmaceutical, preparation time, expiration time, date, and provide a bar code label to allow scanning data into a nuclear medicine information management system.

SCHEDULE OF SUPPLIES (See attachment Schedule of Supplies for details)

1. The Contractor shall provide items on a unit dose basis, pre-drawn into a syringe, calibrated and delivered to the Nuclear Medicine department of the Montana VA Health Care System, 3687 Veterans Drive, Fort Harrison, Montana. Items will be required Monday through Friday during the hours of 7:30am to 4:00pm, and outside of these specified hours on an “as needed” basis.

2. Quantities listed are estimated usage only.