36C25018Q0378-002.pdf

STATEMENT OF WORK (SOW)

The Chillicothe VA Medical Center (VAMC), Chillicothe, OH has a requirement for Radiopharmaceutical Isotopes for patient care. The Contractor is to provide Radiopharmaceutical products as listed herein, as requested by authorized VA Staff, in accordance with Public Law 104-262 and 38 USC 8153 in order to support the VAMC, Chillicothe OH.

DELIVERIES: Deliveries to Chillicothe VAMC shall be made to:

Chillicothe VAMC 17273 State Route 104 Chillicothe, OH, 45601

1. Contractor shall provide routine delivery and pick-up of Radiopharmaceutical items during the hours of 8:00 a.m. to 4:30 p.m., Monday through Friday, excluding holidays. Orders can be placed via telephone, fax or email by staff nuclear medicine technologists or physicians assigned to the Nuclear Medicine Service at the Chillicothe VAMC and will indicate the required calibration time. Delivery personnel will be required to display a photo ID badge at all times

2. All routine deliveries of radiopharmaceuticals, ordered by 4:30 p.m. the previous day, shall be at the VA facility by at least 0.5 hours before the requested calibration time the next business day. All standing orders shall be delivered as routine.

3. Emergency and additional request orders may be made and shall be delivered within one (1) hour of placement of the order, 24 hours a day, 7 days a week. Orders placed after 4:30 P.M. weekdays, and on weekends shall be considered an emergency. Emergencies are defined for the purpose of delivery timeframe requirements only, and should not include a separate charge.

4. Pre-calibrated doses should not expire within 4 hours of calibration time requested by the Nuclear

Medicine Service. Pre-calibrated doses of F-18 and F-18 compounded doses shall not expire within 2 hours of the calibration time.

5. Stat Orders (emergency doses ordered during normal business hours: 8:00 a.m. – 4:30 p.m.) shall be delivered within one (1) hour of placement of the order.

6. The 10 Federal Holidays observed by the Federal Government are:

New Year’s Day January 1 Martin Luther King’s Birthday 3rd Monday in January Presidents Day 3rd Monday in February Memorial Day Last Monday in May Independence Day July 4 Labor Day 1st Monday in September Columbus Day 2nd Monday in October Veterans Day November 11 Thanksgiving Day 4th Thursday in November Christmas Day December 25th

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.

7. 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 DOT.

All products provided under this contract shall be from an FDA approved source with an available NDC number from the manufacturer.

8. Compliance with all OSHA manufacturing, packaging and shipping regulations is required. The awardee shall provide a copy of Type A package certification and certificates of DOT and OSHA training for couriers prior to the commencement of this contract.

9. The contractor shall guarantee the quality of all radiopharmaceuticals. Quality control shall include percent tag and MO99 breakthrough as appropriate. The Contractor shall provide Quality Control on each agent dispensed. Only those products that pass quality control may be sent to the VA.

The Contractor shall provide complete documentation on Quality Control results upon request.

10. The contractor shall label all products to indicate the amount of radiopharmaceutical, preparation time, expiration time and date, comply with specific facility requirements.

11. The contractor shall invoice at least once a month in accordance with VAAR 852.232-72, indicating the purchase order number, period covered, billing date, name of preparation, quantity, and dollar amount. Each radiopharmaceutical dose should be identified as a line item on the invoice, and hard copies of invoices shall be sent to: VAMC Chillicothe, 17273 State Route 104, Attn: Nuclear Medicine Service, Chillicothe, Ohio 45601.

12. The contractor shall not add to the invoice the cost of overages or damaged products. Any cost incurred as a result of overages, or to replace damaged or incorrect products will be at expense to the contractor. Replacements shall be received within 48 hours of notification by the Chillicothe

VAMC.

13. The Contractor shall provide upon request, documentation of inventory, disposal and patient dose records, which documents compliance with Nuclear Regulatory Commission (NRC).

14. 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 shall be liable for costs of processing recalls, i.e. administrative and clinical services to replace recalled / defective products.

15. It is preferred that where applicable the contractor will provide Low Enriched Uranium (LEU) sourced Tc products vice High Enriched Uranium (HEU) sourced. The contactor should indicate which products and in which years that products will come from LEU sources. This will begin on contract start date and continue throughout the remainder of the term of the contract.

16. Performance Period will begin on the date of contract award, and extend for twelve (12) months with four (4), one (1) year option periods to extend the term of the contract.