36C25018Q0077-003.docx

SCOPE OF WORK (SOW)

The Chalmers P. Wylie Ambulatory Care Center, Columbus, 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 Chalmers P. Wylie Ambulatory Care Center, Columbus, OH. The NAICS code for this procurement is 325412 (Pharmaceutical Preparation Manufacturing).

DELIVERIES: Deliveries shall be made to:

Chalmers P. Wylie VA Ambulatory Care Center, Nuclear Medicine Service, 420 N. James Rd.

Columbus, OH, 43219-1834

1. Contractor shall provide routine delivery and pick-up of items during the hours of 7:30 a.m. to 4:00 p.m., Monday through Friday, excluding federal 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 VAACC.

2. All routine deliveries of radiopharmaceuticals, ordered by 4:30 p.m. the previous day, shall be at the VA facility by 8:00 am the next business day. The order shall include the patient name and prescribed radiopharmaceutical.

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.

4. Pre-calibrated doses shall not expire within 1 hour of calibration time requested by the Nuclear Medicine Service.

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:

a. New Year’s Day January 1

b. Martin Luther King’s Birthday 3rd Monday in January

c. Presidents Day 3rd Monday in February

d. Memorial Day Last Monday in May

e. Independence Day July 4

f. Labor Day 1st Monday in September

g. Columbus Day 2nd Monday in October

h. Veterans Day November 11

i. Thanksgiving Day 4th Thursday in November

j. 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 commencement of the 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 shall 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, and comply with specific facility requirements.

11. The contractor shall invoice at least once a month to the Nuclear Medicine Service indicating the purchase order number, period covered, billing date, name of preparation, quantity, and dollar amount. Each radiopharmaceutical dose shall be identified as a separate line item on the invoice. In addition to billing electronically, a hard copy shall be sent to the Nuclear Medicine Department at: VAMC Columbus, 420 N. James Road, Columbus, Ohio, 43219-1834.

12. The contractor shall not add to the invoice the cost of overages. Any cost to replace damaged or incorrect products shall be at the cost of the contractor. Replacements shall be received within 48 hours of notification by the VAMC.

13. The Contractor shall provide complete documentation of inventory, disposal and patient dose records, which documents compliance with NRC upon request.

14. RECALLED AND DEFECTIVE PRODUCTS: the Contractor shall immediately notify the Contracting Officer of any recalls of product or other important product safety issues. As appropriate, the Contractor shall 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 shall indicate which products and in which years that products will come from LEU sources. It is expected that where applicable LEU sourced Tc products shall be provided.

16. Period of Performance will be for one (1) year beginning from the effective date of award for a period of 12 months, and may include four (4) one year option periods.

17. Proposals will only be considered from Offerors that are licensed by the NRC, and who are regularly established in the business of providing radionuclides as called for in this SOW. Offerors shall provide copies of licenses and certification in response to this solicitation (if not provided in response to the Sources Sought Notice).