36C25023Q1143_1.docx

Presolicitation Notice Presolicitation Notice

GENERAL INFORMATION

SET-ASIDE

PLACE OF PERFORMANCE

POSTAL CODE

COUNTRY

CONTACT INFORMATION

CONTRACTING OFFICE ADDRESS

Department of Veterans Affairs Network Contracting Office 10 1700 E 38th Street Marion IN 46953

POINT OF CONTACT*

Contract Specialist Lillie Grey lillie.grey@va.gov 765-677-6112

ADDITIONAL INFORMATION

AGENCY’S URL

URL DESCRIPTION

AGENCY CONTACT’S EMAIL ADDRESS

EMAIL DESCRIPTION

DESCRIPTION

Statement of Work Radiology Service:

Nuclear Medicine Radiopharmaceuticals

1.0 Summary:

Richard L. Roudebush VA Medical Center in Indianapolis Indiana has a requirement for radiopharmaceuticals and radioactive sources for the nuclear medicine department. Due to the terms of USP<797>, the medical center can no longer compound radioisotopes in the facility’s existing hot lab. It is necessary to obtain these products and services that are both vital and critical to patient care from an outside nuclear pharmacy.

2.0 Requirements:

1. The contractor will meet all radiopharmaceutical requirements of Roudebush Indianapolis VAMC in unit dose form.

2. The contractor will provide Non-Highly Enriched Uranium radiopharmaceuticals whenever possible in accordance with the VHA Memorandum dated 01-03-2014 from the VA Under Secretary for Health. (See Attachment B)

3. The contractor shall provide radioactive sealed sources necessary for patient care and quality control.

4. The contractor shall provide Radiopharmaceuticals during standard hours of care Monday through Friday from 0700 (7:00 AM EST) until 1630 hours (4:30 PM EST), not including Federal holidays. After hours coverage will be available 24 hours Saturday and Sunday and Monday through Friday from 1630 (4:30 PM EST) until 0700 hours and including Federal holidays. Radioactive sealed sources will be delivered during normal business hours Monday through Friday from 0700-1630.

5. The contactor will be contacted by staff nuclear medicine technologists assigned to the nuclear medicine department at Roudebush Indianapolis VA Medical Center.

6. All routine orders for Radiopharmaceutical doses will be placed to the contractor one day before they are needed and prior to the clinic close of business via phone or internet. The order will include specified activities of doses and calibration times. The contractor will deliver the first run of ordered Radiopharmaceutical doses to the Nuclear Medicine Clinic, Room C-2187 before 0700 (EST) on the day specified to ensure proper inventory and receipt of the shipment is done by qualified personnel. A subsequent run of ordered radiopharmaceuticals will arrive by 1030 (EST) and if necessary, a 3rd run will arrive for all add-on procedures ordered prior to the close of business. All emergency after hour orders of radiopharmaceutical doses will be placed by an on-call staff Nuclear Medicine Technologists on an emergency need basis. The contractor will deliver all after hour orders of Radiopharmaceuticals within two hours of the Radiopharmaceutical doses being ordered to the Nuclear Medicine Clinic, Room C-2187.

7. The contractor will calibrate all Radiopharmaceutical doses to ensure proper activity ranges of +/- 10 percent of the specified ordered dose based on specific requirements provided by Nuclear Medicine Clinic based on guidelines outlined in 10 CFR Part 35.

8. The contractor shall provide a daily packing slip accompanying all Radiopharmaceutical shipments to the Nuclear Medicine Clinic for all orders placed. The packing slip shall include a bar code that works with the Nuclear Medicine Information System (NMIS) for tracking purposes.

9. The contractor will ensure that all Radiopharmaceutical doses provided are compounded and calibrated by or under the supervision of a certified Nuclear Medicine Pharmacist.

10. The contractor shall provide courier service that is in accordance with Department of Transportation, Nuclear Regulatory Commission and other applicable regulating authorities enabling the delivery of all Radiopharmaceuticals. All couriers shall be licensed and shall submit all required paperwork to be granted access to R L R VA Medical Center, Indianapolis, Indiana. The contractor shall be responsible for the removal of all used and unused radiopharmaceutical doses from the clinic within 72 hours of delivery.

11. The contractor shall notify Roudebush VA Medical Center Nuclear Medicine Clinic immediately, should the inability arise if not able to meet deliver of radio-pharmaceutical doses.

12. The contractor shall provide any training or education required to meet commercial standards related to use of radiopharmaceuticals to all staff Nuclear Medicine Technologists stationed at the Roudebush VA Medical Center.

Packaging, Packing and Shipping Instructions.

Items must be adequately packaged to prevent damage during handling and storage. All packaging and labeling must meet all federal and state regulations. All packaging of radioactive material MUST BE clearly labeled RADIOACTIVE on the outside of the carton in which it is shipped.

Inspection and Acceptance Criteria.

Every package is inspected by the department. Testing is performed on the packaging to make sure it meets requirements and is not contaminated. Associated invoices are compared against the order by the radiation safety office. COR notifies vendor if delivery times fall out of required time.

Risk Control This contract deals with radioactive materials which are regulated by the Nuclear Regulatory commission (NRC), Indiana Emergency Management and Preparedness Division (IDHS), Department of Transportation (DOT) and VA National Health Physics Program (NHPP). The vendor is responsible for safely transporting and delivering the materials from the centralized nuclear pharmacy to the facility.

13. The contractor will calibrate all Radiopharmaceutical doses to ensure proper activity ranges of +/- 10 percent of the specified ordered dose based on specific requirements provided by Nuclear Medicine Clinic based on guidelines outlined in 10 CFR Part 35.

14. The contractor shall provide a daily packing slip accompanying all Radiopharmaceutical shipments to the Nuclear Medicine Clinic for all orders placed. Contractor shall provide current Safety Data Sheets (SDS) and updates on all delivered products if requested.

15. Contractor shall meet all Nuclear Regulatory Commission, Department of Transportation and FDA regulations and USP 825 guidelines. (Federal and State as applicable).

16. The contractor will ensure that all Radiopharmaceutical doses provided are compounded and calibrated by or under the supervision of a certified Nuclear Medicine Pharmacist.

17. The contractor shall provide courier service that is in accordance with Department of Transportation, Nuclear Regulatory Commission and other applicable regulating authorities enabling the delivery of all Radiopharmaceuticals. All couriers shall be licensed and shall submit all required paperwork to be granted access to Roudebush VA Medical Center, Indianapolis, Indiana. The contractor shall be responsible for the removal of all used and unused radiopharmaceutical doses from the clinic within 72 hours of delivery.

18. The contractor shall be able to work within the Nuclear Medicine Information System (NMIS) management program currently in use at the Roudebush VA Medical Center by providing bar codes that work with “Nuclear Medicine Information System (NMIS)”, an ec2 Software Solutions program. NMIS allows for the receipt, inventory, tracking and disposal of Radiopharmaceutical doses.

19. Period of Performance: (Base plus 4 option years) Base = 10/1/2023 to 09/30/2024 OY 1 = 10/1/2024 to 9/30/2025 OY 2 = 10/1/2025 to 9/30/2026 OY 3 = 10/1/2026 to 9/30/2027

Attachment A Various Radiopharmaceuticals Roudebush VA Medical Center

Item

Presolicitation Notice