Sources Sought Downstate Radiopharmaceuticals.docx

TITLE: 38-Sources Sought Notice

SOL: 36C24227Q0115

DUE: 11/17/2026 @ 1600 EST.

SET ASIDE: n/a NAICS: 325412 - Pharmaceutical Preparation Manufacturing POC: Janelle Bonafede Mail all responses only to: Janelle.Bonafede@va.gov

This Sources Sought Notice is for informational and planning purposes and shall NOT be construed as a solicitation or as an obligation or commitment by the Government at this time. This notice is intended strictly for market research. The purpose of this Sources Sought notice is to determine interest and capability of potential Large and Small Business firms relative to the North American Industry Classification Code (NAICS) 325412. The Department of Veterans Affairs is seeking all size business firms, small manufacturers, large manufacturers, or distributors of large and small business manufacturers, of functionally equivalent radiopharmaceuticals, to all the following:

Available Products: The contractor must be able to supply diagnostic radiopharmaceuticals, therapeutic radiopharmaceuticals, radioactive material used for QA purposes and non-radioactive pharmaceuticals and related supplies.

Delivery:

1. Deliveries must be available 24 hours a day, 7 days a week, 365 days per year.

2. Routine deliveries must be available three times a day Monday through Friday (except on Federal Holidays): (a) prior to 7 am, (b) prior to 12 noon and (c) prior to 2 pm.

3. Time of delivery specified or mutually agreed to at the time of receipt of telephone orders shall become mandatory upon the contractor’s acceptance to the commitment.

4. Emergency deliveries must be made within 2 hours of placement and acceptance of the order.

5. Delivery of supplies by the scheduled time will be complete except as otherwise authorized by ordering personnel.

6. Failure to perform in accordance with the delivery commitment may be grounds for termination of contract in accordance with the provisions for default.

7. Invoice shall include period covered, billing date, name of preparation, quantity, and amount.

8. The contractor is responsible for on time delivery of radiopharmaceuticals and must have back-up facilities/production options to maintain greater than 95% on time delivery or risk penalties that include no charge doses that, at a minimum, equal the amount of missed doses.

9. The contractor must provide an emergency plan for deliveries during inclement weather.

10. The contractor must be located close enough to each participating VISN 2 South Medical Center in order to meet time constraints.

11. Deliveries of radioactive products must incorporate sufficient lead or other high-density material shielding to comply with applicable Federal and or State standards relating to shipment of radioactive material.

12. Deliveries are to be made to Nuclear Medicine Hot Labs in each of the participating medical centers. If the medical center has 2 Hot Labs, deliveries are to be made to the specified Hot Lab. General nuclear medicine products are to be delivered to the general nuclear medicine Hot Hab. PET related products are to be delivered to the PET Hot Lab if a medical center has a specific PET hot lab.

13. Access to the Nuclear Medicine Hot Labs (PET and General) during non-business hours shall be obtained by contacting the VA Police Service.

14. Drivers who make deliveries must present acceptable photographic identification to the VA Police Service.

15. Drivers must have documentation of radiation safety training that is available to the receiving facility upon request.

16. Failure to perform in accordance with the delivery commitment may be grounds for termination of contract in accordance with the provisions for default.

Labeling Doses: The contractor shall label all unit doses and bulk doses of delivered radiopharmaceuticals with the amounts, preparation time, expiration time and date, etc., and provide a bar code labeled insert to allow scanning data into the VAMC’s nuclear medicine information management system (NMIS). If the contractor’s system varies from the current NMIS information system in use at the participating medical centers, the contractor shall provide their system as well as data migration, technical support, and training to staff on its use at no additional cost to the government.

A label must be affixed to each syringe, vial, or other container that is used to hold a radioactive radiopharmaceutical to be transferred for commercial distribution. The label must include a radiation symbol and the words "CAUTION, RADIOACTIVE MATERIAL" and an identifier that ensures that the syringe, vial or other container can be correlated with the information on the transport radiation shield label.

Expiration dates for kits intended for reconstitution by the user: Kits must be delivered with an expiration date of at least 3 months from the date of delivery. Kits will be returned to the contractor for credit or replacement if the expiration date is less than 3 months on delivery.

Shipping and Radioactive Labels: All packaging of radioactive materials must be clearly labeled “Caution, Radioactive Material” and contain a radioactive symbol with the proper Transportation Class and exposure levels, preparation time, expiration time and date and order number on the outside of the shipping container in order to comply with specific regulatory requirements. All shipping containers must be free of radioactive contamination both inside and outside and adequately packaged to prevent damage during handling, shipment and storage. The contractor must supply with each shipment/order/delivery a system for spent (used) syringes, which meets OSHA’s Bio Hazard Policy/Regulations and is needless.

Technetium-99m from Low Enriched Uranium: Technetium-99m unit doses must be obtained from non-high (LEU) enriched Uranium-235 versus the standard high enriched Technetium being supplied routinely. Pricing should include the cost for the non-high (LEU) enriched Uranium-235 along with the high enriched Uranium-235 (HEU) in those instances were product availability for the LEU product is limited or unavailable.

Nuclear Regulatory Commission License: The contractor must be licensed by the Nuclear Regulatory Commission and be regularly established in the business of providing radiopharmaceuticals. Additionally, the contractor shall meet the Department of Transportation, NHPP, FDA, OSHA, and all other agency rules and regulations (Federal and State) including USP 797. Contractors shall provide copies of licenses and certifications along with proposals.

CFR10: The contactor shall abide by the Title Code of Federal Regulations (CFR 10).

Sales Representative: The contractor shall assign to each participating medical center an individual sales representative to (1) aid in the facilitation of a smooth coordination between each medical center and the contractor and to (2) aid in the prompt resolution of discrepancies.

Quality Control Manual: The contractor shall provide a copy of their laboratory’s current quality control manual and shall be willing to discuss discrepancies’ in lab results which do not fit the clinical picture. The contractor shall test all products for quality control periodically and only those products that pass quality control may be sent to each participating medical center. The testing and the detailed report shall be furnished to each participating medical center at no additional cost. All contractor quality control testing/procedures shall be performed as required by Federal and State regulatory agencies.

USP 797: The contractor must validate that they are in compliance with USP 797. Each vendor must provide clean room reports and evidence of satisfactory air quality in the clean rooms.

MSDS Sheets: When the contract is awarded, the contractor must provide MSDS sheets (Material Safety Data Sheets) for each radiopharmaceutical, radioactive product and non-radioactive product in the contract to the each participating medical center. Any new or updated additions to the MSDS sheets will be sent by the contractor to the each participating medical center promptly.

Procedure for labeling of patient's White Blood Cells (WBC) with Indium-111 Oxine or Tc99m-Ceretec for re-injecting into the same patient:

1. Telephone orders to the contractor to arrange for the procedure will take place no later than 3:30 PM for a next workday procedure.

2. The contractor will supply the syringe needed for blood specimen collection without an additional charge.

3. Pick up of the patient's blood specimen for labeling by the contractor will be at 9:00 AM or later.

4. The radiolabeled blood specimen will be returned to the ordering medical center by the contractor within 5 (five) hours from the time of specimen pick up.

5. Documentation that confirms that the identification of the labeled blood specimen matches with the blood specimen of the patient's blood specimen submitted for the labeling procedure must accompany the specimen and be completed by the contractor and returned by the contractor to the ordering medical center at the time of delivery of the radiolabeled white blood cells.

HIPAA COMPLIANCE: The Contractor must adhere to the provisions of Public Law 104-191, Health Insurance Portability and Accountability Act (HIPAA) of 1996 and the National Standards to Protect the Privacy and Security of Protected Health Information (PHI). As required by HIPAA, the Department of Health and Human Services (HHS) has promulgated rules governing the security and use and disclosure of protected health information by covered entities, including the Department of Veterans Affairs.

The radiopharmaceuticals will be for delivery to VISN 2 Downstate Hospitals. Addresses will be provided at a later date.

Must be Made in America.

THIS IS NOT A SOLICITATION AND DOES NOT OBLIGATE THE GOVERNMENT TO ISSUE A SOLICITATION. Please be advised that the Government will NOT pay for any information submitted under this announcement. The applicable North American Classification System (NAICS) Code for this requirement is 325412 (Pharmaceutical Preparation Manufacturing). Responses due are to be submitted by e-mail to Janelle.Bonafede@va.gov. Name of firm, Socio-Economic category of the firm (all businesses), complete address, and phone & fax numbers of contacts.