36C24222Q0355 Intent to Sole Source.docx

Presolicitation Notice Presolicitation Notice

GENERAL INFORMATION

SET-ASIDE

113 Holland Ave

Albany NY

COUNTRY

CONTACT INFORMATION

Network Contracting Office 2 James J. Peters VA Medical Center 130 West Kingsbridge Road Bronx NY 10468-3904

POINT OF CONTACT*

Contract Specialist Morgan Weeks Morgan.Weeks1@va.gov

(607) 664-4708

ADDITIONAL INFORMATION

DESCRIPTION

Statement of Work Pylarify (piflufolastat F 18) Intravenous

Albany VA Medical Center – Department of Nuclear Medicine Statement of Need

Pylarify (piflufolastat F 18) is a diagnostic PET radiopharmaceutical that is used to assess the extent of disease in patients with prostate cancer. Delivery of 9.0 mCi doses of intravenous Pylarify (piflufolastat F 18) will be provided to the Albany VA Medical Center (VAMC).

The contractor shall provide all labor, supervision, and transportation necessary to meet the need for the delivery of Pylarify (piflufolastat F 18). The contactor shall have access to an adequate supply of Pylarify (piflufolastat F 18) to meet the requirements of each the Albany VA Medical Center. The contractor shall provide 9.0 mCi IV doses of Pylarify (piflufolastat F 18) on an as needed basis.

Contractor Requirements

Contractor Contact Information: The contractor will provide, with their proposal, the following information:

1. The contractor’s regular daily work hours.

2. Instructions for placing orders over the phone, by fax and through a web-based ordering system.

3. The contractor’s telephone number for call-in orders during regular work hours.

4. The contractor’s telephone number for placing emergency orders after the contractor’s regular working hours including weekends and holidays, 24 hours a day, 7 days a week, 365 days a year.

5. The contractor’s telephone number for expert advice about awarded products.

6. The contractor’s fax number for radiopharmaceutical orders.

7. If there are any changes to the above, the contractor will immediately provide updates to each participating medical center in writing.

Contractor’s RSO Audits: The contractor will supply a copy of the contractor’s RSO safety audits for federal compliance.

Package Inserts: The contractor will ship the current insert (Prescribing Information) for Pylarify (piflufolastat F 18) to each participating medical center at the inception of the contract. Any new or updated additions to the package insert will be sent by the contractor to each participating medical center promptly.

Available Products: The contractor must be able to supply 9.0 mCi of intravenous Pylarify (piflufolastat F 18).

Delivery:

1. Provide deliveries Monday through Friday, 7am –3pm..

2. 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.

3. Delivery of Pylarify (piflufolastat F 18) by the scheduled time will be complete except as otherwise authorized by ordering personnel.

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

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

6. 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.

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

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

9. 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.

10. Deliveries are to be made to the Albany VAMC, Department of Nuclear Medicine.

11. Access to Albany VAMC Nuclear Medicine Hot lab during non-business hours shall be obtained by contacting the VA Police Service.

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

Labeling Doses: The contractor shall label all unit doses of Pylarify (piflufolastat F 18) with the amounts, preparation time, expiration time and date, etc., and provide a bar code labeled insert to allow scanning data into the Albany 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.

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 Biohazard Policy/Regulations and is needless.

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 an individual sales representative to each participating medical center 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. 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.

Canceling orders and returned products: Each participating medical center may cancel ordered doses within a ten-hour (10) notice to contractor.

The contractor shall accept returns for 100 % credit under the following conditions:

1. Product ordered or shipped in error.

2. Product damaged in shipment.

3. Recalled Products

4. Outdated products in unopened, original container (specifically authorized for return by manufacturer).

5. Patient unable to receive the dose due to illness or abnormal lab results.

6. Product not used for scheduled patients who do not show up for their appointment (“no shows”).

The contractor will pick up radioactive products to be returned for proper disposal at no cost to the government.

Credit for the returned product will be reflected in the current month’s invoice.

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

All charges for delivery shall be included in the fee schedule. Additional fuel surcharges will not apply.

SDS Sheets: When the contract is awarded, the contractor must provide the Safety Data Sheet (SDS) for Pylarify (piflufolastat F 18). Any new or updated additions to the SDS sheet will be sent by the contractor to the each participating medical center promptly.

Invoicing and Payments: The contractor must submit an invoice at least once per month that shows the period covered, the billing date, the name of each product delivered, the quantity delivered, the amount delivered, the date each product was delivered and the correct Veterans Administration purchase order number 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.

Information Security: The C&A requirements do not apply, and a Security Accreditation Package is not required.

Presolicitation Notice