SOLICITATION NOTICE
99 -- F-18 FDG (Fludeoxyglucose) Radiopharmacetical 10 Month IDIQ Contract
- Notice Date
- 10/28/2010
- Notice Type
- Presolicitation
- NAICS
- 325412
— Pharmaceutical Preparation Manufacturing
- Contracting Office
- Department of Veterans Affairs;Contracting Office (90C-H);VA Pittsburgh Healthcare System;7180 Highland Drive;Pittsburgh PA 15206
- ZIP Code
- 15206
- Solicitation Number
- VA24411RQ0021
- Response Due
- 11/4/2010
- Archive Date
- 11/11/2010
- Point of Contact
- Ronald Mazzei
- E-Mail Address
-
Contract Specialist
(ronald.mazzei@va.gov)
- Small Business Set-Aside
- N/A
- Description
- SCOPE OF WORK 1.General: Provide and deliver FOB Destination within consignees premises F-18 FDG provided by a radiopharmacist licensed in pharmacy by the appropriate Pennsylvania State Board of Pharmacy as described by the NRC in CFR 35. F-18 FDG to be delivered to the VA Nuclear Medicine Department room 10W138D at University Drive C, Pittsburgh Pennsylvania, 15240. Deliveries will be made Monday through Friday from 7:00AM to 4:30PM. Contractor shall provide emergency deliveries as requested by the VA Pittsburgh Nuclear Medicine department. Pharmacists assigned by the contractor to perform services covered by this contract shall be licensed in a State, Territory, or Commonwealth of the United States or the District of Columbia. The contractor will not bill the Government and the government will not pay any cost incurred by the contractor due to raw material shortage to produce either the specified line item or to procure any material required for Quality Control of line item production equipment. The government will not pay for an increase in line item price due to nuclear reactor maintenance, nuclear reactor malfunction, terror threats causing a supply chain disruption, naturally occurring disasters causing a supply chain disruption or other production or industry-wide supply shortage which ultimately results in the contractors cost to produce the F-18 product to rise. The contractor will not increase set price to offset compliance cost related to 21 CFR Part 212, cGMP requirements, compliance provisions related to the 1995 Federal Food, Drug and Cosmetic Act, cost to comply with the adulteration provision of 501(a)(2)(B) of the Act, the misbranding provision of 502 of the Act, new drug provision 505 of the Act and the registration and listing provisions of 510 of the Act. 2.Doses Contractor warrants to customer that all doses will be manufactured in accordance with the FDA's Modernization Act of 1997. Contractor certifies that all applicable mandated compliance actions will be performed in accordance with 21CFR Part 212 by either 12/12/2011 or other congressionally mandated deadline(s). 3.Work Hours The services covered by this contract shall be furnished by the contractor as defined herein. F-18 FDG will be supplied Monday through Friday beginning no later than 7:00AM on days that F-18 FDG has been ordered for use. Orders may be placed and delivered up until 4:30PM Monday through Friday. Work hours of the VA Nuclear Medicine department at Pittsburgh Pa., are 7:00AM until 4:30PM 4.Delivery Orders: Orders for F-18 FDG will be placed daily before the close of business for the next working day. The contractor will not bill the Government any additional transportation charges incurred by the contractor when multiple deliveries throughout the day are required. The contractor will not bill the Government non-standard delivery trip charges. The contractor will not bill the Government for any out-of-dose-range charges. The contractor will not bill the Government for any fuel surcharges or fuel charges incurred by the vendor to obtain diesel, gasoline, ethanol blends, hybrid blends including natural gas or hydrogen or other fuels obtained during a time of fuel shortage. Orders will be placed by telephone with no patient information disclosed to the contractor. 5.Delivery Location: Veterans Affairs Medical Center University Drive C Pittsburgh Pa., 15240 Nuclear Medicine, 10th floor room 10W138D. Contractor's employees will be given escorted access to room 10W138D for deliveries prior to 7AM. 6.Delivery Commitment: Time of delivery specified at time of telephone order shall become mandatory upon the contractor. Contractors shipping facility must be located within a 90 minute drive time from the VA hospital located in Pittsburgh, zip code 15240. Failure to perform in accordance with the delivery commitment may be grounds for termination of the contract at the Government's convenience. 7.Persons Authorized to Place Orders: All certified Nuclear Medicine Technologists employed by the Pittsburgh VA, Station 646. All Radiology clerks acting in a scheduling role for PET/CT patients. TERMS AND CONDITIONS 1.Administration: Contractor will bill on a monthly basis in arrears. All services rendered by the contractor will be itemized by date of service, item provided, unit cost and purchase order number. Contractor will provide a payment option for discount pricing in terms of days post invoicing. 2.Security and Confidentiality: Contractor is responsible for maintaining ADP security if and when any Automated Data Processing is utilized by the contractor whether the utilization of such a procedure is at the request of the government or is a result of contractor preference. The contractor is responsible for maintaining patient information in confidence and in accordance with the Privacy Act and HIPAA. Contractor must ensure their employees complete and document VHA Privacy Training annually. The Government will provide the necessary training materials to fulfill this requirement. 3.Hazmat requirements: All doses of radiopharmaceuticals will be delivered in suitable shielded lead or lead/tungsten systems, correctly labeled and sealed with plastic zip-tie locks. Lead containers for the radiopharmaceutical supplied by the contractor shall be picked up by the contractor from room 10W138D or other specified hot lab area within the hospital for waste disposal at no additional cost to the Government. The contractor is fully responsible for the safe delivery of radiopharmaceuticals according to the rules and regulations of the U.S. Nuclear Regulatory Commission. The contractor is responsible to be completely familiar with and shall strictly adhere to such rules and regulations. As a shipper, the contractor is required to provide Hazmat training to their employees in the areas of General Awareness Training 49CFR 172.704(a)(1), Function-Specific Training 49CFR 172.704(a)(2), Safety Training 172.704(a)(3) and Security Training 49CFR 172. Mislabeling of doses as to amount or radiopharmaceutical cannot be tolerated and any such occurrences may result in the termination of this contract at the Government's convenience. Contractor is required to submit a current unrevoked Radioactive Material License (RAM) Contractor is required to submit a current unrevoked copy of the radiopharmacist(s) license. Contractor is required to submit a written statement that provides the Government with the assurance that line item(s) are produced from cyclotrons that meet and/or surpass all quality assurance testing applied to the cyclotrons as suggested by regulations or the equipment manufacturer's recommendations. Contractor must provide proof that Quality Control on production equipment is current, acceptable and on-going. A statement, signed by an authorized representative of the contractor attesting to that fact is acceptable.
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- Record
- SN02318831-W 20101030/101028234304-2ac4c3ae4c3876a5cb9fa622194e475f (fbodaily.com)
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