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FBO DAILY - FEDBIZOPPS ISSUE OF APRIL 08, 2018 FBO #5980
DOCUMENT

66 -- Radiopharmaceuticals - Martinsburg VA Medical Center - Attachment

Notice Date

4/6/2018
 

Notice Type

Attachment
 

NAICS

325412 — Pharmaceutical Preparation Manufacturing
 

Contracting Office

Department of Veterans Affairs;VAMC (613);VISN 5 Contract Satellite Office;510 Butler Avenue, Building 306A;Martinsburg WV 25405
 

ZIP Code

25405
 

Solicitation Number

36C24518Q0175
 

Response Due

4/11/2018
 

Archive Date

6/10/2018
 

Point of Contact

Rhett Bohling 304-263-0811 x2033
 

Small Business Set-Aside

N/A
 

Description

THIS IS NOT A REQUEST FOR QUOTES. ALL QUOTES PROVIDED WILL BE DISREGARDED. STATEMENT OF WORK RADIOPHARMACEUTICAL SUPPLIES & SERVICES Objectives: The Contractor will be required to provide radiopharmaceutical supplies and services to the VAMC Martinsburg (VAMC), 510 Butler Avenue, Bldg 500, Martinsburg, WV 25405. Services will include, but are not limited to the following: Qualifications of Contractor: The contractor must employ licensed Nuclear Pharmacists to oversee daily operations. A license for each pharmacist must be provided to VAMC. The contractor must be established as a radiopharmacy for at least 3 years. The contractor must be financially responsible and able to provide past performance evidence of their reliability, ability, experience, equipment, facilities and personnel to provide prompt satisfactory service. The contractor must provide 24 hour services, seven days per week, and holidays. The contractor shall have the resources necessary for VAMC to purchase radioactive sealed sources needed to perform Quality Control. This shall be provided to VAMC at fair market value. The contractor shall have the resources necessary for VAMC to purchase radiation safety supplies such as syringe shields, radiation monitoring devices, etc. This shall be provided to VAMC at fair market value. Hours of Operation: Contractor services shall be routinely required during the hours of 0700-1630, Monday through Friday excluding federal holidays. The contractor shall provide on-call services between the hours of 1630-0700, Monday through Thursday and 24hr service on weekends from 1630 Friday until 0700 Monday and 24 hour service on holidays. Regulatory Requirements: The contractor must be licensed to prepare and distribute radiopharmaceuticals by the US Nuclear Regulatory Commission (USNRC) or Agreement State. A copy of the license and applicable inspection reports must be provided to the VAMC. This shall include any Notices of Violation and corrective actions taken. The contractor must provide documentation that the Technetium-99m generators, utilized for isotope production, are FDA approved for commercial use utilizing low enriched uranium (LEU). This will support the US government s global nuclear security strategy to encourage reliable supplies of medical radioisotopes produced from non HEU sources and comply with the American Medical Isotopes Production Act of 2011. All packages containing radioactive material shall be labeled and shipped in accordance with Title 49, Code of Federal Regulations Part 172 and 173. Compliance with all applicable regulatory bodies, including FDA and US DOT is requisite. Ordering Product: Routine next day orders shall be placed by 1530hrs the day before. The preferred method of next day orders is electronically via our ec2 Software Solutions (Formally Pinestar) Nuclear Medicine Information System (NMIS). Orders shall be made by Nuclear Medicine Technologists designated by the Contracting Officer Representative (COR). The names of these individuals shall be provided to the Contractor. Delivery of Product: Two routine deliveries shall be made daily, during normal working hours, by the contractor at no additional cost to VAMC. The first will be at or before 0700. The second will be delivered between 1200-1230. In addition orders for radiopharmaceuticals used for add on exams can be placed at any time with the expected delivery time within 1.5 hours of the order being placed. If there are unforeseen circumstances out of the Contractors control, such as weather that prevents delivery within 1.5hrs, the Contractor shall notify VAMC and determine a reasonable delivery time. The early morning delivery shall be made via Security escort. The Federal Police shall be contacted to escort Contractor delivery person to Room 1C114B located inside the Nuclear Medicine Department. All other deliveries can be directly delivered to Room 1C114B by contractor delivery personnel. All delivery personnel are required to have background checks completed prior to delivering products to VAMC. The Contractor is to work with the COTR to ensure this is completed within a 3 month timeframe after the issue of the contract. Product Description: Radiopharmaceuticals shall be delivered as unit doses in shielded containers. Each unit dose shall be labeled containing the following information: Customer name Ordering Physician Procedure Radiopharmaceutical Name Calibration Activity Calibration date/time Manufacturer Volume mCi/ml Prescription number Lot number Expiration Date/time An additional label containing the above information shall also be affixed to the dose syringe or other container being utilized. Each unit dose must contain a bar code so that dose information can be scanned into the VAMC Nuclear Medicine Information System. (NMIS) Quality Control: The Contractor shall perform all necessary quality control procedures in accordance with Title 10 Code of Federal Regulations Part 35 and any other Federal/State regulations that are applicable to the radiopharmacy industry. Quality Control results will be furnished to VAMC upon request. Technology Requirements: The contractor shall have a management system that is compatible and can interact with ec2 Software Solutions (formerly Pinestar) Nuclear Medicine Management System. This shall include Shipping and Receiving, product tracking, survey and wipe testing, inventory control, unit dose bar coding, and invoicing. If the Contractors system is not compatible with NMIS, the Contractor shall supply VAMC with a compatible system that will perform the same capabilities at no cost to VAMC. Training on new equipment shall be provided by the Contractor. Packaging and Packing: In accordance with accepted commercial practice and nuclear regulatory requirements. Contractor shall label all unit doses of delivered radiopharmaceutical with the amount, preparation time, expiration time, date, and provide Nuclear Medicine Service (NMS) with the capability to upload radiopharmaceutical data into the Nuclear Medicine Information System (NMIS) to include a bar code labeled insert. All packages containing radioactive material must be labeled and shipped in accordance with Title 49, Code of Federal Regulations Part 172 and 173. Compliance with all applicable regulatory bodies, including FDA and US DOT is requisite. An additional label shall be affixed to each syringe, vial, or other container used to hold a radioactive drug to be transferred for commercial distribution. The label must include the radiation symbol and the words "CAUTION, RADIOACTIVE MATERIAL" or "DANGER, 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. Invoices: The COTR shall be provided with copies of the invoices for review prior to being submitted. Invoices shall be paid to the contractor monthly, in arrears, upon submission of a properly prepared invoice for services/ supplies during the period. All invoices will include name of company name and address, point of contact, contract number, dates of services, purchase order number, invoice number, and an itemized listing of charges. Invoices shall be sent to Austin, Texas for on-line certification. Credits: The Contractor shall accept returns for full credit toward future orders with no associated charges/return charges under the following conditions: Product(s) ordered or shipped in error Product(s) damaged in shipment, Concealed shipping damages, Recalled product(s), Outdated products in unopened, original container, Any mutually agreed upon cause or situations that would be deemed reasonable cause in the routine operations of the vendor. 10% credit allowance for unused Tc99m Sestamibi or Generic Sestamibi unit doses. 10% credit allowance for unused F18-FDG unit doses
 

Web Link

FBO.gov Permalink
(https://www.fbo.gov/spg/VA/MaVAMC613/MaVAMC613/36C24518Q0175/listing.html)
 

Document(s)

Attachment
 

File Name: 36C24518Q0175 36C24518Q0175.docx (https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=4208072&FileName=36C24518Q0175-000.docx)

Link: https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=4208072&FileName=36C24518Q0175-000.docx

 

Note: If links are broken, refer to Point of Contact above or contact the FBO Help Desk at 877-472-3779.
 

Place of Performance

Address: Martinsburg VA Medical Center;510 Butler Avenue, Bldg. 500;Martinsburg, WV

Zip Code: 25405
 

Record

SN04881763-W 20180408/180406231150-4758e4ebda32301c1c42571f20f80b56 (fbodaily.com)
 

Source

FedBizOpps Link to This Notice
(may not be valid after Archive Date)

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