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65--INTEGO PET INFUSION SYSTEM

Awarded
VA25610RQ0354Federal

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The Overton Brooks VA Medical Center in Shreveport, Louisiana, plans to award a sole source contract to MEDRAD Inc. for the purchase of the Intego PET Infusion System, with an estimated cost of $96,160. This specialized medical equipment is designed to enhance patient care by providing accurate and dependable infusion of radiopharmaceuticals during PET imaging, while significantly reducing radiation exposure to both patients and technologists. The procurement will bypass full and open competition under the authority that only one responsible source can meet the agency’s specific requirements, particularly due to the FDA clearance held by MEDRAD for their multi-PET agent infusion system, which is recognized for its precision, safety, and efficiency. The rationale for a sole source acquisition stems from MEDRAD’s unique positioning in the market as the only FDA-cleared supplier of such infusion systems for Sodium Fluoride (F18-NaF) and fluoro-deoxy-glucose (F18-FDG), key compounds in PET imaging, especially in oncology for bone metastasis detection. Market research confirmed no other suppliers offer equivalent products or compatible training formats acceptable to the VA. The contract is set for a performance period from July 1 to August 1, 2010, and the Government has determined the proposed pricing is fair and reasonable. The procurement will be conducted without a competitive solicitation, but the VA will consider any written responses received by August 4, 2010, solely to assess the need for competition.

General Info

VA awards sole source $96,160 contract to MEDRAD for FDA-cleared Intego PET Infusion System.

Contract Value

$96,410

NAICS

334510 - Electromedical and Electrotherapeutic Apparatus Manufacturing

Place of Performance

MS, USA

Set-Aside

NONE

Award Issued Date

Documents

0

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Organization & Contact Information

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AgencyDepartment Of Veterans Affairs → 256-NETWORK Contract Office 16 (36C256)
ContactsNo contacts available
OfficeRIDGELAND, MS, 39157, USA
Office AddressRIDGELAND, MS, 39157, USA
ContactsNo contact information available

Full Description

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The Overton Brooks VA Medical Center, Shreveport LA intends to enter into a sole source contract with MEDRAD Inc, One Medrad Drive, Indianola, PA 15051-0780 to provide the Intego PET Infusion System. This announcement constitutes the only notice issued; a separate written solicitation will NOT be issued. This procurement is being conducted in accordance with FAR 6.301, Only one responsible source and no other supplies or services will satisfy agency requirements. A justification for other than full and open competition has been prepared in support of this acquisition. The NAICS 334510 applies with a size standard of 500 employees. This notice is not a request for competitive proposals. A determination by the Government not to compete this proposed requirement based on responses to this notice is solely within the discretion of the Government. The Government will consider all responses to this notice by 2:00 p.m. (CST) August 4, 2010. Information received will be considered solely for the purpose of determining whether to conduct a competitive procurement. Responses must be in writing to the Contracting Officer. POC: LaTanya Y. Collier at +1 (555) 000-0000 or contact@example.gov. JUSTIFICATION FOR OTHER THAN FULL AND OPEN COMPETITION (SOLE SOURCE) 1. Agency/Contracting Activity: Department of Veterans Affairs Overton Brooks VA Medical Center 510 East Stoner Avenue Shreveport, LA 71111 2. Description of Action: This acquisition is to obtain, by the use of other than full and open competition an Intego Pet Infusion System. This equipment increases quality of care to the patient and also to the technologist performing the exam. This system allows accurate, dependable infusion of radiopharmaceutical while significantly reducing the radiation exposure to the patient and technologist. This is helpful because of the difficulty managing radiation exposure in PET imaging, especially that received by the staff. 3. Description of Services: a. To Obtain a Intego PET Infusion System b. The estimated cost is $96,160.00 4. Statutory Authority: Acquisition by other than full and open competition is provided under the authority of 41 U.S.C. 253(c) (1) and FAR 6.302 (1) (a). 5. Reason for Authority Cited: a. Under the authority of 10 U.S.C. 2304(c)(1) when supplies or services required by the agency are available form only one responsible source and no other type of supplies or services will satisfy agency requirements, full and open competition need not be provided for. b. Effort to Obtain Competition - Based on market research MEDRAD Inc. has received FDA clearance to market the MEDRAD Intego PET Infusion System (Intego) for Sodium Fluoride (F18-NaF) administration in PET imaging. F18-NaF PET is most frequently used in oncology to find and assess bone metastases. With its rapid uptake in the bone and quick bone clearance, there is growing clinical evidence of the value of F18-NaF as a very effective diagnostic imaging agent in bone cancer imaging. PET technology provides high resolution images that may be quantified for detailed and comparative analysis. It is these benefits, in part, that led the Center for Medicare and Medicaid Services (CMS) to announce plans in February 2010 to cover F18-NaF PET imaging for beneficiaries under Coverage with Evidence Development program. Receiving FDA clearance for F18 fluoro-deoxy-glucose (F18-FDG) administration in 2008, Intego is the only multi-PET agent infusion system currently cleared by the FDA. The system is loaded with a multi-dose vial and nuclear medicine technologists can dose on demand from a touchscreen to enable precise, flexible, safe, and efficient administration of PET agents. MEDRAD Intego systems are in place in hospitals and clinics throughout the U.S., Europe, Australia and the Middle East. c. Date of Synopsis - In accordance with FAR 5.101, Dissemination of Information, the sole source solicitation will be posted in a public place for 3 calendar days based on estimated cost for required services. d. The above acquisition will be negotiated with MEDRAD, INC. 6. Contracting Officer Determination: The Contracting Officer has determined that the anticipated cost to the government is fair and reasonable based on price. 7. Market Survey: Based on other companies programs not being compiled in format VA personnel are familiar with and potential cost to the Government to properly train personnel for a different program, requirement to be sole source to MEDRAD, INC. 8. Additional Support for Use of Other than Full and Open Competition: Based on requirement PET imaging utilizes higher energy isotopes that can be challenging to manage from a radiation safety aspect. This infusion system provides an accurate, dependable, and repeatable means of infusing the desired radiopharmaceutical while reducing radiation exposure significantly to technologist performing the exam and moderately to the patient having the test. 9. Other Interested Sources: There are no known sources expressing an interest in this acquisition. 10. Action That Will Be Taken To Overcome Barriers to Future Competition: N/A 11. Delivery Requirements: Period of Performance will be July1, 2010 through August 1, 2010. 12. Acquisition Plan: An Acquisition Plan () is (X) is not required for this acquisition. 13. IT Approval: IT Approval () is (X) is not required for this acquisition. The assertions and recommendations in support of the justification have been prepared by: Alan F. Fraser 06/25/2010 318/990-5082 Technical Representative Date Phone 14. Contracting Officer Certification: The Contracting Officer has determined that the justification is accurate and complete to the best of the Contracting Officer's knowledge and belief. //Signed// ______________________________ Date: 07/15/2010 CAROLYN SUE LEE

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