65--ELEKTA BRACHYTHERAPY SEEDS Notice of Intent to Sole Source

The Department of Veterans Affairs, Veterans Integrated Service Network (VISN 3), James J. Peters VA Medical Center, Bronx New York, intends to award a sole source contract under the authority of 41 U.S.C 253(c) (1) - FAR 6.302-1 Only one responsible source and no other supplies or services will satisfy agency requirements, to ELEKTA, Inc., 4775 Peachtree Industrial Blvd., Ste 300, Norcross, GA 30092-3015. ELEKTA will provide radioactive SEEDS used in Brachytherapy procedures to treat prostate cancer to the New Jersey Healthcare System, East Orange Campus, 385 Tremont Ave., East Orange, NJ 07018. This action will result in a Firm-Fixed Price contract. This notice of intent is not a request for quotations; Interested parties may express their interest by providing a capabilities statement NLT Wednesday November 15, 2017 at 5:00 PM EST. The capabilities statement must provide clear and unambiguous evidence to substantiate the capability of the party to provide the required supplies and services. A determination not to compete this proposed contract upon responses to this notice is solely within the discretion of the Government. Verbal responses are not acceptable and will not be considered. When responding to this announcement, respondents should refer to Announcement 36C24218Q0081-ELEKTA Notice of Intent. If after November 15, 2017, no ACCEPTABLE responses have been received in response to this announcement, Department of VA shall negotiate solely with ELEKTA, Inc. NAICS 325412 Pharmaceutical Preparation Manufacturing NAICS 339112 is NOT on the SBA Class Waiver List nor will SBA issue a Non Manufacturer Waiver for this Brand Name requirement. This notice of intent to award a sole source contract is not a request for competitive quotes. There will be no solicitation available for competitive quotes. Phone calls will not be accepted. The point of contact for this action is Contract Specialist, Paul Speedling who can be reached at [email protected]. The Government anticipates the award of a firm-fixed- price contract. A determination by the Government whether to compete this proposed requirement based upon responses to this notice is solely within the discretion of the government. Information received will normally be considered solely for the purpose of determining whether to conduct a competition. ELEKTA Radioactive Seeds used in Brachytherapy STATEMENT OF WORK The VANJHCS East Orange NJ Radiation Oncology Service will need a 5 year contract for ELEKTA Radioactive SEEDS used in Brachytherapy procedures to treat prostate cancer. Brachytherapy is a procedure in which tiny radioactive seeds about the size of a grain of rice are implanted directly into the prostate while maintaining little or no contact with the healthy surrounding tissue. The Seeds are implanted using a remote delivery system called the ELEKTA Seed Selectron. The ELEKTA Seed Selectron utilizes individually loaded seed cartridges specific for each patient. VANJHCS Radiation Oncology currently orders Seed 2 cartridges of seeds for each patient totaling 75 to 110 Radioactive Seeds per order; one test cartridge for quality assurance and compliance with NHPP and NRC regulation and one patient cartridge for implantation. Both cartridges must be from the same lot and batch number. Each order includes the 2 seed cartridges and all required accessories for prostate implantation and all components arrive in sterile packing. The number of seeds needed for each patient varies depending on the size of the prostate being treated. On average patients usually receive 70 to 100 Seeds for each procedure. All test cartridges are ordered with 10 seeds. Currently VANJCHS Radiation Oncology performs approximately 4 Brachytherapy procedures per month. As the program grows, it is expected the need to grow to 5 procedures per month. ELEKTA is the sole source vendor for the seeds used in the ELEKTA Seed Selectron. The seeds are radioactive and as such the seeds activity will decay over time. Each seed cartridge comes with an expiration date and essentially, the shelf life is less than one week from scheduled date of implantation.