This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in Subpart 12.6, as supplemented with additional information included in the is notice. This announcement constitutes the only solicitation; quotations are being requested and a written solicitation will not be issued. The commercial items procedures of FAR Part 12 will be used. NAICS code is 325412, size standard is 750 employees. This solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular (FAC) 2005-66. This solicitation is requesting Brachytherapy Seeds. These seeds are for the treatment of prostate cancer and because they are radioactive their transportation is regulated by both the Nuclear Regulatory Commission and the Department Transportation. Therefore, these seed must be received at the warehouse and kept in locked storage unit the Radiation Safety signed for them. ITEM # QTY UNIT Description Unit Price Extended Price 1 I125RSRX-Rou 543 EA Projected minimum 12 completed Brachytherapy treatment cases using a total of 1200 seeds model 6711, unk mCi, I-125 RSRX seeds (most seeds stranded, some loose) loaded into Round Hub needles for Low Dose Rate Brachytherapy (LDRBT) treatments per fiscal year, otherwise delivery indefinite. 2 350 EA Product Number: ON200RSRX-Rouund2. Projected minimum 8 completed Pd-103 Low Dose Rate Brachytherapy (LDRBT) treatments per the fiscal year, using approximately 100 seeds per case, using a total of 800 seeds (8X100 = 800). Seeds will be pre-loaded into needles with most being strand and some lose loaded. Otherwise delivery indefinite. 3 2 EA Product Number: Seed return kkit3. Projected provide minimum 4 unused extra I-125 seed return Kits per year (one per quarter) and accept delivery of the unused extra I-125 seeds at Contractor's facility. 4 2 EA Product Number: Pd-103 seed rreturn kit4. Projected provide minimum 4 unused extra Pd-103 seed return Kits per year (one per quarter) and accept delivery of the unused extra Pd-103 seeds at Contractor's facility. 5 7 EA Product Number: SHIPPINGshipping costs will be incurred for the purchase of I-125 and Pd-103 seeds. The cost of shipping is currently $40 per shipment. We anticipate that we will have 12 I-125 shipements and 8 Pd-103 shipments. The projected cost will be 12X$40 = $480 for I-125 shipments and 8X$40 = $320 for Pd-103 shipments. The total projected shipping costs for the year are estimated at approximately $800. Brachytherapy Seeds Salient Characteristics: " Brachytherapy seeds must be used with the prostate cancer treatment option known as Low Dose Rate Brachytherapy. " Brachytherapy seeds shall appropriately size to fit inside of an 18 gauge needle for use with the needle template and implantation of the needs and seeds into patients. The dimensions of the model 6711 125I seeds, are 4.5mm in length and 0.8 mm in width. The dimensions of the Theraseed model 6711 103Pd seeds are 4.5 mm in length and 0.81 mm in width. " The exterior of Brachytherapy seeds shall be constructed of a Titanium Tube, be laser welded shut on the ends and contain an internal marker that makes allows the individual seeds to be seen on an E-Ray or a CT. " The Brachytherapy seeds shall meet the American Association of Physicists in Medicine (AAPMN) Task Group 43 Report, Technical standards and requirements. " Brachytherapy seeds as currently used by the San Francisco (SF) Veterans Affairs medical Center (VAMC) are used for the treatment of early and intermediate stage prostate cancer. " Any Brachytherapy seed product designs that are to be used in a patient shall be approved for use by US Food and Drug Administration prior to use at the SF VAMC. " The SF VAMC utilizes the pre-loaded in needles, "Seattle" method of Low Dose Rate Brachytherapy. Utilizing the patient specific needle loading plan provided to the vendor by the SF VAMC, the vendor shall provide Brachytherapy seeds that match the date of implant millicurie activity called for by the plan. " The vendor or their radiopharmacy shall perform a wipe test as required by the nuclear regulatory Commission (NCR) of 100% of the Brachytherapy seeds to verify sealed source integrity. " The vendor or their radiopharmacy shall perform a Quality Control radiation activity measurement and calculation of 100% of the Brachytherapy seeds to verify that the batch Brachytherapy seed's millicurie activity is within 5% of the prescribed activity required by the patient specific treatment plan on the day of implant/treatment. " The vendor or their radiopharmacy shall pre-load, per the patient's plan, the Brachytherapy seeds into needles and then sterilize the seeds and needles. " The vendor or their radiopharmacy shall ship the boxes containing the sterilized seeds and needles to the SF VAMC so that the material arrives at the SF VAMC at least 2 days prior to the date of implant of the seeds into the patient. DELIVERY SCHEDULE San Francisco VA Medical Center, 4150 Clement Street, San Francisco, CA 94121 Offeror proposed delivery date: 2 Days ARO FOB Destination: Shipping costs must be included in unit prices; no separate shipping charges allowed. Only electronic offers will be accepted. Offers are due to [email protected] by 4:00 P.M. Pacific Time, June 10, 2013. SOLICITATION PROVISIONS/CONTRACT CLAUSES: " FAR 52.212-1 Instructions to Offerors - Commercial Items (Feb 2012). " Addendum to FAR 52.212-1 Instructions to Offerors - Commercial Items " FAR 52.212-3 Offeror Representations and Certifications - Commercial Items (Dec 2012) " FAR 52.212-4 Contract Terms and Condition - Commercial Items (Feb 2012) " FAR 52-212-5 Contract Terms and Conditions Required TO Implement Statuses or Executive Orders - Commercial Items (Jan 2013) For the purposes of this clause items () 4,26, 27, 28, 38, 40(ii), 42, 48 are considered checked and apply. " FAR 52.252-1 Solicitation provisions Incorporated by Reference (Feb 1998); for the purpose of this provision, the fill-in's are http://www.acquisition.gov/far/index.html and http://www.va.gov.oal/library/vaar respectively. " FAR 52.252-2 - Clauses Incorporated by Reference (Feb 1998); for the purpose of this clause, the fill-in's are http://www.acquisition.gov/far/index.html and http://www.va.gov/oal/library/vaar/ respectively. " VAAR 852.203-70 Commercial Advertising (Jan 2008) " VAAR 852.211-70 Service Data Manuals (Nov 1984) (a) 811.107(a0 " VAAR 852.211-73 Brand Name or Equal (Jan 2008) " VAAR 852.246-71 Inspection (Jan 2008) " VAAR 852.232-72 Electronic Submission of Payment Requests (Nov 2012)

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