65--radiopharmaceuticals

Network Contracting Office 17 is conducting market research to help determine the availability of potential businesses with capabilities to provide the radiopharmaceuticals below. This is a sources sought notice only. The information gathered from this request is for information and planning purposes only and will not be released. This does not constitute a solicitation. No solicitation is currently published, pending, or available. If a solicitation is issued, it will be issued at a later date. Responses to this RFI are not offers and cannot be accepted by the Government to form a binding contract. Vendor participation in this response or any informational session is not a promise of future business with the VA. The Government is not obligated, nor shall it pay for any information received from potential sources as a result of this notice. The intended contract period is a one-year base period plus (4) four one-year option periods. Potential contractors shall provide, at a minimum, the following: 1. Company name, address, point of contact, phone number, e-mail address, and DUNS. 2. Is your firm eligible for participation in one of the following small business programs? If so, please indicate the program. Anticipated North American Industry Classification System (NAICS) code is 325412, small business size standard 750 employees. [ ] yes [ ] no Small Business (SB) [ ] yes [ ] no HUBZone [ ] yes [ ] no Small Business 8(a) [ ] yes [ ] no Small Disadvantaged Business (SDB) [ ] yes [ ] no Women-Owned (WO) Small Business [ ] yes [ ] no Service Disabled Veteran Owned Small Business (SDVOSB) [ ] yes [ ] no Veteran Owned Small Business (VOSB) [ ] yes [ ] no Other (please specify) 3. Provide a brief capability statement with enough information to determine if your company can meet the requirement. A short statement regarding the company's capability to provide the radiopharmaceuticals outlined in the draft SOW below. Any commercial brochures or currently existing marketing material may also be submitted with the capabilities statement. Statement of Work 1. Contractor shall meet all Nuclear Regulatory Commission, National Health Physics Program (NHPP), Department of Transportation, FDA, OSHA, and all other agency rules and regulations (Federal and State), as well as any applicable Joint Commission Requirements. 2. Contractor must be licensed by the Nuclear Regulatory Commission and be regularly established in the business of providing radiopharmaceuticals. Offeror must provide copies of licenses and certifications along with proposal to the Contracting Officer. 3. Contractor must be able to provide service of all general & therapeutic Nuclear Medicine radiopharmaceuticals to VA North Texas Healthcare System (VANTHCS) facility. a) VANTHCS, 4500 S Lancaster Rd., Dallas, TX 75216 4. Technetium-99m unit doses will be non-high (LEU) enriched Uranium-235 versus the standard high enriched Technetium being supplied routinely to Nuclear Medicine clinics. Pricing should include cost for the non-high (LEU) enriched Uranium-235 along with the high enriched Uranium-235 (HEU) in those instances were product availability for the LEU product is limited or unavailable. 5. Contractor shall label all unit doses of delivered radiopharmaceutical with the amount, preparation time, expiration time, date, etc. Contractor must supply each VISN 17 facility with a bar code reader or a thumb drive that is compatible the Nuclear Medicine Information System (NMIS). 6. If the Contractor's system varies from the VANTHCS facility NMIS, the Contractor shall provide means for compatibility or alternative system with any needed data migration, technical support and training of staff on its use at no additional price to the Government. Any additional tracking systems provided must comply with VA and associated IT requirements. 7. 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. 8. All packages containing radioactive material must be labeled and shipped in accordance with Title 49, Code of Federal Regulations Part 172 and 173. 9. Contractor shall perform all quality control procedures as required by Federal and State regulatory agencies. Quality Control results will be furnished upon request. 10. Contractor/supplier shall abide by Title 10, Code of Federal Regulation, which states: A Licensee may use for medical purposes only: (a) By-product material or cyclotron produced materials manufactured, labeled, packaged and distributed in accordance with a license issued pursuant to the regulations in Title 10, Code of Federal Regulations, Part 35 and the equivalent regulations of an Agreement State. (b) Reagent kit that has been manufactured, labeled, packed and distributed in accordance with approval by the Commission pursuant to Title 10 CFR 32.72 or an Agreement State under equivalent regulations for the preparation of radiopharmaceuticals for medical use. 11. Contractor shall have available an adequate supply of contract products to meet the requirements of the VA North Texas Healthcare System with proof of contingency supply chain to prevent disruption of clinical care. Pricing will be based on a tiered unit dose price per quantity of doses ordered with no other fees or surcharges. 12. Contractor will deliver radioisotope in amount greater than or equal to the activity ordered with calibration for the specified appointment time. 13. At least three (3) scheduled deliveries of radiopharmaceutical per day with no associated fee and additional isotope availability, as per clinical schedule including emergency/STAT deliveries, as needed. STAT delivery times during routine working hours will be defined at 90 minutes from time of placing order and 2 hours on weekend and nights. 14. Radiopharmaceutical Returns for Credit: The Contractor shall accept returns for full credit toward future orders under the following conditions: a. Product(s) ordered or shipped in error. b. Product(s) damaged in shipment c. Concealed shipping damages d. Recalled product(s) e. Outdated products in unopened, original container. Note: VANTHCS facilities NMS can return at least 10% of radioisotope due to patient cancellation or no show at no cost to the facility. Contractor shall invoice at least once per month showing period covered, billing date, name of preparation, quantity and amount and correct purchase order number. 15. Normal/ Routine Ordering: Orders shall be placed by authorized VA personnel during the normal workday, and first delivery shall be received no later than 07:30 am the following workday to the VANTHCS Nuclear Medicine Service. After award, the Contractor will be furnished the name(s) of VA personnel that are authorized to place orders against the Contract. Orders shall only be placed by authorized VANTHCS NMS personnel via telephone, fax, or e-mail. 16. Normal/ Routine Deliveries: Depending upon Medical Center patient care requirements, the contractor shall provide routine delivery and pick-up, as many times as required by VANTHCS NMS. Delivery orders shall include the following information: " Contract item (s) and quantity, " Time(s) of delivery, " Applicable VA purchase order number. Contractor agrees to accept unused radiopharmaceutical and provide reimbursement per unit dose applicable towards future orders. Contractor is responsible for on time delivery of radiopharmaceutical and will have back-up facilities/production options available to maintain greater than 95% on time delivery or risk penalty that includes no charge doses that, at a minimum, equal the amount of missed doses. 17. Contractor will provide VANTHCS NMS personnel online and/or live CE opportunities at no cost to VANTHCS. Line Item Description Annual Qty (est) 1 Ga-67 Gallium Citrate UD 1-10 mCi 2 2 I-123 Iobenguane Sulfate 1-30 mCi 2 3 I-123 USP NaI 100 uCi Cap 100 4 I-123 USP NaI 200 uCi Cap 100 5 I-131 USP NaI Dx Cap mCi 1-30 mCi 30 6 I-131 USP NaI Tx Cap 1-6 mCi 24 7 I-131 USP NaI Tx Cap Each add'l mCi 1725 8 In-111 Autologous WBC Suspension 58 9 In-111 Capromab Pendetide UD 10 10 In-111 Pentetate SDV/Vial 2 11 In-111 Pentetreotide UD 26 12 Pentetate Vial 30 13 Sincalide Solution (UD) 10 14 99mTc Exametazime(Ceretec) UD 1 15 99mTc Exametazime(Ceretec) WBC 20 16 99mTc Filtered Sulfur Colloid (Melanoma Lympho) UD 11 17 Tc-99m Macro Aggregated Albumin UD 79 18 Tc-99m Mebrofenin UD 31 19 Tc-99m Medronate UD 8 20 Tc-99m Meriatide UD 45 21 Tc-99m NaTc04 MD (Per mCi) 500 22 Tc-99m NaTc04 UD mCi (Up to 30 mCi) 60 23 Tc-99m Oxidronate UD 325 24 Tc-99m Penetate UD (Aerosol) 75 25 Tc-99m Penetate (UD) Renal 5 26 Tc-99m Pyrophosphate UD 5 27 Tc-99m Sestamibi UD 955 28 Tc-99m Sulfur Colloid UD 53 29 Tc-99m Tetrofosmin UD 25 30 Tl-201 Thallous Chloride 17 31 Ultra Tag Kits (GI Bleed, MUGA, Liver Hemangioma) 45 32 Tc-99m Non-HEU Exametazine UD 1 33 Tc-99m Non-HEU Exametazime(Ceretec) WBC 37 34 Tc-99m Non-HEU Filtered Sulfur Colloid (Melanoma Lympho) UD 11 35 Tc-99m Non-HEU MAA UD 80 36 Tc-99m Non-HEU Mebrofenin UD 31 37 Tc-99m Non-HEU Medronate UD 9 38 Tc-99m Non-HEU Meriatide UD 45 39 Tc-99m Non-HEU NaTc04 MD (Per mCi) 500 40 Tc-99m Non-HEU Tc-99m NaTc04 UD mCi (Up to 30 mCi) 60 41 Tc-99m Non-HEU Oxidronate UD 325 42 Tc-99m Non-HEU Penetate 75 43 Tc-99m Non-HEU Sestamibi 2879 44 Tc-99m Non-HEU Sulfur Colloid UD 53 45 I-131 USP NaI Dx UD Sol uCi 1 46 In-111 WBC Blood Kit (Heparin) 53 47 Tc-99m WBC Blood Kit (Heparin) 63 48 Tc-99m Non-HEU NaTc04 UD uCi 240 49 Sm-153 Lexidronam UD 1 50 Tc-99m NaTc04 UD uCi 240 51 In-111 Chloride Point Source 1 52 After-Hours Call Out Charge 15 53 Sr-89 1 54 Tc-99m Succimer 1 55 Lymphoseek (Tilmanocept) 12 56 Syntrac Integration 1 57 Syntrac Software leasing 12 This is a sources sought notice for market research purposes only. Responses will be used to determine the appropriate acquisition strategy for a potential future acquisition. Potential sources are encouraged to respond, by email to Lynn [email protected] no later than February 12, 2016, 4:30PM CST.