SOURCES SOUGHT
65 -- NUCLEAR MEDICINE PHARMACEUTICAL SUPPLIES
- Notice Date
- 5/11/2022 8:08:36 AM
- Notice Type
- Sources Sought
- NAICS
- 325412
— Pharmaceutical Preparation Manufacturing
- Contracting Office
- 256-NETWORK CONTRACT OFFICE 16 (36C256) RIDGELAND MS 39157 USA
- ZIP Code
- 39157
- Solicitation Number
- 36C25622Q0863
- Response Due
- 5/18/2022 2:00:00 PM
- Archive Date
- 06/17/2022
- Point of Contact
- Tammie Chaney, Contracting Officer, Phone: 601-206-6963
- E-Mail Address
-
tammie.chaney@va.gov
(tammie.chaney@va.gov)
- Awardee
- null
- Description
- This Sources Sought Notice is for informational and planning purposes only and shall not be construed as a solicitation or as an obligation or commitment by the Government at this time. This notice is intended strictly for market research. The purpose of this Sources Sought notice is to determine interest and capability and potential qualifications of service-disabled veteran owned small businesses, veteran owned small businesses, and small businesses relative to the North American Industry Classification Code (NAICS) 325412 (Pharmaceutical Preparation Manufacturing). Potential sources are to respond by email at tammie.chaney@va.gov no later than May 18, 2022 at 4:00 pm Central Standard Time, and provide to following information: Capabilities and experience for providing this product Manufacturer Country of Origin Business Size (i.e. Small Business, SDVOSB, Woman Owned Small Business etc.) SAM UEI Tax Identification Number GENERAL REQUIREMENTS Radiopharmaceutical preparations of doses, tagging of blood, testing performed at contractor facility provided by a board-certified radiopharmacist and delivered to the Nuclear Medicine Departments at the G.V. Sonny Montgomery VA Medical Center, 1500 E. Woodrow Wilson Drive, Jackson, MS. 39216. Deliveries will be made Monday through Friday from 6:00 am to 3:00 pm. Contractor shall provide emergency deliveries as requested by the VA Nuclear Medicine Departments. Personnel assigned by the contractor to perform services covered by this contract shall be licensed in a State, Territory, or Commonwealth of the United States or the District of Columbia Contractor will secure FDA only approved radiopharmaceutical generators, kits, and any other products required to prepare radiopharmaceuticals. Contractor will obtain such products only from suppliers licensed and inspected by the U.S. Nuclear Regulatory Commission or an Agreement State to provide such goods and services. Contractor shall secure FDA only approved radiopharmaceutical generators, kits, and any other products required to prepare radiopharmaceuticals. Contractor will obtain such products only from suppliers licensed and inspected by the U.S. Nuclear Regulatory Commission or an Agreement State to provide such goods and services. Contract shall comply to the guidance of the January 3, 2014 Memorandum from the Under Secretary for Health, under the request of the White House Interagency Policy Committee that the VA preferentially procure medical radioisotopes from non-High Enriched Uranium (HEU) sources. Delivery requirements: Contractor must be able to deliver within 1 hour of receipt of a request for those radioactive isotopes listed in the Schedule which have limited shelf life. Diagnostic radioactive isotopes have a short shelf life and must be delivered on a daily basis. Doses are ordered specific for each patient study. The Contractor shall have the delivery capabilities to provide doses when needed. The VA Medical Center needs the capability to perform nuclear scans immediately when procedures are added during the day, whether an emergency or a new diagnosis. The Contractor shall deliver the radiopharmaceuticals provided in the Schedule to the Nuclear Medicine Department no more than one hour after the order has been placed. Radiopharmaceuticals shall be prepared in accordance with state and federal regulations governing the receipt, handling, preparation and delivery of these isotopes for human use. Contractor shall provide verification of a valid radioactive material license issued by the MS State Department of Health/Division of Radiological Health or the U.S. Nuclear Regulatory Commission. Proof of such licensure will be considered as verification that the Contractor has approved distribution procedures in place to ensure security of radioisotopes during receipt, preparation and delivery, as well as required training for delivery personnel and any others that may come in contact with radiopharmaceuticals. Contractor will provide verification of licensure of all radio pharmacists preparing radiopharmaceuticals. Contractor shall provide its Quality Management Program (QMP). This program shall include, but not be limited to (1) the Contractors procedure for the preparation of radiopharmaceuticals (2) where preparation of radiopharmaceuticals is carried out (3) QC guidelines the Contractor follows for the dispensing of radiopharmaceuticals for human use (4) verification of the steps followed to test labeling efficiency of radiopharmaceutical kits and (4) the frequency of this testing. Contractor shall provide the protocol followed (such as FDA and or professional standards or guidelines) in determining expiration time or date on radiopharmaceutical doses. Contractor shall provide steps followed to ensure purity and sterility during preparation of radiopharmaceuticals. In addition, Contractor shall state what procedures or guidelines are followed to ensure an aseptic environment. VA requires Contractor to provide guarantee of the quality and efficacy of labeled compounds (radiopharmaceuticals), in addition the Contractor shall declare the steps taken daily to ensure such efficacy. The QMP shall include the procedure used by the Contractor in the dispensing, packaging and delivery of radiopharmaceuticals. The names and addresses of all sources supplying radioisotopes to the Contractor shall be included, along with the names and addresses of all sources providing radiopharmaceutical kits to the Contractor. Items listed are estimated quantities per year Product Description Quantity Manufacturer Country of Origin Tc-99m Calibration Source (up to 1mCi) 658 Tc-99m Calibration Source (each mCi over 1) 8 Tc-99mUD Misc. (MUGA, GI Bleed, etc.) 125 Tc-99m Choletec UD (Mebrofenin) 100 Tc-99m HDP UD (Oxidronate) 500 Tc-99m MAA UD 60 Tc-99m MAG-3 UD (Mertiatide) 60 Tc-99m DTPA UD (ventilation imaging) 60 Tc-99m Sulfur Colloid UD 60 Tc-99m Filtered Sulfur Colloid UD 50 Tc-99m Sestamibi UD 2000 Gallium-67 UD per mCi (5mCi/dose) 10 Thallium-201 UD per mCi (4mCi/dose) 12 I-123 Sodium Iodide caps 200 uCi (2 caps/dose) 80 I-131 Sodium Iodide caps (up to 6mCi) 50 I-131 Sodium Iodide caps (ea. mCi over 6) 50 In-111 Octreotide (Pentetreotide) 12 In-111 WBC Labeling Study 500uCi 4 Tc-99m Ceretec WBC Labeling (exametazime) 12 WBC Kit 12 WBC pickup and disposal fee 12 Ventilation Scan Kit 30 Ultra-Tag Kit 12 Sincalide (Kinevac) vial 12 PYROPHOSPHATE (PYP) vial 25 Ra-223 Xofigo 12 I 123 Iofluplane 36 99mtc Ceretic unit dose 12 I-123 Sodium Iodide caps 100 uCi 2 I-123 MIBG (Adreview) 2 Indium 111-DTPA 5
- Web Link
-
SAM.gov Permalink
(https://sam.gov/opp/155638152d9c42d8a9454ca0c632d5ad/view)
- Place of Performance
- Address: Department of Veterans Affairs G.V. ""Sonny"" Montgomery VA Medical Center 1500 E. Woodrow Wilson DR., Jackson 39216
- Zip Code: 39216
- Zip Code: 39216
- Record
- SN06324736-F 20220513/220511230106 (samdaily.us)
- Source
-
SAM.gov Link to This Notice
(may not be valid after Archive Date)
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