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FBO DAILY - FEDBIZOPPS ISSUE OF OCTOBER 02, 2016 FBO #5427
DOCUMENT

65 -- Radiopharmaceutical Supplies - Attachment

Notice Date

9/30/2016
 

Notice Type

Attachment
 

NAICS

325412 — Pharmaceutical Preparation Manufacturing
 

Contracting Office

Department of Veterans Affairs;G.V. (Sonny) Montgomery VAMC;Network Contracting Office 16;715 South Pear Orchard Road;Ridgeland, MS 39157
 

ZIP Code

39157
 

Solicitation Number

VA25616N1406
 

Response Due

10/12/2016
 

Archive Date

11/11/2016
 

Point of Contact

Tammie Chaney
 

E-Mail Address

6-6963<br
 

Small Business Set-Aside

N/A
 

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 October 12, 2016 at 12pm Central Standard Time, and provide to following information: a.Capabilities and experience for providing this product b.Business Size (i.e. Small Business, SDVOSB, Woman Owned Small Business etc.) c.DUNS Number d.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 use of a local Contractor is required due to the short life of the radioisotopes. 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 Tc-99m Calibration Source (up to 1mCi)658.00EA Tc-99mUD Misc. (MUGA, GI Bleed, etc.)125.00EA Tc-99m Choletec UD (Mebrofenin)100.00EA Tc-99m HDP UD (Oxidronate)500.00EA Tc-99m MAA UD60.00EA Tc-99m MAG-3 UD (Mertiatide)60.00EA Tc-99m DTPA UD (ventilation imaging)60.00EA Tc-99m Sulfur Colloid UD60.00EA Tc-99m Filtered Sulfur Colloid UD50.00EA Tc-99m Sestamibi UD2,000.00EA Gallium-67 UD per mCi (5mCi/dose)10.00EA Thallium-201 UD per mCi (4mCi/dose) 12.00EA I-123 Sodium Iodide caps 200 uCi (2 caps/dose)80.00EA I-131 Sodium Iodide caps (up to 6mCi)50.00EA I-131 Sodium Iodide caps (ea. mCi over 6)50.00EA In-111 Octreotide (Pentetreotide)12.00EA Sr-89 SrCl (Strontium)4.00EA In-111 WBC Labeling Study 500uCi4.00EA Tc-99m Ceretec WBC Labeling (exametazime)12.00EA WBC Kit12.00EA WBC pickup and disposal fee12.00EA Ventilation Scan Kit30.00EA Ultra-Tag Kit12.00EA Sincalide (Kinevac) vial12.00EA PYROPHOSPHATE (PYP) vial 25.00 EA Ra-223 Xofigo12.00 EA DISCLAIMER This RFI is issued solely for information and planning purposes only and does not constitute a solicitation. All information received in response to this RFI that is marked as proprietary will be handled accordingly. In accordance with FAR 15.201(e), responses to this notice are not offers and cannot be accepted by the Government to form a binding contract. Responders are solely responsible for all expenses associated with responding to this RFI.
 

Web Link

FBO.gov Permalink
(https://www.fbo.gov/spg/VA/JaVAMC/VAMCCO80220/VA25616N1406/listing.html)
 

Document(s)

Attachment
 

File Name: VA256-16-N-1406 VA256-16-N-1406.docx (https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=3036037&FileName=VA256-16-N-1406-000.docx)

Link: https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=3036037&FileName=VA256-16-N-1406-000.docx

 

Note: If links are broken, refer to Point of Contact above or contact the FBO Help Desk at 877-472-3779.
 

Place of Performance

Address: Department of Veterans Affairs;G.V.'Sonny' Montgomery VA Medical Center;1500 E Woodrow Wilson Dr.;Jackson, MS

Zip Code: 39216
 

Record

SN04294266-W 20161002/160930234304-049048a9275f10ea7689651d594087eb (fbodaily.com)
 

Source

FedBizOpps Link to This Notice
(may not be valid after Archive Date)

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