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FBO DAILY - FEDBIZOPPS ISSUE OF MARCH 01, 2018 FBO #5942
DOCUMENT

66 -- Radiopharmaceutical Delivery - Attachment

Notice Date

2/27/2018
 

Notice Type

Attachment
 

NAICS

325412 — Pharmaceutical Preparation Manufacturing
 

Contracting Office

Department of Veterans Affairs;VAMC (613);VISN 5 Contract Satellite Office;510 Butler Avenue, Building 306A;Martinsburg WV 25405
 

ZIP Code

25405
 

Solicitation Number

36C24518Q0121
 

Response Due

3/5/2018
 

Archive Date

4/4/2018
 

Point of Contact

Rhett Bohling
 

E-Mail Address

3-0811
 

Small Business Set-Aside

N/A
 

Description

Statement of Work RADIOPHARMACEUTICAL ISOTOPES BECKLEY VAMC ***THIS IS A SOURCES SOUGHT POSTING. THIS IS NOT A SOLICITATION OR REQUEST FOR QUOTES, THIS IS FOR INFORMATION ONLY. ANY QUOTES OR PROPOSALS RECEIVED WILL BE DISREGARDED.*** DESCRIPTION/SPECIFICATIONS/STATEMENT OF WORK February 2018 1. GENERAL Contractor shall provide radiopharmaceutical products in accordance with Public Law 104-262 and 38 USC 8153 for the Department of Veterans Affairs Medical Center (Beckley VAMC), 200 Veterans Avenue, Beckley, West Virginia 25801. Contractor and any/all sub-contractors shall be licensed by the Nuclear Regulatory Commission and be regularly established in the business of providing radiopharmaceuticals. The delivery order will specify the item and quantity of the items delivered and the time of delivery. All quantities noted in this solicitation are estimates only; see Section D for estimated volumes. NOTE: White blood cell scans radiolabeled leukocytes should be administered within 1-2 hours of cell labeling. Labeled cells stored longer than 3 hours have a significant loss of cell viability. Temperatures higher than 70 degrees Fahrenheit tend to increase cell damage and should be avoided. The awarded vendor will be responsible for picking up and then delivering blood back to the facility for testing. 2. SCOPE The Contractor is responsible for providing the radiopharmaceuticals at the time as outlined in the SOW. If the ordered radiopharmaceuticals are not available and cannot be delivered to the Beckley VAMC when needed, the contractor will notify the Beckley Nuclear Medicine Department and obtain the needed doses from another source, including another nuclear pharmacy, to be delivered as close to the requested time in order to provide timely care to Beckley VAMC patients. The contractor will provide all radiopharmaceuticals in single dose syringes in lead lined containers as specified per industry standard. The cost of each radiopharmaceutical will be calculated on a per vial, per syringe, or a per millicurie amount as indicated in contract pricing. 3. DELIVERY The contractor will provide, as needed, additional radiopharmaceuticals requested during normal duty hours (7:00 AM to 4:30 PM). Regarding white blood cell scans radiolabeled leukocytes should be administered within 1-2 hours of cell labeling. Labeled cells stored longer than 3 hours have a significant loss of cell viability. Temperatures higher than 70 degrees Fahrenheit tend to increase cell damage and should be avoided. The awarded vendor will be responsible for picking up and then delivering blood back to the facility for testing. Identification of radiopharmaceutical delivery personnel will be readily verifiable by identification badge including name of employee and contractor. Deliveries are sent directly to the Nuclear Medicine Department, room 2A-118. Delivery times and dates will be provided when the order is placed. When ordered by 5:00 p.m. local time, items will be delivered the next morning by 7:00 a.m. for the activity specified. Second same-day deliveries will be provided upon request. Contractor will provide a quarterly linearity source at no charge. The activity requested can range from 25 to 250mCi. Contractor will be responsible for pickup and disposal of all radioactive waste generated by use of the contractor s radiopharmaceuticals. This will be done in accordance with all state and federal laws/regulations. Contractor is responsible for quality control on each agent dispensed. Contractor will provide ceretec leukocyte labeling service via nearest lab to the Beckley VAMC. Contractor must be available 24 hours on call for emergency procedures. Contractor will credit unused doses of cardiolite/myoview, HDP/MDP and DTPA. Contractor shall provide radiopharmaceuticals deliveries on-site to the Department of Veterans Affairs, Veterans Medical Center, 200 Veterans Avenue, Beckley, West Virginia. Deliver directly to the designated hot lab area, room 2A-117 daily (at least one delivery, more if needed), Monday through Friday. The quantities listed herein are estimates only and not to be considered a minimum or maximum number of radiopharmaceuticals required under this contract. The Government has estimated that up to 2000 doses will be required during the contract base period with a possible 10% increase over each contract option period. 4. CERTIFICATION AND LICENSING Personnel assigned by the contractor to prepare and provide the products covered by this contract shall be licensed in a State, Territory or Commonwealth of the United States or the District of Columbia. The qualifications of such personnel shall also be subject to review by the Beckley, WV VAMC Chief of Staff and approval by the Beckley, WV VAMC Facility Director. Contractor will provide, at time of quote submission, all applicable licensing and training. 5. QUALITY The quantity of radioactivity for supplied radiopharmaceuticals will not deviate more than +10% at the time of calibration, from the quantities specified. Contractor will perform all quality control procedures on each radiopharmaceutical according to applicable requirements of licensing authorities and other regulating bodies. A copy of the results of the quality control procedures must be made available to the Beckley VAMC upon request. In the event that a quality control or material defect is suspected and/or detected by any Veterans Affairs COR, the Contractor will be requested to provide any consultation necessary to alleviate any said suspicion and/or defect by the following: a. Provide technical expertise in calibration; b. Provide professional examination of product; submit results and recommendations to the Contacting Officer; c. Make expedient replacement of any product suspected of being deficient d. Contractor shall make quality control records available to the Beckley VAMC upon written request from the Contracting Officer. e. Quantities expressed in the schedule are estimates based on historical usage for one year. However, quantities may vary based on patient demand f. Contractor must provide waste disposal at no additional charge of used radioactive dose syringes, vials, etc. g. Contractor must provide full credit for unused does of Technetium-99m Myoview (Tetrofosmin) and Technetium-99m Cardolite (Sestamibi). h. Contractor shall provide any additional technical support deemed necessary for the technical staff, physicians, and patient education. i. Any recalled dose for any reason shall be credited to the service for the full amount. j. All individual doses shall be traceable to the original elution if requested. k. Any dose deemed below standard by the facility shall be credited toward the account (e.g. unacceptable thyroid, stomach, kidney, or tissue uptake). This shall be determined by the facility RSO and Authorized User. l. Substitutions or Generic Brands may only be used with the express written permission of the facility. m. Contractor will supply Nuclear Medicine Management System for keeping records or QC and QA as required by regulatory agencies. Contractor will meet all requirements of regulatory agencies for shipment of radioactive isotope between facilities and will strictly adhere to these requirements. Shipments not properly handled according to regulations will not be accepted at the Beckley VAMC. Contractor will be responsible for all costs for any radiopharmaceuticals and nonradioactive items contracted for if the Beckley VAMC must find an alternate supplier for contracted items. In the event of a manufacturer or pharmacy recall or quality assurance failure, the contractor will notify the Beckley VAMC Nuclear Medicine Service immediately. A radiopharmacist in the employ of the successful vendor must be available to: a. Set up the quality assurance program on radiopharmaceutical preparations required by FDA, NRC, CAP, USP, and the Joint Commission. b. Act as a reference source concerning questions on regulation of radiopharmaceuticals. c. Provide reference services for research drugs and radionuclides under research protocols. d. Provide instruction (continuing education) to technologists on new changes in radiopharmaceutical products and availability. Quality Assurance Surveillance Plan: Contractor will be monitored for performance of services according to the following criteria, with the incentive/disincentive being past performance ratings: a. Accuracy of delivered order: all daily deliveries should match order placed. b. Timeliness of deliveries: all daily deliveries should arrive according to statements above. c. Compliance of shipping containers: all containers will be secured and labeled according to NRC and DOT regulations. d. Radiation safety review: package surveys and wipes for removable contamination will meet NRC and DOT guidelines. e. Communication of industry issues: industry shortages or product recalls will be communicated within 24 hours. LIST OF REQUIRED ISOTOPES UNIT EST. QTY Cardiolite EA 1000 Myoview EA 710 Technetium EA 3500 mCi I-123 EA 20 Ceretec HMPAO EA 10 Choletec EA 75 Pyrolite EA 10 DTPA EA 30 MAA EA 5 Sulfur Colloid EA 25 HDP EA 300 Mag 3 EA 25 DTPA Aerosol EA 5 IN-111 WBC EA 5 The annual estimate is based on historical usage.
 

Web Link

FBO.gov Permalink
(https://www.fbo.gov/spg/VA/MaVAMC613/MaVAMC613/36C24518Q0121/listing.html)
 

Document(s)

Attachment
 

File Name: 36C24518Q0121 36C24518Q0121_1.docx (https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=4112941&FileName=36C24518Q0121-000.docx)

Link: https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=4112941&FileName=36C24518Q0121-000.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: Beckley Veterans Affairs Medical Center;200 Veterans Avenue;Beckley, West Virginia

Zip Code: 25801
 

Record

SN04836317-W 20180301/180227231417-1fb27bb124253e8989dbb33f19f3bd0a (fbodaily.com)
 

Source

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

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