Radiopharmaceutical Delivery

Added: Feb 27, 2018 2:48 pm 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.