Statement of Work.pdf

STATEMENT OF WORK

December 11, 2020

1. Contractor shall provide items listed in the Schedule of Supplies or Services of this solicitation to the VA Eastern Colorado Healthcare System (VA ECHCS), 1700 N.

Wheeling St, Aurora CO 80045. Included items are:

a. Kits (Pyrophosphate and Ultratag)

b. Unit doses (filtered sulfur colloid, MAA, mebrofenin, mertiatide, bulk technetium, HDP, MDP, DTPA aerosol, sestamibi, tetrofosmin, ceretec WBC labelling, gallium, I-123, I-131, lymphoseek, In-111 pentetreotide, strontium, thallium, F-18 FDG, and any others included in the CLIN)

2. Contractor shall abide by (CFR 10) Title 10 Code of Federal Regulations, which states:

A licensee may use for medical use only:

(a) Byproduct material manufactured, labeled, packaged, and distributed in accordance with a license issued pursuant to the regulations in title 10, code of Federal Regulations, part 30 and SS32.72, or 32.74 of this chapter or the equivalent regulations of an Agreement State.

(b) Reagent kits that have been manufactured, labeled, packaged, and distributed in accordance with the approval by the Commission pursuant to SS32.72 or an Agreement State under equivalent regulations for the preparation of radiopharmaceuticals for medical use.

Title 10 Code of Federal Regulations is available at http://www.nrc.gov/reading-rm/doc-collections/cfr/

3. Contractor shall be available to take dose orders (via telephone or web-ordering) 24 hours a day, 7 days per week.

4. Contractor shall provide, free of charge, up to two deliveries each weekday (M-F) to the Nuclear Medicine Department. There shall be no scheduled weekend or after-hours deliveries.

5. Radiopharmaceuticals ordered the previous day, for the scheduled work load, shall be delivered by 6:45 a.m., or on what is considered the “first run” if they are calibrated before noon. Any afternoon doses not delivered on the a.m. run shall be delivered by 12:00 p.m. Doses should always arrive to the nuclear medicine department at least 30 minutes prior to calibration time.

http://www.nrc.gov/reading-rm/doc-collections/cfr/ http://www.nrc.gov/reading-rm/doc-collections/cfr/

6. Due to ECHCS compliance with USP 797 and USP 825, all deliveries to the nuclear medicine department will be unit doses.

7. The VA will require STAT orders to be delivered to the hospital within 90 minutes of the order being placed, inclusive of normal working hours, after-hours, and weekend deliveries. This will occur most frequently during the workday (Monday-Friday, 0645- 1630); typically, after-hour and weekend call-outs average no more than one per week at this facility.

8. All technetium and non-technetium products shall be in stock and available on both a daily and emergent basis. During wide-spread shortages of molybdenum every effort shall be made to supply the VA ECHCS Nuclear Medicine Department with needed doses in accordance with the statement above. A wide-spread shortage of molybdenum occurs when two or more of the five global molybdenum reactors are out of commission resulting in a shortage of raw material.

9. Contractor shall perform all quality control procedures as required by Federal and State regulatory agencies.

10. Contractor shall meet all Nuclear Regulatory Commission, Department of Transportation, Federal Department of Agriculture and other federal and state rules and regulations.

11. Contractor shall upon request provide a copy of their laboratory’s current quality control manual and shall discuss any discrepancies in lab results which do not meet the requirements of VA standards.

12. Contractor shall upon request provide a copy of their security/ screening process used to hire new drivers.

13. Contractor shall label all supplies as to the radiopharmaceutical name, amount of radiopharmaceutical, calibration time, expiration time, date, patient name, and any other information deemed necessary by the contractor.

14. Contractor shall upon request replace the wrong delivered item or replace damaged item at no cost to the VA ECHCS medical center.

15. Contractor shall assign to the VA ECHCS medical center an individual sales representative to aide in facilitation in the smooth coordination between the medical center and the laboratory pharmacy.

16. All packaging of radioactive material shall clearly be labeled RADIOACTIVE on the outside of the carton it is shipped in.

17. Contractor shall make an effort to procure non-HEU derived Tc-99m and offer non-HEU unit doses to VA ECHCS as supplies become available.

18. Contractor shall include hot lab management software as a part of their proposal;

including software support and maintenance