Statement of Work.doc

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6505--Radiopharmaceuticals IDIQ - Martinez
Solicitation number
36C26124Q0865
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This document is a Statement of Work (SOW) for radiopharmaceutical supplies for the VA Northern California Health Care System (VANCHCS). The SOW describes the scope of work, background, period of performance, general requirements, mandatory tasks, and delivery schedule for radiopharmaceuticals used in diagnostic and treatment applications.

The SOW outlines specific requirements, including that the contractor must be licensed by the Nuclear Regulatory Commission, have adequate supply to meet VANCHCS needs, properly label all supplies, perform quality control, and comply with all relevant regulations. The contractor shall also accept returns under certain conditions. Delivery schedules are provided, including same-day and STAT options. This SOW is related to a federal contract opportunity for an Indefinite Delivery Indefinite Quantity (IDIQ) contract for radiopharmaceuticals, as described in the attached pre-solicitation notice. The pre-solicitation requests capability statements from qualified vendors, including information on business size, socioeconomic status, GSA schedule, pricing, and past performance. Responses are due by July 25, 2024.

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STATEMENT OF WORK

A. GENERAL INFORMATION

1. Title of Project: Statement of Work - Radiopharmaceutical Supplies

2. Scope of Work: The contractor shall provide all resources necessary to accomplish the deliverables described in this statement of work, except as may otherwise be specified.

3. Background: Radiopharmaceuticals are used as a diagnostic tool in the evaluation of organ function and certain disease processes. They are also used in the treatment of certain conditions including but not limited to Hyperthyroidism (Grave’s disease), Thyroid cancer, and palliation of bone pain due to metastatic prostate cancer.

4. Period of Performance:

· Ordering Period 1: April 1, 2025 – March 31, 2026

· Ordering Period 2: April 1, 2026 – March 31, 2027

· Ordering Period 3: April 1, 2027 – March 31, 2028

· Ordering Period 4: April 1, 2028 – March 31, 2029

· Ordering Period 5: April 1, 2029 – March 31, 2030

Normal working hours for the Nuclear Medicine Service at VANCHCS are Monday through Friday, 7:30 a.m. through 5:30 p.m. Services may be required after normal operating hours during the week and on weekends and holidays for emergency patient care. See Section F for list of observed Federal Holidays.

B. GENERAL REQUIREMENTS

*Anticipated Supplies required are estimated based on past usage.*

I123 Adreview, 6 – 10 mCi: 1 doses

I123 NaI, 200 uCi capsule: 110 capsules

I123 NaI diag capsule 2 – 4 mCi 5 capsules

I131 NaI, therpy cap, cancer, 1 – 200 mCi; 10 capsules

I131 NaI, therapy cap, 1 – 200 mCi; 400

I131 NaI therapy cap, hyper, 1-30 mCi: 300 I131NaI, diagnostic capsules .1 – 2 mCi: 30 capsules

In111 DTPA, 0.5 mCi: 1 dose

In111 labeled WBC, 0.5 mCi: 3 doses

Tc99m MAA, 1 – 6 mCi: 30 doses

Xe133, 20mCi vials: 30 doses

Tc99m MAG3, 10 mCi vials: 25 doses

Tc99m MDP, 25 mCi: 320 doses

Tc99m Mebrofenin, 5 – 10 mCi: 130 doses

Tc99m Sestamibi, 10 – 30 mCi: 25 doses Same day delivery – 45

Tc99m Sulfur Colloid, 1 – 8 mCi: 70 doses

Tc99m Filtered Sulfur Colloid, 0.25 – 5 mCi; 65 doses

Tc99m Tetrofosmin, 1 – 40 mCi: 1650 doses

Tc99m NaTcO4, 1-30 mCi: 15 doses Tc99m NaTcO4, 4-200 mCi vials: 2 vials

Tc99m DTPA aresol, 1-40 mCi; 40 doses

Tc99m HMPAO; 1 – 25 mCi, 1dose

Tc99m PYP; 15 mCi, 10 doses

Tc99m Technegas, 70

Ga67, 4 mCi: 5 doses

Xe133 gas, 20 mCi, 10 vials

PYP Cold kits – 5 kits

Kinevac Cold kits – 60 kits Ultra Tag kits – 10 kits

STAT delivery – 10 The contractor agrees to provide prepared single unit doses of radiopharmaceuticals and associated materials to VANCHCS as ordered and at the agreed upon price. Low Enriched Uranium Technetium shall be provided, when at all possible, as mandated by VA Central Office.

Orders shall be placed each day (Monday through Friday by 4:30PM) for delivery the next business day (Monday through Friday). Due to the demands of the Out Patient Clinic patient care requirements, contractor shall provide 3 routine deliveries at no charge.

For additional orders placed during for the same day delivery, deliveries must arrive within 120 minutes of order placement. STAT order for the same day delivery must arrive within 60 minutes of order placement.

Proposals will be considered only from Offerors who are regularly established in the business that is called for, and who in the judgment of the Contracting Officer are financially responsible and able to show evidence of the reliability, ability, experience, equipment, facilities and personnel directly employed or supervised by them to render prompt and satisfactory service.

C. SPECIFIC MANDATORY TASKS AND ASSOCIATED DELIVERABLES

1. Contractor must be licensed by the Nuclear Regulatory Commission and be regularly established in the business of providing radiopharmaceuticals. Offeror must provide copies of licenses and certifications along with quote to the Contracting Officer.

2. Contractor shall have available an adequate supply of contract products to meet the requirements of the VANCHCS at its distribution points.

3. Contractor shall label all supplies as to the amount of radiopharmaceutical, preparation time, expiration time, date, etc. compliant with Nuclear Regulatory Commission Standards.

4. All packaging of radioactive material MUST BE clearly labeled RADIOACTIVE on the outside of the shipping carton.

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

6. Contractor shall meet all Nuclear Regulatory Commission, Department of Transportation, FDA, OSHA and all other agency rules and regulations (Federal and State).

7. It is preferable that the contractor have access to multiple resources for obtaining pharmaceutical kits, Mo99-Tc99m generators to minimize the effect of shortages that occur.

8. The Contractor shall have the resources necessary for VANCHCS (Martinez) to purchase nuclear medicine supplies such as, but not limited to, syringe shields, radiation monitoring devices, Quality Assurance Radioactive Sources, etc. This shall be at fair market value. This will not be priced in the bid. VANCHCS will add the cost of these items at no cost to the contractor.

9. Contractor shall accept returns for credit under the following conditions:

a. Product(s) ordered or shipped in error

b. Product(s) damaged in shipment

c. Concealed shipping damages

d. Recalled product(s)

e. Outdated products in unopened, original container (specifically authorized for return by manufacturer)

D. SCHEDULE FOR DELIVERABLES

Orders can be placed by the VANCHCS ordering personnel via telephone, fax, or e-mail.

The following Federal Holidays are observed:

New Year’s Day

Birthday of Martin Luther King, Jr. (day of observance)

Washington’s Birthday

Memorial Day

Juneteenth

Independence Day

Labor Day

Columbus Day

Veterans Day

Thanksgiving Day

Christmas Day

Delivery of supplies by the scheduled date will be complete except as otherwise authorized by the Ordering Personnel.

Radiopharmaceuticals shall be delivered to:

VA Northern California Health Care System

Nuclear Medicine Department

Building 19, Room C155 150 Muir Rd

Martinez, CA 94553

If for any reason any deliverable cannot be delivered within the scheduled time frame, the contractor is required to notify the VANCHCS Nuclear Medicine Service by phone or in writing as soon as is feasible.

Point of Contact: The POC for this contract is, Chief Nuclear Medicine Technologist, telephone number is .

E. Radioactive Waste.

All used radioactive waste syringes and/or vials of acceptable radiopharmaceuticals will be transferred back to the Contractor for decay and storage. All such radioactive waste shall be returned (picked-up) by the next working day. The contractor shall supply the “secure system” for the prevention of biohazard and radioactive contamination of reusable lead container.

F. CHANGES TO STATEMENT OF WORK

Any changes to this SOW shall be authorized and approved only through written correspondence from the CO. A copy of each change will be kept in a project folder along with all other products of the project. Costs incurred by the contractor through the actions of parties other than the CO shall be borne by the contractor.

(End of SOW)

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