DRAFT STATEMENT OF WORK.doc

DRAFT STATEMENT OF WORK

A. GENERAL INFORMATION

Title of Project: Statement of Work – Radiopharmaceuticals and Related Supplies Scope of Work: The contractor shall provide all resources necessary to accomplish the deliverables described in this statement of work.

Background: Radiopharmaceuticals are used as a diagnostic tool in the evaluation of patient organ function, certain disease processes and 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. Radiopharmaceuticals have short half-lives on the order of hours and must be delivered within certain specified time periods on an "as needed" basis, limiting suppliers to those located in the immediate Fresno, CA, area.

Performance Period: For time period covering 10/01/2025-9/30/2030 Proposals will be considered only from offerors who are regularly established in the radiopharmaceutical business, who in the judgment of the Contracting Officer are financially responsible and able to show evidence of the reliability, ability, experience, necessary equipment, proper facilities and personnel directly employed or supervised by to render prompt and satisfactory service.

B. GENERAL REQUIREMENTS

1. Deliver routine and non-routine radiopharmaceuticals to VA Central California Health Care System (VACCHCS) on a daily basis.

2. Have processes in place to ensure timely and flexible delivery of radiopharmaceuticals. Contractor shall deliver routine pharmaceuticals before the beginning of the workday (before 8:00 a.m., Monday – Friday, excluding Federal holidays). Deliver planned intra-day radiopharmaceutical deliveries at contractor’s convenience as long as arrival is more than 15 minutes before the patient’s scheduled appointment time, as indicated on the dose order form (Note: Patient arrival-time is earlier than the radiopharmaceutical calibration-time). For unscheduled intra-day orders, deliver routinely-available radiopharmaceuticals generally within one-hour and not more than two-hours from the time of order.

3. Establish mutually agreeable radiopharmaceutical-specific procedures in advance for non-routine radiopharmaceuticals that require specific scheduling or long lead-times.

4. All compounding must be USP-825 compliant with successful State inspection history.

5. White Blood Cell tagging orders are generally intra-day Stat orders. Therefore, contractor selection is preferential to those with redundant processes for USP-825 compliant White Blood Cell tagging that assures blood turnaround time within about 4-5 hours: this includes same-day kit delivery, blood pickup, tagging, and then redelivery of tagged blood before about 4:00 p.m.

6. Availability of Xofigo is preferred.

7. Supply FDA compliant products (not radiochemical compliant) when available in the marketplace.

8. Supply the full range of radiopharmaceuticals required by VACCHCS.

9. Maintain a dual supply system for Technetium generators to assure availability during periods of radioactive-material shortages. Maintain regional backup that is capable of supplying all required radiopharmaceuticals in the event of unforeseen local supply disruption.

10. Preferentially supply medical radionuclides from Low Enriched Uranium (LEU) sources. The VA encourages LEU-produced technetium and will pay an additional price if a reasonable strategy can be offered that help promote the transition to LEU.

11. Provide a packing list with each delivery that correlates with each invoice and is consistent with the recordkeeping requirements of 10 CFR 35.2063, indicating not less than the radiopharmaceutical, the patient's name or the indicated code-name, the ordered dosage at the calibration date and time. Have processes in place to protect patient identity and confidentiality (fax machine in secured location).

12. Contractor must supply a comprehensive quarterly Quality Assurance Summary Report.

13. All contractor personnel requiring access to VA Facilities must meet the security background check requirements that are acceptable to VACCHCS Police Service and maintain compliance with Police Service security requirements. This includes following Police guidance for temporary parking during package delivery. The VA reserves the right to bar any contractor personnel from its premises.

14. Whenever reasonably possible for intra-day deliveries, obtain the attention of a member of Nuclear Medicine staff at the time of delivery to assist in maintaining compliance with 10 CFR 20.1906 and to expedite direct patient care.

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

3. All shipments must be compliant with all Nuclear Regulatory Commission and Department of Transportation packaging and transport regulations.

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

D. SCHEDULE FOR DELIVERABLES

1. VACCHCS Nuclear Medicine personnel place orders via telephone, fax, or other mutually agreeable procedure.

2. The following Federal Holidays are observed (The Fresno VA Nuclear Medicine department is not open on Federal holidays):

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

3. If an anticipated daily order is not received as expected by the usual time near the End Of Business, establish in advance and maintain a system with pre-approved contact numbers to resolve the issue to prevent the possibility of an unfilled order.

4. Radiopharmaceuticals shall be delivered within the Nuclear Medicine Department and properly secured according to predefined security procedures:

VA Central California Health Care System Nuclear Medicine Section (115) 2615 E. Clinton Ave Fresno, CA 93703-2286

5. If for any reason any delivery cannot be completed within the scheduled time frame, the contractor is required to immediately notify a responsible VACCHCS Nuclear Medicine staff member by phone or in person (559-228-5311 or other pre-approved contact numbers). Phone-mail messages are not adequate: the contact must be personal.

E. CHANGES TO STATEMENT OF WORK

1. 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.

2. VA Point of Contact: The VA Point of Contact for this contract will be named upon award.

F. PERFORMANCE MONITORING

1. The VA Point of Contact (POC) / Supervisory Nuclear Medicine Technologist will monitor contractor performance. The POC will certify the work was done in accordance with the SOW.

G. BID-SHEET

Use the following worksheet or submit an equivalent price sheet for the items indicated (contracted prices must clearly correlate with each orderable item as invoiced). The indicated estimated annual quantities are based on historical deliveries that will vary based on actual patient-care requirements. Zero-quantity items may be ordered in low quantity: enter price to indicate availability or indicate N/A or unavailable.

Note that there are three known pricing strategies: 1) the preferred is a single unit price for a reasonable range of activity, 2) a fixed price per unit of activity, and 3) a combination where there is a fixed initial price for an activity up to a designated value followed by a fixed price per unit of additional activity.

Be sure to indicate which strategy is used for each item (recommend grouping separately into the three groups or into any other group that is clearly defined.

The organization below is only suggested: modify according to the contractor’s pricing strategy. Use the following designated quantities. Indicate price where quantity is not indicated if the product is available just in case a requirement develops during the contract period.

If the suggested group below is incorrect, move the radiopharmaceutical to the correct group.

Excel spreadsheet is available upon request but contractor is responsible for the calculations.

Somewhere indicate items available for 1-hour delivery, special order, etc.

1) Radiopharmaceuticals priced based on fixed unit dose price

Adjusted Qty "C" Contract Price A*B*C= Cost

F-18 FDG Fludeoxyglucose UD

I-123 Iobenguane Sulfate; I-123 MIBG (Adreview) UD

In-111 Capromab Pendetide (Prostascint) UD

Tc99m Bicisate Dihydrochloride (Neurolite®) UD

Tc99m Disofenin UD

Tc99m Ceretec (Exametazime aka HMPAO) UD {brain study}

Tc99m HDP (Oxidronate) UD

Tc99m Sestamibi as Cardiolite UD

Tc99m Tetrofosmin (Myoview) UD

Lidocaine dilution for sulfur colloid intradermal injection

Tl-201 (Thallous Chloride) UD (1 mCi per UD)

Tl-201 (Thallous Chloride) UD (4 mCi per UD)

Sn-PYP (Pyrophosphate) VIAL for Labeling Red Blood Cells (per vial)

Labeled WBC (autologous leukocytes) In-111 Chloride (Tropolone) UD

Labeled WBC (autologous leukocytes) Tc99m Ceretec (Exametazime HMPAO) UD

Adenoscan (Adenosine) Single Use per # mg ordered

Adenoscan (Adenosine) 20 mL VIAL

Adenoscan (Adenosine) 30 mL VIAL

Captopril 50 mg tablet

Kinevac (Cholecystokinin - CCK) UD

Kinevac (Cholecystokinin - CCK) VIAL

Lexiscan™ (Regadenoson) UD

2.5 cc Lifetime Syringe Shield

3 cc Lifetime Syringe Shield

5 cc Lifetime Syringe Shield

10 cc Lifetime Syringe Shield

AV-100H Aero/Vent Jr Kit (Medi Nuclear)

GM Meter Calibration

SSM-057-100U Co-57 100 micro curie spot marker (Cardinal)

MED3709 Co 57 10 milli curie Flood Source (Eckert & Ziegler)

2) Radiopharmaceuticals priced based on fixed price per unit of activity (millicurie or microcurie)

Base Qty UD

Adjusted Qty "C" Contract Price A*B*C= Cost

0.08

3) Radiopharmaceuticals priced based on Initial unit dose price (top line) and fixed price per each additional unit of activity (microcurie or millicurie)

Base Qty UD

Adjusted Qty "C" Contract Price A*B*C= Cost

Additional cost for activity above base cost:

Additional cost for activity above base cost:

Totals

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