FINAL SOW.docx

Statement of Work Radiopharmaceuticals Supply Southeast Louisiana Veterans Health Care System New Orleans, LA Date: _06/24/2026

1. PURPOSE

1.1 The purpose of this Statement of Work (SOW) is to establish requirements for the supply and delivery of radiopharmaceuticals and related ancillary items for the Southeast Louisiana Veterans Health Care System (SLVHCS), located at 2400 Canal St, New Orleans, LA.

1.1.1 Period of Performance

• Period of Performance: October 1, 2026 – September 30, 2027

• Period of Performance: October 1, 2027 – September 30, 2028

• Period of Performance: October 1, 2028 – September 30, 2029

• Period of Performance: October 1, 2029 – September 30, 2030

• Period of Performance: October 1, 2030 – September 30, 2031

2. SCOPE

2.1 The Contractor shall provide all radiopharmaceuticals and calibration sources listed in this SOW.

2.2 All products must meet FDA, USP <825>, NRC 10 CFR Part 35, DOT hazardous transport regulations, and all applicable VA requirements.

2.3 The Contractor shall provide all labor, materials, and services necessary to prepare, package, transport, and deliver radiopharmaceuticals safely and on time.

2.4 The Contractor is responsible for ensuring all products are properly labeled, shielded, sealed, and contamination‑free.

2.5 The Contractor must ensure all products meet activity tolerance, calibration requirements, and quality control standards at the time of delivery.

Salient Characteristics

· All radiopharmaceuticals shall be delivered as unit doses unless otherwise specified.

· Containers must be shielded, sealed, tamper‑evident, and radiation‑compliant.

· All doses must include lot number, activity, volume, calibration time, and expiration.

· All items must comply with DOT, IATA, and NRC packaging and shipping requirements.

· Contractor must provide STAT, after‑hours, weekend, and holiday delivery.

· STAT doses must arrive within 60 minutes of order placement.

· Delivery must be made directly to authorized SLVHCS personnel; no unattended drops permitted.

2.1 PET Radiopharmaceuticals

A. PET Radiopharmaceuticals

B. SPECT Radiopharmaceuticals

C. Therapeutic Isotopes

D. Ancillary Pharmaceuticals

E. Calibration Sources & Phantoms

F. Support Items

G. PET / SPECT Additional Products

H. Delivery & After‑Hours Charges

3. DELIVERY

3.1 All deliveries shall be made to:

SLVHCS Nuclear Medicine Department Room 2G221 2400 Canal Street New Orleans, LA 70119

3.2 First daily delivery must arrive no later than 6:30 AM unless otherwise approved.

3.3 STAT doses must be delivered within 60 minutes of order placement.

3.4 The Contractor shall provide after‑hours, weekend, and holiday delivery as required.

3.5 All deliveries shall be escorted by VA staff into the department.

3.6 Contractor shall maintain proper shielding and transport security at all times.

3.7 Contractor shall comply with DOT, NRC, and VA arrival, handling, and radiation safety requirements.

3.7 FEDERAL HOLIDAYS

Federal Holidays observed by the U.S. Government:

· New Year’s Day – January 1

· Martin Luther King Jr. Day – Third Monday in January

· Washington’s Birthday – Third Monday in February

· Memorial Day – Last Monday in May

· Juneteenth National Independence Day – June 19

· Independence Day – July 4

· Labor Day – First Monday in September

· Columbus Day – Second Monday in October

· Veterans Day – November 11

· Thanksgiving Day – Fourth Thursday in November

· Christmas Day – December 25 If a holiday falls on a Sunday, the following Monday is observed.

If a holiday falls on a Saturday, the preceding Friday is observed.

Additional holidays may be declared by Executive Order.

3.8 WEATHER & HURRICANE EMERGENCY REQUIREMENTS

3.8.1 The Contractor shall maintain operational capability during severe weather, hurricane watches/warnings, flooding, and declared emergencies to the maximum extent safe and permitted by law.

3.8.2 The Contractor shall notify the COR and Nuclear Medicine staff of any anticipated delivery delays and provide updated ETAs within 30 minutes of status changes.

3.8.3 Contractor shall maintain contingency plans including:

· Alternate radiopharmacy production locations

· Redundant delivery routes

· Backup generators at production facilities

· Emergency staffing plans

3.8.4 For critical STAT doses, Contractor shall make best effort to deliver despite adverse weather. If delivery is not possible, Contractor must notify VA immediately with the earliest safe alternative.

3.8.5 Force majeure delays may be excused only when legally required (e.g., road closures, unsafe conditions), but Contractor must resume service as soon as it is safe.

4. SITE CONDITIONS

4.1 No eating, drinking, or smoking in clinical areas.

4.2 Contractor personnel shall comply with VA PPE, infection control, and radiation safety rules.

5. DELIVERABLES

· Radiopharmaceutical doses as ordered

· Packing list for each delivery

· Lot number and activity documentation

· Monthly usage/delivery report if requested

6. TRAINING

6.1 Vendor orientation only, if requested.

7. PROTECTION OF PROPERTY

7.1 Contractor shall protect all VA property during delivery activities.

7.2 Contractor shall repair any damage caused by their personnel.

8. SECURITY REQUIREMENTS

8.1 All contractor personnel must display ID and be escorted as required.

8.2 Contractor shall not access patient information.

9. WARRANTY

9.1 All radiopharmaceuticals must meet manufacturer specifications at delivery.

9.2 Defective or non‑conforming doses must be replaced at no cost to the Government.

10. REGULATORY COMPLIANCE REQUIREMENTS

Contractor must comply with:

· NRC 10 CFR Part 35

· DOT 49 CFR Parts 171‑180

· FDA radiopharmaceutical guidance

· USP <825>

· VA medical center radiation safety policies Non‑compliance constitutes material breach.

11. NON‑CONFORMING PRODUCTS

Any dose that is incorrect, contaminated, mislabeled, under‑dosed, expired, late, or improperly packaged is non‑conforming and must be:

· Replaced immediately at no cost

· Reported to Nuclear Medicine and COR Three non‑conformances in 90 days may trigger a Contract Deficiency Report.

12. DELIVERY FAILURE & SERVICE INTERRUPTION

If the Contractor fails to meet required delivery times:

· Contractor must notify Nuclear Medicine immediately

· Provide ETA

· Provide alternate supply source if needed Repeated failures may result in termination for cause.

13. CHAIN‑OF‑CUSTODY & SECURITY

· Packages must be sealed, intact, and tamper‑evident

· No unattended drop‑offs permitted

· Chain‑of‑custody must be maintained for all radioactive materials

14. INCIDENT REPORTING

Contractor shall report within 30 minutes:

· Incorrect dose

· Wrong patient preparation

· Lost or missing material

· Damage, leakage, contamination

· Delivery to wrong location VA reserves right to notify NRC/DOT.

15. INDEMNIFICATION / CONTRACTOR LIABILITY

The Contractor is responsible for:

· Package damage

· Leakage or contamination

· Regulatory violations

· Delivery errors or delays

· Facility damage caused by contractor personnel This does not waive VA sovereign immunity.