Performance_Work_Statement__FDA-Approved_Radiopharmaceuticals.pdf

Performance Work Statement (PWS)

FDA-APPROVED RADIOPHARMACEUTICAL SUPPLIES AND COLD KITS

DWIGHT DAVID EISENHOWER ARMY MEDICAL CENTER (DDEAMC), FORT

EISENHOWER, GA

PART 1: GENERAL INFORMATION

1.1 This is a non-personal services contract to provide Federal Drug Administration (FDA) approved radiopharmaceutical supplies and cold kits on an as-needed basis to the Nuclear Medicine Section at the Dwight David Eisenhower Army Medical Center (DDEAMC).

1.2 Description of services/introduction: The contractor shall provide all personnel, equipment, supplies, facilities, transportation, tools, materials, supervision, and other items and non-personal services necessary to ensure the continuous provision and timely delivery of FDA-approved radiopharmaceuticals and cold kits as defined in this Performance Work Statement (PWS). The contractor shall perform to the standards in this PWS.

1.3 Background: The Military Treatment Facility (MTF) requires a reliable, continuous supply of FDA-approved radiopharmaceuticals and cold kits to support diagnostic imaging and therapeutic patient care. Due to the short half-life of these materials and the critical nature of nuclear medicine, deliveries must be highly coordinated, timely, and responsive to routine and emergency clinical needs.

1.4 Objectives:

• Ensure the continuous availability of critical radiopharmaceuticals and cold kits for diagnostic and therapeutic procedures.

• Ensure all products meet FDA, Nuclear Regulatory Commission (NRC), and

Department of Transportation (DOT) compliance standards.

• Maintain a highly responsive delivery network to fulfill routine and emergency nuclear medicine orders.

1.5 Scope: The contractor shall provide FDA-approved radiopharmaceutical supplies, including active isotopes, cold kits, and associated shielding/supplies, on an as-needed basis. The contractor shall accomplish safe, regulatory-compliant transport and secure handover of these materials to the DDEAMC Nuclear Medicine Department.

1.6 Period of Performance (PoP): The period of performance shall be one (1) Base Year of 12 months and four (4) 12-month Option Years.

1.7 Administrative specifications

1.7.1 Place of performance: Dwight D. Eisenhower Army Medical Center (DDEAMC), c/o Nuclear Medicine Room 2M-04, 300 Hospital Road, Fort Eisenhower, Georgia 30905.

1.7.2 Hours of operation: The contractor's customer service and delivery network must be available twenty-four (24) hours a day, seven (7) days a week to support DDEAMC's diagnostic and emergency patient needs. The Government's standard business hours are from 07:00 am to 16:00 pm Monday through Friday.

1.8 Quality

1.8.1 Quality Control (QC): The contractor shall develop and maintain an effective QC program to ensure services are performed in accordance with this PWS. The contractor’s written Quality Control Plan (QCP) shall describe the methods for identifying and preventing defects in supplies and deliveries before the level of performance becomes unacceptable. The QCP shall be submitted to the Contracting Officer (CO) within 30 days of award. See Part 7, Technical Exhibit 1 - CDRL A001.

1.8.2 Quality Assurance (QA): The government will evaluate the contractor’s performance under this contract in accordance with the Quality Assurance Surveillance Plan (QASP).

1.9 Contingency/Disaster Plans: The Contractor shall establish and maintain a written Contingency Plan indicating alternative methods of providing radiopharmaceuticals and cold kits in the event their primary facility is rendered unsafe or inoperable (e.g., natural disaster, sabotage).

PART 2: DEFINITIONS AND ACRONYMS

• AQL: Acceptable Quality Level

• COR: Contracting Officer Representative

• DOT: Department of Transportation

• FDA: Food and Drug Administration

• MSDS: Material Safety Data Sheet

• MTF: Military Treatment Facility

• NRC: Nuclear Regulatory Commission

• PRS: Performance Requirements Summary

• PWS: Performance Work Statement

PART 3: GOVERNMENT FURNISHED PROPERTY, EQUIPMENT, AND

SERVICES

The Government will NOT provide Government Furnished Property, Equipment, or Services in support of this contract.

PART 4: CONTRACTOR FURNISHED ITEMS AND SERVICES

4.1 General: The contractor shall furnish all supplies, radiopharmaceuticals, cold kits, shielding, transport vehicles, equipment, and services required to perform the work listed under Section 5 of this PWS.

PART 5: SPECIFIC TASKS

5.1 Provision of Radiopharmaceuticals and Cold Kits: The contractor shall ensure the availability and provision of FDA-approved radiopharmaceuticals, associated cold kits, and related delivery accessories (e.g., syringe shields, chromatography strips, carriers) based on DDEAMC's clinical needs. The contractor shall ensure that all products tendered for acceptance conform strictly to FDA regulations and safety standards.

5.2 Ordering and Customer Service Integration: The contractor shall establish a reliable order-fulfillment system (accessible via phone) 24 hours a day, 7 days a week. A trained customer service representative must be available at all times.

The outcome is successful, uninterrupted order placement and confirmation for routine and emergency clinical needs.

5.3 Delivery and Transportation Services:

5.3.1 Routine Delivery: The contractor shall execute the safe and timely transport of ordered supplies to the DDEAMC Nuclear Medicine Service.

Routine deliveries must arrive no later than thirty (30) minutes prior to the scheduled calibration time, and within 24 hours of contractor acknowledgment of the order.

5.3.2 Emergency Delivery: The contractor shall ensure rapid-response delivery for emergency orders, ensuring products arrive at DDEAMC within two (2) hours of the contractor’s acceptance of the emergency order.

5.3.3 Drop and Pick-Up: The contractor shall manage the drop-off of new materials and the safe pick-up/return of expended materials or shielding in accordance with DDEAMC Nuclear Medicine department instructions.

5.4 Regulatory Compliance and Documentation:

5.4.1 The contractor shall ensure that all transportation, packaging, labeling, and handling of radioactive materials strictly comply with FDA, NRC, and DOT regulations.

5.4.2 The contractor shall provide accurate and complete delivery documentation (e.g., shipping order) with each shipment. Documentation shall ensure traceability and include, at a minimum: Supplier’s Name/Address, Product Name, Lot Number/Unique Identifier, Total Amount/Activity delivered, and Signature of an authorized representative.

5.4.3 The contractor shall supply and maintain current Material Safety Data Sheets (MSDS) for all applicable components.

PART 6: INFORMATION TECHNOLOGY & SECURITY

6.1 All work under this contract is unclassified.

6.2 HIPAA Compliance: The contractor shall comply with all requirements of the Non-Defense Health Agency (Non-DHA) Health Insurance Portability and Accountability Act (HIPAA) Business Associate Agreement (BAA). The contractor shall protect all Protected Health Information (PHI) in the event that patient-specific dosages contain identifiable information.

6.3 Onboarding and Security Requirements: Contractor delivery personnel shall wear a contractor identification badge at all times while performing deliveries on-site at Fort Eisenhower. Personnel requiring network or facility system access shall comply with standard DHA onboarding, training, and Common Access Card (CAC) procedures.

PART 7: ATTACHMENTS AND TECHNICAL EXHIBITS

ATTACHMENT 1: PERFORMANCE REQUIREMENTS SUMMARY (PRS)

Performance Objective

PWS Reference Acceptable Quality Level

(AQL)

Method of Surveillance

PRS #1: Timely Routine Delivery.

Ensure radiopharmaceuticals and cold kits are delivered no later than 30 minutes prior to calibration.

5.3.1 98% of all routine deliveries arrive on or before the required deadline per month.

Periodic Inspection by COR (Delivery Logs).

PRS #2: Emergency Responsiveness.

Ensure emergency orders are fulfilled and delivered within 2 hours of order acceptance.

5.3.2 100% of emergency orders are fulfilled within the 2-hour window.

100% Inspection by COR/Nuclear Medicine staff.

PRS #3: Product Quality and Accuracy. Ensure all delivered products are FDA-approved, match the requested order (isotope, dose, and form), and are accompanied by correct documentation.

5.1 & 5.4.2 Zero deviation (100% accuracy) on product type, dosage, and FDA approval status.

100% Inspection upon receipt by Nuclear Medicine staff.

PRS #4: Regulatory Compliance. Ensure all packaging, labeling, and transportation align with DOT, NRC, and FDA regulations.

5.4.1 Zero safety

violations or incidents of non-compliance.

Validated Customer/Staff Complaint;

Periodic Surveillance.

ATTACHMENT 2: ESTIMATED WORKLOAD DATA (DDEAMC

CONSOLIDATED ITEM LIST)

(Note: Quantities are annual estimates for DDEAMC based on combined requirements)

Radiopharmaceuticals & Supplies Estimated Annual Quantity

Cu-64 Dotatate UD 15

Syringe Carrier, Small Small 001-181 (Mirion)

10cc Syringe Shield 3CC 3

Dose Drawings Syringe Shield 5CC &

6CC

PRO-TEC III Syringe Shield 1CC Press Fit

Syringe Shield, 3CC 5

Syringe Shield, 5CC 2

Syringe Shield, 10CC 2

NM Pharm Tungsten Vial Shield 3

Moly Shield, Syringe 1

Moly Shield, Vial 1

TEC-Control Red Strip 4

TEC-Control Black 4

TEC-Control Orange 4

TEC-Control Light Blue 4

Chromatography Test Strips, Aluminum

TEC-Control Pink 4

Aerotech Radioaerosol Kit, Per Unit 30

NM Pharm Labels Radioactive 15

Vial dipper Capintec 2

Chamber insert dose calibrator Capintec

Forceps Curved 12.5" 2

Tc99m Medronate UD 100

Tc99m Macro Aggregated Albumin

UD

Tc99m Sulfur Colloid UD 40

Tc99m Filtered Sulfur Colloid (uCi) UD 20

Tc99m Pentetate UD 30

Tc99m Mebrofenin UD 50

DMSA Tc99m UD 5

Tc99m Mertiatide UD 20

Tc-99m NaTcO4 UD mCi (up to 30mCi)

I-123 100 uCi 10

I-123 200 uCi 50

Ga-67 Gallium Citrate UD per 50

I-131 DX Capsule 10-100 uCi Cap 10

I-131 DX/TX Capsule 1 -6 mCi 20

I-131 DX/TX Capsule each add'l mCi 500

In-111 Pentetreotide UD 2

Tc99m Sestamibi UD 50

Tl-201 Thallous Chloride mCi 50

Ioflupane I-123 10

In-111 Pentetate Vial 1

In-111 Indium Oxine WBCs 10

Medronate Vial 200

Pentetate Vial 25

Macro Aggregated Albumin Vial 25

Sulfur Colloid Vial 80

Mebrofenin Vial 100

Sincalide Vial 20

UltraTag Vial 100

Pyrophosphate Vial 5

AdreView (mibg I-123) 1

F-18 FDG UD 50

NaF - 18 UD 10

Ba-133 vial source (250uCi/vial) 1

Cs-137 vial source (200uCi/vial) 1

Co-57 vial source (5.0 mCi/vial) 2

Co-57 Flood Sheet 1

Co-57 Spot Marker (50 µCi) 1

Co-57 “L” and “R” Spot Markers (100 µCi)

Tc-99m NaTcO4 vial 100 mC 10

PART 7, TECHNICAL EXHIBIT 1: DELIVERABLES SCHEDULE

Deliverable Frequency Medium/Format Submit To Applicable

PWS

Section

CDRL A001 –

Quality Control Plan

(QCP)

Within 30 days of contract award

Contractor's Discretion / MS Word

CO & COR 1.8.1

Contingency & Disaster Plan

Submitted with proposal / Updates as required

Contractor's Discretion / MS Word

CO & COR 1.9

Material Safety Data Sheets

(MSDS)

Upon initial delivery or as updates become available

Electronic (PDF) or Printed Hard Copy

COR & Clinic Staff

5.4.3

Unfavorable Security Clearances Report

Within 5 days of occurrence

Secure Encrypted Email

(PDF)

CO &

Personnel Security

6.3