STATEMENT OF NEED FOR THYROID UPTAKE SYSTEM.docx
DOCX document 21 KB Posted
- Attached to
- Captus 4000e Thyroid Uptake System
- Solicitation number
- HT941026QE012
- Issued by
-
Defense Health Agency
About this file
This is a Statement of Need for a specialized medical equipment procurement by the Defense Health Agency for Madigan Army Medical Center. The Government requires procurement and delivery of one new Captus 4000e Thyroid Uptake System (P/N: 5430-30151), one compatible Neck Phantom (P/N: 5230-0038), associated proprietary software, and deployment services. The system is a critical clinical asset used to perform diagnostic thyroid uptake measurements necessary for calculating accurate therapeutic dosages of radioactive iodine for patients with thyroid disorders and thyroid cancer, as well as for regulatory compliance with Nuclear Regulatory Commission and Defense Health Agency safety requirements.
The technical specifications require a 1024-channel multichannel analyzer board, a 2-inch NaI(Tl) detector with flat-field collimator meeting ANSI N44.3 standards, a 20-inch all-in-one touch screen computer running Windows, an ergonomically designed mobile stand with 360-degree casters and articulating arm, and comprehensive software including thyroid uptake protocols, wipe test modules, and customizable QA reporting. The neck phantom must be made of clear Lucite with two-part inserts and etched alignment markings. All deliverables including delivery, installation, and clinical training must be completed by September 30, 2026, with FOB Destination shipping to Madigan Army Medical Center at Joint Base Lewis-McChord in Tacoma, Washington. Equipment must be brand new in original OEM packaging, and the Contractor must be an Authorized Reseller providing a minimum twelve-month comprehensive OEM warranty covering all parts, labor, travel costs, and software updates.
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Other files
| File | Type | Posted |
|---|---|---|
| ATTACHMENT A Addendum to FAR 52.212-1.pdf | ||
| Solicitation - HT941026QE012.pdf | ||
| ATTACHMENT B Addendum to FAR 52.212-2.pdf |
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STATEMENT OF NEED
Purchase Description / Technical Specifications This document establishes the procurement, delivery, and training requirements for one (1) new, commercial-off-the-shelf Captus 4000e Thyroid Uptake System (P/N: 5430-30151), one (1) compatible Neck Phantom (P/N: 5230-0038), and associated deployment services for the Nuclear Medicine Clinic at Madigan Army Medical Center (MAMC).
1. General Scope
1.1 Procurement Objective
The Government requires the procurement, delivery, installation, calibration, and clinical training for a new (not refurbished or demonstration) Captus 4000e Thyroid Uptake System (P/N: 5430-30151), a Thyroid Uptake Neck Phantom (P/N: 5230-0038), and its proprietary operational software.
1.2 Clinical Mission & Purpose
· Diagnostic & Therapeutic Support: This system is a critical clinical asset used to perform diagnostic thyroid uptake measurements. These measurements are mathematically required to calculate accurate therapeutic dosages of Iodine-131, I-125 and I-123 for patients undergoing treatment for thyroid disorders (such as hyperthyroidism and Graves' disease) and thyroid cancer.
· Calibration & Quality Control: The Neck Phantom will be utilized as a physical reference standard to perform geometry calibrations, daily quality assurance (QA), and detector efficiency calculations for the main uptake unit.
· Regulatory Compliance: This system is vital for conducting mandated staff bioassays, automated wipe tests, and area monitoring to maintain compliance with Nuclear Regulatory Commission (NRC) licensing and Defense Health Agency (DHA) safety regulations.
2. Salient Characteristics (Technical Specifications) The procured system must meet or exceed the following technical and functional performance parameters:
| Item |
| Part Number |
| Salient Characteristics / Requirements |
| Captus 4000e Thyroid Uptake System |
| 5430-30151 |
| MCA board: 1024-channel multichannel analyzer with auto/manual calibration |
• Uptake Detector: 2-inch NaI(Tl) detector with flat-field collimator meeting ANSI N44.3 standards.
• Interface & PC: 20-inch All-in-One Touch Screen Computer running a secure Windows environment.
• Mobile Stand: Ergonomically designed stand with lockable 360-degree casters, articulating collimator arm with 34-inch vertical range, and built-in isolation transformer.
• Software Suite: Predefined thyroid uptake protocols, wipe test modules with isotope identification, bioassay monitoring, and customizable QA reporting
| Thyroid Uptake Neck Phantom |
| 5230-0038 |
| Material: Made of clear Lucite designed to represent a standard patient's neck. |
• Inserts: Two-part insert allowing counting in a bottle, vial, or capsule.
• Alignment: Etched marking for precise caliper/probe placement for reproducible geometry
Clinical & Technical Training
Virtual clinical application training for Nuclear Medicine staff covering patient study protocols, QA workflow, and wipe test archiving.
Provision of electronic and physical operations manuals, quick-start guides, and warranty document
3. Conformance & Documentation
· Standards Conformance: The items must conform to the specifications provided by the industry standard.
· Verification Documentation: The Contractor must include any manufacturer’s literature or official technical documentation with their proposal that verifies conformance to all technical specifications outlined in this document.
4. Shipping, Delivery, & Installation Requirements
| Phase / Parameter | Requirement Description |
| Required Delivery Date (RDD) | All deliverables (including delivery and installation) must be completed on or before September 30, 2026. |
| Shipping Terms | FOB Destination to the delivery address below. The Contractor is responsible for all shipping, handling, and logistics. |
| Delivery Address | Madigan Army Medical Center Attn: Clinical Investigations – Nicholas Ieronimakis, 9040 Jackson Ave Tacoma, WA 98431 |
| Access & Security | Delivery is to Joint Base Lewis-McChord (JBLM). The delivery carrier and on-site technician must comply with all base access control and security protocols. |
| Condition | All equipment must be strictly brand new in original OEM packaging. Grey-market, used, or refurbished equipment is prohibited. |
5. Warranty & Support Standard Warranty: The analyzer must be covered by a minimum twelve (12) month comprehensive OEM warranty.
Coverage Scope: The warranty must cover all parts, labor, travel costs for on-site repairs at Madigan Army Medical Center, and any necessary software updates for the duration of the warranty period.
Authorized Support: The Contractor must be an Authorized Reseller and guarantees that the Government will receive full, uninterrupted technical support directly from the manufacturer,
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