Requirements Doc.docx

Statement of Work Calibrations of Whole Body Counting System

Background WEAC’s Whole Body Counting system provides radiation exposure data to ORA personnel who have inadvertently ingested or inhaled radioactive material. The capability of having a Whole Body Counting system (WBC) is a requirement per ORA's NRC License #20-08361-01.

Objectives

The WBC uses an array of HPGe spectrometers for operation which use Cryo-Pulse 5 mechanical cooling to remain at operating temperature. One detector in the array has a faulty cooling unit requiring repair by an authorized vendor. WEAC is requesting repair of the faulty components of the detector cooling system and restore WEAC’s full capability to perform in-vivo assays using the WBC.

Additionally WEAC’s WBC requires calibration annually. The calibrations require the use of the BOMAB, Livermore Lung, and ANSI neck phantom with corresponding radioactive sources. This will include shipping of the phantoms to/from the calibrator's chosen destinations. Vendor must provide history of calibrating similar instrumentation at facilities with a Broadscope Type A Radioactive Materials Nuclear Regulatory Commission License with access to required calibration sources (BOMAB, Livermore Lung, and ANSI neck phantom). The on-site calibration must occur after repair and delivery of the faulty detector.

Scope

1. The Contractor shall provide repair of the Cryo-Pulse 5 cooling unit on one Broad Energy Germanium (BEGe) 6530 detector. The Cryo-Pulse 5+ cooling unit shall satisfy the performance criteria listed below:

Minimum Technical Requirements

The equipment shall have the following characteristics:

Compatible with existing Cryo-Pulse 5+ (CP-5+) controllers

Environmental:

Trade and Service Specifications

1. The instrument repair must include newly manufactured components, not used and refurbished or previously used for demonstration.

1. FOB Point destination to include inside delivery and clean-up of area after installation.

1. The entire system must be warranted for parts and labor for 12 months from the date of formal government acceptance. The vendor must also be capable of servicing the instrument through the covered warranty period. Any equipment repair and maintenance work shall be performed by an OEM-trained engineer. This factory-trained engineer shall have (verified by the OEM) the following: 1) access to OEM factory telephone support; 2) access to the most current OEM factory training for both hardware and software components; and 3) access to all current OEM factory parts, not build-to-order parts. The OEM-trained service engineer shall not use salvaged parts from other instruments for performing maintenance and repairs. All parts used in PM and repairs must be guaranteed, factory-tested, OEM quality parts.

1. Instrument operators shall have access to a technical representative call center at no additional charge, for technical assistance and troubleshooting, which is staffed by senior engineers to provide a high level of expertise for troubleshooting the instrument.

2. The government requires calibration of the Whole Body Counting System, which includes Whole Body Orientation and Lung Orientation:

· The WBC:

· Whole Body

· Contractor shall conduct energy calibration

· Contractor shall conduct efficiency calibration utilizing a BOMAB (Eu-152 source)

· Contractor shall conduct efficiency confirmation counts

· Contractor shall conduct QC counts

· Lung:

· Contractor shall conduct energy calibration

· Contractor shall conduct efficiency calibration utilizing the Livermore Lung Phantom with chest overlays using 5 different chest wall thicknesses.

· Contractor shall conduct efficiency confirmation counts

· Contractor shall conduct QC counts

3. The government requires calibration of the Thyroid System as combined unit and as two separate units:

· Contractor shall conduct energy calibration

· Contractor shall conduct efficiency calibration utilizing an ANSI neck phantom and mixed gamma source

· Contractor shall conduct efficiency confirmation counts

· Contractor shall conduct QC counts

The above calibrations require the use of the BOMAB, Livermore Lung, and ANSI neck phantom with corresponding radioactive sources. This will include shipping of the phantoms to/from the calibrator's chosen destinations.

Vendor must provide history of calibrating similar instrumentation at facilities with a Broadscope Type A Radioactive Materials Nuclear Regulatory Commission License with access to required calibration sources (BOMAB, Livermore Lung, and ANSI neck phantom)

Deliverables

Security

Check in with Security at front entrance. Deliveries accepted weekdays 8:00am to 4:30pm.

Shipping location

Delivery must be coordinated with ORA/WEAC at least 48 hours in advance:

U. S. FDA Winchester Engineering and Analytical Center Attn: POC to be identified at time of award 109 Holton Street Winchester, MA 01890

Place of Performance

U.S. FDA Winchester Engineering and Analytical Center 109 Holton Street, Winchester, MA 01890

Period of Performance

The Period of Performance begins the date of contract award execution and continues for one year from the date of formal government acceptance, or longer depending on how long the OEM offered warranty period is. Instrument repair shall be immediate. Calibration must occur after repair. Shipment of calibration equipment to site to occur prior to calibration.