In accordance with FAR 6.302-1, Only one responsible source and no other supplies or services will satisfy agency requirements.

STATEMENT OF WORK

BACKGROUND
The Division of Applied Regulatory Science (DARS) performs laboratory research related to drug safety. An important aspect of this research is to determine drug induced injury on the tissue and cellular levels. This information and information about mechanisms of injury can be obtained by analyzing histopathology changes from tissue derived from in vivo animal toxicology studies. Tissue samples from animal toxicology studies are embedded and sectioned onto glass slides. The Aperio equipment allows glass slides to scanned into digital images that can then be stored, shared, and analyzed with accompanying image analysis software. Presently, this equipment is used to support multiple projects within CDER as well as collaborative studies with other FDA Centers. The Division requires these capabilities to fulfill current study protocols and evolving experimental aims. Preventative maintenance and a service agreement are required to keep this equipment functioning properly and have timely repairs as needed.

OBJECTIVES
The objective of this project is to renew an existing service/maintenance agreement with Leica Microsystems to provide coverage for repairs and preventative maintenance for an Aperio Scanscope digital imaging system.

REQUIREMENTS
System components being covered:
• Aperio ScanScope CS (serial #5348) with Spectrum Plus
• Image Analysis Toolbox
• 4 TB Server

SERVICE REQUIREMENTS

1. Annual onsite preventative maintenance including evaluation of all hardware and required calibrations, alignments, cleaning, and parts replacement.
2. Software upgrades and Notifications as they become available
3. Technical support within the limits of the contractor's regular operating hours.
4. Additional on-site service calls and replacement parts as needed.
5. New or Certified replacement parts so that it does not void the manufacturer's warranty.
6. Loaner unit if service will be extensive.
7. Reimbursements (Cost, Travel, Parts) should be included in the service agreement.

REPORTING REQUIREMENTS

The Contractor shall, commensurate with the completion of each service call, provide the end-user of the equipment with a copy of a field service report/ticket identifying the equipment name, manufacturer, model number, and serial number of the equipment being serviced/repaired and detailing the reason for the service call, a detailed description of the work performed, the test instruments or other equipment used to affect the repair or otherwise perform the service, the name(s) and contact information of the technician who performed the repair/service, and for information purposes, the on-site hours expended and parts/components replaced.

DELIVERABLES / SPECIFIC TASKS

As needed repairs and annual onsite preventative maintenance services will be provided at the location shown below:

Service location:

10903 New Hampshire Ave
WO Bldg 64 Rm 2061
Silver Spring MD 20993

As needed repairs and annual onsite preventative maintenance services will be provided between the hours of 8:00 am and 5:00 pm Monday thru Friday

Repair and preventative maintenance onsite visits will include labor, travel and replacement parts, as required, (excluding consumable items).

Spectrum Plus Device software and Image Analysis Toolbox software upgrades and telephone support will be provided.

This notice of intent is not a request for competitive quotes. However, all responsible sources may submit a capability statement within five (5) days after the publication of this synopsis which shall be considered by the agency. Responses received after 5 days or without the required information may not be considered. For information concerning this acquisition contact:

Susan Bechtel
Contract Specialist
[email protected]
No phone calls please

A determination by the Government not to compete because of information received is solely within the discretion of the Government. Information received will normally be considered solely for determining whether to conduct a competitive procurement.