Whole Slide Scanner

Added: Feb 26, 2016 12:33 pm Part 1 - Description

The U.S. Food and Drug Administration's (FDA) Center for Drug Evaluation and Research (CDER) has a requirement for a digital pathology whole slide scanner which will be used to investigate integrative signaling between growth factors and developmental pathways in situ within formalin-fixed paraffin-embedded and froze tissue sections.

This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in Federal Acquisition Regulation (FAR) Subpart 12.6, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; quotes are being requested, and a separate written solicitation will not be issued.

This solicitation is a Request for Quote (RFQ) using FAR Parts 12 and 13 procedures. The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular (FAC) 2005-86. The North American Industry Classification System (NAICS) code for the proposed acquisition is 334516, Analytical Laboratory Instrument Manufacturing. The associated small business standard is 500 employees. This requirement is for a small business set-aside.

Part 2 - Supplies or Services and Prices/Costs

Purchase Order Type: Firm-Fixed Price
Base Year
Manufacturer Product Code Description Quantity Price
Digital Pathology Whole Slide Scanner System and Accessories
Shipping
Installation and training
One (1) year warranty on parts, labor, and travel
Total Firm-Fixed Price

Option Years
Option Year Description Price
1 Service Agreement
2 Service Agreement
3 Service Agreement
4 Service Agreement
Total Firm Fixed Price

The total price for the base and four option years is $____________.
Part 3 - Description/Specifications

3.1 Background
CDER/OBP has a requirement for a digital pathology whole slide scanner which will be used to investigate integrative signaling between growth factors and developmental pathways in situ within formalin-fixed paraffin-embedded and froze tissue sections. Using in-situ hybridization technology or immuno-histochemical techniques, OBP will be able to investigate multiple signaling pathways while maintaining tissue architecture and morphology.

Understanding this integrative signaling will provide insight on adverse events, product efficacy, and biomarkers of beneficial and detrimental patient responses associated with targeted therapeutics. The current slide scanners available within OBP are not capable of providing the scanning requirements needed to conduct critical research.

3.2 Statement of Work/Technical Specifications
The Digital Pathology Whole Slide Scanner system shall include:
1. Scanner:
• Shall scan 12 slides at a time
• Shall scan formalin-fixed paraffin-embedded and frozen tissue sections
• Shall scan brightfield and multi-channel fluorescence in the same machine
• Shall have automatic slide loading, previewing, barcode reading, and scanning (acceptable slide formats of 25 X 75 mm; 0.95 - 1.05 thickness)
• Shall have manual camera changer up to 2 objectives and motorized objective changer
• Shall be no larger than 70 x 50 x 50 cm (W x D x H)

2. Camera and Optics Module:
• Shall have at least 4 megapixel monochrome and multispectral illumination camera for fluorescence
• Shall have at least 4 megapixel camera for brightfield imaging
• Shall have brightfield and fluorescence (up to 9-channels) capability
• Shall have brightfield magnification of 25X and 40X (upgradable to 50X and 80X)
• Shall have fluorescence magnification of 20X and 40X (upgradeable to 64X)
• Shall have brightfield illumination with halogen lamp (5W)
• Shall have fluorescence illumination with metal halide (120W)
• Shall have quad band filter cube for DAPI/FITC/TRITC/Cy5
• Shall be able to be upgraded with Cy7 filter cube
• Shall have extended focus, Z-stack function
3. Image Acquisition Module:
• Shall have brightfield scanning speed (15 X 15 mm) of 150s at 25X
• Shall have fluorescence compensation
• Shall have digital slide format of MRXS, JPG, and JPG 2000

4. Computer Module:
• Shall include high performance desktop workstation with high resolution (2560 X 1440 pixel) 27-inch widescreen monitor for slide viewing, mouse, and keyboard
• Shall have scanner control software
• Shall include HASP local dongle
• Shall include viewing, database, and archiving software
• Shall include quantitative image analysis software with the following capabilities:
• Chromogenic in situ hybridization (CISH) signal and tissue morphology analysis
• Fluorescence in situ hybridization (FISH) signal and tissue morphology analysis

5. Delivery, Installation, Training and Warranty:
• Installation shall include of the installation of the system and all components, as well as calibration, quantification, and software installation
• Shall include a demonstration/training for lab personnel
• Shall include a warranty for at least one (1) year from date of installation which covers all labor, parts, and travel expenses required for repairs for equipment and software. Technical support and troubleshooting assistance shall be provided via phone, email, or live-chat interface.

3.3 Optional Service/Maintenance Agreement

The FDA shall have a unilateral right to exercise optional periods to continue the maintenance work described below:

The offerors pricing for optional service agreement shall include coverage of labor, parts and travel expenses.

Parts- The service plan will include all Original Equipment Manufacturer (OEM) certified parts.

Services On-site- The contractor will initiate corrective maintenance/repairs within 48 hours from the service call. The repairs will be completed within 72 hours from the on-site arrival of the technician/service engineer. There will be no limit to the number of on-site repair service visits. The service shall be delivered by an authorized OEM service provider.

Services Off-site- Technical support and troubleshooting assistance will be provided by the contractor via phone, email, or live-chat interface within 1 hour of initial contact.

Part 4 -Performance and Deliverables

4.1 Place of Performance and Work Hours

All applicable equipment is located at the location listed below. Normal workdays are Monday through Friday except US Federal Holidays. Work hours are typically from 8 am to 5 pm (et). Service visits shall be coordinated with TBD, see below.

Location and Point of Contact:
Food and Drug Administration
White Oak Campus (WO52-72)
10903 New Hampshire Avenue
Silver Spring, MD 20993

ATTN: TBD

The slide scanner system will be delivered to the WO Bldg 52/72 Loading Dock, and transported to WO bldg 72 room 2229 assembly.

4.2 Period of Performance

The equipment shall be delivered by June 1, 2016. The warranty shall start when equipment is installed and accepted by FDA and be in effect for one year.

Optional Periods

Deliverable Period of Performance
Option Period 1 -Service Agreement To begin 1st year following receipt of equipment
Option Period 2 -Service Agreement To begin 2nd year following receipt of equipment
Option Period 3 -Service Agreement To begin 3rd year following receipt of equipment
Option Period 4 -Service Agreement To begin 4th year following receipt of equipment

Part 5 -Contract Administration

5.1 Representative's
The Contracting Officer's Representative (COR) will perform inspection and acceptance of materials and services to be provided.

For the purpose of this PART, (COR TBD) is the authorized representative of the Contracting Officer.

The COR is responsible for the following as required by this order: (1) monitoring the Contractor's technical progress, including the surveillance and assessment of performance and recommending to the Contracting Officer changes in requirements; (2) interpreting the Statement of Work and any other technical performance requirements; (3) performing technical evaluations; (4) performing technical inspections and acceptances; and (5) assisting in the resolution of technical problems encountered during performance.

The Contracting Officer is the only person with authority to act as an agent of the Government under this order. Only the Contracting Officer has authority to: direct or negotiate any changes in the order, including modifying or extending the period of performance, changing the delivery schedule, authorizing reimbursement to the Contractor for any costs incurred during the performance of this order, or otherwise change any terms and conditions of this order.

The contact information for the Contracting Officer is the following:

Sean Wybenga
U.S. Food and Drug Administration
Office of Acquisitions and Grants Services
5630 Fishers Lane
Rockville, MD 20857
Sean.Wybenga@fda.hhs.gov;
(240) 402-7629

The contact information for the Contract Specialist is the following:

Lisa Yaw
U.S. Food and Drug Administration
Office of Acquisitions and Grants Services
5630 Fishers Lane
Rockville, MD 20857
Lisa.Yaw@fda.hhs.gov;
(240) 402-4018

The contact information for the Contractor is the following:
(TBD)