75F40126Q131912 Digital Slide Scanner Detailed Response Template Amendment 01.docx

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Digital Slide Scanner System
Solicitation number
75F40126Q131912
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This is a Technical Capability Response Matrix template and amendment for a Digital Slide Scanner solicitation (75F40126Q131912) issued by the Food and Drug Administration (FDA) National Center for Toxicological Research (NCTR). The FDA requires offerors to complete and submit this matrix by the solicitation closing date in both Microsoft Word and Adobe PDF formats, with failure to fully address every requirement rendering a quote ineligible for award. Offerors must indicate whether their proposed solution meets, partially meets, or does not meet each requirement and provide explanations where specified, with responses required to align precisely with submitted quotes.

The solicitation specifies detailed technical requirements across eight categories: Type 1 (Scanning) requires magnification capabilities at 1.25X through 40X with specified resolutions (minimum 4 MP), pixel sizes (maximum 5.5-6.5 micrometers depending on magnification and channel), brightfield and fluorescent scanning across seven channels (360-770 nm), barcode scanning, automatic tissue finder, and z-stack capability (minimum 10 focal planes); Type 2 requires TIFF conversion capability; Type 3 requires image analysis software with quantification capabilities, ability to open .svs images, and minimum two concurrent licenses; Type 4 requires a 50-slide autoloader and workstation; Type 5 requires network connectivity, multi-factor authentication compliance with Executive Order 14028, and data encryption at rest and in transit; Type 6 requires installation footprint under 9'x9' and 110/115V 20-amp power supply; Type 7 requires minimum one-year OEM warranty commencing upon acceptance; and Type 8 through B require delivery, installation, testing, training, and comprehensive post-warranty annual service including one preventative maintenance visit, unlimited corrective maintenance within five calendar days, unlimited technical support within eight business hours, formally trained technicians, unlimited software/firmware updates, and detailed field service reporting.

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75F40126Q131912 Solicitation Amendment 01.pdf PDF
Sol Doc 131912.pdf PDF

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75F40126Q131912 Digital Slide Scanner Technical Capability Response Matrix – Amendment 01 (April 21, 2026)

1. Instructions:

a. Offerors shall complete this Technical Capability Response Matrix and submit the completed document by the closing date and time in the solicitation. Failure to submit this Matrix completed in full (i.e., every requirement addressed) may render a quote ineligible for award.

b. Offerors shall provide the required information in Section 2 where highlighted in yellow.

c. In the Offeror Response column: Offerors shall respond to every requirement in Section 3 indicating whether their proposed product or service does/will (1) Meet the requirement, (2) Partially Meet the requirement, or (3) Does Not Meet the requirement.

d. In the Instruction/Explanation column only:

1) If the Offeror exceeds the requirement, the Offeror shall briefly describe how their solution exceeds the Government’s requirement.

i. In the case of certain requirements, as marked by a footnote, an Exceeds response requires an explanation of the manner in which the product/service exceeds the requirement.

2) If the Offeror meets the requirement but does not exceed the requirement, the Offeror shall leave this column blank.

i. In the case of certain requirements, as marked by a footnote, a Meets response requires an explanation of the manner in which the product/service meets the requirement.

3) If the Offeror partially meets the requirement, the Offeror shall briefly describe how their solution partially meets the Government’s requirement, which aspects of the requirement are not met, and any proposed “workaround” for the unmet requirements.

4) If the Offeror does not meet the requirement, the Offeror shall briefly describe why the proposed product or service does not meet the Government’s requirement.

5) Where specific instructions for a given requirement are provided (e.g., “Instruction: Please describe (1) the actual magnification resolution of the proposed device…”), the Offeror shall provide the requested information as defined.

e. The Offeror shall not enter any information into the column labeled “For Government Use Only”. Any information entered into this column will be ignored for the purpose of the evaluation.

f. The Offeror shall submit the completed Technical Product and Services Solution Response Matrix in Microsoft Word and Adobe PDF formats only. No other formats are acceptable.

g. The Offeror’s Technical Capability Response Matrix shall precisely mirror the Offeror’s submitted quote. Updated quotes will not be accepted and will not be evaluated.

2. Offeror Summary:

Solicitation ID
75F40126Q131912, Amendment 01
Solicitation Name
Digital Slide Scanner
Offeror Name
Insert company name here
Offeror UEID
Insert company Unique Entity ID (UEID) here
Respondent Name
Insert the name of the person completing this Matrix here
Respondent Email Address
Insert the email address of the person completing this Matrix here
Location of Product Manufacture
Insert the location where the product is manufactured here

3. Detailed Technical Product and Services Solution Response

ID
Requirement
Offeror Response

· Meets

· Partially Meets

· Does Not Meet Instruction / Explanation (see instructions in Section 1, item d above) For Government Use Only

Type 1: Scanning

1.1a
Shall scan at 1.25X magnification at a minimum resolution of 4 MP and a maximum pixel size of 6.5 um (micrometers)
1.1b
Shall scan at 5.00X magnification at a minimum resolution of 4 MP and a maximum pixel size of 6.5 um (micrometers)
1.1c
Shall scan at 10.00X magnification at a minimum resolution of 4 MP and a maximum pixel size of 6.5 um (micrometers)
1.1d
Shall scan at 20.00X magnification at a minimum resolution of 4 MP, a maximum pixel size of 6.5 um and a scan speed no greater than five (5) minutes for the fluorescent channel

Instruction: Please describe (1) the actual magnification resolution of the proposed device, (2) the specific pixel size of scan as performed by the proposed device, and (3) the speed of the scan (in minutes) as performed by the proposed device.

1.1e
Shall scan at 20.00X magnification at a minimum resolution of 4 MP and a maximum pixel size of 5.5 um for the brightfield channel

Instruction: Please describe (1) the actual magnification resolution of the proposed device, and (2) the specific pixel size of scan as performed by the proposed device.

1.1f
Shall scan at 40.00X magnification at a minimum resolution of 4 MP and a maximum pixel size of 6.5 um for the fluorescent channel

Instruction: Please describe (1) the actual magnification resolution of the proposed device, and (2) the specific pixel size of scan as performed by the proposed device.

1.1g
Shall scan at 40.00X magnification at a minimum resolution of 4 MP and a maximum pixel size of 5.5 um for the brightfield channel

Instruction: Please describe (1) the actual magnification resolution of the proposed device, and (2) the specific pixel size of scan as performed by the proposed device.

1.2
Shall scan both 1” X 3” and 2” X 3” slides
1.4a
Shall have brightfield scan capabilities.
1.4b
Shall have the ability to scan, for the fluorescent channels from 360 nm to 770 nm across seven (7) channels.
1.5
Shall be able to scan slide label bar codes in 2D and 3D.
1.6
Must have an automatic tissue finder which can focus on and scan samples from a single cell up to a whole tissue without manual input.
1.7
Shall have z-stack capability which can capture images from a minimum of 10 focal planes and create a 3D composite image.

Type 2: Image Management

2.1
Shall be able to convert image files to TIFF

Type 3: Software

3.1a
Shall include image analysis software with the ability to quantify stained cell numbers and stained areas on any animal tissue and any type of stain including membrane, nuclear, and cytoplasmic staining.
3.1b
Shall include image analysis software with the ability to open .svs images [footnoteRef:1] [1: An Exceeds response requires an explanation of the manner in which the product/service exceeds the requirement. A Meets response requires an explanation of the manner in which the product/service meets the requirement.]
3.2
Image analysis software shall be provided with a minimum of two (2) concurrent licenses[footnoteRef:2] [2: An Exceeds response requires an explanation of the manner in which the product/service exceeds the requirement. A Meets response requires an explanation of the manner in which the product/service meets the requirement.]
3.3
Shall have the ability to analyze both brightfield and fluorescence.

Type 4: Hardware and Accessories

4.1
Shall include a slide autoloader capacity of at least fifty (50) slides
4.2
Shall include the required Workstation on which image analysis software is loaded.

Type 5: Connectivity

5.1
Shall be able to connect to a network server for both data storage and software usage.
5.2
Shall utilize multi-factor authentication (MFA) login in compliance with executive order 14028.
5.3
Shall encrypt data at rest and in transit in compliance with executive order 14028.

Type 6: Facility and Power

6.1
Shall be installed in a footprint that is less than 9’x9’ due to current lab space constraints.
6.2
Shall accept power supply of a dedicated 110/115V 20 AMP Circuit.

Type 7: Warranty

7.1
Shall include a minimum of one (1) year original equipment manufacturer (OEM) warranty.
7.2
Warranty coverage shall commence on the date of acceptance.

Type 8: Delivery, Installation, and Training:

8.1
Shall include delivery and installation of the Digital Slide Scanner.

Type A: Installation, Testing and Training Requirements

A.1
The Contractor shall provide all labor, travel, and tools to install the equipment at the address provided below, to include inside delivery. The equipment shall be tested once installed to verify all aspects of the system are operating within parameters of the required technical and performance specifications listed above. The Contractor shall demonstrate upon completion of installation and testing that the item meets all specifications.
A.2
All standard information on the equipment, including but not limited to User Manuals, Operation and Maintenance (O&M) Manuals, Material and Safety Data Sheets (MSDS), troubleshooting guides and any other applicable documentation, shall be provided upon installation of the system.
A.3
Upon acceptance of the system, training shall be provided to attendees/users by the Contractor’s trained and certified personnel.
A.4
The components and equipment shall be newly manufactured, not used or refurbished, or previously used for demonstration.
A.5
Offered systems shall be a turn-key solution i.e., the contractor shall be responsible for providing all hardware, components, instruments, computers, software, and that otherwise required to meet these specifications and the FDA’s stated need.
A.6
The systems shall be delivered with all necessary supplies and accessories required for installation and start-up.
A.7
System shall be warranted for not less than one (1) year from FDA acceptance of the system(s) to include on-site training. Warranty service shall include troubleshooting capabilities based on complete knowledge of the entire system, immediate access to replacement parts, and immediate access to system improvements and updates. Phone and email technical support shall be included for a minimum of one (1) year.
A.8
The Contractor shall provide three (3) days of training on both instrument operation and technical help on running and setting up analysis algorithms.

Type B: Post-Warranty Service Requirements: Annual on-site service agreement for Digital Slide Scanner

B.1
One (1) onsite preventative maintenance visit per contract year inclusive of all labor, travel, and parts, components, subassemblies, etc. necessary to provide the service.
B.2
Unlimited on-site corrective/remedial maintenance/repairs to be scheduled at the time of service request within five (5) calendar days from service call. On-site repair service shall be inclusive of all labor, travel, certified replacement parts, components, subassemblies, etc. needed to return the system to operational capacity.
B.3
Unlimited technical support and trouble-shooting assistance, Mondays – Fridays (excluding Federal Holidays) during the Contractor’s normal business hours, within eight (8) business hours of contact for assistance (e.g., telephone-based, email-based, website-based, etc.)
B.4
Formally trained and certified technicians/engineers for all maintenance and repair activities performed, following Original Equipment Manufacturer (OEM) specifications, manuals, and service bulletins, using new OEM replacement parts, components, subassemblies, etc.
B.5
Unlimited software and firmware updates.
B.6
The Contractor shall, commensurate with the completion of each service call (inclusive of warranty service), provide the end-user of the equipment with a copy of a field service report/ticket by email 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. In addition, the Contractor shall provide a written report to the FDA Contracting Officer’s Representative and Contract Specialist by email, summarizing all maintenance and repair activities (including warranty work) each time service and/or repair is performed.
B.7
All preventative maintenance and repair service pricing shall be inclusive of labor, travel, replacement parts, components, subassemblies, etc.

END OF REQUIREMENTS

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