NCTR-2026-131912 Digital Slide Scanner Sources Sought Notice.pdf

MARKET RESEARCH PURPOSES ONLY

NOT A REQUEST FOR PROPOSAL OR SOLICITATION

Digital Slide Scanner System

The U.S. Food and Drug Administration (FDA) is conducting market research to support the National Center for Toxicological Research (NCTR) requirement for a Digital Slide Scanner system.

The FDA is seeking to identify capable small business sources to determine the availability and capability of small businesses equipped to provide the required products/services. Businesses that are ‘Other than small’ business concerns are also encouraged to submit capability statements. The following information is requested to assist the FDA in conducting Market Research to identify potential sources for this effort.

The associated North American Industry Classification System (NAICS) Code is: 334516 – Analytical Laboratory Instrument Manufacturing; the applicable Small Business Size Standard is 1,000 employees.

Statement of Work

1.0 INTRODUCTION

1.1 Background

The Food and Drug Administration (FDA) National Center for Toxicological Research (NCTR) needs a Digital Slide Scanner in the Pathology Lab to replace aging equipment that is no longer supported by the manufacturer. The existing instrument will only be allowed on the NCTR network for a limited time due to its’ use of out-of-date software. The Digital Slide Scanner is used for all studies in Pathology that require digital copies of the slides that are produced by the Pathology Lab or that require digital image analysis for data collection.

1.2 Objectives

The Digital Slide Scanner is needed to create digital copies of tissues on glass slides that can be shared with other researchers or used in research publications. It is also needed to provide image analysis to obtain quantitative data from images. A service contract for the Digital Slide Scanner is also needed to keep the instrument functioning in optimal condition, to provide quick repairs, and to provide software updates as needed.

2.0 CONSTRAINTS

The Digital Slide Scanner must be approved to be connected to the NCTR network, and it must be approved prior to deployment in the ServiceNow Product Catalog.

1. NCTR has a database of digital slides produced using the Leica Aperio ScanScope. The new Digital Slide Scanner will need to be able to view and manipulate these digital slides.

3.0 SCOPE

NCTR’s Molecular Pathology Lab requires a Digital Slide Scanner to replace an existing system (Leica Aperio AT2) that is no longer supported by the manufacturer. The current instrument will remain on the NCTR network for a limited time due to its’ use of out-of-date software. The replacement Digital Slide Scanner will be employed for all Pathology studies which require digital copies of slides produced by the Pathology Lab or studies which require digital image analysis for data collection.

Specifically, this Digital Slide Scanner imaging system is required to:

1. Create digital copies of tissues on glass slides that can be shared with other researchers or used in research publications;

2. Provide image analysis to obtain quantitative data from images;

3. Include preventive maintenance and repair services (PM/R) for the Digital Slide Scanner to:

a. Keep the instrument calibrated;

b. Maintain the software functioning in optimal condition;

c. Provide technical support; and

d. Provide rapid repairs as necessary.

The replacement Digital Slide Scanner system will support pathology studies insofar as NCTR conducts scientific research to generate data for FDA decision-making and the development of innovative health approaches. As a national scientific resource, NCTR conducts peer-reviewed research to advance scientific approaches and tools required to support public health and to improve FDA's ability to assess the safety of products it regulates. NCTR research supports two FDA Goals: 1) Enhance oversight of FDA-regulated products and 2) Improve and safeguard access to FDA-regulated products.

The Digital Slide Scanner imaging system described herein will be employed to assist researchers in pursuit of research activities necessary to the “NCTR Research Support” program.

Specifically, the required system with analysis software is a crucial tool in enhancing the accuracy, efficiency, and reproducibility of all pathology projects at NCTR as follows:

1. Enhances accuracy by using the software to gather quantitative data rather than qualitative as well as increasing the dynamic range of analysis into the hundreds rather than the traditional 1-3 scale for pathologists;

2. Increases efficiency and reproducibility in the same way. It can scan hundreds of slides without human input and apply the same algorithm analysis to every slide; and

3. Is capable of analysis on any color stain as well as different types of stains including fluorescent and polarized. This is a much-needed improvement over previous scanners which could only analyze blue and brown. This not only adds value to current and future studies but creates new avenues for data collection on previous studies as well.

As previously stated, the current Leica Aperio AT2 system is no longer supported by the manufacturer, so a replacement system must be researched and acquired to continue to contribute to the missions of both FDA and HHS.

This requirement encompasses:

1. Item 1: Delivery and installation of a Digital Slide Scanner;

2. Item 2: Training of FDA personnel on the Digital Slide Scanner;

3. Item 3: Warranty coverage for the Digital Slide Scanner; and

4. Item 4: Service Agreements for the Digital Slide Scanner.

4.0 DELIVERY

1. The Digital Slide Scanner will be delivered to:

National Center for Toxicological Research (NCTR) 3900 NCTR Rd., BLDG. 85/Receiving/Property Jefferson, AR 72079 Attn: Kim Maynard

Receiving dock hours of operation are Monday-Friday from 8:00 AM – 4:00 PM (except during Federal Holidays.)

2. The Digital Slide Scanner will be installed at:

National Center for Toxicological Research (NCTR) 3900 NCTR Rd., Building 5B Jefferson, AR 72079

3. Training for the Digital Slide Scanner will be delivered at:

National Center for Toxicological Research (NCTR) 3900 NCTR Rd., Building 5B Jefferson, AR 72079

5.0 TECHNICAL AND PERFORMANCE SPECIFICATIONS

5.1 Basic Requirements:

The selected device:

Type 1: Scanning:

1. Shall scan at both 20X and 40X magnifications.

2. Shall scan both 1X3 and 2X3 slides.

3. Shall provide image resolution of at least 1um/pixel at 20x and 0.5 1um/pixel at 40x.

4. Shall have both brightfield and fluorescent capabilities.

5. Shall be able to scan slide label bar codes.

6. Must be able to focus on and scan samples from a single cell up to a whole tissue.

7. Shall have z-stack capability.

Type 2: Image Management:

1. Shall be able to convert image files to TIFF.

Type 3: Software:

1. Shall include image analysis software with the ability to quantify stained cell numbers and stained area and open .svs images.

Type 4: Hardware and Accessories:

1. Shall include a slide autoloader capacity of at least fifty (50) slides.

2. Shall include the required Workstation on which image analysis software is loaded.

Type 5: Connectivity:

1. Shall be able to connect to a network server for both data storage and software usage.

Type 6: Facility and Power:

1. Shall be installed in a footprint that is less than 9’x9’ due to current lab space constraints.

2. Shall accept power supply of a dedicated 110/115V 20 AMP Circuit.

Type 7: Warranty:

1. Shall include a minimum of one (1) year original equipment manufacturer (OEM) warranty.

2. Warranty coverage shall commence on the date of acceptance.

Type 8: Service Agreement(s):

1. Shall include a Service Agreement for one (1) base year.

2. Shall include a Service Agreement for four (4) option years.

Type 9: Delivery, Installation, and Training:

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

5.2 Installation, Testing and Training Requirements:

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.

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. Upon acceptance of the system, training shall be provided to attendees/users by the Contractor’s trained and certified personnel.

3. The components and equipment shall be newly manufactured, not used or refurbished, or previously used for demonstration.

4. 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.

5. The systems shall be delivered with all necessary supplies and accessories required for installation and start-up.

6. 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.

5.3 Post-Warranty Service Requirements:

At a minimum, the Contractor shall provide the following services during the post-Warranty option periods:

1. One (1) preventative maintenance visit per contract year inclusive of all labor, travel, and parts, components, subassemblies, etc. necessary to provide the service.

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.

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.)

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.

5. Unlimited software and firmware updates.

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.

7. All preventative maintenance and repair service pricing shall be inclusive of labor, travel, replacement parts, components, subassemblies, etc.

6.0 PERIOD OF PERFORMANCE

All dates are approximate.

Delivery of instrument: No more than thirty (30) calendar days after award

Base period: Beginning on acceptance and including one year of warranty (4/1/2026 – 3/31/2027)

Option Year 1: 4/1/2027 – 3/31/2028

Option Year 2: 4/1/2028 – 3/31/2029

Option Year 3: 4/1/2029 – 3/31/2030

Option Year 4: 4/1/2030 – 3/31/2031

The period of performance for the option period in any resultant award will be established based on the date of award, required delivery of the system (inclusive of inside delivery, installation, and training), and the offered warranty period. If/when Option Year 1 Post-Warranty Service/maintenance is exercised; the period of performance for the post-warranty option will be firmed via bilateral modification.

Each year shall be funded at the time the option year is exercised; options will be exercised based on funds availability and the needs of the Federal Government. The initial Service period shall be for one (1) year and each subsequent period of performance may be renewed at the government’s option.

7.0 PLACE OF PERFORMANCE

National Center for Toxicological Research (NCTR) 3900 NCTR Rd.

BLDG. 5B

Jefferson, AR 72079

8.0 GOVERNMENT FURNISHED EQUIPMENT/GOVERNMENT FURNISHED

INFORMATION

No government-furnished property or government-furnished information will be provided in the scope of this acquisition.

END OF STATEMENT OF WORK

SOURCES SOUGHT RESPONSE INSTRUCTIONS

The offeror shall furnish sufficient technical information necessary for the Government to conclusively determine that the offered products/services and components meet the technical requirements identified above. Though the target audience is small business manufacturers or small businesses capable of supplying a U.S. made product/service of a small business manufacturer or producer all interested parties may respond.

At a minimum, responses shall include the following:

1. Part 1: Company Overview

a. Business name;

b. SAM Unique Entity ID number;

c. Business address;

d. Business website;

e. Business size status (i.e., SB, VOSB, SDVOSB, HUBZone SB, SDB, WOSB, LB); and

f. Point of contact name and mailing address (if different from business address), phone number and email address.

2. Part 2: Descriptive Literature

a. Sufficient descriptive literature that unequivocally demonstrates that offered products and services can meet the requirements articulated in the Statement of Work (SOW).

b. All descriptive material necessary for the government to determine whether the service/product offered meets the technical requirements including technical specifications, ISO certifications, descriptive material, literature, brochures and other information which demonstrates the capabilities of the contractor to meet the requirement.

3. Part 3: Past Performance

a. Three (3) years of past performance product/service information, where the respondent has provided same or substantially similar products/service solutions on the same or near-same brand name equipment.

b. For each past performance reference include:

i. Date of sale;

ii. Description;

iii. Dollar value;

iv. Client name and client address;

v. Client point of contact name, mailing address (if different from that provided for client), phone number, and email address; and

vi. Name of the manufacturer (to include SAM Unique Entity ID number and size status) if not the respondent.

4. Part 4: Requirements Response

a. Please indicate if any of the above specifications are too restrictive and recommend an alternative.

5. Part 5: Software and Security Questions

a. Please discuss the basic functionality of the provided image analysis software application;

b. Please discuss how and where the provided image analysis software application is hosted and the security posture of the hosting environment;

c. Please clarify how and where the image analysis data and other data that is collected by the software is stored;

d. Please discuss how the provided image analysis software application authenticates users;

e. Please discuss whether the provided image analysis software application supports Government Personal Identity Verification (PIV) authentication;

f. Please discuss whether the provided image analysis software application leverages multi-factor authentication (MFA) in accordance with Executive Order 14028 and, if so, how;

g. Please discuss whether the provided image analysis software application is FedRAMP appraised and at what level (e.g., low, moderate, high);

h. Please discuss whether the provided image analysis software application complies with FISMA 800-53 controls and at what level (e.g., low, moderate, high);

i. Please discuss whether and how the provided image analysis software application provides encryption of data both at rest and in transit in accordance with Executive Order 14028; and

j. Please discuss whether the provided image analysis software application includes a mobile application for use on FDA mobile devices.

6. Part 6: Other Information

a. GSA Schedule contract(s): If applicable, identify the respondent’s GSA Schedule contract(s) by Schedule number and SINs that are applicable to this potential requirement. Include a detailed list of items included and not included on the GSA contract to meet this requirement.

b. Best in Class (BIC) contracts: If applicable, identify the respondent’s Best in Class (BIC) contract information or other Government-wide or HHS-wide contracts that the equipment/service is available on.

c. Section 508: Demonstrate the capability and understanding of accessibility testing and customization to conform with the applicable Section 508 standards identified herein. Provide information if the respondent has an Accessibility Conformance Report (ACR) for the products offered for the Revised 508 Standards. The ACR should be based on the Voluntary Product Accessibility Template Version 2.0 (MS Word) provided by the Industry Technology Industry Council (ITIC).

d. Subcontracting Opportunities: If a large business, identify the subcontracting opportunities that would exist for small business concerns.

e. Warranty and Terms: Include your standard commercial warranty and payment terms.

f. Place of Manufacture: Indicate the place of product manufacture or service performance and any other applicable information to enable review and analysis pertaining to the Buy American statute and requirements relating to Made in America in the event a nonavailability waiver request through the MIAO Digital Waiver Portal is needed; and

g. Informational Pricing: Though this is not a request for quote, informational pricing is encouraged.

Response Date and Time

The successful awardee shall be prepared to submit the following information for Master Approved Technology (MAT) list approval should a solicitation come out or with this technical http://www.itic.org/dotAsset/d432b9da-3696-47fe-a521-7d0458d48202.doc http://www.itic.org/dotAsset/d432b9da-3696-47fe-a521-7d0458d48202.doc http://www.itic.org/policy/accessibility http://www.itic.org/policy/accessibility capability response. Offerors if/when a solicitation comes out will only have a limited number of days to submit the documentation.

1. Version/Model number of the proposed software.

2. Description of what your software does (if the software contains a suite of products, please provide the function of each product contained within the suite.

3. All specs to the Computer

4. Website URL for Software and computer, when available.

The government is not responsible for locating or securing any information, not identified in the response.

The Government encourages any comments and/or suggestions from any interested party, regarding the specifications. While the Government will not respond directly to your comments and/or suggestions, we will consider them as we finalize the specifications in preparation for the forthcoming solicitation.

Response Date and Time

Interested Parties shall respond with capability statements which are due by email to the point of contact listed below on or before December 18, 2025 by 13:00 hours (Central Time in Jefferson, Arkansas) to david.kramer@fda.hhs.gov. Reference NCTR-2026-131912.

Notice of Intent

Responses to this sources sought announcement will assist the Government in determining whether or not any future requirement similar to this one should be set aside for small business, made available to full and open competition or procure through sole-source acquisition procedures.

Disclaimer and Important Notes

This notice does not obligate the Government to award a contract or otherwise pay for the information provided in response. The Government reserves the right to use information provided by respondents for any purpose deemed necessary and legally appropriate. Any organization responding to this notice should ensure that its response is complete and sufficiently detailed to allow the Government to determine the organization’s qualifications to perform the work.

mailto:david.kramer@fda.hhs.gov

Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted. After a review of the responses received, a pre-solicitation synopsis and solicitation may be published in sam.gov. However, responses to this notice will not be considered adequate responses to a solicitation.

Confidentiality

No proprietary, classified, confidential, or sensitive information should be included in your response. The Government reserves the right to use any non-proprietary technical information in any resultant solicitation(s).