JA_NanoZoomer S60 _75N91024Q00170_Redacted.pdf

Justification and Approval for Brand Name Acquisition Under FAR 13

1. Identification of the agency and contracting activity.

a. Federal agency and contracting activity.

HHS/NIH/CCR

b. Sponsoring organization.

National Cancer Institute (NCI), Center for Cancer Research (CCR), Laboratory of Cancer Biology and Genetics (LCBG), Molecular Pathology Unit (MPU),

c. Project Officer information.

Project Officer name.

Mailing address.

NIH, NCI, CCR, LCBG, Molecular Pathology Unit 37 Convent Dr, Bethesda, MD 20892

E-mail address.

Telephone number.

2. Nature and/or description of the action being approved.

a. Acquisition purpose and objectives.

This acquisition aims to obtain a high-throughput, high-resolution digital imaging whole-slide scanner specifically designed for brightfield tissue scanning. The primary objective is to ensure the seamless continuation and enhancement of cancer research by providing advanced, reliable equipment that integrates with existing NIH-wide digital pathology systems, such as HALO. This acquisition will support the National Cancer Institute's need for precise, consistent, and scalable histopathological imaging, which is critical for effective analysis, diagnosis, and research of cancerous tissues.

b. Project background.

The National Cancer Institute, Center for Cancer Research, Laboratory of Cancer Biology and Genetics requires scanned whole-slide images of brightfield optical labeling of specific molecular markers on histopathological tissue sections. Digitized histological images are essential for cancer research, enabling advanced analysis of tissue lesions through computer vision and machine learning, integrated with pathologist diagnosis. MPU has been supporting the NCI by scanning histology/immunohistochemical slides and transferring images to HALO, the NIH-wide platform for image storage, analysis, and sharing. A reliable slide scanner with timely manufacturing support is crucial for cancer research and pathology training. The current Leica AT2 digital slide scanner is obsolete, with no replacement unit or parts availability from Leica. Therefore, MPU is pursuing the Hamamatsu NanoZoomer S60 digital pathology instrument. The NanoZoomer S60 is widely used by researchers across NIH due to its superior image quality and its seamless interface with HALO, NCI’s digital repository and image analysis software.

This minimizes the need for training current staff who are already familiar with the instrument and software through routine collaborations with other research and clinical laboratories across NIH. Furthermore, acquiring the S60 NanoZoomer eliminates the need for new software, as it effortlessly integrates with the already established HALO digital pathology platform, a tool consistently used throughout NIH, ensuring a seamless transition and integration process.

3. Description of the supplies or services required to meet the agency’s needs (including the estimated value).

a. Project title.

Acquisition of one (1) Brand Name NanoZoomer S60 Brightfield System

b. Project description.

The project involves acquiring and examining specimens through digital display, with capabilities for computational image analysis and data storage. High-quality, high-resolution images must be consistently acquired via digital optical microscopy for research and disease diagnosis. The project requires ongoing high-throughput image acquisition, minimizing repeat scans, and adding to an existing 15TB image database from legacy scanning instruments nearing obsolescence.

System specifications are detailed in the accompanying Statement of Need (SON) document.

Requirement type.

Research & development (R&D) R & D support services Support services (non-R&D) x Supplies/equipment Information technology (IT) Construction Architect-engineer (A & E) services

Design-build Other (specify): ____________________

Type of action.

x New requirement Follow-on Other (specify): ______________________

Proposed contract/order type.

x Firm-fixed-price Other fixed-price (specify, e.g., fixed-price award-fee, fixed-price incentive-fee): __________ Cost-plus-fixed-fee Other cost reimbursement (specify, e.g., cost-plus-award-fee, cost-plus-incentive-fee): ___________

Time and materials Indefinite delivery (specify whether indefinite quantity, definite quantity, or requirements): ___________ Other (specify): ___________ Completion Form Term form

Acquisition identification number.

Requisition Number:

POTS Number:

c. Total estimated dollar value and performance/delivery period.

Delivery time would be 120 days from the time of purchase.

4. Identification of the statutory authority permitting other than full and open competition.

This acquisition is conducted under FAR 13.106-1 (b)(1)(i)

5. Demonstration that the proposed contractor(s) unique qualifications or the nature of the acquisition requires use of the authority cited.

a. Name and address of the Brand Name contractor(s).

Hamamatsu Photonics K.K.

360 Foothill Road P.O. Box 6910 Bridgewater, NJ 08807-0910 Phone: 908-231-0960

Fax: 908-450-1140 Email: order@hamamatsu.com

Agilent Technologies, Inc.

2850 Centerville Rd Wilmington DE 19808 U.S.A.

orders@agilent.com

b. Nature of the acquisition and proposed unique qualifications of the contractor(s).

The Hamamatsu NanoZoomer S60 Brightfield Slide Scanner offers sensitive, high-resolution, automated, high throughput scanning and digitization of glass slides. Its compact design fits within the allocated space in building 37. The user-friendly image analysis software is compatible with both PC and Mac platforms and does not require individual licenses. Additionally, the system supports direct upload to the NIH-sponsored HALO platform for image sharing and analysis, ensuring seamless data exchange without file conversion or metadata loss.

Remote image viewing via the internet makes the system telework-friendly, and it will serve multiple labs across the NCI community.

Three unique features of the NanoZoomer S60 are its rapid scanning speed (60 seconds per slide), flexibility, and ease of use. The system can generate high-quality brightfield images from single or double-sized slides at 20X or 40X magnification and offers z-stacking of thick tissue sections with customizable levels and spacing—features not available in other scanners with similar capacity. Moreover, the scanner can be field-upgraded to fluorescence scanning by adding a 3-color fluorescence imaging module and/or barcode reader, enabling advanced biomarker analysis through overlaying brightfield and fluorescence images.

Importantly, the NanoZoomer's software and image transfer portal is already interfaced with the HALO platform across the NIH. This existing integration provides a significant advantage, as it facilitates a seamless and rapid transfer of data between systems, thereby enhancing efficiency and reducing the potential for data transfer errors, further underscoring the instrument's value to NIH's research and clinical operations.

6. Description of the efforts made to ensure that offers are solicited from as many potential sources as practicable. Indicate whether a FedBizOpps notice was or will be publicized as required by FAR Subpart 5.2 and, if not, which exception under FAR 5.202 applies.

In an effort to identify potential vendors capable of meeting the requirements for this acquisition, a sources sought notice (#75N9102Q00170) was posted on SAM.gov from 08/15/2024 to 08/19/2024. This notice aimed to solicit interest from a broad range of vendors, including small businesses that might have the capability to supply the necessary equipment. Despite this effort, the notice yielded no responses, indicating that there were no vendors, including small businesses, that expressed interest or could meet the specific requirements of this acquisition. This outcome highlights the challenges in sourcing this specialized equipment from the current market. The only alternative vendor is Agilent Technologies, a certified reseller of the NanoZoomer S60.

7. Determination by the Contracting Officer that the anticipated cost/price to the Government will be fair and reasonable.

Prior to award the Contracting Officer (CO) will make a determination that the price is fair and reasonable. It is anticipated that determination will be made utilizing the IGE and historical data; however, the CO reserves the right to utilize any other means deemed appropriate in accordance with FAR 13.106-3 (a)(2).

As required by FAR Subpart 5.2, a SAM.gov combined synopsis solicitation will be publicized and cited as a commercial item purchase (as stated FAR Part 12) with the authority to use simplified procedures of commercial items as authorized in FAR 13.106-1 (b)(1)(ii). In accordance with FAR 5.102(a)(6), this brand name justification is being published with the solicitation.

8. Description of the market research conducted (see FAR Part 10) and the results, or a statement of the reasons market research was not conducted.

Market research was conducted by both the Contracting Officer and Program Manager for the requiring Core Facilities, drawing on the program's deep knowledge of the industry and specific requirements. This research included a comprehensive review of historical data from previous NCI and government procurements for similar equipment, as well as an analysis of current pricing from informal quotes, publicly available information, standard industry terms, and product literature.

To further assess market capability, a sources sought notice (#75N9102Q00170) was posted on SAM.gov from 08/15/2024 to 08/19/2024. This notice was intended to identify potential vendors, including small businesses, capable of meeting the specialized requirements. However, the notice yielded no responses, indicating a lack of interested or capable small business vendors. Despite thorough efforts, no small businesses were identified that could fulfill the requirement, underscoring the limited availability of suitable sources in the market. Agilent Technologies, a certified reseller of the NanoZoomer S60, remains the only alternative vendor.

9. Any other facts supporting the use of other than full and open competition.

The Hamamatsu NanoZoomer S60 Brightfield System is the only scanner on the market that offers a unique combination of high-speed scanning (60 seconds per slide), ultra-high-slides), along with complimentary viewing and analysis software. Additionally, this product is already in use across the NIH and seamlessly integrates with HALO, the digital pathology software systems used by all NIH researchers, pathologists, and clinicians treating patients.

10. Listing of sources, if any, that expressed, in writing, an interest in the acquisition.

No sources expressed interest in this acquisition. Despite extensive efforts to identify potential vendors, including the posting of a sources sought notice #75N9102Q00170 on SAM.gov, no responses were received. This indicates that there were no interested or capable vendors, including small businesses, willing or able to meet the requirements of this acquisition.

11. Statement of the actions, if any, the agency may take to remove or overcome any barriers to competition before any subsequent acquisition for the required supplies or services.

NCI LCBG is confident that the current requirement will be successfully fulfilled.

However, if additional equipment is needed in the future, the NCI program office and the contracting officer will conduct thorough market research to assess advancements in technology and identify any new sources capable of providing the necessary equipment. This research will include a SAM.gov announcement, if required. An award will only be made if it is demonstrated during negotiations that the anticipated cost to the Government is fair and reasonable.

12. Program office certification.

This is to certify that the portions of this justification that have been developed by the undersigned program office personnel, including supporting information and/or data verifying the Government’s minimum needs, schedule requirements and other rationale for other than full and open competition, are accurate and complete.

Official Name & Title Signature Date

Project Officer

Official Name & Title Signature Date

Project Officer’s

Immediate Supervisor

13. Contracting Officer certification.

This is to certify that the justification for the proposed acquisition has been reviewed and that to the best of my knowledge and belief the information and/or data provided to support the rationale and recommendation for approval is accurate and complete.

Official Name & Title Signature Date

Contracting Officer