RFQ-NIAID-23-2178661 - FACSymphony A5 SE - JA Brand Name.pdf

applications and that includes the ability to modify and adapt capabilities as new applications are developed. In general, this requirement is satisfied by using instrumentation with a wide range of laser excitation wavelengths, detectors and power outputs combined with the ability to custom configure fluorescence detector capabilities.

The new assays developed at the VRC can reach 30 parameters and are expected to reach 50 parameters. The FCC currently manages outdated analyzer production units (FACSymphony A5 analyzers) that do not have the capability to run 50 parameter samples and limiting the development of more advanced panels.

Advanced spectral flow cytometer cell analyzers can increase the understanding of biological science required to make decisions in vaccine development. In addition, the high parameter capability produces an increase in cell cluster resolution that can be used for cell sorters and downstream genetics. The new instrument can support existing research projects, to provide seamless transition to the new equipment, and to maintain experimental compatibility between existing equipment and the new equipment.

Therefore, the VRC requires one (1) spectral 50 parameter capable BD FACSymphony A5 SE cell analyzer to increase the cell receptor capabilities and to comply with developed panels currently acquired on production analyzers at this same facility. Critically, the instrument required must provide seamless continuity between the existing instruments and the new instrument such that data, from existing assay formats, produced on current instrumentation will be identical to that from the new instruments. This includes the transfer of data and gating parameters to existing S6 cell sorters for downstream genetic analysis.

The manufacturer/supplier of the FACSymphony A5 SE cell analyzer is Becton, Dickinson and Company (BD), and the requested instrument must be obtained through BD or an authorized BD reseller.

3. Description of the supplies or services required to meet the agency’s needs

(including the estimated value).

a. Project title.

BD Symphony A5 SE Cell Analyzer

b. Project description.

This acquisition is to procure a BD FACSymphony A5 SE cell analyzer, which includes the high throughput sampler (HTS) robotics and miscellaneous components (see Appendix 1 – Bill of Materials), to the FCC Facility and Vaccine Immunology Program’s satellite laboratory.

The laboratory requires the following salient characteristics of the equipment:

- Has 5 lasers in the standard configuration with the potential of adding 4 additional lasers.

o This feature allows the advancement to more parameters, if necessary, without the purchase of new instrumentation, therefore providing a built-in future expansion as experiments expand. At the VRC, this allows for multidimensional cell sorting for cells involved in protective immunity.

- Must contain simultaneous 50 parameter detection of 48 fluorescence markers plus forward scatter (FSC) and side scatter (SSC) signals.

Upgradable to at least 60 parameters with increased laser capability.

o This provides the ability to sort complex cell clusters in 50 parameter space and to match panels currently measured on existing 30 parameter cell analyzers and cell sorters that will be required to sort the same number of parameters (i.e., 48 fluorescence colors plus two physical parameters). At the VRC, this allows for multidimensional cluster cell sorting for cells involved in protective immunity.

- Must include a LED pulser technology or equivalent measurements for Quality Control (QC) by measuring relative background using automated voltage ranging.

o This feature allows for rapid instrument setup and inter and intra instrument comparison, which are required for large research or clinical experiments. This improves more accurate quality control for increased precision and reproducibility of data.

- Must include a high throughput sampler (HTS) robotics.

o This device will allow 96 well plates (and other plate formats) to be used and sampled directly into the BD FACSymphony A5 SE to allow for faster data collection speeds.

o Plates used in processing can be directly used on the HTS system and therefore can reduce potential transfer errors.

- Must use high quality photomultiplier tubes (PMT) known as the GaASP and GaA. These detectors are a proven technology and are compatible with our existing instruments and are currently used research cell panels developed in prototype instrument used at the VRC. Therefore, these detectors are compatible with our existing instruments and previous panel development, requiring minimal impact on existing panels and future panels.

- Requires the use of standard FACS-DIVA software, which is compatible with existing instruments, including the BD-S6 cell sorter. This workflow pipeline is required for continuity of cellular and genetic experiments.

- Can process Flow Cytometry Standard files in version.3.1 for use in the BD- FlowJo software for standard and multidimensional data analysis.

• Requirement type.

Research & development (R&D) R & D support services Support services (non-R&D) × Supplies /equipment Information technology (IT) Construction Architect-engineer (A & E) services Design-build Other (specify): ____________________

• Type of action.

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

• Proposed contract/order type.

× 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.

AMBIS #2178661; Solicitation ID: RFQ-NIAID-23-2178661

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

The Independent Government Estimate (IGE) The estimated delivery of the instrument is 90 days after receipt of order. Total estimated period of performance is September 22, 2023 to December 22, 2023.

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

This acquisition is conducted under the authority of 41 United States Code (U.S.C.) 253(c)(1) and 3304(a)(1) as set forth in Federal Acquisition Regulation (FAR) 6.302-1.

X This acquisition is conducted under the authority of 41 United States

Code (U.S.C.) 1901(e)(2) as set forth in Federal Acquisition Regulation (FAR) 13.106 -1(b)(1) and 13.501(a)(1)(ii).

This acquisition is conducted under the authority of the Services Acquisition

Reform Act of 2003 (41 U.S.C. 428a).

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 proposed contractor(s).

Becton, Dickinson and Company BD Biosciences Business Unit One Becton Drive Franklin Lakes, NJ 07417

FedPoint Systems LLC 13042 Blackbird Place, Suite 100 Fairfax, VA 22033

Based on the results of the market research that was conducted in accordance with FAR Part 10, it is determined that the competition for this acquisition will be limited to BD and authorized resellers of BD brand-name instruments.

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

The VRC requires a BD FACSymphony A5 SE cell analyzer system for the FCC facility that currently operates one prototype of the FACSymphony A5 SE cell analyzer manufactured by Becton, Dickinson and Company. The BD FACSymphony A5 SE analyzer is the only available flow cytometer that provides all the analytical capabilities as well as technological advances described in the specifications, and thus BD is the only vendor that can meet the salient characteristics of the requirement detailed in the specifications above. Further, only the BD FACSymphony A5 SE analyzer provides for uninterrupted continuity of research and immediate compatibility with existing software that is currently used in the prototype instruments (i.e., beta proven), and only BD Biosciences can provide the maintenance support and service the VRC requires in order to maximize instrument operability. The following describes the unique qualifications of the contractor/manufacturer:

i. Continuity of research. The FCC facility has used BD instrumentation for many years. Current instrumentation comprises of four (4) BD FACSymphony S6 cell sorters and eight (8) BD FACSymphony A5 cell analyzers. Thus, hundreds of protocols for BD instruments have been developed in the facility and published by facility users. Procurement of a new spectral BD instrument will allow facility staff and users to use these existing protocols whereas switching to a different manufacturer would require development of new protocols. In addition, ongoing experiments have been optimized for the particular characteristics (sensitivity, resolution, multiplexing, etc.) of the BD platforms and are uniquely positioned to transfer complex cell populations to cell sorters for genetic analysis. Using a different platform would require extensive re-optimization of immune assays, and revalidation by the FCC, and thereby introduce significant downtime and harm the mission of the VRC to develop and test new vaccine candidates.

ii. Compatibility with existing computer software. VRC’s FCC facility is currently developing new flow cytometry data analysis software (beta testing software) that is compatible with BD file structures from the BD DIVA data collection software programs. Current software (DiVa v.8.5) is based on a 64-bit platform using high speed computers. Purchase of the BD FACSymphony A5 SE analyzer instrument will allow us to use this new software without modification to analyze files and sort samples based on the specifications as listed above that would otherwise be necessary should a different instrument or platform be used.

iii. High parameter acquisition and cell sorting: The BD FACSymphony A5 SE has a high parameter acquisition, offering 50-parameter capability with spectral fluorescent separation. This capability is required to enhance existing experiments performed in ongoing research projects with the current flow cytometers.

iv. Cluster Cell Sorting: The BD FACSymphony A5 SE analyzer will allow higher resolution in cluster cell analysis. These gating strategies can be easily transferred to the existing cell sorters for additional genetic testing or marker analysis. The BD FACSymphony A5 SE analyzer offers automated gating from cluster analysis software, called “HyperFinder.”

This function will rapidly be translated from complex phenotypic expression into logical automated gating from cell clusters as defined by cluster programs (e.g., FlowSOM, Cluster Explorer, tSNE, UMAP, etc.).

Proprietary agreements: Due to proprietary agreements with the laser manufacturer, BD is the only vendor that can offer proprietary instrument software controlled high-powered solid-state lasers in the power ranges and wavelengths required for applications as detailed above in the specifications.

Local service force: Because of the high volume of BD flow cytometers in the Baltimore Washington region, BD has several readily available local service engineers trained on the BD FACSymphony A5 SE analyzer. This capability is required for minimizing down time in the busy core facility of the VRC. This requirement is critically important due to the nature of the work in VRC’s core facility. More than 75% of the work is with freshly explanted or very short term cultured (hours) cells prepared from various organs. These cells are extremely fragile and die less than 12 hours after they are harvested. Some of the samples used are genetically modified and are extremely valuable. Therefore, these experiments are extraordinarily expensive to perform. If a flow cytometer malfunctions, but cannot be repaired within 4-6 hours, the experiment will be lost because the samples have already been prepared. BD Biosciences has 7 local service engineers, and usually 2 or more of them are at NIH on any given day. On at least 10 occasions during the last 12 months, a local service engineer had already been on the NIH campus and had repaired a problem within 6 hours of the breakdown. This saved the program thousands of dollars that would have otherwise been lost.

This response is possible due to a sizeable local service force.

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:

As required by FAR Subpart 5.2, a combined synopsis/solicitation will be posted on SAM.gov and cited as a commercial item purchase (as stated in FAR Part 12) with the authority to use simplified acquisition procedures for certain commercial items as authorized in FAR 13.500(a). In accordance with FAR 5.102(a)(6), a brand name justification will be published with the solicitation.

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

NIAID intends to base price reasonableness on competitive quotations received in response to the solicitation. If only one response is received, then NIAID will consider the government estimate; comparison of industry prices for similar products; and comparison of proposed prices found reasonable on previous purchases as a determining factor for price reasonableness. A final determination by the Contracting Officer will be conducted prior to award of this contract.

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 in accordance with FAR Part 10. The Program Office conducted the initial market research with the laboratory manager, who has more than 30 years of experience with flow cytometry. Two types of research were done. First, the most current available literature from vendors was reviewed to determine the technical specifications that would be the most appropriate for the Government’s need. Additional research was done by regular attendance at the twice-yearly NIH-wide Flow Cytometry Interest Group (FCIG) (of which the Project Officer is a member) meetings, and by daily reading of posts to the Purdue Flow Cytometry List Group, to which posts are made from all over the world. The FCIG meetings feature frequent presentations by technical specialists from the vendors and are attended by representatives (technical and marketing) of all major flow cytometer vendors. These meetings and talks with technical and marketing representatives of flow cytometer vendors provided additional information that may not be readily available through vendor literature.

The market research demonstrated that multi-laser spectral flow cytometer analyzer systems are available from several vendors but do not meet the salient characteristics required by the VRC.

Furthermore, the Contract Specialist reviewed the mandatory priorities in accordance with FAR Subpart 8.002(a)(1) Priorities for Use of Government Supply Sources and determined that none of the mandatory Government sources could satisfy this requirement. The Contract Specialist reviewed the required sources, the GSA Federal Supply Schedule, NIH Strategic Sources, and Commercial Websites and in the process of conducting market research, identified that the BD FACSymphony A5 SE cell analyzer was available through the original equipment manufacturer (OEM), Becton, Dickinson and Company and a small 8(a) business, FedPoint Systems LLC. In an effort to identify additional small business sources, a Small Business Sources Sought Notice was posted on SAM.gov on August 3, 2023 and closed on August 15, 2023 at 12:00 PM EST and no responses from additional small business sources were received.

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

N/A

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

No sources expressed an interest, in writing, to the sources sought notice that was published on SAM.gov.

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.

It is the policy of NIAID to promote the use of competitive procedures whenever and wherever possible. In an effort to remove or overcome barriers to competition in the future, the market will be scanned frequently for new vendors and products that could satisfy the Government’s need. Although there are no future plans as of now to acquire the same type of equipment for upcoming years, market research will continue to be conducted to search for new innovative creations for flow cytometry instruments that will allow staff to use existing protocols. At this time, developing new protocols would be costly to the government due to the amount of existing data that would be lost.

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

APPENDIX 1: Bill of Materials

Bill of Materials

Project: BD Symphony A5 SE Cell Analyzer 8/3/2023

Qty Product Catalog #

1 FACSymphony A5 SE 664954 1 LSRfortessa Instrument Table 647741 1 Option FACSFlow Supply Sys LSRFortessa 649908

High-Parameter System (HPS) Fluorochrome

Evaluation Kit 566352

1 HPS Prototype Fluorochrome Eval Kit 624371 1 High Parameter Immunology Panel 625838

BD High Throughput Sampler (HTS)

LSRFortessa 647701 1 FACS Shutdown Solution 334224 1 BD FACS Sheath Solution With Surfactant 336524 1 BD FACSDiva CS&T Research Beads Kit 50T 655050 1 Workstation N/A 1 34 inch Monitor N/A 1 Coherent Connection with Integration kit N/A 1 Shipping and handling N/A 1 12-month warranty N/A

Note: Symphony A5 SE 50 parameter system w/ 5 lasers include - Laser Blue 488nm 150mw, Laser Red 637nm 140mw, Laser Violet 405nm 200mw, Laser UV 349nm 60mw, and Laser YG 561nm 150mw