75N91024Q00096_SON.pdf

STATEMENT OF NEED (SON)

National Institutes of Health / National Cancer Institute / Office of Acquisitions

1.0 TITLE

Purchase of one (1) Brand Name or Equal Sony ID7000 Spectral Flow Cytometer.

2.0 BACKGROUND

The National Cancer Institute (NCI), Center for Cancer Research’s (CCR), Vaccine Branch Flow Cytometry Core is supporting an upcoming Phase I HIV Vaccine Trial designed by NCI investigators.

This trial has received funding from the NIH Office of AIDS Research (OAR) and will commence in 2025 but assay validation and additional samples from other HIV studies will be analyzed in 2024.

Conventional flow cytometry has been used to analyze samples in previous clinical trials, but that technology is limited to measuring 28 markers simultaneously. Full spectrum flow cytometry is a new technology that allows for the measurement of over 45 markers simultaneously. To leverage the full value of the samples from this trial, full spectrum flow cytometry will be used to maximize the number of markers that can be evaluated simultaneously. The NCI CCR Vaccine Branch Flow Cytometry Core is preparing for this trial by developing and validating extensive flow cytometry panels.

To meet the analysis demand of their Flow Cytometry Core, the Vaccine Branch seeks a full spectral flow cytometer. Therefore, the Vaccine Branch requires one (1) Brand Name or Equal Sony ID7000 Spectral Flow Cytometer.

3.0 TYPE OF ORDER

This shall be a Firm Fixed-Price Purchase Order.

4.0 SPECIAL ORDER REQUIREMENTS

4.1 PRODUCT FEATURES/SALIENT CHARACTERISTICS

The following product features/characteristics are required for this requirement:

• Spectral Flow Cytometer must have a minimum of five lasers meeting or exceeding the following specifications:

Lasers: 488nm 150 mW 637nm 140 mW 405nm 100 mW 561nm 100 mW 355nm 50 mW

• The equipment must have detectors that are able to be configured in order to generate data as needed, or able to be configured as follows:

Detectors: Photomultiplier Tubes (PMT)

Forward Scatter (FSC), Side Scatter (SSC) (488nm), and 147 Fluorescent) 488nm: 32 Detectors (493-844nm) + FSC, SSC 637nm: 19 Detectors (646-844nm)

405nm: 35 Detectors (414-844nm) 561nm: 26 Detectors (565-844nm) 355nm: 35 Detectors (361-844nm)

Equipment must have and meet the following characteristics:

• Instrument must have real-time spectral unmixing during data acquisition

• Instrument must have the ability to adjust laser power output for each laser

• Instrument must be able to be operated with 355nm, 405nm, 561nm or 637nm lasers turned off

• Instrument must have the ability to be upgraded with the addition of 320nm and/or 808nm lasers

• Instrument must have a user-operated system to automatically optimize optical alignment

• Instrument must have a Standardization Mode of operation, in which, the signal output of each detector array is adjusted daily to meet the criteria set by a fluorescent calibration bead. Standardization Mode maintains consistent data output from each ID7000 over time and provides uniform data output from multiple ID7000 instruments.

• Instrument must be equipped with PMT (photomultiplier tube) detectors for fluorescence measurement.

• Instrument must be equipped with a minimum of 147 fluorescent detectors capable of captures in the

361-844 nm range or better.

• Instrument must be capable of small particle detection (160 nm).

• Instrument must be equipped with an autosampler with the capability to autosample from 5 mL tubes, 96-well plates (Flat-bottom, V-bottom, and U-bottom), 96-well plates (mid-depth), 96-well plates (deep-well), and 384-well plates.

• Instrument must be equipped with individual sample agitation with these three options: 1) once,

2) periodic, or 3) continuous sample agitation during data acquisition.

• Instrument must be equipped with an integrated thermoelectric sample cooling that works with 5 mL tubes, 96-well plates, and 384-well plates.

• Instrument must have the option to automatically clean and shutdown after acquiring data from a rack of 5 mL tubes, a 96-well plate, or a 384-well plate.

• Instrument must have automated cleaning from a dedicated cleaning fluid station that holds 5 mL tubes.

• Instrument must have automatic clog detection and remediation during data acquisition

• Instrument must have a low dead volume mode that leaves less than 5 µL of sample in the tube or well.

• Instrument software must have the ability to dissect the autofluorescence of unstained cell samples, identify multiple autofluorescence sources, and calculate a spectral reference for each source.

• Instrument software must have the ability for the user to be able to manually adjust the spectral unmixing settings to correct discrepancies between the spectral references and the stained multi-color samples.

• Instrument must have a supporting workstation that utilizes a Windows operating system and has associated monitor and keyboard.

4.2 WARRANTY

In addition to the Implied warranty contained in FAR Clause 52.212-4, quoters are encouraged to provide express warranties. At a minimum, the Contractor shall provide a 12-month warranty from date of final installation on all equipment and associated items provided under, or as a part of this purchase order. The warranty shall include repair and or replacement of parts, including travel, labor, and materials, at no additional cost to the Government. The warranty shall not exclude or limit the Governments rights for an Implied warranty as established in the terms and conditions of clause 52.212-4.

4.3 DELIVERY / INSTALLATION

Delivery shall be within thirty (30) calendar days of purchase order award. All shipping/handling (including FOB Destination) and delivery/installation fees shall be included in the quote. Upon delivery, the Contractor shall notify the respective NCI Technical Point of Contacts to schedule installation dates and times. Installation shall occur within fourteen (14) calendar days of delivery, and shall be performed by, or under the direct super vision of, an Original Equipment Manufacturer (OEM) certified technician.

Equipment shall be delivered to and installed at the following address:

Vaccine Branch Flow Cytometry Core

National Institutes of Health/NCI 9000 Rockville Pike Bethesda, MD 20892

Technical Point of Contact: [to be provided upon award]

4.3.1 DELIVERY GUIDANCE

The Contractors shall communicate and follow instructions from the Technical Point of Contact (TPOC) to coordinate delivery and installation.

The Contractor shall direct all courier and delivery services – including those not operated by the Contractor (e.g. FedEx, USPS, UPS) – to follow the instructions in this section.

All companies delivering to the NIH main campus must comply with Commercial Vehicle Inspection Facility (CVIF) access procedures. Upon arrival, the CVIF will provide a list of buildings and loading docks to delivery personnel.

Deliveries will be logged in at the loading dock, and the loading dock contractor or Government personnel will attempt to contact the TPOC listed on the package. In the event that the TPOC is unable to accept the package, the delivery shall not be left at the loading dock station. The delivery must be returned to the Contractor, and the Contractor must coordinate with the TPOC to deliver on another date at no additional cost.

Deliveries can only be made between 6:00 a.m. and 4:00 p.m. EST, Monday – Friday, excluding federal holidays.

4.4 INSPECTION AND ACCEPTANCE

Pursuant to FAR Clause 52.212-4, all items to be delivered in relation to this Purchase Order are subject to final inspection and acceptance by an authorized representative of the Government. The authorized representative of the Government is the TPOC who is responsible for inspection and acceptance of all services, materials, or supplies to be provided by the Contractor.

4.5 TRAINING

The Contractor shall provide two (2) training sessions, on-site at the laboratory in which the equipment is installed (See Section 4.3). The provided training shall be for two (2) days and accommodate a minimum of three (3) staff. This training shall be conducted within seven (7) calendar days after equipment installation in the designated laboratories. All training expenses, including materials and or travel expenses shall be included in the quoted price.

5.0 PAYMENT

Payment shall be made in full after the successful delivery, installation, training and acceptance of equipment by the NCI Technical Point of Contact (TPOC). Payment authorization requires submission and approval of invoices to the NCI TPOC and NIH OFM.