SON_ SS-75N91024Q00096.pdf

STATEMENT OF NEED (SON)

SS-75N91024Q00096 1

1.0 TITLE

Procurement 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)

SS-75N91024Q00096 2

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.

SS-75N91024Q00096 3

• 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, the Contractor is 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 four (4) weeks of the 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 Contact 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 supervision of, a certified operator.

The contractor shall deliver and install the equipment 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.

SS-75N91024Q00096 4

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 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, in accordance with the payment provisions listed below:

The following clause is applicable to all Purchase Orders, Task or Delivery Orders, and Blanket Purchase Agreement (BPA) Calls: Prompt Payment (Jan 2017) FAR 52.232-25.

Highlights of this clause and NIH implementation requirements follow:

I. Invoice Requirements

A. An invoice is the Contractor's bill or written request for payment under the contract for supplies delivered or services performed. A proper invoice is an "Original" which must include the items listed in subdivisions 1 through 12, below, in addition to the requirements of FAR 32.9. If the invoice does not comply with these requirements, the Contractor will be notified of the defect within 7 days after the date the designated billing office received the invoice (3 days for meat, meat food products, or fish, and 5 days for perishable agricultural commodities, dairy products, edible fats, or oils) with a statement of the reasons why it is not a proper invoice. (See exceptions under II., below.) Untimely notification will be considered in the computation of any interest penalty owed the Contractor.

1. Vendor/Contractor: Name, Address, Point of Contact for the invoice (Name, title, telephone number, e-mail and mailing address of point of contact).

2. Remit-to address (Name and complete mailing address to send payment).

3. Remittance name must match exactly with name on original order/contract. If the

Remittance name differs from the Legal Business Name, then both names must appear on the invoice.

4. Invoice date.

5. Unique invoice #s for all invoices per vendor regardless of site.

6. NBS document number formats must be included for awards created in the NBS:

Contract Number; Purchase Order Number; Task or Delivery Order Number and

SS-75N91024Q00096 5

Source Award Number (e.g., Indefinite Delivery Contract number; General Services Administration number); or, BPA Call Number and BPA Parent Award Number.

7. Unique Entity Identifier (UEI) which is in the System for Award Management (SAM) and replaces the Dun & Bradstreet Data Universal Numbering System (DUNS) number.

8. Federal Taxpayer Identification Number (TIN). In those rare cases where a contractor does not have a UEI number or TIN, a Vendor Identification Number (VIN) must be referenced on the invoice. The VIN is the number that appears after the contractor’s name on the face page of the award document.

9. Identify that payment is to be made using a three-way match.

10. Description of supplies/services that match the description on the award, by line billed.*

11. Freight or delivery charge must be billed as shown on the award. If it is included in the item price do not bill it separately. If identified in the award as a separate line item, it must be billed separately.

12. Quantity, Unit of Measure, Unit Price, Extended Price of supplies delivered or services performed, as applicable, and that match the line items specified in the award.*

NOTE: If your invoice must differ from the line items on the award, please contact the Contracting Officer before submitting the invoice. A modification to the order or contract may be needed before the invoice can be submitted and paid.

Shipping costs will be reimbursed only if authorized by the Contract/Purchase Order.

If authorized, shipping costs must be itemized. Where shipping costs exceed $100, the invoice must be supported by a bill of lading or a paid carrier's receipt.

B. The Contractor shall submit invoices to the Department of Treasury’s Invoice Processing Platform (IPP) at https://www.ipp.gov with a copy to the approving official, as directed below.

The Contractor shall submit a copy of the electronic invoice to the following Approving Official (Technical Point of Contact):

Approving Official: Technical Point of Contact Name- Email Address-

II. Invoice Payment A. Except as indicated in paragraph B., below, the due date for making invoice payments by the designated payment office shall be the later of the following two events:

1. The 30th day after the designated billing office has received a proper invoice.

2. The 30th day after Government acceptance of supplies delivered or services performed.

B. The due date for making invoice payments for meat and meat food products, perishable agricultural commodities, dairy products, and edible fats or oils, shall be in accordance with the Prompt Payment Act, as amended.

III. Interest Penalties

A. An interest penalty shall be paid automatically, if payment is not made by the due date and the conditions listed below are met, if applicable.

1. A proper invoice was received by the designated billing office.

2. A receiving report or other Government documentation authorizing https://www.ipp.gov/

SS-75N91024Q00096 6

payment was processed and there was no disagreement over quantity, quality, or contractor compliance with a term or condition.

3. In the case of a final invoice for any balance of funds due the contractor for supplies delivered or services performed, the amount was not subject to further settlement actions between the Government and the Contractor.

B. Determination of interest and penalties due will be made in accordance with the provisions of the Prompt Payment Act, as amended, the Contract Disputes Act, and regulations issued by the Office of Management and Budget.

IV. PROVIDING ACCELERATED PAYMENT TO SMALL BUSINESS

SUBCONTRACTORS, FAR 52.232-40 (MAR 2023)

(a) Upon receipt of accelerated payments from the Government, the Contractor shall make accelerated payments to its small business subcontractors under this contract, to the maximum extent practicable and prior to when such payment is otherwise required under the applicable contract or subcontract, after receipt of a proper invoice and all other required documentation from the small business subcontractor.

(b) The acceleration of payments under this clause does not provide any new rights under the Prompt Payment Act.

(c) Include the substance of this clause, including this paragraph (c), in all subcontracts with small business concerns, including subcontracts with small business concerns for the acquisition of commercial products or commercial services.

(End of Clause)

V. HHSAR 352.232-71 Electronic Submission of Payment Requests (February 2, 2022)

(a) Definitions. As used in this clause—

Payment request means a bill, voucher, invoice, or request for contract financing payment with associated supporting documentation. The payment request must comply with the requirements identified in FAR 32.905(b), ‘‘Content of Invoices’’ and the applicable Payment clause included in this contract.

(b) Except as provided in paragraph (c) of this clause, the Contractor shall submit payment requests electronically using the Department of Treasury Invoice Processing Platform (IPP) or successor system. Information regarding IPP, including IPP Customer Support contact information, is available at www.ipp.gov or any successor site.

(c) The Contractor may submit payment requests using other than IPP only when the Contracting Officer authorizes alternate procedures in writing in accordance with HHS procedures.

(d) If alternate payment procedures are authorized, the Contractor shall include a copy of the Contracting Officer’s written authorization with each payment request.

(End of Clause) http://www.ipp.gov/