SON.pdf

STATEMENT OF NEED (SON)

1.0 TITLE: Acquisition of Attune Xenith Flow Cytometer

2.0 BACKGROUND

The National Institutes of Health (NIH), National Cancer Institute (NCI), Center for Cancer Research (CCR), Pediatric Oncology Branch (POB), requires the acquisition of a spectral flow cytometer to support ongoing cancer research and the development of new immunotherapies for children and young adults with cancer.

The Pediatric Oncology Branch conducts laboratory and clinical research focused on understanding cancer biology and improving treatment options for patients with difficult-to-treat and relapsed cancers. Many of these research efforts involve studying patient blood, tumor, and immune cell samples to better understand how cancers respond to treatment and to identify new therapeutic approaches.

The requested instrument will provide researchers with the ability to analyze complex cell populations using limited patient samples and will support multiple research programs within the Pediatric Oncology Branch. The acquisition will help ensure that investigators have access to modern technology needed to conduct research efficiently and generate high-quality data in support of NIH's mission to advance scientific knowledge and improve human health.

The requiring Federal agency is the National Institutes of Health (NIH). The sponsoring organization is the National Cancer Institute (NCI), Center for Cancer Research (CCR), Pediatric Oncology Branch (POB). The contracting activity is the National Cancer Institute Office of Acquisitions.

3.0 TYPE OF ORDER

This is a Firm Fixed-Price Purchase Order.

4.0 SPECIAL ORDER REQUIREMENTS: NA

4.1 PRODUCT FEATURES/SALIENT CHARACTERISTICS

The Pediatric Oncology Branch (POB), Center for Cancer Research (CCR), National Cancer Institute (NCI), requires a spectral flow cytometry system capable of supporting advanced immunophenotyping and functional analysis of patient-derived and preclinical samples used in pediatric cancer and cellular immunotherapy research.

The required system shall possess the following minimum features and capabilities:

• Spectral Flow Cytometry Capability o The system shall support both spectral unmixing and conventional compensation workflows.

o This capability is required to support both existing flow cytometry assays and next-generation high-parameter experiments performed across multiple Pediatric Oncology Branch laboratories.

• Six-Laser Optical Configuration o The system shall include a minimum of six excitation lasers, including ultraviolet (UV), violet, blue, yellow-green, red, and near-infrared (NIR) laser configurations.

o Multiple laser excitation sources are required to support complex multicolor antibody panels used for characterization of immune cell populations, cellular therapy products, and tumor samples.

• High-Parameter Detection Capability o The system shall include a minimum of 51 fluorescent detectors and 6 scatter detectors.

o This capability is required to permit simultaneous measurement of large numbers of cellular markers while conserving limited patient-derived specimens and reducing the need for multiple experimental runs.

• Acoustic-Assisted Hydrodynamic Focusing Technology o The system shall utilize acoustic-assisted hydrodynamic focusing technology.

o This capability is required to improve sample acquisition speed, maintain data quality at high cell concentrations, and support analysis of challenging tumor and tissue-derived samples while minimizing clogging and instrument downtime.

• High-Speed Sample Acquisition o The system shall provide high-throughput sample acquisition capabilities.

o High-speed operation is required to support multiple research groups sharing the instrument and to process time-sensitive patient and experimental samples efficiently.

• Compatibility with Complex Biological Samples o The system shall be capable of analyzing tumor, tissue, blood, and cellular therapy samples.

o This capability is required because Pediatric Oncology Branch research programs routinely analyze complex patient-derived specimens obtained from pediatric cancer patients participating in clinical and translational research studies.

• Automated Sample Loading o The system shall include compatibility with an automated sample loading system capable of processing both 96-well and 384-well plate formats.

o Automated sample handling is required to support large-scale screening studies, improve throughput, reduce operator variability, and maximize utilization of the shared resource.

• Integrated Instrument Control and Analysis Software o The system shall include software for instrument control, data acquisition, spectral analysis, quality control monitoring, and data export.

o These capabilities are required to support standardized operation across multiple laboratories and facilitate downstream data analysis.

• Touchscreen Operation and Automated Maintenance Functions o The system shall include integrated touchscreen controls and automated maintenance features.

o These capabilities are required to simplify routine operation, reduce training burden, and maximize instrument availability for researchers.

• Remote Diagnostics and Service Support o The system shall provide remote diagnostic capabilities and manufacturer-supported service coverage.

o These capabilities are required to minimize instrument downtime and ensure continued operation of a shared resource supporting multiple ongoing NIH intramural research studies.

• CytKick Max Automated Sample Loader o The system shall include the CytKick Max automated sample loading system.

o Automated sample loading is required to support high-throughput research workflows and efficient processing of large sample sets generated by multiple Pediatric Oncology Branch research programs.

• Installation, Training, and Warranty Coverage o The vendor shall provide installation, operational startup, user training, and manufacturer-supported service coverage.

o These services are required to ensure proper deployment, operation, and long-term reliability of the instrument within the Pediatric Oncology Branch shared instrumentation program.

4.2 DELIVERY / INSTALLATION

4.3 Delivery Address: Building 10CRC, Rm. 1-3872 10 Center Drive Bethesda, MD. 20892

Government POC: Miki Kasai, 240-858-3407

Item will be delivered in 8 week of award date

4.3 TRAINING

The system shall include vendor-provided startup and training services associated with the Attune Xenith Flow Cytometer (and CytKick Max automated sample loader, if needed).

5.0 PAYMENT

Payment shall be made monthly or quarterly in the arrears. Payment authorization requires submission and approval of invoices to the COR and NIH OFM, in accordance with the payment provisions listed below:

Invoice and Payment Provisions (Vendor has Transitioned to IPP)

The following clause is applicable to all Purchase Orders, Task or Delivery Orders, and Blanket Purchase Agreement (BPA) Calls: Revolutionary FAR Overhaul (RFO) 52.232-25 Prompt Payment (Jan 2017). 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 RFO 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 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 must submit invoices to the Department of Treasury’s Invoice Processing Platform (IPP) at https://www.ipp.gov with a copy to the approving official for approval, as directed below, No Later Than (NLT) 30 days after delivery or acceptance of goods whichever is later. For ongoing services, invoices for the previous billing period (month, quarter, etc.) must be submitted NLT 30 days following the period for which the services were delivered.

The contractor’s failure to submit timely invoice(s) to the Government, as set forth in the preceding paragraph, waives the contractor’s rights to receive payment pursuant to this contract.

In the event of the contractor’s failure to submit timely invoice(s), the Government is not obligated to make such payment, and the Contracting Officer shall have the authority to unilaterally deobligate the funds in accordance with the requirements at 31 U.S.C. 1552(a) and downwardly adjust the total amount of the award by the amount of the deobligation. The https://www.ipp.gov/ contractor shall be given an opportunity to request the excusal of a late invoice from the Contracting Officer. If excused, the Contracting Officer will respond in writing to confirm that the contractor’s right to receive payment has not been waived.

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 receives a proper invoice from the contractor.

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, must be in accordance with the Prompt Payment Act, as amended.

III. Interest Penalties

A. An interest penalty will 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 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. RFO 52.232-40 PROVIDING ACCELERATED PAYMENT TO SMALL BUSINESS

SUBCONTRACTORS, (Mar 2023)

(a)

(1) In accordance with 31 U.S.C. 3903 and 10 U.S.C. 3801 , within 15 days after 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.

(2) The Contractor agrees to make such payments to its small business subcontractors without any further consideration from or fees charged to the subcontractor.

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

https://www.govinfo.gov/content/pkg/USCODE-2022-title31/pdf/USCODE-2022-title31-subtitleIII-chap39-sec3903.pdf https://www.govinfo.gov/content/pkg/USCODE-2022-title10/pdf/USCODE-2022-title10-subtitleA-partV-subpartD-chap277-sec3801.pdf

(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/