SS-75N91024Q00086ON_Statement of Need_NextSeq550Dx.pdf

STATEMENT OF NEED (SON)

SS-75N91024Q00086 1

1.0 TITLE

Procurement of One (1) Brand Name or Equal Illumina NextSeq 550 Dx Sequencing System

2.0 BACKGROUND

The National Cancer Institute (NCI), Laboratory of Pathology (LP), has implemented the Comprehensive Oncologic Molecular Pathology and Sequencing Service (NCI-COMPASS). The goal of NCI-COMPASS is to provide state of the art clinical sequencing services to CCR Principal Investigators (PIs). To this end, the NCI-COMPASS program is developing large Next-Generation-Sequencing (NGS) panels, as well as additional cancer -omics technologies to establish a Clinical Laboratory Improvement Amendments (CLIA)-certified and College of American Pathologists (CAP)-accredited program to support precision cancer diagnostics. Since its start in 2018, COMPASS has seen a large increase in the demand for its clinical analysis services.

To meet this increased demand, NCI-COMPASS seeks a clinical-grade benchtop In-Vitro Diagnostic (IVD) instrument. Therefore, NCI-COMPASS requires one (1) Brand Name or Equal Illumina NextSeq Dx sequencing system.

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:

• Instrument is intended for sequencing of DNA libraries when used with in vitro diagnostic assays performed on the instrument and will be able to be used with specific registered, certified or approved in vitro diagnostic reagents and analytical software as they become available.

• Sequencing instrument that measures fluorescence signals of labeled nucleotides through the use of instrument specific reagents and flow cells, imaging hardware, and data analysis software.

• Sample capabilities are 8 to 96 samples per run, with a sequencing output of >90 Gb.

• Scalability (20–120 Gb) in a single run to support a broad range of applications and study sizes

• Fully automated on-board cluster generation enables prepped libraries to be loaded directly onto the instrument.

• High accuracy using Illumina SBS

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• Proven SBS chemistry with single-base extension enables accurate sequencing of homopolymers.

• Fully automated paired-end sequencing

• Automated BeadChip array scanning and image file generation

• >75 of reads should have Phred scale equal or quality greater than 30.

• System should be qualified to detect deletions and insertions up to 24bp.

4.2 TRADE-IN

The Contractor shall accept trade-in of one existing system as part of this requirement. The trade-in includes one (1) Ion S5 XL Sequencer (Serial Number 245745700661). The Contractor shall provide all applicable services for removal of the existing system such as labor, equipment, packaging/crates, shipping, and insurance. Removal of equipment from laboratory spaces must be coordinated with the TPOC to minimize impact on laboratory operations.

4.3 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.

4.4 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:

Laboratory of Pathology/NCI-COMPASS National Institutes of Health/NCI 9000 Rockville Pike Bethesda, MD 20892

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

4.4.1 DELIVERY GUIDANCE

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

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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.

4.5 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.

4.6 TRAINING

Training is not required for this equipment.

5.0 PAYMENT

Payment shall be made in full after the successful delivery, installation, 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.

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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 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.

https://www.ipp.gov/

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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 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.

http://www.ipp.gov/

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(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)