75N91024Q00086_Statement of Need.pdf

STATEMENT OF NEED (SON)

RFQ 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

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

• Fully automated paired-end sequencing

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• 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.

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.

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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.