Illumina MiSeq i100 System

Justification for Other Than Full and Open Competition

This document justifies a sole-source procurement for one (1) Illumina MiSeq i100 Whole Genome Sequencing System. The acquisition is being conducted under FAR Part 12 (Acquisition of Commercial Products and Commercial Services) and FAR Part 13 (Simplified Acquisition Procedures).

• One (1) Illumina MiSeq i100 Whole Genome Sequencing System.

• Associated components, software, and manufacturer warranty support.

• The system must be fully compatible with the FDA Irvine Medical Products Laboratory (IRVLMP) microbiological testing mission, including existing validated laboratory workflows, consumables, analytical methods, and operational procedures.

• A firm-fixed-price purchase order is intended.

• Not applicable, as this is a justification for a sole-source procurement.

• This procurement is being conducted on a sole-source basis because only one source is reasonably available to satisfy the Government's minimum requirements.

• Market research was conducted, including a Sources Sought Notice, but no other vendor could meet the requirements without significant modification to existing validated workflows and laboratory procedures.

• The Government will determine price reasonableness in accordance with FAR 13.106-3.

• The Government will continue to monitor the marketplace for future competitive sources.

Statement of Work (SOW)

To procure one (1) Whole Genome Sequencing instrument for the Food and Drug Administration (FDA), Irvine Medical Products Laboratory (IRVLMP) to support the sequencing of microorganisms from regulatory pharmaceutical samples.

• Provide one (1) Whole Genome Sequencing instrument meeting specific "Salient Characteristics".

• Key characteristics include:

  • Sequencing-by-synthesis next-generation technology
  • Support for single-read and paired-end libraries
  • Output range up to 25 Gigabases
  • Up to 50 million paired-end reads per run
  • Maximum read length of at least 2 x 300 base pairs
  • ≥85% of bases achieving Q30 at 2 x 300bp
  • RFID or equivalent consumable tracking
  • Reagents stored at room temperature
  • Includes onboard data collection and sequence alignment software
  • Includes monitor and control computer
  • Benchtop system not exceeding 16" x 18" x 26" (W×D×H)

• Delivery: Within 60 days of award.

• Place of Performance: FDA / IRVLMP, 19701 Fairchild, Irvine, CA 92612.

• Warranty: Begins upon final Government acceptance.

• Warranty: Minimum one (1) year manufacturer's warranty covering all parts, labor, and operational support.

• Records and Reports: Provide service reports for any warranty-related service.

• Training: Provide operator training and system familiarization for up to (3) end-users upon installation and prior to Government acceptance.

• Hours of Operation/Site Access: On-site work to be performed during normal Government business hours, Monday through Friday, excluding Federal holidays, unless otherwise approved.

• Whole Genome Sequencing System: 1 unit, due within 60 days after award.

• Manufacturer Warranty: 1 unit, begins upon acceptance.

• Contracting Officer (CO): Iris Johnson (Iris.Johnson1@fda.hhs.gov, (301) 796-3353).

• Contracting Officer Representative (COR): To be designated at the time of award.

Solicitation / RFP / RFQ

This is a combined synopsis/solicitation for commercial products and services for the Food and Drug Administration (FDA), Irvine Medical Products Laboratory (IRVLMP). The FDA requires the purchase of one (1) Whole Genome Sequencing system to perform whole genome sequencing of microorganisms obtained from regulatory pharmaceutical samples. The acquisition is not set-aside for small business concerns.

• One (1) Illumina MiSeq i100 System, including onboard software, monitor, and control computer, in accordance with the Statement of Work (Attachment 1).

• All equipment must be new, not used or refurbished.

• Delivery and Installation to FDA IRVLMP, Irvine, CA.

• Training and system familiarization for up to three (3) personnel.

• One (1) Year Manufacturer Warranty.

• Contract type: Request for Quotation (RFQ).

• Period of Performance: Delivery within sixty (60) days after award. Warranty period begins on the date of Government final receipt and acceptance.

• FOB Point: Destination.

• Quotations are due as listed on the SAM.gov notice.

• Submission Method: Email to the POCs listed in the SAM.gov posting.

• Basis for Award: Lowest Price Technically Acceptable (LPTA). Award will be made to the lowest-priced offeror whose quotation is determined technically acceptable. Technical acceptability will be determined on a pass/fail basis against the salient characteristics and minimum requirements stated in the SOW.

• Offer Acceptance Period: Prices must be held firm for 60 calendar days from the date specified for receipt of quotations.

• Not set-aside for small business concerns.

• NAICS Code: 334516 – Analytical Laboratory Instrument Manufacturing. Small Business Size Standard: 1,000 employees.

• Amendments will be posted to SAM.gov.

• Attachment 1 (Statement of Work) details salient characteristics including sequencing techniques, output range, read length, quality score, and physical dimensions.

• All relevant provisions and clauses are incorporated by reference and accessible electronically.