SB1341-16-RQ-0431_SOW.pdf

STATEMENT OF WORK

TITLE: Ion Torrent S5XL System

LAB REQUESTING SERVICE: Material Measurement Laboratory, Biomolecular Measurement Division

I. BACKGROUND INFORMATION

The Applied Genetics Group (AGG) within the Biomolecular Measurement Division conducts research into the use of next generation sequencing (NGS) for forensic DNA biometrics and human identification (HID) as well as development of clinical DNA reference materials. The work being performed will evaluate NGS technology’s suitability for use in forensics and clinical applications through assessment in the areas of: accuracy, precision, sensitivity, concordance with current methods, and improved capabilities for HID and clinical pathogen detection. Ion Torrent (a brand of Thermo Fisher Scientific) has recently launched a new NGS instrument, the Ion Torrent S5XL. The S5XL system vastly simplifies the NGS workflow through the use of cartridge-based consumable reagents. Cartridge-integrated reagents significantly reduce hands-on time, complexity, and potential for error in the NGS workflow.

Mitigation of potential errors is crucial in forensic and clinical laboratories.

The AGG requires that the instrument being acquired be compatible with current liquid handling infrastructure for NGS sample preparation at NIST. Namely, the Ion Chef manufactured by Life Technologies. The Ion Chef system is capable of fully automated production of NGS sequencing template for the Ion Torrent S5XL. In contrast, manual sample processing is a complex, time consuming, and potentially error prone procedure. Errors in sample preparation can lead to waste in labor and costly reagents, and may result in sample mix-up errors. The latter of which is an unacceptable scenario in both the forensic and clinical laboratory settings. Fully automated template preparation is anticipated to be a reliable, economical, and expeditious method for generating NGS results in regulated clinical laboratories. Without the ability to evaluate this technology, NIST will not be able to support its mission of increasing the competitiveness of U.S. industry and improving accuracy of metrology in forensic and clinical DNA laboratory practice.

II. SPECIFICATIONS

The Contractor shall provide one (1) Life Technologies Branded Ion Torrent s5XL (OEM Part # A27214) next generation DNA sequencing system that meets the following minimum technical requirements. The Contractor shall deliver and install the instrument and provide training as described below.

System Requirements:

Must be capable of producing more than 50 million sequencing reads in a sequencing run lasting no more than six (6) hours.

Must use semiconductor technology for signal detection.

Must use integrated, cartridge-based reagents.

Must be able to successfully sequence libraries and templates generated with Ion Torrent

OEM reagent kits currently used on NIST’s Ion Chef system.

The instrument shall integrate with NIST’s Ion Chef software for sample tracking, secondary analysis, and data storage.

The instrument must include a server class computer which is capable of analyzing the results of 50 million sequencing reads in under 8 hours.

Server must be configured with software compatible with processing and analysis of Ion

Torrent raw data.

The system must include an operations and maintenance manual covering proper operation, routine maintenance, and troubleshooting for the instrument, controlling computer, and software o The manual may be supplied in hard copy or electronic format (or both).

Delivery / Installation:

The Contractor shall deliver and install the instrument in Building 227, Room B261, at NIST Gaithersburg, MD. The Contractor shall deliver the instrument within 120 days of award. F.O.B.

Destination.

Installation shall include, at a minimum, uncrating/unpacking of all equipment, set-up and hook-up of all equipment, start-up, demonstration of specifications, and removal of all trash.

Instrument will operate to manufacturer’s specifications upon installation. Installation will take place during normal business hours, between 8:30 am and 5:00 pm Eastern Time, Monday through Friday except Federal Holidays, and will be coordinated with the NIST Technical Point of Contact (TPOC). Installation is to occur within 120 days of award.

Warranty:

The Contractor shall provide, at a minimum, a one-year warranty for the equipment. The warranty shall cover all parts, labor and travel necessary to ensure that the instrument is operating in accordance with the manufacturer’s specifications. Warranty shall include all hardware and software updates, and a minimum of one annual preventive maintenance service.

All work to be completed on site. Best effort will be made to ensure response time to maintenance needs does not exceed two business days from identification of required maintenance. Technical support shall be available by telephone during business hours (at minimum, 8 AM to 5 PM, Monday through Friday, Eastern Time Zone).

The warranty shall commence upon successful completion of delivery and installation

Four (4) optional one-year periods of service contract coverage shall be offered with identical terms as the original manufacturer’s warranty.

Training:

Include at least 2 hours of training at NIST for up to 2 NIST personnel covering normal operation, troubleshooting, and routine maintenance. Training will be provided during normal business hours, between 8:30am and 5:00pm Eastern Time, Monday through Friday, except Federal Holidays, and will be coordinated with the NIST Technical Point of Contact (TPOC) to ensure maximum availability of NIST personnel. Training is to occur within 21 days of installation. The training may be completed on-site at NIST immediately after installation and demonstration of specifications.

III. PLACE OF PERFORMANCE

Delivery, installation of the instrument, training, and service under the warranty and service coverage shall be accomplished at NIST, Gaithersburg, Maryland. Normal duty hours are Monday through Friday, 8:30 a.m. to 5:00 p.m. with the exception of Federal holidays.

IV. DELIVERABLES

Description Quantity Due Date

Analytical instrument One (1) 120 days after award of this requirement.

Installation of the analytical instrument Once 120 days after award of this requirement.

Operations and maintenance manual for the analytical instrument

One (1) 120 days after award of this requirement

Training of NIST personnel at NIST, Gaithersburg, MD

Once 21 days after installation.

V. PERFORMANCE REQUIREMENT SUMMARY

The Contractor shall demonstrate that all performance standards in this statement of work have been met.

VI. GENERAL INFORMATION

Security: NIST is a restricted campus. An identification badge is required for access for entry into buildings and also is shown to the armed Security Police when entering the campus.

Identification Badges: Contractor employees shall comply with NIST identification and access requirements. The Contractor employee is responsible for absences due to expired identification and access documents. Each Contractor employee shall wear a visible identification badge provided by the NIST Security Office. The badge must show the full name, title, and if required by NIST, the words “Contractor” in front. The Contractor employee shall turn in the NIST identification badge and vehicle pass to the TPOC, COR, or Contracting Officer (CO) upon termination of their services under this contract.

Vehicle Registration: All Contractor employees must register their vehicles with the NIST Security Office to gain access to the campus. A valid driver’s license, Government-furnished civilian ID, proof of insurance and current registration must be presented to the NIST Security Office, at which time a NIST vehicle pass will be issued. The pass shall be displayed on the vehicle’s rear view mirror in accordance with instructions. The Contractor employee shall follow NIST procedures for removal and turn-in of the vehicle pass upon termination of services under this contract.