Statement of Requirement (Final).pdf

STATEMENT OF WORK

Automated DNA Extraction System

I. BACKGROUND INFORMATION

The Applied Genetics Group (AGG) in the Biomolecular Measurement Division of the Materials Measurement Lab conducts research to support the forensic human identification and clinical genetics communities. A key aspect of this research is the requirement to extract DNA (and/or RNA) of high quality and purity from various sources (tissues, bodily fluids, and other biological materials, often deposited on challenging substrates encountered in the investigative and clinical environments). Automation of the DNA extraction increases the reproducibility and reliability of the resulting extract while reducing the labor input from the researcher. Typically, the number of samples processed in each workday ranges from one or two to a few dozen. A large-scale system or instrument is not required.

The AGG has a Qiagen EZ1 Advanced XL extraction instrument in use in the Biosafety Level 2 (BSL-2) laboratory used for viral characterization. The AGG requires an identical or similar unit with compatible chemistry and comparable throughput to support the human DNA extraction function within the AGG’s programs. To mitigate potential cross-contamination human DNA is extracted in a separate BSL-2 lab from viral samples. The second extraction robot should be able to act as a backup if one instrument experiences a failure.

II. SCOPE OF WORK

The contractor shall provide an automated system capable of extracting high-quality, high-purity DNA and RNA from various sample types encountered in investigative methodology and clinical environments. The extraction chemistry shall efficiently remove inhibitory substances which could negatively impact downstream workflows using the extracts.

III. SPECIFICATIONS

The Contractor shall provide one (1) analytical instrument system that meets the following minimum technical requirements. The Contractor shall install the instrument and provide training as described below.

System Requirements: Must be a benchtop nucleic acid extraction instrument.

• Must be able to extract DNA and RNA of high quality and purity fit for purpose for downstream PCR analysis from a variety of sources such as blood, buccal, tissue, and saliva.

• Must have capacity of no less than 14 samples per run.

• Instrument software shall be compatible with protocol cards (DNA Investigator, Virus, and

Buccal protocol cards) used by the current AGG EZ1 Advanced XL.

• Extraction reagent kits shall be compatible with existing AGG EZ1 Advanced XL.

• Must have an internal U.V. irradiation system for mitigating contamination.

• The instrument shall have an embedded barcode reader for tracking sample and reagent information.

• Must contain a safety interlock mechanism to prevent contact with potentially infectious samples during operation of the instrument.

• The instrument shall allow walk-away operation with minimal user training.

• The extraction method shall be based on magnetic particle technology.

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

Installation:

The Contractor shall install the instrument in Building 227, Room B229, at NIST Gaithersburg, MD. 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 30 calendar 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. The warranty shall commence upon successful completion of delivery, installation, training and demonstration of all required specifications.

Training:

Include in-person training at NIST, Gaithersburg, 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 10 calendar days of installation. The training may be completed on-site at NIST immediately after installation and demonstration of specifications.

IV. PERIOD OF PERFORMANCE

The period of performance shall be one (1) year from award of this requirement.

V. PLACE OF PERFORMANCE

All work shall be completed at the Contractor’s facility. Installation of the instrument and training shall be accomplished at NIST, Gaithersburg, Maryland. Normal duty hours are Monday through Friday, 8:30 a.m. to 5:00 p.m. except for Federal holidays.

VI. DELIVERABLES

Description Quantity Due Date

Analytical instrument One (1) 60 days after award of this requirement.

Installation of the analytical instrument Once 30 days after receipt of the instrument.

Operations and maintenance manual for the analytical instrument

One (1) 60 days after award of this requirement

Training of NIST personnel at NIST, Gaithersburg, MD

Once 10 days after installation.

VII. ACCEPTANCE CRITERIA

The Contractor shall demonstrate that all performance specifications are met.

VIII. GENERAL INFORMATION

Safety: The Contractor employee shall be responsible for knowing and complying with commercial installation safety prevention regulations. Such regulations include, but are not limited to, general safety, fire prevention, and waste disposal.

Security: NIST is a restricted campus. Contractors shall be familiar with entry requirements for the NIST campus. All personnel entering the NIST campus must provide a government-issued REAL-ID act compliant photo identification.

Identification Badges: Contractor employees shall comply with NIST identification and access requirements. The Contractor shall provide the name and citizenship information of employees for on-site visits to the NIST Technical Point of Contact (TPOC) prior to arrival. The TPOC will submit the name(s) and citizenship information to the NIST Office of Security in order for a given Contractor employee to enter the NIST campus. The Contractor employee is responsible for absences due to missing or expired identification and access documents. Each Contractor employee shall wear a visible identification badge provided by the NIST Security Office.

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 (which in most cases can be a valid driver's license), proof of insurance and current registration must be presented to the NIST Security Office.