Final SOR.pdf

STATEMENT OF REQUIREMENTS

Bio-Rad QX600 AutoDG Droplet Digital PCR System

I. BACKGROUND

The Biomarker and Genomic Sciences Group within the National Institute for Standards and

Technology (NIST) needs to acquire an automated droplet digital polymerase chain reaction

(ddPCR) system with a capability of multiplexing 6 dyes to make absolute quantifications of

Standard Reference Materials. This type of instrument would be the main work horse in the

Biomarker and Genomic Sciences Group to validate cancer biomarker materials and determine absolute DNA quantitation for genome editing consortium materials.

II. SPECIFICATIONS

The Contractor shall provide one (1) Bio-Rad QX600 AutoDG Droplet Digital PCR System that includes an automated droplet generator and droplet reader that can detect at least 6 dyes and meets the following specifications:

• Automated droplet generator creates droplets for up to 96 samples in 45 min or less.

• Automated droplet generator must contain a high efficiency particulate air (HEPA)-filtered enclosure to reduce sample contamination.

• Automated droplet generator must be able to partition a 20 microliter (µL) reaction into approximately 20,000 nanoliter (nL)-sized droplets.

• Automated droplet generator shall require no supervision or hands on activity during droplet generation.

• Droplet reader must detect a minimum of 6 fluorescent dyes (must include: FAM

(EvaGreen), HEX (VIC), Cy5, Cy5.5, ROX, and ATTO 590).

• Droplet reader must have the capability to quantify up to 12 targets in a single well with at least a 6-color dye detection system.

• Droplet reader must be capable of running both TaqMan and EvaGreen chemistries.

• Software analysis to analyze droplet reader data (number of positive droplets, negative droplets, total number of droplets, etc.) must be included.

• Droplet reader must be capable of processing between 1-96 samples per run.

• An operations and maintenance manual (electronic, hardcopy, or both) shall be provided.

III. DELIVERY

Delivery shall occur within 90 calendar days of award.

Delivery shall be made to the NIST campus at 100 Bureau Drive, Building 227/Room B237, Gaithersburg, MD, 20899, USA. Normal duty hours are Monday through Friday, 8:30 a.m. to

5:00 p.m. with the exception of Federal holidays.

IV. INSTALLATION

The Contractor shall install the Automated Droplet Digital PCR system at 100 Bureau Drive, Building 227/Room B237, Gaithersburg, MD 20899 within 30 calendar days of delivery.

Installation shall include, at a minimum, uncrating/unpackaging of the system, assembly, set-up, and demonstration of all required minimum salient characteristics, and removal of trash.

Installation shall take place during normal business hours, between 8:30 am and 5:00 pm Eastern

Time, Monday through Friday except Federal Holidays, and shall be coordinated with the NIST

Contracting Officer Representative (COR).

V. TRAINING

The Contractor shall provide in-person training for up to two (2) NIST personnel within 30 calendar days of installation. The training shall provide, at a minimum, a demonstration of all instrument functions and instrument operation which will allow NIST personnel to operate the instrument to its full capabilities, calibration, basic troubleshooting, and routine maintenance procedures. Training must be scheduled, in advance, with the NIST COR and SME identified in the purchase order award document under "General Award Information”. Training shall be provided during normal business hours, between 8:30am and 5:00pm Eastern Time, Monday through Friday, except Federal Holidays. If campus restrictions exist, or are imposed after installation has concluded, training shall be re-scheduled to a mutually agreeable date/time.

VI. WARRANTY

The Contractor shall provide, at minimum, a one (1) year warranty to include all parts, materials, labor, and travel for the instrument to keep the instrument operating to manufacturer's specifications. The warranty period shall commence upon Government acceptance.

VII. ACCEPTANCE

The Contractor shall demonstrate that performance specifications are met within 14 calendar days of installation.

VIII. OPTIONAL SERVICE CONTRACT

Upon expiration of the 1-yr. instrument warranty, the Contractor shall provide a service contract for 1year for maintenance and repair inclusive of travel, parts, and labor.

• Preventative Maintenance: The annual service contract shall include one scheduled preventive maintenance (PM) visit to ensure long-term performance and reliability of the system. At a minimum, preventative maintenance shall include the following:

- For droplet reader: checking waste bottle for mold, check syringes, inspecting wash well & tip, inspecting cartridge bay and ii)

- For droplet generator: cleaning inside of sample bay, cleaning underside of clamping arm and replacement of covers.

• Emergency Repair: The Contractor shall respond within 24 to 48 hours via phone or email to an emergency maintenance call and will provide emergency visits within 72 hours. The Contractor shall furnish all parts required for all repairs and maintenance and secure parts within 72 hours, after identifying the need for a replacement part for the covered system. If parts are not available within 72 hours, a loaner instrument shall be considered while the instrument is down.

• Email/Telephone Support: The Contractor shall provide unlimited remote (email, telephone, or teleconference) support when issues arise with operation of the system.

All repairs must result in the instrument meeting Original Equipment Manufacturer (OEM) specifications and a service ticket shall be submitted once completed.

IX. DELIVERABLES

Description Quantity Recipient Due Date

Bio-Rad QX600 ddPCR System with automated droplet generator 1 COR and SME

90 calendar days of award

Installation Once COR and SME 30 calendar days after delivery

Manual (electronic, hardcopy, or both) 1 COR and SME

30 calendar days after installation

Training Once COR and SME 30 calendar days after installation

The Contractor shall submit a service ticket prior to departure from NIST on any given service call for maintenance or repairs. The service ticket shall include the following:

a. Date and time of arrival to NIST.

b. Description of service performed.

c. Name and quantity of any parts that were repaired.

d. Name and quantity of any parts that were replaced.

e. Date and time of departure from NIST.

f. Diagnostic test results or narrative summary demonstrating that the instrument and/or accessories are meeting the performance standards.

g. Any comments or recommendations.

h. Signature of Contractor’s service person

i. Signature block for NIST personnel accepting the services rendered.

X. 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. 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 shall provide the name and citizenship information of employees for on-site visits to the COR and SME prior to arrival. The COR 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.