FINAL_SOW.docx

STATEMENT OF WORK

Procurement of a Digital PCR Instrument

I. BACKGROUND INFORMATION

The Biomolecular Measurement Division performs fundamental and applied research on the measurement of macromolecules such as proteins and nucleic acids, as well as peptides, glycans, metabolites, lipids, and natural products. The Division provides measurement science, reference materials, reference data, and technologies to foster innovation and confidence in measurements needed to advance biotechnology, DNA forensics, biomedical and bioscience research, and health care.

II. SCOPE OF WORK

A digital droplet polymerase chain reaction (PCR) instrument is used to determine the accurate and reproducible concentration of DNA samples. NIST requires a Digital PCR Instrument for use in certifying the concentration of Standard Reference Materials (SRM) that are produced in the Biomolecular Measurement Division. The instrument is required to produce high levels of data quality for the accurate measurement of the samples. In addition to high accuracy and reproducibility (precision) the instrument must also be able to measure large number of samples in a reasonable time (sample throughput) and at a reasonable cost per sample.

A Droplet Digital PCR instrument works on the principal that single DNA molecules can be partitioned into droplets (compartments) and then PCR (polymerase chain reaction) is applied to amplify the single DNA molecules to detectable amounts. The PCR step can be done on a separate device (a thermocycler, many are already available at NIST) or part of the instrument.

Each droplet that contains a single DNA molecule that is amplified by the PCR reaction and then detected by using a fluorescent dye molecule. The droplets that contain the amplified DNA are termed positives and droplets that do not contain a DNA molecule are termed negatives. The fraction of negative droplets and the size of the droplets is used to calculate the concentration of DNA in the original sample.

The instrument must have provisions for multiple samples, dispersion of the samples into the droplets and detection of the positives by detection of fluorescent dyes and software for data manipulation for calculation of the concentration values.

III. BRAND NAME OR EQUAL

This is a brand name or equal purchase. The Government considers the following instrument manufactured by Bio Rad Laboratories, 2000 Alfred Nobel Drive, Hercules, CA 94547as meeting the specifications cited below:

· QX200 Droplet Digital PCR

Offerors may propose another item but must include with their proposal documentation that demonstrates that it meets the salient characteristics. Documentation must include drawings, diagrams, brochures or other literature that demonstrates these salient characteristics. Failure to provide such documentation will cause the proposal to be unacceptable.

IV. SPECIFICATIONS

The Contractor shall provide one (1) analytical instrument system equal to Bio Rad Laboratories QX200 Droplet Digital PCR model that meets the following minimum technical requirements. The Contractor shall install the instrument and provide training as described below.

Salient Characteristics:

· The droplet generator, the droplet reader, and the data analysis module must fit on a laboratory bench top size (each unit up to 48 inches in depth, 48 inches in width and 48 inches in height)

· The droplet generator must capable of generating at least 20,000 droplets using a sample size of 20 microliters, allowing for detection of samples that differ in concentration up to 5 orders of magnitude

· The instrument must be capable of detection of at least 2 fluorescent channels for at least 2 target sequences using common fluorescent dyes such as FAM, EvaGreen, HEX and VIC

· The droplet reader capacity must have capability of automated reading for as few as 1 sample and up to 96 samples

· The 96 samples must be analyzed by the droplet reader in less than 4 hours

· The sample to sample reproducibility shall be within 10% of the calculated concentration values (precision).

· The instrument shall include a data analysis module that is capable of collecting, storing and processing the data for at least 96 samples.

· The instrument shall include software that can calculate the concentration of the DNA in each droplet for at least two fluorescent dyes by fitting the fraction of negative droplet data to a Poisson calculation to determine the copy numbers of the DNA targets

· The software shall be able to display the fluorescent dye intensity for at least two dyes for each droplet.

· The software shall be able to allow the adjustment of the threshold settings for calling positive droplets in individual wells or up to 96 samples.

· The system shall include an operations and maintenance manual covering proper operation, routine maintenance, and troubleshooting for the instrument and controlling software

Installation:

The Contractor shall install the instrument in Building 227, Room B225, 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 90 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:

Training at NIST for up to 2 NIST personnel covering normal operation, troubleshooting, and routine maintenance shall be included. Training shall be provided during normal business hours, 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 days of installation. The training may be completed on-site at NIST immediately after installation and demonstration of specifications.

Service Agreement Options:

The contractor shall provide four additional one-year option periods for on-site repair and maintenance services for the instrument being purchased. The services shall include unlimited repair inclusive of travel, parts and labor, repair and maintenance of the Droplet Generator and Droplet Reader and all updates to instrument software and firmware. The contractor is not responsible for PC service. The Government will be responsible to obtain PC service. However, if PC service does occur, reinstallation of Bio-Rad provided software and PC re-configuration is covered by this agreement.

1) Preventive Maintenance

a. Provide one (1) preventive maintenance visit during each one-year term of the service agreement.

b. Scheduling of the visits shall be consistent with the maintenance requirements of the instrument as detailed in the service and use manuals for the equipment.

c. Preventive maintenance visits shall occur during NIST’s regular business hours. The contractor shall contact the NIST Technical Point of Contact (TPOC) to schedule a mutually acceptable date and time for the preventive maintenance visit. The scheduled maintenance visit may be made at the same time as an unscheduled visit for corrective or other action if such a visit occurs within one month before a scheduled preventive maintenance visit. All visits must be scheduled, in advance with the NIST TPOC.

2) Service Calls

a. Respond to an unlimited number of requests for service calls in the event of instrument failure which requires immediate repair.

b. Respond to service calls during regular business hours only, within a targeted 48-hour timeline. A service technician will provide on-site service at NIST Gaithersburg, MD within a targeted 48-hour response time after the call is placed. No weekend service visits shall be required.

c. If the Contractor is unable to resolve the problem during the service call, the Contractor shall provide telephone support and on-site support as needed to expedite a solution for NIST.

d. Responsible to obtain all parts and software updates required for all repairs and maintenance. The Contractor shall make a commercially reasonable effort to secure parts and software updates within 72 hours after identifying the need.

e. Replacement parts provided under this agreement must be OEM Certified and may be either new or remanufactured. The Contractor may exchange and/or repair existing components of the instrument.

f. All repairs must result in the equipment meeting manufacturer’s specifications.

g. Any parts or components removed for replacement shall become the property of the Contractor unless otherwise agreed to by the parties. The Contractor shall remove the parts from the NIST campus at the time of the service call, or provide shipping instructions and return shipping information that NIST may return the parts to the Contractor within 3 days after the service visit is completed. The Contractor shall assume all charges and liability for all shipments.

3) Service Conditions

a. All service provided under this agreement must be provided by factory trained and certified personnel who are fluent in the operation of the covered equipment.

b. Service must be rendered on-site at NIST Gaithersburg, MD unless otherwise agreed by the parties.

c. If a part needs to be repaired off-site, the Contractor shall be responsible for all packaging, shipping and transportation costs as well as liability for the shipment to and from NIST Gaithersburg. The Contractor shall be responsible for providing a “Return Authorization Number” or other information authorizing return of the shipment to their facility prior to the shipment.

d. All parts shall be certified for use with the instrument by Bio-Rad Laboratories. The Contractor shall only employ tools, instruments, test apparatus, methodologies, techniques, and practices approved for use with the instrument by the manufacturer. The service protocols and instrument specifications shall be adhered to always.

4) Service Report The Contractor shall submit a service ticket to the designated TPOC for each instrument prior to departure from NIST on any given service call for maintenance and repairs. The service ticket shall include the following for all instrument repairs and maintenance:

a. Model number.

b. Serial number.

c. Date and time of arrival to NIST.

d. Description of service performed.

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

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

g. Date and time of departure from NIST.

h. Diagnostic test results or narrative summary demonstrating that the instrument is meeting the performance standards.

i. Any additional comments or recommendations.

j. Printed name and signature of service technician. Signature block for NIST personnel accepting the services rendered.

Additionally, copies of the service ticket performed within a billing cycle must be submitted with the accompanying invoice.

5) Telephone Support

a. Provide telephone support for the covered equipment during regular business hours.

b. Telephone support must include response to questions about operating practices, application use, and service issues that can be diagnosed and resolved over the telephone. All labor, replacement parts and components (excluding consumables) provided by the Contractor are guaranteed for a period of ninety (90) days from the service visit completion date.

V. PERIOD OF PERFORMANCE

· Delivery, installation and training shall be completed within 90 days after award.

· Warranty: 12 months from the date of acceptance of the instrument

· Optional (FAR 52.217-9) Service Agreement Period 1: 12 months from the date of warranty expiration

· Optional (FAR 52.217-9) Service Agreement Period 2: 12 months from the date of Optional Maintenance Period 1 expiration

· Optional (FAR 52.217-9) Service Agreement Period 3: 12 months from the date of Optional Maintenance Period 2 expiration

· Optional (FAR 52.217-9) Service Agreement Period 4: 12 months from the date of Optional Maintenance Period 3 expiration *FAR 52.217-7 Optional Line Items: may be exercised at the time of award or any time within 12 months from the date of award.

VI. PLACE OF PERFORMANCE

The instrument shall be manufactured at the Contractor’s facility. Delivery, installation of the instrument and training shall be accomplished at NIST, 100 Bureau Drive, Gaithersburg, Maryland during normal business hours.

VII. DELIVERABLES

VIII. ACCEPTANCE CRITERIA & PAYMNET

After installation at NIST, the Contractor shall demonstrate performance specifications of the instrument are met. NIST personnel will verify equipment operation meets technical standards post installation via visual inspection, and training during acceptance testing.

Acceptance testing shall occur not later than 10 business days from the date of completed installation. Final acceptance by the Government will be given after successful delivery, and demonstration of instrumentation specifications.

The contractor may invoice in one lump sum after all required items have been accepted by the Government. Partial payments are not authorized. Advance payment is not authorized.

IX. GENERAL INFORMATION

Compliance with NIST Rules and Regulations: While on the NIST campus, the Contractor’s representative(s) shall abide by all NIST rules and regulations. The Contractor shall provide all information necessary for the TPOC to authorize entrance to the NIST campus in accordance with NIST Security Policy and Procedures.

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 is to be 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 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.