SOW_Illumina_19000972_Nov2018.docx

STATEMENT OF WORK

PROJECT INDENTIFICATION:

Project Title: Service Contract for Illumina Sequencing Instruments;

Project Location:

(NextSeq500 & iScan) NIH-NIDCD, Genomics and Computational Biology Core Bldg 35A Room 1F333, Bethesda, MD

Date: December 17, 2018

PROJECT BACKGROUND INFORMATION.

1.0 Laboratory background information

The Genomics and Computational Biology Core (GCB), provides DNA sequencing support for the NIDCD intramural program. The NextSeq500 is used to identify genetic mutations in DNA, or characterize and quantify the RNA representation in specific tissues or cells. This instrument uses a laser to excite chemical reactions on a flowcell, a microscope lens and a camera to capture images of the excitation, a fluidics pump system to deliver chemical reagents, a refrigeration unit to store chemicals, a peltier device to control temperature on the flowcell, and a large data storage computer to operate the software and store the image data. iScan is used for microarray analysis to detect differentially expressed genes.

Project purpose The GCB performs basic biological research on hearing disorders in humans and gene expression in animal models of human hearing disorders. The research results are published in scientific journals and are subjected to strict peer review. In order for the GCB to remain competitive, the equipment used for experiments must be kept in top working condition so that errors are not introduced into the data and downtime from broken instrumentation is kept to a minimum. The purpose of this acquisition is to provide a comprehensive plan contract to keep the Illumina Instraments, unit in the laboratory operating within the GLP standards, to prevent problems and downtime, and to quickly repair the instrument should the need arise, minimizing the impact of broken instruments on the researchers who rely on them. This plan covers full coverage for parts, labor, HW failures, remote and on site technical support; support, HW/SW updates, and discounts on advanced training.T he most qualified technicians are ones that have been trained directly by Illumina, the manufacturer. The scientists and technicians who work in the laboratory performing biological experiments, the building maintenance staff, and the technicians in the DSEIS at NIH are not qualified to perform repair or PM work on these instruments.

1.1 Project description and objective

All units are located at Building 35A, room 1F333 (cBot, MiSeq, HiSeq1500, iScan) and are under the care of the Director of the GCB. The GCB is requesting a Fixed Price Contract for a service provider to provide the following services on the instrument:

a. Preventative maintenance (PM) check to verify instrument is working within the manufacturer’s specifications.

b. PM consists of cleaning, calibration, inspection, lubrication, adjustments, and functional test.

c. Unlimited emergency repairs in the event of an instrument malfunction.

d. All parts needed for PM or emergency repairs, excluding consumables.

e. Any software upgrades that are needed

f. Access to pertinent training

1.2 Quality Control Standards for instrument function

a. The laser must perform at the optimum level and generate an image.

b. Instruments must turn on, turn off, and have no reagent leaks.

c. No error messages should appear during a run.

d. Doors should open and close easily.

e. Power light comes on and instruments turn on.

2 CONTRACTOR REQUIREMENTS

The laboratory needs a service plan that will allow for a service technician, directly trained by Illunina, Inc, to come on site during regular working hours, 8 am-5 pm.

2.1 The service plan should allow for unlimited repairs during working hours and a small overtime fee (2 hours labor, travel) for emergency repairs that occur after hours, on holidays, or weekends.

2.2 The repair call should cover all labor, parts, travel time, non-consumable parts and software upgrades.

2.3 The service plan should include one yearly preventative maintenance visit (PM) that includes cleaning, calibration, inspection, adjustments and a function test of the instrument. The contractor should expect to come out infrequently, at least once per year for the PM visit. The PM visit may be done during a remedial service call.

2.4 Period of performance for an award is one year

3 GOVERNMENT FURNISHED PROPERTY AND SERVICES

The government will provide the service technician with reasonable access to the instruments and a signature when the work is complete and done to satisfaction.

3.1 The government will provide the service technician with a land-line telephone to make calls related to the repair or PM and any reagents needed to run the instrument.

3.2 The government will make sure that there are no safety hazards posed during the visit and will provide the service technician with disposable nitrile gloves and a lab coat to use during the visit if he or she requests..

4 CONTRACTOR FURNISHED PROPERTY AND SERVICES

The contractor must provide the government with the following items after a service call, either scheduled or emergency:

a. Any instruction manuals or SOP’s, either paper or electronic copies.

b. Any software or hardware upgrades

c. A briefing to the equipment users on any new requirements, procedures, software, or hardware.

d. A verbal explanation to users of the problems found during the visit and the solutions for preventing the problem in the future.

e. Written documentation of the repair call or PM and a list of problems found with corrective measures noted.

5 PERFORMANCE REQUIREMENTS SUMMARY

The instrument users are responsible for ensuring that the instruments are satisfactory.

5.3 Call dispatch is the amount of phone calls placed to the service department. Call turn-around time is the time between placing the call and the arrival of a technician to do the work. Technician arrival time is the time the technician arrives at the facility. Call completion time is the time taken from the technician’s arrival until completion of the work.

6 QUALITY ASSURANCE-- INSPECTION AND ACCEPTANCE CRITERIA

In order to determine whether or not the performance requirements in Section 5.2 are being met, the lab manager will look at the number of complaints from users per year against the equipment’s performance and do a surveillance checklist every six months. The checklist for the quality control status of the whole process of instrument repair for both non-scheduled and PM repairs is given below. This includes monitoring five main items-- the initiation of the service request, the turn-around time between call initiation and technician arrival, quality of the repairs done, user satisfaction with the work done, and that a contractor furnished final work report summarizing the repairs accomplished was provided within a couple of days.

Performance Indicator Acceptable Quality (AQ) Contractor met AQ?

Call dispatch reasonable? 3 calls or less Yes or No

Turn-around time quick? 7 days or less Yes or No

Technician punctual? 8 hours or less Yes or No

Work completed promptly? 3 days or less Yes or No

Temperature control working? 100% Yes or No

Pipettes correctly after visit? 100% Yes or No

Error messages after visit? 0 Yes or No

Computer crashes after visit? 0 Yes or No

Number of user complaints 0 Yes or No

Work report provided after? 2 days or less Yes or No

The instrument manager will consult with users to get feedback on performance of the instrument and to try to initially solve the problem. If the problem cannot be solved by the instrument manager, a service call to the contractor will be placed. Problems with the instrument are mentioned in lab meetings. The lab manager will review the work report and keep all records of repairs. In order to be given a rating of satisfactory, the contractor must perform as shown below:

Monitoring area Satisfactory rating criteria

7 ATTACHEMENTS