Final SOW QX200 Service.pdf

STATEMENT OF WORK

TITLE: Service Contract for Bio-Rad QX200 ddPCR System

I. BACKGROUND

The National Institute of Standards and Technology’s Biosystems and Biomaterials Division

(BBD) performs research and standards development of cancer biomarkers and targets. The

Biomarker and Genomic Sciences Group supports NIST’s focus areas of precision medicine and clinical standards. To perform this work, a droplet digital Polymerase Chain Reaction (ddPCR) is used to assign quantitative copy number values to reference materials used in clinical or research laboratory settings.

II. SCOPE OF WORK

• The Contractor shall provide maintenance and repair services for QX200 ddPCR system which includes the droplet generator (serial #772BR6056) and droplet reader (serial

#771BR3031). NOTE: instruments were covered by service plans until June 3, 2024, and both instruments received annual preventative maintenance on January 2, 2024.

• The Contractor shall provide on-site repairs for covered instruments through unlimited emergency service visits, including all travel, original equipment manufacturer (OEM) certified parts, and OEM-certified software updates for equipment failures.

• The Contractor shall provide one (1) preventative maintenance visit during the support plan term.

• The Contractor shall provide telephone or other remote support for troubleshooting the covered equipment during NIST's normal business hours.

• The Contractor shall provide all support for equipment, administration, and technical execution of this contract. The Contractor is responsible for maintaining accurate records of maintenance and repair activities.

• The Contractor shall perform all repairs on-site at NIST Gaithersburg unless agreed otherwise by the NIST Contract Officer Representative (COR). In case of any off-site repairs, the Contractor shall be responsible for all packaging, shipping, transportation, and liability in transit for the equipment, both outgoing from NIST to the Contractor’s facility and returning from the Contractor’s facility to NIST.

• Any parts or components removed for replacement shall become the property of the

Contractor unless otherwise agreed to by NIST COR and Contractor. The Contractor shall remove such parts from the NIST campus at the time of repair or otherwise provide to NIST COR shipping instructions, necessary packaging, and a pre-paid shipping label along with any needed return of materials authorization (RMA) so that NIST may return the parts to the Contractor within three (3) business days after the service is completed.

The Contractor shall be responsible for all costs and assume all liability for all shipments.

III. SPECIFIC TASKS

Preventative Maintenance Visit

• Preventative maintenance shall include routine maintenance actions recommended by the

OEM to ensure instrument performance within specifications.

• Preventative maintenance may be performed at the same time as an emergency service visit if such a visit occurs within one month before a scheduled preventative maintenance visit.

• Preventative maintenance shall include the installation of any OEM software or firmware updates.

• Contractor shall provide all consumables specified by the OEM for performing preventative maintenance.

• Preventative maintenance visits shall only occur during NIST's normal business hours.

• The Contractor shall contact the NIST Contract Officer Representative (COR) to schedule the preventative maintenance visit at least three (3) weeks in advance of the visit.

Emergency Service Visits

• Emergency service visits shall only occur during NIST's normal business hours.

• The Contractor shall respond, by scheduling an emergency service visit, to a report by

NIST of instrument failure within three (3) business days.

• The Contractor is responsible for obtaining all parts required for repairs.

Telephone or other Remote Support

• The Contractor shall provide unlimited telephone or other remote support for the covered equipment during NIST’s normal business hours for troubleshooting the equipment for other than normal operation or failure.

• Contractor shall respond to requests for remote support within two (2) business days.

IV. SERVICE REPORT

The Contractor shall submit a service report to the NIST COR prior to departure from NIST on any emergency service visit for maintenance and repairs. The COR's signature on the service report shall constitute acceptance of the work performed.

The service report must 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 the service technician.

k. Signature block for NIST COR accepting the services rendered.

V. WARRANTY

All labor, replacement parts and components provided by the Contractor are guaranteed for ninety (90) days from the service visit completion date.

VI. CONTRACTOR’S MINIMUM QUALIFICATIONS

The Contractor shall provide service engineers trained and certified by Bio-Rad Laboratories to repair Bio-Rad instrumentation used in ddPCR.

VII. PERIOD OF PERFORMANCE

September 23, 2024, to September 22, 2025.

VIII. PLACE OF PERFORMANCE

National Institute of Standards and Technology

Building 227

100 Bureau Drive

Gaithersburg, MD 20899

IX. PERFORMANCE REQUIREMENT SUMMARY

Desired Output Performance Standard Monitoring Method

Preventative Maintenance

Visit

OEM-specified preventative maintenance actions are performed.

Necessary consumables for preventative maintenance are provided.

Acceptance of service report by

NIST COR.

Emergency Service Visits The system is returned to normal operation through on-site repair, or off-site repair is agreed to by NIST and the Contractor and arranged by the Contractor.

Acceptance of service report by

NIST COR.

Telephone or other

Remote Support for

Troubleshooting

The Contractor responds to NIST requests for support within two business days.

Contractor resolves system trouble or initiates an emergency service visit for on-site repair.

Documentation of requests for support and responses received by

NIST COR.

X. 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 NIST COR to obtain authorization for Contractor Employees and SubContractor Employees to enter the NIST campus in accordance with NIST Security Policy and Procedures. The Contractor shall provide this information at least three weeks in advance of any preventative maintenance visit and at least two business days in advance of any emergency service visit.

Security

NIST is a restricted campus. An identification badge is required for access for entry into buildings and is shown to the armed Security Police when entering the campus. Contractor personnel must wear the identification badge issued by NIST Security while working at any

NIST campus and comply with all escort requirements for any areas requiring such escort as instructed by the NIST COR and NIST Subject Matter Expert (SME).

Normal Business Hours

Normal business hours are Monday through Friday, 8:00 a.m. to 5:00 p.m. local time, with the exception of Federal holidays.

Vehicle Registration

All Contractor employees must register their vehicles with the NIST Security Office to gain access to the campus. They must present a valid driver’s license, REAL-ID compliant government-furnished civilian ID (which, in most cases, can be a valid driver's license), proof of insurance, and current registration to the NIST Security Office.