Final SOW Bio-Rad Equipment Maint services s.pdf

STATEMENT OF WORK

TITLE: Service contract agreement for Bio-Rad droplet digital PCR instruments.

LAB REQUESTING SERVICE: Materials Measurement Laboratory, Biomolecular

Measurement Division

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.

A digital PCR (dPCR) instrument is used to determine the concentration of DNA and RNA samples accurately and reproducibly. NIST’s Applied Genetics Group (AGG) has previously acquired two droplet digital PCR readers, two manual droplet generator instruments, and one automated droplet generating liquid handling instrument for use in certifying the concentration of

Standard Reference Materials (SRM) produced in the Biomolecular Measurement Division. The

Bio-Rad instruments have been characterized, through studies at NIST, to produce high quality data for the reproducible measurement of DNA and RNA samples. The dPCR equipment operated by the AGG is essential to daily operations of the AGG in certification and monitoring of NIST Standard Reference Materials (SRMs). Significant instrument down time or disrepair will impede NIST’s mission to provide highly characterized, homogeneous, and stable SRMs for calibration of nucleic acid concentration in a number of fields (e.g., forensic and clinical nucleic acid testing).

NIST also provides digital PCR as a measurement service activity. NIST, along with two other

National Measurement Institutes, collaborates with an External Quality Assessment (EQA) scheme provider to provide digital PCR based copy number concentrations for SARS-CoV-2 viral materials in an EQA scheme. These schemes occur quarterly, and accurate measurements are essential to ensure that labs can detect SARS-CoV-2. NIST’s digital PCR measurement services have also been requested by other Federal agencies (e.g., The Centers for Disease

Control) in response to pandemic and other biothreat monitoring requirements. These are highly time-sensitive measurements, which may be requested on short notice. Prolonged down time or lack of appropriate preventive care and maintenance for the AGG’s dPCR instruments could potentially delay EQA schemes and other measurement services, resulting in interruption of issuance of certificates necessary to process SARS-CoV-2 samples and/or response to urgent measurement needs.

To maintain readiness and deliver on its nucleic acid measurement activities and goals, NIST requires reliable and timely maintenance of the AGG digital PCR instruments. The crucial role these dPCR instruments play in NIST’s mission to deliver calibrated reference materials and measurement services to the U.S. biotechnology sector necessitates rapid response of no less than 72 hours to repair and maintenance needs of the equipment.

II. SCOPE OF WORK

• The Contractor shall provide unlimited telephone support, unlimited on-site emergency repair service, unlimited travel and travel-related expenses, unlimited replacement parts, and unlimited labor for the instruments listed below, housed at NIST Gaithersburg, building 227.

Product Serial Number

Droplet Reader QX200 771BR3717

Manual Droplet Generator 772BR6412

Droplet Reader QX200 771BR8840

Manual Droplet Generator 772BR7838

Automated Droplet Generator 773BR1246

• The Contractor shall provide support for integrated controller-computers and software. In the case of external controller-computers, the contractor is not responsible for PC hardware but shall support Bio-Rad provided software; including updates, re-installation

(if required), and PC reconfiguration.

III. SPECIFIC TASKS

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 the following tasks in support of the scope of work listed in Section II of this Statement of Work (SOW).

Repair

Repairs will be accomplished by Original Equipment Manufacturer (OEM) trained personnel who are proficient in the operation of the covered equipment and will meet the requirements outlined in section III.

Repairs must be rendered on-site at the NIST Gaithersburg campus unless otherwise agreed by the parties.

If a part or the equipment 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 from and to

NIST Gaithersburg.

The Contractor shall adhere to OEM approved procedures and only employ parts, tools, instruments, software, test apparatus, methodologies, techniques, and practices approved for use with the instrument by the OEM.

Preventive Maintenance

Provide one (1) preventive maintenance visit during each one-year term.

Preventative maintenance will include routine maintenance actions recommend by the OEM to ensure optimum instrument performance. Preventive maintenance will ensure the instrument is operating to OEM specifications and will act as necessary to ensure optimum instrument operation until the next scheduled visit.

Scheduling of the visits shall be consistent with the maintenance requirements of the instrument in accordance with the most recent service practice and maintenance protocols.

Preventive maintenance visits shall occur during NIST’s regular business hours Monday through

Friday, between 8:30 a.m. and 5:00 p.m. Eastern Time except for Federal Holidays and will be scheduled in advance with the NIST Subject Matter Expert (SME) or Contracting Officer’s

Representative (COR). The scheduled maintenance visits 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.

System Enhancements

Install, or if NIST technical personnel can install the upgrades without compromising system performance make available for installation, all software upgrades for the purposes of instrument optimization not later than 60 days after any such upgrade is released.

If contractor installation is necessary to ensure proper performance, prior to completion of the installation, the Contractor shall test the equipment, review the equipment’s performance, and take whatever steps are necessary to ensure the equipment is functioning in accordance with the manufacturers’ specifications.

Service Calls

Respond to an unlimited number of requests for service calls in the event of instrument failure which requires immediate repair. The contractor shall provide travel, labor, and any factory-certified parts that required replacement.

Respond to service calls during regular business hours only - Monday through Friday, between

8:30 a.m. and 5:00 p.m. Eastern Time except for Federal Holidays. A service technician will provide on-site service at NIST Gaithersburg within a maximum 72-hour response time after the call is placed. No weekend service visits shall be required.

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.

The Contractor is responsible to obtain all parts required for all repairs and maintenance. The

Contractor shall make a reasonable effort to secure parts within 24 hours after identifying the need for a replacement part for the covered equipment.

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

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.

Service Conditions

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

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.

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

Telephone Support

Provide telephone support for the covered equipment during regular business hours as specified in Section XII.

Telephone support must include response to questions about operating practices, application use, and service issues that can be diagnosed and resolved over the telephone.

Warranty. 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.

The Contractor shall provide all information necessary for the COR or COR’s designated point of contact to authorize entrance to the NIST campus in accordance with NIST Security Policy and Procedures.

Options

Option 1 through 4: Perform the work specified in Section III for one additional year, each option period.

IV. PERIOD OF PERFORMANCE

Service and Maintenance:

BASE: shall be for one (1) year from instrument recertification or the end of the period of performance of the previous service agreement.

OPTION PERIODs: one additional year per option period for up to four (4) years.

V. PLACE OF PERFORMANCE

Performance will be at NIST, 100 Bureau Dr, Gaithersburg, MD 20899 except when mutually agreed upon by both parties. Normal business hours are Monday through Friday, 8:30 a.m. to

5:00 p.m. except for Federal holidays.

VI. GOVERNMENT FURNISHED PROPERTY

All property, data and information provided by the Government in the performance of this task remains the property of the Government and shall be surrendered to the government upon completion or termination of this requirement. Likewise, all deliverables generated under this requirement remain the property of the Government.

The Government will provide visitor’s access to the NIST facilities during the performance of this service contract. If a given hand tool is available, the Government will provide such tools during the performance of a given service call.

VII. DELIVERABLES

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.

VIII. PERFORMANCE REQUIREMENT SUMMARY

Desired Output Performance Standard Monitoring Method

Repair and recertification of instruments.

All parts shall be approved for use with the instrument by the original equipment manufacturer (OEM).

The Contractor shall only employ

Acceptance by COR

Desired Output Performance Standard Monitoring Method tools, instruments, software, test apparatus, methodologies, techniques, and practices approved for use with the instrument by the

OEM. The service protocols and instrument specifications shall be always adhered to.

Onsite response to an unlimited number of requests for service calls in the event of instrument failure.

Same as above Acceptance by COR

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

Same as above Acceptance by COR

Telephone support Contractor responds to telephone support calls made during regular business hours 99% of the time.

COR tracks and logs telephone support requests.

IX. TRAVEL

Travel to the NIST, Gaithersburg is required. All travel expenses will be included in the price of this agreement.

X. CONTRACTOR’S MINIMUM QUALIFICATIONS

The Contractor shall provide OEM certified engineers and/or technicians during the performance of this requirement. Contractor personnel must be eligible to access the

NIST, Gaithersburg campus. Requirements for access are available on the NIST website:

www.nist.gov.

XI. GENERAL INFORMATION

This work does not involve confidential or proprietary data.

Safety: The Contractor employee shall be responsible for knowing and complying with all 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.

Regular Business Hours. Regular business hours are Monday through Friday, 8:30 am to 5:00 pm Eastern Time.

Identification Badges: Contractor employees shall comply with NIST identification and access requirements. 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, proof of insurance and current registration must be presented to the NIST Security

Office, at which time a NIST vehicle pass will be issued. The pass shall be displayed on the vehicle in accordance with NIST Security Office instructions.