SOW Attune Service Contract Final.pdf

STATEMENT OF WORK

SERVICE AGREEMENT FOR ATTUNE NXT FLOW CYTOMETER

I. BACKGROUND

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

(BBD) is focused on developing methods that will assure reliability and confidence in the measurements that underpin research and applications in genomic measurements, biomaterials, protein therapeutics and cell therapies, cancer diagnostics, nanoparticle safety, and microbial identification and quantification. BBD carries out this work through fundamental research in measurement science and the development of reference materials, reference data, and protocols.

To meet mission requirements, a service agreement for maintenance and repair for an Attune

NxT Flow Cytometer and Attune autosampler is needed. The maintenance agreement(s) will ensure that the measurements carried out by BBD using the Attune instruments are reliable, reproducible, and of high enough quality to meet the needs of BBD’s stakeholders.

II. SCOPE OF WORK

The Contractor shall provide a one-year service agreement for maintenance and repair and three one-year option periods for a Attune NxT Flow Cytometer (serial number: 2AFC213240816) and a Cytkick Max Autosampler (serial number: 2AAS404290421). The service agreement and one-year option periods shall include all travel and labor costs for preventative maintenance calls and emergency service visits. Preventative maintenance calls and emergency service visits shall only occur during NIST regular business hours, which are Monday through Friday, 8:30 am to 5:00 pm Eastern time, except for Federal holidays.

The Contractor shall dispatch technicians for preventative maintenance and/or emergency service visits during NIST’s regular business hours only. No weekend visits shall be performed. The

Contractor shall provide emergency service visits with a dispatch to site time of two (2) business days or less for instrument failures. If the Contractor is unable to return the instrument to functionality within specifications during the service visit, the Contractor shall provide follow-up service visits and/or continuing telephone or other virtual support to expedite instrument repair until the instrument is returned to functionality.

All repairs must result in the instrument meeting the performance specifications as set forth by the manufacturer indicating that the instrument is returned to functionality. The Contractor shall only employ tools, instruments, software, test apparatus, methodologies, techniques and/or practices approved for use with the instrument by the original equipment manufacturer (OEM).

The Contractor shall be responsible for obtaining all parts required for all repairs and maintenance. Contractor shall only use new parts that are obtained from the (OEM) or documented by the OEM to be accepted as equivalent. The Contractor shall initiate efforts to secure part(s) within one (1) business day after identifying the need for any replacement part for the covered equipment. Any part(s) removed by the Contractor because part(s) have been replaced shall become the property of the Contractor unless otherwise agreed to by the parties.

The Contractor shall remove part(s) from the NIST campus at the time of the service visit or the

Contractor shall provide to NIST, within three (3) business days, all packing instructions and materials Contractor deems necessary, a Return Authorization Number (if applicable), and either a pre-paid shipping label or a shipping service account number for full payment of shipment costs. The Contractor shall assume all charges and liability for all shipments.

To the maximum extent practicable, service shall be rendered on-site at the NIST Gaithersburg, MD campus. In the event that (a) part(s) need(s) to be repaired off-site, the Contractor shall be responsible for all packaging, shipping and transportation costs including any charges and/or liability for shipments from and to NIST. If Contractor does not remove part(s) during service visit, the Contractor shall, within three (3) business days, provide to NIST all packing instructions and materials Contractor deems necessary, a Return Authorization Number authorizing the return of the shipment to Contractor’s facility, and either a pre-paid shipping label or a shipping service account number for full payment of shipment costs. The Contractor shall assume all charges and liability for all shipments.

III. SPECIFIC TASKS

The Contractor shall provide the following:

1. One (1) preventative maintenance service call per year to ensure long-term performance and reliability of the instrument. Preventive maintenance visits shall be scheduled at least 30 days in advance with the NIST Contract Officer Representative

(COR). The Contractor will contact the COR to schedule a mutually acceptable date and time for the preventive maintenance visits. Preventative maintenance service shall include:

a. Startup Attune Cytometer and run a Performance Test.

b. Remove instrument covers and inspect that all cables are correctly routed and that connectors are secure.

c. Confirm that all four air vents have flowing air.

d. Clean the interior and exterior of the cytometer.

e. Clean the cove tray and visor.

f. Clean the tube lifter and check for proper operation.

g. Replace the SIP tube.

h. Inspect the inside of the instrument for any traces of salt residue.

i. Check all fittings, valves, pumps, and syringe pump for internal leaks and damage.

j. Replace the 1 mL Syringe in the main cytometer unit. The Contractor shall provide the replacement syringe.

k. Run the system decontamination script.

l. Replace both 0.2-micron filters in the main cytometer unit. The Contractor shall provide the replacement filters.

m. Check to verify that the optical filter configuration is correct.

n. Inspect all optical filters and clean if necessary.

o. Verify the laser alignment, including the pinholes and blocker bar.

p. Run the System Test and ensure that all criteria passes.

q. Check leak detector functionality.

r. Record the lase time for all lasers in the system, and inform COR of lase time in person or in the written service report.

s. Run the Attune NxT Auto Sampler calibration script.

t. Replace the Auto Sampler syringe. Contractor shall provide the replacement syringe.

u. Run the 4-Corner Install Test experiment shown in the Attune NxT Acoustic

Focusing Cytometer Installation Service Manual (Pub. No. MAN0010009).

v. Run the Data Gap experiment shown in the Attune NxT Acoustic Focusing

Cytometer Installation Service Manual (Pub. No. MAN0010009).

w. Prime the system fluidics.

x. Run the system Baseline and Performance Tests.

y. Ensure that the Baseline and Performance Tests pass the specification shown in the Attune NxT Acoustic Focusing Cytometer Installation Service Manual

(Pub. No. MAN0010009).

z. Save the Baseline Results Report, Performance Test Results Report, and Levy-

Jennings Report to the Service folder on the instrument control PC.

2. Unlimited dispatches of a technician for emergency service visits when the instrument becomes inoperable or fails to perform to specifications due to a failure in the instrument. Emergency service shall meet the following specifications:

a. a guaranteed response time of 2 business days after receipt of a service call.

b. include telephone and email access to instrument technical support.

c. include telephone and email access to application technical support.

d. Include replacement of defective parts with OEM replacement parts or OEM-certified replacement parts.

IV. SERVICE REPORT

The Contractor shall submit a service report to the NIST COR prior to departure from NIST on any given service call for maintenance and repairs. 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 service technician. Signature block for NIST COR.

V. PERIOD OF PERFORMANCE

Base Year: 7/26/2024 – 7/25/2025

Option Year I: 7/26/2025 – 7/25/2026

Option Year II: 7/26/2026 – 7/25/2027

Option Year III: 7/26/2027 – 7/25/2028

VI. PLACE OF PERFORMANCE

The Contractor shall perform services at NIST, 100 Bureau Drive, Gaithersburg, MD. Services shall occur during regular business hours. Regular business hours are Monday through Friday, 8:30 a.m. to 5:00 p.m. Eastern Time except for Federal holidays and weekends.

VII. CONTRACTOR’S MINIMUM QUALIFICATIONS

The Contractor shall provide original equipment manufacturer certified engineers and/or service technicians during the performance of the base award and each option period. Contractor personnel shall have experience in maintenance, repair and calibration of the Attune and Cytkick instruments and accessories for which the service is being rendered.

VIII. PERFORMANCE REQUIREMENT SUMMARY

Desired Output Performance Standard Monitoring Method

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

Contractor uses only tools, instruments, software, test apparatus, methodologies, techniques and/or practices approved for use with the instrument by the (OEM). All parts are from OEM or documented as acceptable equivalent by the OEM.

Response time is inoperable instrument shall two (2) business or less. Efforts to secure part(s), if needed, are initiated within one (1) business day after identifying need.

Follow-up visits and/or continuing telephone or other virtual support is provided until instrument is returned to functionality if this cannot be accomplished during visit.

Acceptance by COR of the service ticket

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

System performs to manufacturer specifications upon completion of the maintenance. Contractor uses only tools, instruments, software, test apparatus, methodologies, techniques and/or practices approved for use with the instrument by the (OEM). All parts are from

OEM or documented as acceptable equivalent by the OEM. Efforts to secure part(s), if needed, are initiated within one (1) business day after identifying need.

Acceptance by COR of the service ticket.

IX. ACCEPTANCE CRITERIA

After maintenance or repair of the instrument, NIST shall demonstrate that all minimum requirements have been met.

X. GENERAL INFORMATION

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.

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.

Media Inquiries: The Contractor employee shall not respond to any media inquiries. Any inquiries from the media shall be immediately relayed to the COR and/or CO. There shall be no interviews, comments, or any other response without the knowledge and approval of the NIST

Director.