Draft Statement of Work- OC-2025-129298- SSN Supplemental Documentation.pdf

STATEMENT OF WORK

Service Agreement

Multiple Agilent (1200, 1260, 1290) HPLC/UHPLC Instruments

Background

The Center for Tobacco Product (CTP) Tobacco Products Laboratory (TPL) located in Atlanta, Georgia has a requirement for a preventative maintenance agreement/operational qualification for two Agilent 1200 HPLC/UHPLC instruments (1260 Infinity II, 1290 Infinity II, and 1260 System Enhanced). The instruments are integral components that support the Food and Drug Administration (FDA) Office of Chief Scientist (OCS) to meet the legislative requirements and the sample workload that are an integral part of the Agency response to the legislation. The proposed instruments are needed to develop methods for identifying and, in some cases, quantifying analytes in tobacco products under the Food and Drug Administration (FDA) regulatory jurisdiction and to establish expertise in the analyses of tobacco products.

Salient Characteristics

The Contractor shall be capable of providing the Service Agreement for all systems specified in the Statement of Work to ensure uninterrupted performance within manufacturer’s specification as well as complying with local quality assurance and ISO 17025 certification.

Instruments for Preventative Maintenance and Operational Qualification:

Description Age Current Working Condition

Date of Last Service Serial Numbers

1. Agilent 1260 System Enhanced Equipment ID:

TOB-LC03

8 Good 03/27/25 Fluorescence Detector:

DE83700631

Refractive Index Detector:

DEAA605241

Diode Array Detector:

DE73458063

Quaternary Pump:

DEAB714404

1260 Infinity Micro Degasser: JP82009534 Autosampler:

DE64155967

Thermostat Column Comp.:

DE60559202

Thermostat:

DE60565635

ELSD:

FR92800513

2. Agilent 1290

Infinity II UHPLC Equipment ID:

TOB-LC06

9 Good 08/06/24 Fluorescence Detector:

DEABV01509

Diode Array Detector Fixed Slit: DEBAV00542 Flexible Pump:

DEBAX00680

Vial Sampler and Thermostat Column Comp.:

DEBA900302

All the following are minimum requirements.

Preventative Maintenance and Operational Qualification (PM/OQ):

The Contractor shall provide at least one (1) preventative maintenance inspection (PMI) service visit during each 12-month period of performance for each instrument. The Technical Point of Contact (TPOC) will contact the Contractor to schedule the PMI. All visits will be scheduled by the TPOC at least seven (7) business days in advance.

The Preventative Maintenance Service shall be performed in accordance with the specifications contained in the original equipment manufacturer’s service manual.

The PMI and all PM service shall include all consumables, parts, labor and travel for remedial repair.

The contractor shall obtain all new parts required for all repairs and maintenance which meet the original equipment manufacturer’s specifications at no additional cost to the Government.

The Contractor shall repair or replace any part or parts which prove to be defective at no additional charge to the government.

The Contractor shall make arrangement for the fastest delivery and will resume work upon receipt of parts.

The Contractor shall provide documentation of preventative maintenance duties performed.

(See Records and Reports section).

The Contractor shall provide Qualification Service after the planned PM and after any other repairs of the system.

The Qualification Service shall include Operation Qualification/Performance Verification

(OQ/PV).

The Contractor shall perform at least one (1) annual OQ/PV verification for the systems that is equal to or exceeds the qualification requirements of the original equipment manufacturer.

The OQ/PV service shall be performed by a qualified engineer. The Contractor shall provide documentation that the system is functioning according to the original equipment manufacturer’s specifications.

The OQ/PV shall include all supplies needed to perform the service. Both the OQ and PV shall be scheduled at a date approved by the TPOC or Alternate TPOC.

The Contractor shall provide the TPOC documentation for temperature verification, calibrations, and an instrument performance run.

If at any point during the Qualification Service, the system fails a test, the Contractor shall provide onsite service to remedy the failure and re-execute the Qualification Service to demonstrate to the TPOC that the system passed all the Functional Requirements Specification and the system is operating in accordance with OEM specifications.

If parts are needed to re-execute the OQ, the Contractor shall schedule delivery of the necessary parts and perform a return service visit within 48 hours.

Service Calls

The Contractor shall provide unlimited telephone and email access to instrument technical support Monday – Friday between the hours of 9-5 p.m. EST.

The Contractor shall provide a minimum of two (2) service calls per year.

All repairs must result in the instrument serviced meeting the manufacturer specifications and must use factory new replacement parts.

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 site at the time of the service call or provide shipping instructions and return shipping information that the FDA may return the parts to the Contractor at the Contractor’s cost within 3 business days after the service visit is completed. The Contractor shall assume all charges and liability for all shipments.

The Contractor shall perform a diagnostic test results or narrative summary demonstrating that the instrument is meeting the manufacturer’s specifications.

Service Conditions

To the maximum extent practicable, service must be rendered on-site at the FDA.

In the event 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 the FDA, 60 8th ST.NE, Atlanta, GA 30309 or upon moving to the new location which will be 1777 Hardee Ave. Atlanta, GA 30310. 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. The Contractor shall also provide a shipping account number to pay for the shipment.

The Contractor shall only employ tools, parts, instruments, test apparatus, methodologies, techniques, and practices approved for use by Agilent with the Agilent instrument specified in this contract.

The Contractor shall remove all packaging materials from the site at the time of service.

Records and Reports

The Contractor shall, commensurate with the completion of each service call (inclusive of warranty service), provide the end-user of the equipment with a copy of a field service report/ticket identifying the equipment name, manufacturer, model number, and serial number of the equipment being serviced/repaired and detailing the reason for the service call, a detailed description of the work performed, the test instruments or other equipment used to affect the repair or otherwise perform the service, the name(s) and contact information of the technician who performed the repair/service, and for information purposes, the on-site hours expended and parts/components replaced. In addition, the Contractor shall provide monthly reports to the FDA Project Officer and Contract Specialist, not later than the 5th workday following the end of each month, summarizing all maintenance and repair activities (including warranty work) for the previous month during months that work is performed.

Place of Performance

Food and Drug Administration Tobacco Products Laboratory 60 Eighth Street NE Atlanta, GA 30309 POC: Kristin Hester-Jackson/ TPOC: John Mathis

Moving to new location estimated move date of 07/2026.

Food and Drug Administration Tobacco Products Laboratory 1777 Hardee Ave.

Atlanta, GA 30310 POC: Kristin Hester-Jackson/ TPOC: John Mathis

Period of Performance

The period of performance shall be for a base period of one year period for Preventative Maintenance and Operation Qualification Services.

Base Year – 07/01/2025 – 06/30/2026

Unless otherwise specified, services shall be performed Monday through Friday (excluding Federal Holidays) between the hours of 8:00 a.m. and 4:30 p.m. EST.

Supplies or services scheduled for delivery on a Federal holiday shall be made the next business day.

Government Holidays

Workplace is not available on the Government Holidays stated below, or as prescribed by an Executive Order (EO) due to inclement weather.

January (New Year’s Day) September (Labor Day) January (Martin Luther King Day) October (Columbus Day) February (President’s Day) November (Veterans Day) May (Memorial Day) November (Thanksgiving Day)

June (Juneteenth Day) July (Independence Day) December (Christmas Day)