Statement of Work final.docx

STATEMENT OF WORK

LECO BT4D PEGASUS with PM/OQ/IQ (Preventative Maintenance Agreement, Qualification Service, and Service Calls) with an AGILENT GC System

Background

The Food and Drug administration (FDA), Office of Chief Scientist (OCS), Office of Analytical and Regulatory Laboratories (OARL), Tobacco Products Laboratory (TPL) located in Atlanta, Georgia has a requirement for a Preventative Maintenance and Qualification Agreement for a LECO BT4D PEGASUS System (hereafter called the System).

The System is an integral component that support the Food and Drug administration (FDA), Office of Chief Scientist (OCS), Office of Analytical and Regulatory Laboratories (OARL), Tobacco Products Laboratory (TPL). The System is required to help FDA meet legislative requirements and the conduct sample workload. The required System is needed to develop methods for identifying and, in some cases, quantifying analytes in tobacco products under FDA regulatory jurisdiction and to establish expertise in the analyses of tobacco products. The System is also necessary for performing non-targeted analytical work in the field.

Requirements

This requirement is to purchase only a Service Contract Agreement for one (1) base year and four (4) option years. This requirement does not purchase the actual instruments/components of the System. The System will remain the property of the manufacturer (LECO Corporation) for as long as the Service Contract option years are exercised by FDA. If at any time FDA chooses not to maintain a yearly Service Contract Agreement, then the equipment will be returned to the Contractor. In addition, the Contractor reserves the right to offer the equipment for sale after any given year if FDA chooses to purchase the equipment, but FDA reserves the right to either accept or refuse an offer for an outright equipment purchase without forfeiting any years of the Service Contract Agreement for the duration of the period of performance of this contract (base and four (4) option years). The Service Contract Agreement is not contingent upon a sale of the equipment unless FDA and the Contractor mutually agree on a purchase price at any given time.

The Contractor shall provide both the Preventative Maintenance (PM) and Qualification Service for the System specified in the Statement of Work to ensure uninterrupted performance within the original equipment manufacturer’s (OEM) specification as well as complying with local qualify assurance and ISO 17025 certification.

Instruments for Preventative Maintenance and Qualification Service

(1) LECO BT4D System

4 Years

GOOD

n/a

NONE

The Contractor shall meet the following requirements:

Preventative Maintenance (PM)

· The Contractor shall provide one (1) PM service visit each year of the contract’s period of performance for each instrument of the System.

· The PM shall include parts, labor and travel for remedial repair and shall include MS filaments and vacuum pump oil.

· The Contractor shall be responsible for obtaining all new parts required for all repairs and maintenance.

· The Contractor Officer Representative (COR) or Technical Point of Contact (POC) will contact the Contractor to schedule a mutually acceptable date and time for the PM visit. All visits shall be scheduled in advance with a date and time agreed upon by the COR or TPOC.

· The Contractor shall provide documentation of PM duties performed. (See Records and Reports section).

· The Contractor shall remove any packaging materials

System Components

The system consists of a turnkey analytical instrument, capable of performing experience and obtaining scientific data. It should include at least the following:

· Pegasus BT4D (TOFMS) Benchtop

· Vacuum system

· Multi-dimensional gas chromatography system (GC X GC) with appropriate connections to the BT4D (TOFME)

· Data station (computer, monitor)

· Operations, data acquisition, and data processing software

· All peripherals needed to ensure system operation

Qualification Service

The Qualification service for each instrument of the System shall include operational qualification (OQ)/Instrument Qualification (IQ) to be performed after the planned PM visit and in the event of a critical repair. The Qualification service shall include:

· Documentation for calibrations and an instrument performance run.

· The OQ/IQ service shall be performed by a LECO Corporation trained and certified engineer and shall provide documentation that the instrument is functioning according to the OEM specifications. The Contractor shall provide an annual PM/OQ report that the System and/or instruments equal or exceed the qualification requirements from the OEM.

· If at any point during the qualification an instrument fails a test, the Contractor shall provide onsite service needed to remedy the failure and re-execute the qualification service to demonstrate a passing result. If required, the Contractor shall immediately schedule delivery of the necessary parts and a return service call to happen in a timely manner.

· The Contractor is responsible for removing any packaging materials.

Service Calls

· The Contractor shall respond within three (3) business days after receipt of a service call.

· The Contractor shall provide unlimited telephone and email access for system technical support.

· The Contractor shall provide unlimited service calls per year as necessary.

· All repairs shall result in the instrument(s) of the System serviced meeting OEM specifications and shall use factory new replacement parts.

· Any parts or components removed for replacement shall become the property of the Contractor unless otherwise agreed to by FDA. The Contractor shall remove the parts from the site at the time of the service call.

· The Contractor is responsible for removing any packaging materials.

· The Contractor shall perform a diagnostic test result demonstrating that the instrument from the system meets OEM specifications.

Service Conditions

· To the maximum extent practicable, service shall 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 laboratory in Atlanta, Georgia. 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 LECO Corporation and Agilent for the Agilent systems specified in this contract.

Warranty

All labor, replacement parts and components (excluding consumables) shall be warrantied.

• All labor performed under this contract shall be warranted from the date of service completion. If any defect in workmanship becomes apparent within this warranty period, the Contractor shall return to the site and re-perform the work at no additional cost to the Government.

• All replacement parts and components (excluding consumables such as filaments, oils, filters, and other items with normal wear characteristics) shall be warranted against defects in materials and workmanship for a minimum period of one (1) year from the date of installation or the manufacturer's standard warranty period, whichever is longer.

Records and Reports

The Contractor shall 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.

Deliverables

ITEM

DESCRIPTION

QTY

UNIT OF ISSUE

W/OQ (Preventative Maintenance. Agreement, Qualification Service, Service Calls) for:

· LECO BT4D PEGASUS System (S/N: upon request) with setup and installation

EA

Place of Performance

Food and Drug Administration Tobacco Products Laboratory 1777 Hardee Avenue SW Atlanta, GA 30310 POC: To be determined.

Delivery

Due to the laboratory facility move taking place in mid-December, the Tobacco Laboratory is requesting delivery to be made no earlier than mid-January 2026, but no later than February 13, 2026.

Delivery shall be coordinated with the COR and laboratory POC at least 14 days prior to scheduled delivery.

Period of Performance

The period of performance shall be for a base period of 16 months with four (4) one (1)-year option periods for Preventative Maintenance and Operation Qualification Services.

BASE YEAR September 2025 (maintenance period begins after installation in January 2026) to January 2027

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.

July (Independence Day)